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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

4,686 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4,686 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 4,686 FDA device recalls in CA.

Clear
DateProductReasonClassFirm
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.
May 22, 2023 PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 22, 2023 DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10 Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di... Class II Universal Meditech Inc.
May 12, 2023 Driver Instrument, part of the Superion Indirect Decompression System, REF: 1... Pending update to indirect decompression system instructions for use informing users that excessi... Class II Boston Scientific Neuromodulation Corporation
May 2, 2023 LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2M... Non-engaging abutments were distributed without FDA clearance; the performance characteristics ha... Class II Implant Direct Sybron Manufacturing LLC
Apr 24, 2023 Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could resu... Class II Cepheid
Apr 24, 2023 Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD, pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could resu... Class II Cepheid
Apr 21, 2023 Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794 TC-I tip clip sensor may produce readings outside the accuracy specification. Class II Masimo Corporation
Apr 21, 2023 Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895 TC-I tip clip sensor may produce readings outside the accuracy specification. Class II Masimo Corporation
Apr 21, 2023 Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053 TC-I tip clip sensor may produce readings outside the accuracy specification. Class II Masimo Corporation
Apr 21, 2023 Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503 TC-I tip clip sensor may produce readings outside the accuracy specification. Class II Masimo Corporation
Apr 6, 2023 Metal Tray, 178 x 135 x 37 mm, REF: 11580A; Metal Tray, 275 x 178 x 35 mm, R... Metal sterilization trays used to encase and protect medical devices during sterilization have a ... Class II Karl Storz Endoscopy
Apr 5, 2023 Beckman Coulter Bicarbonate, REF: OSR6237, 4x50 mL There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result... Class II Beckman Coulter Inc.
Apr 5, 2023 BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med E... Automated dispensing cabinet software is experiencing: 1) ES device download failure resulting in... Class II CareFusion 303, Inc.
Apr 5, 2023 BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES ... Due to an automated dispensing cabinet software issue, when a medication single order contains mo... Class II CareFusion 303, Inc.
Apr 5, 2023 NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Servic... Cybersecurity vulnerability concerning the software used for sequencing instruments. Class II Illumina, Inc.
Apr 5, 2023 KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C,... Plastic sterilization trays used to encase and protect medical devices during sterilization have ... Class II Karl Storz Endoscopy

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.