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calendar

13,661 catalysts · 3,350 8k filing · 2,401 grant · 2,188 approval · 1,517 device 510k · 1,123 device recall · 1,026 device pma

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2026-08-10: 0 catalysts2026-08-11: 0 catalysts2026-08-12: 0 catalysts2026-08-13: 0 catalysts2026-08-14: 0 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 1 catalyst2026-08-18: 2 catalysts2026-08-19: 3 catalysts2026-08-20: 0 catalysts2026-08-21: 0 catalysts2026-08-22: 0 catalysts2026-08-23: 0 catalysts2026-08-24: 0 catalysts2026-08-25: 0 catalysts2026-08-26: 1 catalyst2026-08-27: 1 catalyst2026-08-28: 0 catalysts2026-08-29: 0 catalysts2026-08-30: 0 catalysts2026-08-31: 0 catalysts2026-09-01: 1 catalyst2026-09-02: 0 catalysts2026-09-03: 1 catalyst2026-09-04: 0 catalysts2026-09-05: 0 catalysts2026-09-06: 0 catalysts2026-09-07: 0 catalysts2026-09-08: 0 catalysts2026-09-09: 0 catalysts2026-09-10: 0 catalysts2026-09-11: 0 catalysts2026-09-12: 0 catalysts2026-09-13: 0 catalysts2026-09-14: 0 catalysts2026-09-15: 0 catalysts2026-09-16: 0 catalysts2026-09-17: 0 catalysts2026-09-18: 0 catalysts2026-09-19: 0 catalysts2026-09-20: 0 catalysts2026-09-21: 0 catalysts2026-09-22: 0 catalysts2026-09-23: 2 catalysts2026-09-24: 0 catalysts2026-09-25: 0 catalysts2026-09-26: 0 catalysts2026-09-27: 0 catalysts2026-09-28: 0 catalysts2026-09-29: 0 catalysts2026-09-30: 0 catalysts2026-10-01: 0 catalysts2026-10-02: 0 catalysts2026-10-03: 0 catalysts2026-10-04: 0 catalysts2026-10-05: 0 catalysts2026-10-06: 0 catalysts2026-10-07: 0 catalysts2026-10-08: 2 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 1 catalyst2026-10-14: 1 catalyst2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts2026-10-19: 1 catalyst2026-10-20: 2 catalysts2026-10-21: 2 catalysts2026-10-22: 2 catalysts2026-10-23: 1 catalyst2026-10-24: 0 catalysts2026-10-25: 0 catalysts2026-10-26: 1 catalyst2026-10-27: 8 catalysts2026-10-28: 12 catalysts2026-10-29: 21 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts2026-11-02: 9 catalysts2026-11-03: 18 catalysts2026-11-04: 22 catalysts2026-11-05: 37 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts
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  • 8k filing3,350
  • grant2,401
  • approval2,188
  • device 510k1,517
  • device recall1,123
  • device pma1,026
  • device adverse event1,000
  • earnings584
  • recall391
  • phase 2 completion172
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    • Oncology148
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    • Ophthalmology16
    • Pain15

    Week of Oct 27, 2025

    50
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. NF1503 15 DR UNIV SPIKE, INJ SITE, BCV; Catalog Number: 490062. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/ 15 DROPS/ML, 99 IN; Catalog Number: 490511. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/ 15 DROPS/ML, 118 IN.; Catalog Number: 490437. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/CARESITE EXT SET; Catalog Number: 490407. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/ 2 CARESITE, 140 IN; Catalog Number: 490309. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ANES 15DROP W/2 CARESITE 2 ULTRAPORT; Anesthesia IV Set with 2 CARESITE injection sites and two high-flow ULTRAPORT stopcocks; Catalog Number: 354210. 2. IV ADMIN SET 15 DR/ML, 2 B/C VLV, 97IN.; Catalog Number: 490389. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. 15DR 2SAFELINE 1CARESITE 1STOPCOCK 131IN; Catalog Number: 490612. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. Caresite Extension Set_Export; Catalog Number: 470183. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 3 CARESITE LADS, 131 IN.; Catalog Number: 490274. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 117 IN.; Catalog Number: 490468. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 15 DR/ML,2 CARESITE,146 IN; Catalog Number: 490315. 2. IV ADMN SET,2 CARESITE, SAFEPORT,129 IN.; Catalog Number: 490331. 3. IV ADMIN SET 15 DROPS/ML, CARESITE,98 IN; Catalog Number: 490376. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML, 126 IN.; Catalog Number: 490488. 2. IV ADMIN SET W/15 DROPS/ML, 132 IN.; Catalog Number: 490492. 3. IV ADMIN SET W/15 DROPS/ML, 139 IN.; Catalog Number: 490503. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. 130 IN. IV ADMIN SET W/ 9 IN. EXT SET; Catalog Number: 490412. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoMedtronic, Inc. device recall (Cls II)Medtronic plc

    Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4 — Reason: There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur. — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoCopan Italia device recall (Cls II)

