Browse Device Recalls

35,653 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,653 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 35,653 FDA device recalls, Class II.

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DateProductReasonClassFirm
Apr 24, 2026 Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Ca... The cannulation of the CCS screw is not centered. Class II Medartis AG
Apr 24, 2026 CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3 Electrical sparking may occur at the printer head. If the Electrostatic Discharge (ESD) printer b... Class II GE Medical Systems Information Technologies Inc
Apr 24, 2026 Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Nu... Due to unintentionally activated near infrared handheld camera when attempting to turn off illumi... Class II Intuitive Surgical, Inc.
Apr 24, 2026 Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) us... Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on... Class II Bayer Medical Care, Inc.
Apr 24, 2026 GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Prod... GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 moni... Class II GE Medical Systems Information Technologies Inc
Apr 24, 2026 GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - O... GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 moni... Class II GE Medical Systems Information Technologies Inc
Apr 24, 2026 GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, ... GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 moni... Class II GE Medical Systems Information Technologies Inc
Apr 24, 2026 HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3 Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual pack... Class II Devicor Medical Products Inc
Apr 24, 2026 GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697... GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 moni... Class II GE Medical Systems Information Technologies Inc
Apr 24, 2026 GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV... GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 moni... Class II GE Medical Systems Information Technologies Inc
Apr 24, 2026 GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, ... GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 moni... Class II GE Medical Systems Information Technologies Inc
Apr 23, 2026 Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 108845... Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) p... Class II Covidien LLC
Apr 23, 2026 Arvis Hip & Knee 2.0 Instrument Set, REF: IN-21200 containing one of the foll... The Impactor V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or c... Class II Kico Knee Innovation Company
Apr 23, 2026 Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM RE... Temperature probe devices lack FDA clearance. Class II Covidien LLC
Apr 23, 2026 Covidien Mon-a-Therm General Purpose Temperature Probe REF: 90044 Temperature probe devices lack FDA clearance. Class II Covidien LLC
Apr 23, 2026 Sharpoint 2.2MM, ANGLED, DOUBLE- BEVEL Model/Catalog Number: 72-2231 Micr... 3.0mm surgical knives labeled and packaged as 2.2mm surgical knives. Class II SSC- Surgical Specialties Corporation
Apr 23, 2026 Arvis Hip & Knee 3.0 Instrument Set, REF: IN-28000 containing one of the foll... The V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion ... Class II Kico Knee Innovation Company
Apr 23, 2026 Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050 Temperature probe devices lack FDA clearance. Class II Covidien LLC
Apr 23, 2026 Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33... Due to stain present on the surface of affected foley catheters. Class II C.R. Bard Inc
Apr 23, 2026 OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X ... Intervertebral body fusion system straight inserter failed to properly attach to affected cages, ... Class II Novapproach Spine, LLC
Apr 22, 2026 Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS-... Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray ... Class II Boston Scientific Neuromodulation Corporation
Apr 22, 2026 Da Vinci ASSY, PSS, SP1098, Part Number: 380601 Operative components of surgical systems potentially distributed with E-brake retainer pin, so in... Class II Intuitive Surgical, Inc.
Apr 22, 2026 Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalo... Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of th... Class II Baxter Healthcare Corporation
Apr 22, 2026 BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit. Contamination to in-vitro diagnostic test may result in false positives. Class II BioFire Diagnostics, LLC
Apr 21, 2026 Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in con... The Adapter for Head Positioning accessory may become loose during patient positioning and uninte... Class II Baxter Healthcare Corporation
Apr 21, 2026 Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310 A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in ... Class II PFM MEDICAL INC.
Apr 21, 2026 MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analys... Software in development inadvertently made available for customer use. Use of this software versi... Class II GE Medical Systems China Co., Ltd.
Apr 21, 2026 Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Mode... Certain lots of product have the potential for a sterile barrier breach. Class II Medtronic Perfusion Systems
Apr 21, 2026 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model... Certain lots of product have the potential for a sterile barrier breach. Class II Medtronic Perfusion Systems
Apr 21, 2026 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... Certain lots of product have the potential for a sterile barrier breach. Class II Medtronic Perfusion Systems
Apr 21, 2026 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... Certain lots of product have the potential for a sterile barrier breach. Class II Medtronic Perfusion Systems
Apr 21, 2026 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... Certain lots of product have the potential for a sterile barrier breach. Class II Medtronic Perfusion Systems
Apr 21, 2026 Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Mo... Certain lots of product have the potential for a sterile barrier breach. Class II Medtronic Perfusion Systems
Apr 21, 2026 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... Certain lots of product have the potential for a sterile barrier breach. Class II Medtronic Perfusion Systems
Apr 21, 2026 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model... Certain lots of product have the potential for a sterile barrier breach. Class II Medtronic Perfusion Systems
Apr 21, 2026 Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... Certain lots of product have the potential for a sterile barrier breach. Class II Medtronic Perfusion Systems
Apr 20, 2026 navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navif... Due to complaints received for the Image Management System regarding image/metadata discrepancy w... Class II Ventana Medical Systems, Inc.
Apr 20, 2026 Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 ... Due to a software coding issues for calculating the implant orientation diagram printout for the ... Class II Staar Surgical AG
Apr 20, 2026 Allia IGS 7 Pulse angiographic X-ray system GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS ... Class II GE Medical Systems, LLC
Apr 20, 2026 Allia IGS 5 Pulse angiographic X-ray system GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS ... Class II GE Medical Systems, LLC
Apr 20, 2026 Allia Moveo angiographic X-ray system GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS ... Class II GE Medical Systems, LLC
Apr 20, 2026 Allia IGS Pulse angiographic X-ray system GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS ... Class II GE Medical Systems, LLC
Apr 20, 2026 Allia IGS 3 Pulse angiographic X-ray system GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS ... Class II GE Medical Systems, LLC
Apr 20, 2026 Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography... Electromagnetic contactors within high voltage generator may weld together, resulting in current ... Class II Shimadzu Medical Systems
Apr 16, 2026 Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Numbe... It was reported that plates 2 and 3 were marked as passed , although it appeared that QC had not... Class II The Binding Site Group, Ltd.
Apr 15, 2026 Fresh Roast Systems ColorTrack. Model Name: ColorTrack. Model Number: BENCH ... A defect has been identified in the manufacture of the Fresh Roast Systems ColorTrack instrument ... Class II Fresh Roast Systems Inc
Apr 15, 2026 Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 1700... The presence of holes in the pouch may compromise the package s ability to maintain the sterile b... Class II Covidien, LP
Apr 15, 2026 COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI ... Due to customer complaint regarding incorrect display box labeling. Class II Covidien LLC
Apr 14, 2026 Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: D... A software defect in which a low-priority file I/O check blocks the higher-priority thread respon... Class II Dexcom, Inc.
Apr 14, 2026 Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dex... A software defect in which a low-priority file I/O check blocks the higher-priority thread respon... Class II Dexcom, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.