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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

4,602 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.

Clear
DateProductReasonClassFirm
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular
Jan 29, 2020 NC TRAVELER Coronary Dilatation Catheter, REF 1013157-15, Rx Only,NC Traveler... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Class I Abbott Vascular
Jan 23, 2020 DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an ... A software issue was identified which could result in user or patient injury, or may adversely im... Class II Ra Medical Systems, Inc.
Jan 22, 2020 Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36... Past updates to programmers and transmitters may lead some implantable cardioverter defibrillator... Class II St Jude Medical, Cardiac Rhythm Management Divi...
Jan 20, 2020 Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2... Labeled for diagnostic use and sold to clinical labs without a 510(k). Firm corrected labeling t... Class II Carolina Liquid Chemistries Corp
Jan 17, 2020 Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Ster... Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards... Class II Kentec Medical, Inc
Jan 17, 2020 Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Ster... Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards... Class II Kentec Medical, Inc
Jan 17, 2020 SnapLink, Ref Part No. 438-2191, L6L SnapLink, Slot .022, TQ--28, Ang +2, Rot... The action is being taken due to an increase in complaints relating to the lower buccal tube slid... Class II Ormco/Sybronendo
Jan 17, 2020 Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Ster... Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards... Class II Kentec Medical, Inc
Jan 17, 2020 Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Ster... Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards... Class II Kentec Medical, Inc
Jan 17, 2020 Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Ster... Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards... Class II Kentec Medical, Inc
Jan 17, 2020 LabPro Data Management System, UDI: 15099590676872 - Product Usage: The LabPr... A security-only update was released via remote diagnostics on January 14, 2020 to customers with ... Class II Beckman Coulter Inc.
Jan 17, 2020 Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Ster... Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards... Class II Kentec Medical, Inc
Jan 17, 2020 SnapLink, Ref Part No. 438-2190, L6R SnapLink, Slot .022, TQ--28, Ang +2, Rot... The action is being taken due to an increase in complaints relating to the lower buccal tube slid... Class II Ormco/Sybronendo
Jan 17, 2020 Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Ster... Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards... Class II Kentec Medical, Inc
Jan 14, 2020 Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used ... Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. ... Class II Medtronic CoreValve LLC
Jan 14, 2020 Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a p... Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. ... Class II Medtronic CoreValve LLC
Jan 14, 2020 Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, ... The bracket torque was mislabeled on the packaging. Class II Ormco/Sybronendo
Jan 7, 2020 Spy-Phi Drape only (HH2020) Pack of 20 HH2000 (Sold internationally only). Dr... Sterile drapes packaged in an unsealed pouch. Class II Stryker Corporation
Jan 7, 2020 Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. ... Sterile drapes packaged in an unsealed pouch. Class II Stryker Corporation
Jan 2, 2020 Central Venous Catheters are indicated for the assessment of hemodynamic stat... Inability for the guidewire to pass through the needles included with the catheter kits. Class II ICU Medical, Inc.
Jan 2, 2020 Central Venous Catheters are indicated for the assessment of hemodynamic stat... Inability for the guidewire to pass through the needles included with the catheter kits. Class II ICU Medical, Inc.
Jan 2, 2020 Central Venous Catheters are indicated for the assessment of hemodynamic stat... Inability for the guidewire to pass through the needles included with the catheter kits. Class II ICU Medical, Inc.
Jan 2, 2020 Central Venous Catheters are indicated for the assessment of hemodynamic stat... Inability for the guidewire to pass through the needles included with the catheter kits. Class II ICU Medical, Inc.
Jan 2, 2020 Central Venous Catheters are indicated for the assessment of hemodynamic stat... Inability for the guidewire to pass through the needles included with the catheter kits. Class II ICU Medical, Inc.
Jan 2, 2020 Central Venous Catheters are indicated for the assessment of hemodynamic stat... Inability for the guidewire to pass through the needles included with the catheter kits. Class II ICU Medical, Inc.
Jan 2, 2020 Central Venous Catheters are indicated for the assessment of hemodynamic stat... Inability for the guidewire to pass through the needles included with the catheter kits. Class II ICU Medical, Inc.
Dec 19, 2019 STAINLESS STEEL REPROCESSING TRAY, 2D CAMERA HEAD, IS4000, Model No. 400499-... Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope steriliz... Class II Intuitive Surgical, Inc.
Dec 19, 2019 STAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000, Model No. 400498-02... Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope steriliz... Class II Intuitive Surgical, Inc.
Dec 13, 2019 Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-1... Due to customer reports it has been determined that the inoculation system contains the incorrec... Class II Beckman Coulter Inc.
Dec 11, 2019 Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.... Incorrect reference ranges of analytes. Class II Abaxis Inc
Dec 6, 2019 Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following R... The firm has become aware that there is a potential that the glass cover at the distal end of the... Class II Karl Storz Endoscopy
Dec 3, 2019 Healon GV PRO 0.85 mL, Model (U.S.): 10-2400-14, Model (O.U.S.): 10-2705-14, ... Ophthalmic viscosurgical device may be difficult to remove from the eye, leading to increased pos... Class II Johnson & Johnson Surgical Vision Inc
Dec 2, 2019 HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 1... Excessive static electricity can potentially cause unrecoverable power loss and damage to the mob... Class II Thoratec Corp.
Nov 27, 2019 QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI:... If the venous cannula is used in an unintended manner (longer than 6 hours; particularly during e... Class II Edwards Lifesciences, LLC
Nov 24, 2019 Terumo AZUR Peripheral Coil System, Detachable 35, Framing Coil, REF numbers ... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 24, 2019 Terumo AZUR CX Peripheral Coil System, Detachable 18, CX Coil, REF numbers 45... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 24, 2019 Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 24, 2019 Terumo AZUR Peripheral Coil System, Detachable 18, Helical HydroCoil Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 24, 2019 Terumo AZUR Peripheral Coil System, Detachable 18, Framing Coil, REF numbers ... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 24, 2019 Terumo AZUR CX Peripheral Coil System, Detachable 35, CX Coil, REF numbers 45... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embo... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo Microplex 18, Platinum Embolization Coil, Cosmos 18, Ster... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo HydroFrame 10, HydroCoil Embolic System, Endovascular Emb... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo Microplex, Platinum Coil System, Endovascular Embolizatio... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 . The abutment provided with the Implant System may be out of specification, which could lead to a ... Class II Zest Anchors 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.