    1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP* *Compatible with Copan s WASP (Walk-Away Specimen Processor for Microbiology) System — Reason: Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed. — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. V1782F UNIV IV SET W/0.2 MICRON FILTER; Catalog Number: 352447. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 15 DROP, 132 IN; Catalog Number: 490519. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML, 108 IN.; Catalog Number: 490504. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 103 IN.; Catalog Number: 490239. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/10 DROPS, 138 IN.; Catalog Number: 490426. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV SET 15DR 3 CARESITE, 124 IN.; Catalog Number: 470005. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 124 IN.; Catalog Number: 490451. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML, 125 IN.; Catalog Number: 490487. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 129 IN, 3 CARESITE LADS; Catalog Number: 490225. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET HF STOPCOCK,107 IN.; Catalog Number: 490241. 2. IV ADMIN SET W/15 DROPS/ML, 116 IN.; Catalog Number: 490298. 3. IV ADMIN SET,15 DROP,4 CARESITE, 119 IN.; Catalog Number: 490360. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 15DR, 92 IN W/EXT SET 9 IN.; Catalog Number: 490489. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/CARESITE EXT SET; Catalog Number: 490400. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    RATE FLOW set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. RATEFLOW ADMIN 15 DROP W/2 CARESITES; Catalog Number: 375258. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 2-HIGH FLOW STPCKS, 124 IN; Catalog Number: 490476. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. OUTLOOK IV SET 15DROP W/3 CARESITE; Catalog Number: 354213. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. EXT SET ULTRAPORT STOPCOCK, 37IN.; Catalog Number: 490234. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/ 10 DROPS/ML, 134 in.; Catalog Number: 490357. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMINISTRATION SET WITH 15 DROPS/ML; Catalog Number: 490507. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoMedicrea International device recall (Cls II)Jin Medical International Ltd.

    Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000 — Reason: Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant. — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV AD SET CARESITE 127 IN. EXT SET 9 IN.; Catalog Number: 490317. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. EXTENSION SET, 25 IN.; Catalog Number: 490629. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV AD. SET,15 DROPS/ML, W/EXT SET; Catalog Number: 490467. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS, 162 IN.; Catalog Number: 490484. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/ 15 DROPS/ML 124 IN.; Catalog Number: 490427. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. EXTENSION SET W/ ULTRAPORT, 48 IN.; Catalog Number: 490291. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 15D 2 CARESITE LAD, 126 IN; Catalog Number: 490444. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET,3 CARESITE LADS, 137 IN; Catalog Number: 490303. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. OUTLOOK PUMP SET,3 CARESITE LADS,115 IN.; Catalog Number: 490361. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoCopan Italia device recall (Cls II)

    1ml of DTT in liquid phase, in PET tube with capture cap, in bulk — Reason: Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed. — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. NF1270A SAFELINE ANESTHESIA IV SET; Anesthesia IV Administration Set with 3 CARESITE Injection Sites and Manifold; Catalog Number: NF1270A. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

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    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    Caresite utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog numbers: 1. Primary Gravity IV Set with 2 CARESITE¿ Injection Sites; IV ADMIN SET 15 DROP W/2 CARESITE; Catalog Number: 354202. 2. Primary Gravity IV Set with 2 CARESITE¿ Injection Sites; IV ADM 15DROP W/2 CARESITE SLIDECLMP; Catalog Number: 354203. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

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    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMN SET W/15 DROP, ULTRAPORT,134 IN.; Catalog Number: 490312. 2. IV ADMIN SET W/ 15 DROPS/ML, 120 IN.; Catalog Number: 490432. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    ULTRASITE set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/ 2 ULTRASITE VLV, 104 IN; Catalog Number: 352049-C. 2. IV ADMIN SET W/ 3 ULTRASITE VLV, 112 IN; Catalog Number: 375100-C. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ANES 15DROP W/2 CARESITE ULTRAPORT; Anesthesia IV Set with 2 CARESITE injection sites and high-flow ULTRAPORT stopcock; Catalog Number: 354209. 2. IV ADMIN SET W/60 DROPS/ML 106 IN.; Catalog Number: 490392. 3. IV ADMIN SET W/ 60 DROPS/ML 120 IN.; Catalog Number: 490428. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

    full page →fda device recalls ↗
    ›Oct 29, 2025device recall290d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

    CARESAFE utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog numbers: 1. CARESAFE IV ADMIN SET w/AIRSTOP, 104 IN.; Catalog Number: 354302. 2. CARESAFE ADMIN SET w/15um FILTER, 104 IN; Catalog Number: 354303. 3. CARESAFE IV ADMIN SET w/AIRSTOP, 114 IN.; Catalog Number: 354304. 4. CARESAFE ADMIN SET w/15um FILTER, 114 IN; Catalog Number: 354305. 5. CARESAFE IV ADMIN SET w/AIRSTOP, 110 IN.; Catalog Number: 354306. 6. CARESAFE ADMIN SET w/15um FILTER, 110 IN; Catalog Number: 354307. 7. CARESAFE" IV Administration Set with AirStop Filter, Not made with PVC or DEHP, 2 CARESITE¿ Injection Sites, 2 ULTRAPORT¿ High-FlowFour-Way Stopcocks; CARESAFE ANESTH SET W/AIRSTOP, 134 IN.; Catalog Number: 354308. 8. CARESAFE ANESTH SET w/15um FILTER,134IN.; Catalog Number: 354310. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

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