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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

2,115 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,115 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 2,115 FDA device recalls in N/A.

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DateProductReasonClassFirm
Jul 3, 2023 LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 17 - indicated for p... Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Jun 30, 2023 Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interve... Loss of availability of the wireless foot switch during procedures. Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jun 23, 2023 UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿... There is an improperly performed weld between the cone of the sheath lock and tube of the obturat... Class II Scholly Fiberoptic Gmbh
Jun 22, 2023 STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by... The STATCLAVE G4 is a dynamic air removal (prevacuum) tabletop steam sterilizer intended for use ... Class II Scican Ltd.
Jun 22, 2023 Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access Three lots of product may be labeled with an incorrect expiration day Class II Creganna Medical Devices
Jun 22, 2023 STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by... The STATCLAVE G4 is a dynamic air removal (prevacuum) tabletop steam sterilizer intended for use ... Class II Scican Ltd.
Jun 21, 2023 Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in... (1) There is vial to vial variation resulting in some vials recovering positive for hCG, which sh... Class II Randox Laboratories Ltd.
Jun 19, 2023 ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to gui... Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request Class II Materialise N.V.
Jun 13, 2023 Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (... Carryover from the Direct LDL-cholesterol assay on the Rx instruments may result in a negative bi... Class II Randox Laboratories Ltd.
Jun 12, 2023 Allura Xper FD10 and FD20. X-ray Imaging System. The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear i... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jun 12, 2023 Azurion 7 M20. X-ray Image guided Therapy System. The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear i... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jun 9, 2023 REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, S... Sterility of Ultrasound gel can not be guaranteed. Class II Turkuaz Saglik Hizmetleri Medikal Temizlik Kim....
Jun 5, 2023 VITROS Immunodiagnostic Products Troponin I ES Calibrators Reagent packs could potentially contain incorrect wells, which will generate incorrect, and poten... Class II ORTHO-CLINICAL DIAGNOSTICS
Jun 5, 2023 VITROS Immunodiagnostic Products Troponin I ES Reagent Pack Reagent packs could potentially contain incorrect wells, which will generate incorrect, and poten... Class II ORTHO-CLINICAL DIAGNOSTICS
Jun 2, 2023 Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 1... A software defect in the DxA Automation System may cause tests to be run on patient samples in tu... Class II Beckman Coulter Biomedical GmbH
Jun 2, 2023 Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240... A software defect in the DxA Automation System may cause tests to be run on patient samples in tu... Class II Beckman Coulter Biomedical GmbH
May 31, 2023 UFSK Treatment chair 500 XLE- Treatment chair for positioning and support of ... Service life of the electrical seat part drive of the treatment chair may be shortened unexpected... Class II UFSK - International OSYS Gmbh
May 31, 2023 Trexo Device Electrical issues that could potentially render the device non-functional, give off electromagnet... Class II Trexo Robotics Holdings Inc.
May 30, 2023 REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R Due to manufacturing issue, their is a potential for peripheral holes to be out of specification. Class II Limacorporate S.p.A
May 30, 2023 GE Healthcare Vivid S60, ultrasound device GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely f... Class II GE Vingmed Ultrasound As
May 30, 2023 GE Healthcare Vivid S70, ultrasound device GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely f... Class II GE Vingmed Ultrasound As
May 30, 2023 REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R Due to manufacturing issue, their is a potential for peripheral holes to be out of specification. Class II Limacorporate S.p.A
May 30, 2023 GE Healthcare Vivid S70N, ultrasound device GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely f... Class II GE Vingmed Ultrasound As
May 30, 2023 GE Healthcare Vivid S60N, ultrasound device GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely f... Class II GE Vingmed Ultrasound As
May 24, 2023 RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a labo... DNAs used during the manufacture of two affected models were accidentally inverted during manufac... Class II Cytocell Ltd.
May 24, 2023 EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In ... Complaints that specific samples produced false positive EliA GBM results. A positive signal was ... Class II Phadia Ab
