Calendar

Week of Mar 2, 2026

Mar 5, 2026device pma163d agoPhysio-Control, Inc. — LIFEPAK 35 monitor/defibrillator (PMA supplement)

Supplement type: 30-Day Notice. Product code: MKJ. Advisory committee: CV. Decision: OK30

Mar 5, 2026device recall163d agoCook Incorporated device recall (Cls II)

COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order Number G58419 — Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. — Status: Ongoing

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Mar 5, 2026device recall163d agoCook Incorporated device recall (Cls II)

Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G32193; Reference Part Number C-TCCSB-500-UNI-01, Order Number G47665. — Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. — Status: Ongoing

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Mar 5, 2026device recall163d agoCook Incorporated device recall (Cls II)

COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number G09108 — Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. — Status: Ongoing

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Mar 5, 2026device recall163d agoCook Incorporated device recall (Cls II)

COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532; Reference Part Number C-UTPT-1400-WAYNE-112497-IMH, Order Number G56535. — Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. — Status: Ongoing

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Mar 5, 2026device recall163d agoCook Incorporated device recall (Cls II)

COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703; Reference Part Number C-PTISY-100-UNL-HC-G-NA, Order Number G57706; Reference Part Number C-PTISY-100-UNS-HC-G-NA, Order Number G57704. — Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. — Status: Ongoing

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Mar 5, 2026device recall163d agoCook Incorporated device recall (Cls II)

COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part Number CMW-14-300-18G, Order Number G50792 — Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. — Status: Ongoing

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Mar 5, 2026device recall163d agoCook Incorporated device recall (Cls II)

COOK MEDICAL Spectrum¿ Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, Order Number G44800; Reference Part Number C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-RD, Order Number G44809; Reference Part Number C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, Order Number G44806; Reference Part Number C-UTLMYJ-701J-RSC-ABRM-HC-IHI-FST-A-RD, Order Number G44807. — Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. — Status: Ongoing

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Mar 5, 2026device recall163d agoCook Incorporated device recall (Cls II)

COOK MEDICAL Spectrum¿ Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983; Reference Part Number C-UDLM-401J-ABRM-HC-CAH, Order Number G24754; Reference Part Number C-UDLM-401J-LSC-ABRM-HC, Order Number G43986; Reference Part Number C-UDLM-401J-PED-ABRM-HC, Order Number G43984; Reference Part Number C-UDLM-401J-PED-ABRM-HC-CAH, Order Number G24752; Reference Part Number C-UDLM-401J-RSC-ABRM-HC, Order Number G43985; Reference Part Number C-UDLM-501J-ABRM-HC, Order Number G43995; Reference Part Number C-UDLM-501J-PED-ABRM-HC, Order Number G43996; Reference Part Number C-UDLM-501J-RSC-ABRM-HC, Order Number G43997; Reference Part Number C-UDLM-801J-ABRM-HC, Order Number G50817; Reference Part Number C-UQLM-1001J-ABRM-HC-RD, Order Number G51537; Reference Part Number C-UQLM-1001J-RSC-ABRM-HC-RD, Order Number G51539; Reference Part Number C-UTLM-501J-ABRM-HC, Order Number G44005; Reference Part Number C-UTLM-501J-ABRM-HC-CAH, Order Number G24803; Reference Part Number C-UTLM-501J-LSC-ABRM-HC, Order Number G44008; Reference Part Number C-UTLM-501J-PED-ABRM-HC, Order Number G44006; Reference Part Number C-UTLM-501J-RSC-ABRM-HC, Order Number G44007; Reference Part Number C-UTLM-501J-RSC-ABRM-HC-CAH, Order Number G24765; Reference Part Number C-UTLM-701J-ABRM-HC-RD, Order Number G47825; Reference Part Number C-UTLM-701J-ABRM-HC-RD-CAH, Order Number G24809; Reference Part Number C-UTLM-701J-ABRM-HC-RD-P, Order Number G53599; Reference Part Number C-UTLM-701J-LSC-ABRM-HC-RD, Order Number G47827; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, Order Number G47829; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD-CAH, Order Number G24810. — Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. — Status: Ongoing

Mar 5, 2026device recall163d agoCook Incorporated device recall (Cls II)

COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786 — Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. — Status: Ongoing

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Mar 5, 2026device recall163d agoCook Incorporated device recall (Cls II)

COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G07242 — Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. — Status: Ongoing

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Mar 5, 2026device recall163d agoTornier, Inc device recall (Cls II)

Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max Tuberosity Body No Coat, Small, Cat. No. ARS1041102 3. TORNIER HRS Max Trial, Cat. No. ARS10252 — Reason: Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system. — Status: Ongoing

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Mar 5, 2026device recall163d agoCook Incorporated device recall (Cls II)

COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685; Reference Part Number C-PTIS-100-HC-G-NA, Order Number G57682; Reference Part Number C-PTIS-100-UNL-HC-G-EU, Order Number G57687; Reference Part Number C-PTIS-100-UNS-HC-G-EU, Order Number G57686. — Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. — Status: Ongoing

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Mar 5, 2026device recall163d agoCook Incorporated device recall (Cls II)

COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775 — Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. — Status: Ongoing

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Mar 5, 2026device recall163d agoCook Incorporated device recall (Cls II)

COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Order Number G32092; Reference Part Number C-PTIS-100-HC, Order Number G12115. — Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. — Status: Ongoing

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Mar 5, 2026device recall163d agoCook Incorporated device recall (Cls II)

COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250; Reference Part Number C-NTSE-2.4-115-NCT4, Order Number G36251. — Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. — Status: Ongoing

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Mar 5, 2026device recall163d agoCook Incorporated device recall (Cls II)

COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Part Number CMW-14-300-12G, Order Number G50791 — Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. — Status: Ongoing

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Mar 5, 2026device recall163d agoCook Incorporated device recall (Cls II)

COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537. — Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. — Status: Ongoing

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Mar 5, 2026device recall163d agoCook Incorporated device recall (Cls II)

COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, Order Number G56424; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0018, Order Number G21053; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, Order Number G34914; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0047, Order Number G44431; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0048, Order Number G44432. — Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. — Status: Ongoing

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Mar 5, 2026device recall163d agoCook Incorporated device recall (Cls II)

COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24073 — Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. — Status: Ongoing

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Mar 5, 2026device recall163d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Vue Motion V12. Product Number: 1017979. — Reason: Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence. — Status: Ongoing

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Mar 5, 2026grant163d agoUNIVERSITY OF MICHIGAN AT ANN ARBOR — Reprogramming cells for repair of chronic wounds

GM grant. $409,941. PI: Aaron Harvey Morris

Week of Mar 2, 2026