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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

4,602 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4,602 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 4,602 FDA device recalls in CA.

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DateProductReasonClassFirm
Aug 7, 2023 Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & Heart... Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical... Class II Thoratec Corp.
Jul 27, 2023 PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS Due to a manufacturing issue, when using valve repair systems, intended to repair insufficient mi... Class II Edwards Lifesciences, LLC
Jul 18, 2023 Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, S... The healing abutments contain a dimensional condition that may lead to a gap between the healing ... Class II Preat Corp
Jul 18, 2023 Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Ste... The healing abutments contain a dimensional condition that may lead to a gap between the healing ... Class II Preat Corp
Jul 18, 2023 Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, S... The healing abutments contain a dimensional condition that may lead to a gap between the healing ... Class II Preat Corp
Jul 14, 2023 COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 100... Due to plastic defects, the pipette aspiration capability potentially doesn't meet the expected t... Class II Copan Diagnostics Inc
Jul 12, 2023 Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2 Lipemic interference failed to meet the performance specification listed within the IFU. Class II Beckman Coulter Inc.
Jul 12, 2023 FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Li... If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn'... Class II Abbott Diabetes Care, Inc.
Jul 7, 2023 LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine... Awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventin... Class II Alphatec Spine, Inc.
Jul 7, 2023 Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only Flexible intubation endoscopes sterility assurance can not be confirmed. Class II Karl Storz Endoscopy
Jul 6, 2023 TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fidu... Class II Johnson & Johnson Surgical Vision, Inc.
Jul 6, 2023 TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fidu... Class II Johnson & Johnson Surgical Vision, Inc.
Jun 28, 2023 Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink I... Product labeling contains incorrect expiration date Class II Medtronic Neurosurgery
Jun 22, 2023 INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE C... The C-arm, used to set the position and angle of the x-ray exposure field, may not function due t... Class II Canon Medical System, USA, INC.
Jun 14, 2023 Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct A... There is a potential for the direct amplification disc to malfunction which may result in spilla... Class II DiaSorin Molecular LLC
Jun 13, 2023 Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; ... Dura regeneration matrix may have out-of-specification endotoxin levels due to issues with in-pro... Class II Medtronic Neurosurgery
Jun 12, 2023 da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12 Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper... Class II Intuitive Surgical, Inc.
Jun 7, 2023 FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3... Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent leng... Class II MICROVENTION INC.
Jun 2, 2023 Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytos... Cell Collection Device may be at increased risk of the sponge detaching from the string during re... Class II Covidien, LLC
May 30, 2023 ACETABULAR BEARING (xx)MM I.D X (xx) O.D. UHMWPE 1020, STERILEEO, Reference N... Medical device components were marketed without FDA clearance Class II Synovo Production
May 30, 2023 ACETABULAR FIXATION CUP, (xx)MM, 5 HOLE, Ti-6AI-4V ELI TiN CERAMIC W/PLASMA S... Medical device components were marketed without FDA clearance and without FDA approval Class II Synovo Production
May 30, 2023 Femoral Resurfacing Cup - (xx)MM, Ti-6AI-4V ELI, TiN CERAMIC W/ PLASMA SPRAY,... Medical device components were marketed without FDA clearance Class II Synovo Production
May 30, 2023 VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs ... Weld protrusion/physical gap between the housing and pack cover, may exceed design specification,... Class II Johnson & Johnson Surgical Vision, Inc.
May 25, 2023 Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-... Raw material issue may cause cardiac panel products to have an average of 30% troponin signal red... Class I QUIDEL CARDIOVASCULAR INC
May 22, 2023 PrestiBio Pregnancy Strips REF 100-4 25 HCG Test Strips Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 Am I Pregnant? One Step HCG Pregnancy Test REF 100-17 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 PrestiBio BREAST MILK ALCOHOL TEST STRIP REF 910-10 25 TESTS Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 To Life hCG Pregnancy Urine Test Strips Format REF Cat No: 100-10 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 BD Pyxis CII Safe, Software: V7, REF: 107-96, 107-97, 107-97-201; BD Pyxis CI... Automated dispensing cabinet devices plugged into any multi-socket outlet power strips may presen... Class II CareFusion 303, Inc.
May 22, 2023 HealthyWiser KetoFast" Ketone Test Strips REF 900-1K 150 test strips Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 One Step Ovulation Test REF 200-01 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 Lem Fertility LH Ovulation Test (Strip) REF 200-07 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 DiagnosUS Ovulation Predictor Midstream REF 200-17 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 HealthyWiser pH-Aware pH 4.5 - 9.0 pH Test Strips REF 900-1P 120 STRIP Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 DiagnosUS hCG Pregnancy Urine Test Strip Format REF 100-12 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 HealthyWiser UriTest" UTI Test Strips REF 900-UTI Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format REF 100-27 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 DiagnosUS One Step LH Ovulation Test Strip REF 200-07 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 DiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 PrestiBio Ovulation and Pregnancy Strips REF 100-4 and REF 200-4 60 LH Test S... Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 DiagnosUS¿ One Step FSH Menopausal Test (Strip) REF 210-07 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 PrestiBio Ovulation Strips REF 200-4 60 LH Test Strips Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 HealthyWiser UriTest" 10 Parameter Reagent Test Strips for Urinalysis REF 900-10 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 One Step Pregnancy Test REF 100-01 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 OMTMO One Step Ovulation (LH) Test Strips REF 200-07 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 Lem Fertility hCG Pregnancy Urine Test REF 100-12 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 DiagnosUS Pregnancy Test Midstream REF 100-17 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech 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.