May 24, 2023 RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a labora... DNAs used during the manufacture of two affected models were accidentally inverted during manufac... Class II Cytocell Ltd.
May 23, 2023 wDR 2.2 Mobile Digital Diagnostic X-Ray System There is a software login in issue that may prevent the user from logging in. Class II SEDECAL SA
May 19, 2023 TruSignal Ear Sensor, REF TS-E-D; Oximeter There is a potential reduction of energy reaching patient during defibrillation, potential contac... Class I GE Healthcare Finland Oy
May 19, 2023 TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear There is a potential reduction of energy reaching patient during defibrillation, potential contac... Class I GE Healthcare Finland Oy
May 19, 2023 TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N; Oximeter There is a potential reduction of energy reaching patient during defibrillation, potential contac... Class I GE Healthcare Finland Oy
May 19, 2023 TruSignal Wrap Sensor, REF TS-W-D; Oximeter There is a potential reduction of energy reaching patient during defibrillation, potential contac... Class I GE Healthcare Finland Oy
May 19, 2023 TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs;... There is a potential reduction of energy reaching patient during defibrillation, potential contac... Class I GE Healthcare Finland Oy
May 19, 2023 TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, ... There is a potential reduction of energy reaching patient during defibrillation, potential contac... Class I GE Healthcare Finland Oy
May 19, 2023 QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not ... Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis... Class II Qiagen GmbH
May 19, 2023 TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter There is a potential reduction of energy reaching patient during defibrillation, potential contac... Class I GE Healthcare Finland Oy
May 19, 2023 QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for... Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis... Class II Qiagen GmbH
May 19, 2023 TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; ... There is a potential reduction of energy reaching patient during defibrillation, potential contac... Class I GE Healthcare Finland Oy
May 19, 2023 TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter There is a potential reduction of energy reaching patient during defibrillation, potential contac... Class I GE Healthcare Finland Oy
May 12, 2023 Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; I... A mechanical lock used to connect and release a locking liner into a prosthetic socket have an at... Class II Ossur H / F
May 9, 2023 QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and ... If cartridges of the affected Serial numbers (SNs) are used, in most cases, the error codes 0xY00... Class II Qiagen GmbH
May 8, 2023 Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 Defibrillator/pacemaker module (DPM) may encounter a problem causing communication from the Mainb... Class II Remote Diagnostic Technologies Ltd.
May 4, 2023 BETTA LINK SR REUSABLE FISHMOUTH GUIDE-Intended for use in soft tissue to bon... Drill guides might bend when axial forces are applied by surgeon during procedure and result in p... Class II T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
May 4, 2023 BETTA LINK SR KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fi... Drill guides might bend when axial forces are applied by surgeon during procedure and result in p... Class II T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
May 4, 2023 Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed qua... Delay in reporting results due to Quality Controls running high outside of range. Target value an... Class III Randox Laboratories Ltd.
May 4, 2023 Betta Link LG Reusable ProngED Guide - Intended for use in soft tissue to bon... Drill guides might bend when axial forces are applied by surgeon during procedure and result in p... Class II T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
May 4, 2023 BETTA LINK LG KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fi... Drill guides might bend when axial forces are applied by surgeon during procedure and result in p... Class II T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
May 4, 2023 BETTA LINK SR REUSABLE PRONGED GUIDE- Intended for use in soft tissue to bone... Drill guides might bend when axial forces are applied by surgeon during procedure and result in p... Class II T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
May 4, 2023 Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality contr... Delay in reporting results due to Quality Controls running high outside of range. Target value a... Class III Randox Laboratories Ltd.
May 4, 2023 Betta Link LG Reusable Fishmouth Guide-Intended for use in soft tissue to bon... Drill guides might bend when axial forces are applied by surgeon during procedure and result in p... Class II T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.

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.