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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

4,686 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.

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DateProductReasonClassFirm
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 IV Sets with drip chambers Intravascular administration tubing set drip chambers may have black specks potentially due to th... Class II ICU Medical, Inc.
May 12, 2026 IV Sets with drip chambers Intravascular administration tubing set drip chambers may have black specks potentially due to th... Class II ICU Medical, Inc.
May 12, 2026 IV Non-Dedicated Gravity Administration Sets with drip chambers Intravascular administration tubing set drip chambers may have black specks potentially due to th... Class II ICU Medical, Inc.
May 12, 2026 IV Sets with drip chambers Intravascular administration tubing set drip chambers may have black specks potentially due to th... Class II ICU Medical, Inc.
May 12, 2026 Plum administration sets Intravascular administration tubing set drip chambers may have black specks potentially due to th... Class II ICU Medical, Inc.
May 12, 2026 IV Sets with drip chambers Intravascular administration tubing set drip chambers may have black specks potentially due to th... Class II ICU Medical, Inc.
May 12, 2026 Oncology sets with drip chambers Intravascular administration tubing set drip chambers may have black specks potentially due to th... Class II ICU Medical, Inc.
May 12, 2026 Oncology sets with drip chambers Intravascular administration tubing set drip chambers may have black specks potentially due to th... Class II ICU Medical, Inc.
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.
Apr 24, 2026 Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Nu... Due to unintentionally activated near infrared handheld camera when attempting to turn off illumi... Class II Intuitive Surgical, Inc.
Apr 23, 2026 Sharpoint 2.2MM, ANGLED, DOUBLE- BEVEL Model/Catalog Number: 72-2231 Micr... 3.0mm surgical knives labeled and packaged as 2.2mm surgical knives. Class II SSC- Surgical Specialties Corporation
Apr 22, 2026 Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS-... Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray ... Class II Boston Scientific Neuromodulation Corporation
Apr 22, 2026 Da Vinci ASSY, PSS, SP1098, Part Number: 380601 Operative components of surgical systems potentially distributed with E-brake retainer pin, so in... Class II Intuitive Surgical, Inc.
Apr 21, 2026 Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310 A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in ... Class II PFM MEDICAL INC.
Apr 20, 2026 Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography... Electromagnetic contactors within high voltage generator may weld together, resulting in current ... Class II Shimadzu Medical Systems
Apr 14, 2026 Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: D... A software defect in which a low-priority file I/O check blocks the higher-priority thread respon... Class II Dexcom, Inc.
Apr 14, 2026 Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dex... A software defect in which a low-priority file I/O check blocks the higher-priority thread respon... Class II Dexcom, Inc.
Apr 14, 2026 Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dex... A software defect in which a low-priority file I/O check blocks the higher-priority thread respon... Class II Dexcom, Inc.
Apr 9, 2026 Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 ... Due to nonconforming products being inadvertently distributed. Class II Stryker Corporation
Apr 8, 2026 Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6... Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) pr... Class II Becton, Dickinson and Company
Apr 8, 2026 Swan-Ganz Pacing Catheter, Models: D200F7; Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) pr... Class II Becton, Dickinson and Company
Apr 8, 2026 Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) pr... Class II Becton, Dickinson and Company
Apr 6, 2026 INZONE DETACHMENT SYSTEM, REF: M00345100950 Embolization coil detachment system devices may experience premature battery drain causing device... Class II Stryker Neurovascular
Apr 6, 2026 QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, strepto... Product has the potential for false positive results Class II Quidel Corporation
Apr 6, 2026 LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xW... Stent-assisted coiling device may due to commingling during manufacturing have dimensional noncon... Class II MICROVENTION INC.
Apr 2, 2026 Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgica... Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to break... Class II Intuitive Surgical, Inc.
Mar 27, 2026 Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO Labeling update to provide warning if functionality of the valve replacement delivery system is ... Class II Edwards Lifesciences, 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.