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Week of Mar 2, 2026

45

Mar 2, 2026device recall150d agoPhilips Respironics, Inc. device recall (Cls I)

Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device. — Reason: Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient. — Status: Ongoing

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Mar 3, 2026device recall149d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall149d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD20/15 OR Table; System Code: 722059; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall149d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall149d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall149d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Azurion 5 M12; System Code: (1)722227, (2)722231; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall149d agoOxoid Australia Pty Limited device recall (Cls II)THERMO FISHER SCIENTIFIC INC.

OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem — Reason: Oxoid Ltd., part of Thermo Fisher Scientific, confirmed that Microbact 12L Kit 20 Tests MB1128A lot 4494873 may identify incorrect organism due to inconclusive result from ambiguous color reactions in wells. — Status: Ongoing

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Mar 3, 2026device recall149d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall149d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

ALLURA Xper FD10F; System Code: 722002; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall149d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD20/10; System Code: 722029; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall149d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall149d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only); — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall149d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall149d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only); — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall149d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD20/20 OR Table; System Code: 722039; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall149d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall149d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall149d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD20/15; System Code: 722058; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall149d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD20/20; System Code: 722038; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall149d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall149d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only); — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall149d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD10C; System Code: 722001; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall149d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 3, 2026device recall149d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026; — Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. — Status: Ongoing

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Mar 4, 2026device recall148d agoKoven Technology, Inc. device recall (Cls II)WM TECHNOLOGY, INC.

Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe). Software Version: N/A Product Description: Hand-held, battery-powered ultrasonic Doppler blood-flow detector with LCD numeric display, used with interchangeable probes to detect vascular blood-flow signals and display heart rate; affected units were packaged with a 2 MHz BT2M20S8C fetal probe and labeled for both vascular and fetal applications. — Reason: Product labeling includes a fetal indication for use that is not cleared under its 510(k). — Status: Ongoing

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Mar 5, 2026device recall147d 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 recall147d 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 recall147d 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 recall147d 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 recall147d 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 recall147d 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 recall147d 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 recall147d 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 recall147d 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 recall147d 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 recall147d 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 recall147d 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 recall147d 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 recall147d 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 recall147d 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 recall147d 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 recall147d 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 recall147d 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 recall147d 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 recall147d 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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Week of Mar 9, 2026

3

Mar 10, 2026device recall142d agoSiemens Medical Solutions USA, Inc device recall (Cls II)

ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700. — Reason: During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements. — Status: Ongoing

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Mar 12, 2026

Week of Mar 16, 2026

2

Mar 17, 2026device recall135d agoStraumann USA LLC device recall (Cls II)

Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620; — Reason: A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06. — Status: Ongoing

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Mar 17, 2026

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