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Vehicle Safety

Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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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
May 13, 2026 Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Sti... A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By... Class II Medtronic Neuromodulation
May 13, 2026 Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Sti... A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By... Class II Medtronic Neuromodulation
May 12, 2026 IV Sets with drip chambers Intravascular administration tubing set drip chambers may have black specks potentially due to th... Class II ICU Medical, Inc.
May 12, 2026 IV Sets with drip chambers Intravascular administration tubing set drip chambers may have black specks potentially due to th... Class II ICU Medical, Inc.
May 12, 2026 IV Non-Dedicated Gravity Administration Sets with drip chambers Intravascular administration tubing set drip chambers may have black specks potentially due to th... Class II ICU Medical, Inc.
May 12, 2026 IV Sets with drip chambers Intravascular administration tubing set drip chambers may have black specks potentially due to th... Class II ICU Medical, Inc.
May 12, 2026 Plum administration sets Intravascular administration tubing set drip chambers may have black specks potentially due to th... Class II ICU Medical, Inc.
May 12, 2026 IV Sets with drip chambers Intravascular administration tubing set drip chambers may have black specks potentially due to th... Class II ICU Medical, Inc.
May 12, 2026 Oncology sets with drip chambers Intravascular administration tubing set drip chambers may have black specks potentially due to th... Class II ICU Medical, Inc.
May 12, 2026 Oncology sets with drip chambers Intravascular administration tubing set drip chambers may have black specks potentially due to th... Class II ICU Medical, Inc.
May 12, 2026 Octopus Evolution Tissue Stabilizer, Model TS2000 During the manufacturing process, Medtronic personnel identified an assembly issue where the tubi... Class II Medtronic Perfusion Systems
May 12, 2026 Octopus 4 Tissue Stabilizer, Model 29400 During the manufacturing process, Medtronic personnel identified an assembly issue where the tubi... Class II Medtronic Perfusion Systems
May 12, 2026 Octopus Evolution AS Tissue Stabilizer, Model TS2500 During the manufacturing process, Medtronic personnel identified an assembly issue where the tubi... Class II Medtronic Perfusion Systems
May 12, 2026 Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model... Software malfunction may occur during pacing capture threshold test of pacemaker resulting in pr... Class II Abbott Medical
May 12, 2026 Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-5... Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water a... Class II Boston Scientific Corporation
May 12, 2026 Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-... Given the increased number of leaks reported by users, it was determined to be the appropriate c... Class II Fresenius Medical Care Holdings, Inc.
May 11, 2026 Power Over Fiber Base Module Device not certified - no laser product report was filed with CDRH prior to distribution. Produc... Class II Terex Utilities
May 11, 2026 5008X Blood Tubing Set, 24 units per case. Includes the below model numbers a... Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 500... Class II Fresenius Medical Care Holdings, Inc.
May 11, 2026 Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Meta... Firm received a complaint with no clinical impact in which a posterior augment was found within t... Class II Zimmer, Inc.
May 11, 2026 Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantab... There is the potential for leakage along the drug pathway from the pump through the end of the ca... Class II Boston Scientific Corporation
May 11, 2026 Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory ... Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf ... Class II Inspire Medical Systems Inc.
May 11, 2026 Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation ... Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf ... Class II Inspire Medical Systems Inc.
May 11, 2026 NeoSpan¿ SuperElastic Compression Staple w/Instruments Catalog Number and P... Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient l... Class II In2bones USA, LLC
May 8, 2026 Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog N... Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 sy... Class II Instrumentation Laboratory
May 8, 2026 GEM Premier 5000 with IQM2 Model/Catalog Number: 00024019255 and GEM Premie... Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 sy... Class II Instrumentation Laboratory
May 8, 2026 Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQ... Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 sy... Class II Instrumentation Laboratory
May 8, 2026 Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog N... Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 sy... Class II Instrumentation Laboratory
May 8, 2026 Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog N... Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 sy... Class II Instrumentation Laboratory
May 8, 2026 Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog N... Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 sy... Class II Instrumentation Laboratory
May 8, 2026 TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibi... Due to manufacturing/design issue where the knob on the tracking array may loosen causing potenti... Class II Think Surgical, Inc.
May 8, 2026 GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When... Class II GE Medical Systems SCS
May 8, 2026 VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001 Respiratory system intended to provide continuous/intermittent ventilator support, may have a dam... Class II Ventec Life Systems, Inc.
May 8, 2026 Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C Neurological sponges used to moisten or absorb biological fluid during neurological surgery and m... Class II AMD Medicom Inc.
May 8, 2026 Ritmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C... Neurological sponges used to moisten or absorb biological fluid during neurological surgery and m... Class II AMD Medicom Inc.
May 8, 2026 Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 0088445... Due to unsealed portions of pouches. Class II Merit Medical Systems, Inc.
May 7, 2026 3mensio Workstation (Vascular Fenestrated) software User measurement value reported by diagnostic bioimaging software intended to measure/visualize c... Class II PIE Medical Imaging B.V.
May 7, 2026 Halyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit. Incorrect concentration of Betadine solution contained within certain AVID convenience kits. Class II AVID Medical, Inc.
May 7, 2026 Brand Name: Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Co... Due to out-of-specification, or potential out-of-specification, levels of endotoxins Class II TELEFLEX LLC
May 7, 2026 Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 107... A potential positive bias in quality control (QC) and patient sample results in three lots of the... Class II Siemens Healthcare Diagnostics, Inc.
May 7, 2026 Bicarby Dialysate; Model number: RFP-400-G; There is an error in the labeling of the GTIN on the product. When scanned; however, the case lab... Class II Fresenius Medical Care Holdings, Inc.
May 6, 2026 nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US, CAT 81... Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitor... Class II Criticare Technologies, Inc.
May 6, 2026 Neptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of th... It has been identified that the impacted docking station (SN 2521008873) was not product released... Class II Stryker Corporation
May 5, 2026 Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A. Some sterilization parameters included in the IFU may not consistently render the devices adequat... Class II Olympus Corporation of the Americas
May 5, 2026 Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A. Some sterilization parameters included in the IFU may not consistently render the devices adequat... Class II Olympus Corporation of the Americas
May 5, 2026 Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188. Some sterilization parameters included in the IFU may not consistently render the devices adequat... Class II Olympus Corporation of the Americas
May 5, 2026 Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex B... Some sterilization parameters included in the IFU may not consistently render the devices adequat... Class II Olympus Corporation of the Americas
May 5, 2026 Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser. Software anomaly that causes a false display of error code 5018. Class II IPG Medical Corporation
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: ADULT TRACHEOSTOMY TUBE INSERT,... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: KIT URO ROBOT CYSTECTOMY, D AND... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 14... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP

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.