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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

39,969 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 39,969 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 39,969 FDA device recalls.

DateProductReasonClassFirm
Dec 26, 2023 GE Healthcare Care Plus Hood Field Replacement Unit (FRU) kit, Part Numbers: ... GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ... Class I Wipro GE Healthcare Private Ltd.
Dec 26, 2023 GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169... GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ... Class I Wipro GE Healthcare Private Ltd.
Dec 26, 2023 GE Healthcare Care Plus Hood Door FRU kit, Part Numbers: 6600-0082-850, 6600-... GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ... Class I Wipro GE Healthcare Private Ltd.
Dec 26, 2023 Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002 Knee batteries may need replacement with conforming batteries to ensure there isn't a failure to ... Class II Ossur H / F
Dec 26, 2023 Senographe Pristina X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermit... Class II GE Medical Systems, SCS
Dec 26, 2023 GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 100... GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ... Class I Wipro GE Healthcare Private Ltd.
Dec 22, 2023 ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03... Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that ... Class II Onkos Surgical, Inc.
Dec 22, 2023 HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use, st... Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing fo... Class II Howmedica Osteonics Corp.
Dec 22, 2023 Baxter Exactamix Pro 2400, REF EXM24DY An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" ... Class I Baxter Healthcare Corporation
Dec 22, 2023 ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03... Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that ... Class II Onkos Surgical, Inc.
Dec 22, 2023 Baxter Exactamix Pro 1200, REF EXM12DY An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" ... Class I Baxter Healthcare Corporation
Dec 22, 2023 AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (... Filling process qualification did not demonstrate adequate process capability. Possible consequen... Class II Musculoskeletal Transplant Foundation, Inc.
Dec 22, 2023 GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ul... GE HealthCare has become aware of an issue with certain IC9-RS ultrasound probes (see Affected Pr... Class II GE HEALTHCARE AUSTRIA GMBH & CO
Dec 22, 2023 Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO Sterility assurance for saline included in surgical kits cannot be guaranteed. Class I Windstone Medical Packaging, Inc.
Dec 22, 2023 AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (... Filling process qualification did not demonstrate adequate process capability. Possible consequen... Class II Musculoskeletal Transplant Foundation, Inc.
Dec 22, 2023 Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO Sterility assurance for saline included in surgical kits cannot be guaranteed. Class I Windstone Medical Packaging, Inc.
Dec 22, 2023 Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO Sterility assurance for saline included in surgical kits cannot be guaranteed. Class I Windstone Medical Packaging, Inc.
Dec 22, 2023 HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, steri... Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing fo... Class II Howmedica Osteonics Corp.
Dec 22, 2023 Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO Sterility assurance for saline included in surgical kits cannot be guaranteed. Class I Windstone Medical Packaging, Inc.
Dec 21, 2023 MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1626B Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 21, 2023 TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600 Due to, during the manufacturing process, the prescribed manufacturing and quality processes were... Class II MICROVENTION INC.
Dec 21, 2023 Phantom TTC Nail, 10.0 X 200mm, Right Medical devices distributed, prior to sterilization Class II Paragon 28, Inc.
Dec 21, 2023 HENRY SCHEIN¿ CRITERION¿ ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570... Level 3 masks were produced on alternate non-validated production equipment that were not include... Class II AMD Medicom Inc.
Dec 21, 2023 Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 ... Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The e... Class II Covidien LP
Dec 21, 2023 MEDLINE BLOOD CULTURE TRAY ADULT, Reorder Number DYNDH1194A Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 21, 2023 Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L Medical devices distributed, prior to sterilization Class II Paragon 28, Inc.
Dec 21, 2023 Article No. NA6050411, Valiant PhD No. 1 Econo Affected product may not perform as expected; the amalgam powder may not triturate correctly and ... Class II Ivoclar Vivadent, Inc.
Dec 21, 2023 Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R Medical devices distributed, prior to sterilization Class II Paragon 28, Inc.
Dec 21, 2023 MEDLINE ADULT BLOOD CULTURE KIT, Reorder Number DYNDH1694A Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 21, 2023 FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, t... Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to pati... Class II G & H Wire Company
Dec 21, 2023 MEDLINE BLOOD CULTURE BOTTLE KIT, Reorder Number DYNDH1738A Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 21, 2023 Cardinal Health MEDI-VAC CRD Suction Canister Liner, 1000 mL Suction Caniste... The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience ... Class II Cardinal Health 200, LLC
Dec 21, 2023 Cardinal Health Suction Canister Liner, MEDI-VAC CRD 1000 mL Suction Caniste... The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience ... Class II Cardinal Health 200, LLC
Dec 21, 2023 HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448) Level 3 masks were produced on alternate non-validated production equipment that were not include... Class II AMD Medicom Inc.
Dec 21, 2023 MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1714A Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 21, 2023 Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla... Holding arm could move (twist) uncontrollably in the front area. This could lead to a serious det... Class II Medagent Inc
Dec 21, 2023 MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1622C Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 21, 2023 MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1723 Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 21, 2023 PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code ... Level 3 masks were produced on alternate non-validated production equipment that were not include... Class II AMD Medicom Inc.
Dec 21, 2023 Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 8... Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The e... Class II Covidien LP
Dec 21, 2023 CardinalHealth Suction Canister Liner, MEDI-VAC CRD, REF 65651-510 The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience ... Class II Cardinal Health 200, LLC
Dec 20, 2023 Bard¿ Nasogastric Sump Tube with ENFit, 12Fr., 48in Long, REF EN0042120 BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... Class II C.R. Bard Inc
Dec 20, 2023 Bard¿ Nasogastric Sump Tube with ENFit, 16Fr., 48in Long, REF EN0042160 BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... Class II C.R. Bard Inc
Dec 20, 2023 global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), ... The firm has become aware of a sudden increase in complaints for three associated lots. Performan... Class II CooperSurgical, Inc.
Dec 20, 2023 Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, ... BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... Class II C.R. Bard Inc
Dec 20, 2023 Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ ... BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... Class II C.R. Bard Inc
Dec 20, 2023 Bard¿ Suction Connector with ENFit, REF EN0066000 BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... Class II C.R. Bard Inc
Dec 20, 2023 Bard Nasogastric Sump Tube with ENFit, 10Fr., 36in Long, REF EN0042100 BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... Class II C.R. Bard Inc
Dec 20, 2023 Bard¿ PreVent¿ Anti-Reflux Filter with ENFit, REF EN0046000 BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes wi... Class II C.R. Bard Inc
Dec 20, 2023 Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenou... When utlizing the patient query feature on the Zyno Medical Z-800WF pumps with software version 5... Class II Zyno Medical LLC

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.