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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

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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

4,653 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4,653 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 4,653 FDA device recalls in CA.

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DateProductReasonClassFirm
Aug 4, 2026 Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digit... Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X... Class II Canon Medical System, USA, INC.
Jul 15, 2026 Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5... a software defect in which the Parameter Package (PP) import logic overwrites all predefined cal... Class II Beckman Coulter Inc.
Jul 15, 2026 Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1... a software defect in which the Parameter Package (PP) import logic overwrites all predefined cal... Class II Beckman Coulter Inc.
Jul 13, 2026 MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712; Loaner insulin pumps may have been cleaned with chemically incompatible products that could damag... Class II Medtronic MiniMed, Inc.
Jul 13, 2026 MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782; Loaner insulin pumps may have been cleaned with chemically incompatible products that could damag... Class II Medtronic MiniMed, Inc.
Jul 13, 2026 MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLW Loaner insulin pumps may have been cleaned with chemically incompatible products that could damag... Class II Medtronic MiniMed, Inc.
Jul 2, 2026 OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17... Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone gra... Class II IsoTis OrthoBiologics, Inc.
Jun 26, 2026 REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic install... Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results... Class II Beckman Coulter Inc.
Jun 26, 2026 REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the foll... Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results... Class II Beckman Coulter Inc.
Jun 23, 2026 Charger for the Therabody Theragun, G4 PRO massage device, and products which... Charging cradle for the device may overheat while charging the device's removable battery pack, p... Class II Therabody, Inc
Jun 17, 2026 INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INF... Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may re... Class I Boston Scientific Neuromodulation Corporation
Jun 17, 2026 Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal a... Class II Freudenberg Medical, LLC
Jun 17, 2026 Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal a... Class II Freudenberg Medical, LLC
Jun 16, 2026 MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android) For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and misse... Class II Medtronic MiniMed, Inc.
Jun 8, 2026 STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540 There has been an increased amount in reported complaints consistently describing leaking from th... Class II Stryker Corporation
Jun 8, 2026 STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620 There has been an increased amount in reported complaints consistently describing leaking from th... Class II Stryker Corporation
Jun 8, 2026 STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530 There has been an increased amount in reported complaints consistently describing leaking from th... Class II Stryker Corporation
Jun 8, 2026 HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefideroc... Due to incorrect cartridges include in affected products that there is the potential for false-su... Class II Hardy Diagnostics
Jun 8, 2026 STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600 There has been an increased amount in reported complaints consistently describing leaking from th... Class II Stryker Corporation
Jun 8, 2026 STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640 There has been an increased amount in reported complaints consistently describing leaking from th... Class II Stryker Corporation
Jun 8, 2026 Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027... Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implan... Class II Micro Therapeutics, Inc.
Jun 8, 2026 Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027... Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implan... Class II Micro Therapeutics, Inc.
Jun 3, 2026 Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT Due to manufacturing issues, reperfusion catheters may fractures Class II Penumbra, Inc.
May 28, 2026 SeaSpine Polyaxial Head REF Number: 41-3010 Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following... Class II SEASPINE ORTHOPEDICS CORPORATION
May 27, 2026 MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896 A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circ... Class II Medtronic MiniMed, Inc.
May 27, 2026 Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dex... Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction wer... Class II Dexcom, Inc.
May 22, 2026 Medtronic Harmony Delivery Catheter System Devices containing inner shaft assemblies from specific manufacturing lots may have an increased ... Class I Medtronic Heart Valves Division
May 21, 2026 Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain exp... Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures... Class II Karl Storz Endoscopy
May 13, 2026 EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 108... The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them... Class II Covidien, LLC
May 13, 2026 SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix ... Intraoperative neuromonitoring device, due to a software issue, may experience loss or interrupti... Class II Alphatec Spine, Inc.
May 13, 2026 Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model... Due to 11 volt Backup Battery failures. Class II Thoratec LLC
May 13, 2026 Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVA... Due to 11 volt Backup Battery failures. Class II Thoratec LLC
May 13, 2026 Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Ca... Due to 11 volt Backup Battery failures. Class II Thoratec LLC
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 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.
Apr 30, 2026 BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL... Due to an increase rate of balloon pinhole defects. Class II MICROVENTION INC.
Apr 30, 2026 directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number... Assayed Whole blood control contains labeling with incorrect performance range. Class II Accriva Diagnostics, Inc.
Apr 30, 2026 BD Pyxis MedStation ES Tower REF: 352 Medication cabinet Fingerprint scanner may overheat to a temperature to cause 1st degree burn. Class II CareFusion 303, Inc.
Apr 30, 2026 BD Pyxis MedBank Mini REF: 1147-00 Medication cabinet Fingerprint scanner may overheat to a temperature to cause 1st degree burn. Class II CareFusion 303, Inc.
Apr 30, 2026 BD Pyxis MedStation 4000 REF: 303 Medication cabinet Fingerprint scanner may overheat to a temperature to cause 1st degree burn. Class II CareFusion 303, Inc.
Apr 30, 2026 BD Pyxis Anesthesia Station ES REF: 327 Medication cabinet Fingerprint scanner may overheat to a temperature to cause 1st degree burn. Class II CareFusion 303, Inc.
Apr 30, 2026 BD Pyxis MedStation ES REF: 323 Medication cabinet Fingerprint scanner may overheat to a temperature to cause 1st degree burn. Class II CareFusion 303, Inc.
Apr 30, 2026 Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI ... Due to incorrect shelf-life expiration date. Class II Advanced Bionics, LLC
Apr 30, 2026 BD Pyxis Anesthesia Station 4000 REF: 338 Medication cabinet Fingerprint scanner may overheat to a temperature to cause 1st degree burn. Class II CareFusion 303, Inc.
Apr 30, 2026 BD Pyxis Mini Main REF: 349 Medication cabinet Fingerprint scanner may overheat to a temperature to cause 1st degree burn. Class II CareFusion 303, Inc.
Apr 30, 2026 BD Pyxis MedBank Tower REF: 1145-00 Medication cabinet Fingerprint scanner may overheat to a temperature to cause 1st degree burn. Class II CareFusion 303, Inc.
Apr 29, 2026 Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x... Reusable electrodes may not meet expected performance levels. Class II Boston Scientific Neuromodulation Corporation
Apr 29, 2026 Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180 Sterile anchors my lack sterility assurance. Class II Boston Scientific Neuromodulation Corporation
Apr 29, 2026 Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS ST... Reusable electrodes may not meet expected performance levels. Class II Boston Scientific Neuromodulation Corporation
Apr 27, 2026 Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/C... Due to device not having FDA Clearance Class II Prismatik Dentalcraft, 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.