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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.

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DateProductReasonClassFirm
Oct 20, 2015 ArcPoint Labs 10 Panel Dip Screen (OXY), Item No. APD-10MO These Drugs of Ab... Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Class II Ameditech Inc
Oct 20, 2015 Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU These Drugs ... Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Class II Ameditech Inc
Oct 20, 2015 12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP These Drugs of... Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Class II Ameditech Inc
Oct 20, 2015 11 Panel Dip Card (OPI 2000), Item No. 11125AA2K; 11 Panel Dip Card (OPI 300)... Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Class II Ameditech Inc
Oct 20, 2015 THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU, MTPA-8MBAU These Drugs ... Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Class II Ameditech Inc
Oct 20, 2015 DrugSmart 11 Test Cup, Item No. 61127D; DrugSmart 12 Test Cup (Multi & BUP),... Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Class II Ameditech Inc
Oct 20, 2015 CLIA RDTC 12-Panel Cup and CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. ... Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Class II Ameditech Inc
Oct 20, 2015 10-Panel Pipette Drug Screen, Item No. PSP-10M These Drugs of Abuse Tests ar... Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Class II Ameditech Inc
Oct 13, 2015 NovoCut Suture Manager; Ceterix catalog number CTX-001. General and Plasti... The NovoCut Suture Manager device may cut the suture during knot tensioning and this may cause th... Class II Ceterix Orthopedics, Inc.
Oct 13, 2015 Access CEA Assay, Part No. 33200. For the quantitative determination of Carc... Beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly. Class II Beckman Coulter Inc.
Oct 13, 2015 Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7... A component on the systems power board can fail in a manner which can cause the ventilator to shu... Class I Event Medical LTD
Oct 9, 2015 SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medic... CareFusion is recalling the SmartSite Extension Set due to disconnection and leakage issues. Class II CareFusion 303, Inc.
Oct 9, 2015 miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Han... Update to labeling for the miraDry Console to remind users to only use approved lubricants in a t... Class II Miramar Labs, Inc.
Oct 7, 2015 ACUSON SC2000 ultrasound systems model 10433816 Imaging system that pro... Siemens will provide all customers a new version of system software (VA35E or VB10C depending on ... Class II Siemens Medical Solutions USA, Inc.
Oct 2, 2015 Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF145... Focus Diagnostics is recalling the Anaplasma phagocytophilum IFA IgM kit because of the potential... Class II Focus Diagnostics Inc
Oct 1, 2015 ABG-HM-1 Hummi Micro Draw Blood Transfer Device Product Usage: It is used... Hummingbird Med Devices, Inc. is recalling ABG-HM-1 Hummi Micro Draw Blood Transfer because the c... Class I Hummingbird Med
Sep 30, 2015 BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 Hematology: The CD3 a... Two lots of CD3 (SK7) FITC label contains an error in the Spanish Small text. Class III Becton, Dickinson and Company, BD Biosciences
Sep 30, 2015 Shimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table. The C-arm may interfere with the table top under certain circumstances. Class II Shimadzu Medical Systems
Sep 29, 2015 TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811 Tekia is recalling the Single Piece Hydrophillic Acrylic Intraocular Lenses (IOLs) because they m... Class II Tekia, Inc.
Sep 28, 2015 ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assess... An anomaly was identified with the ARIA for Radiation Oncology software with a Clinical Assessmen... Class II Varian Medical Systems, Inc.
Sep 25, 2015 MiniMed 620G, 3.0mL mg/dL, Model No. MMT-1710 The MiniMed 620G and MiniMed... The pump drive motors may experience a malfunction which would result in a pump error message ala... Class II Medtronic MiniMed Inc.
Sep 25, 2015 MiniMed 640G, 3.0mL mmol/L, 3.0mL mg/dL, Model No. MMT-1711 and MMT-1712 T... The pump drive motors may experience a malfunction which would result in a pump error message ala... Class II Medtronic MiniMed Inc.
Sep 10, 2015 MICroSTREP plus 2 Panel, Part No. B1027-202 Product Usage: MicroScan MICr... Beckman Coulter is recalling MICroSTREP plus 1 and MICroSTREP plus 2 panels because a manufacturi... Class II Beckman Coulter Inc.
Sep 10, 2015 Carto 3 EP Navigation System. Electro physiology system which views of the el... Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed... Class II Biosense Webster, Inc.
Sep 10, 2015 MICroSTREP plus 1 Panel, Part No. B1027-201 Product Usage: MicroScan MICr... Beckman Coulter is recalling MICroSTREP plus 1 and MICroSTREP plus 2 panels because a manufacturi... Class II Beckman Coulter Inc.
Sep 10, 2015 SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac ... Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed... Class II Biosense Webster, Inc.
Sep 9, 2015 Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical... B. Braun 2 gang 4-way stopcocks in the Fluorescence Imaging Procedure Kit may experience damage ... Class II Intuitive Surgical, Inc.
Sep 8, 2015 Smooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers: CM... Certain catalog numbers and lots of Smooth Muscle Actin may stain some cell types that are typica... Class II Biocare Medical, LLC
Sep 5, 2015 ACUSON X700 Ultrasound System with software version 1.0.04. Model numbers: ... Due to a communication error between the software and V5Ms transducers rotation function, ACUSON ... Class II Siemens Medical Solutions USA, Inc.
Sep 4, 2015 EnVision FLEX/HRP visualization reagent found in the following kits: EnVisio... There is a defect in one lot of a buffer, non-specific background staining that has, in some inst... Class II Dako North America Inc.
Sep 4, 2015 -Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipe... The firm is recalling Pipeline and Pipeline Flex Embolization Devices from U.S. since the devices... Class II Micro Therapeutics Inc, Dba Ev3 Neurovascular
Aug 31, 2015 Access Free T3 Reagent Kit, P/N A13422 The Access Free T3 assay is a param... Beckman Coulter, Inc. is recalling Access Free T3 Reagent Kit because they were filled incorrectl... Class II Beckman Coulter Inc.
Aug 27, 2015 CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Cata... CD4 FITC label contains an error in the Spanish small text - it states CD8 FITC. Class III Becton, Dickinson and Company, BD Biosciences
Aug 27, 2015 Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773. Enables u... Alere San Diego is recalling the Alere Cholestech LDX Multianalyte Control because the assigned c... Class III Alere San Diego, Inc.
Aug 21, 2015 Monode, Shortwave Accessory Model #: 02200002 Used in conjunction with th... Overheating and burning of the wire insulation inside the applicator. Class II DJO, LLC
Aug 19, 2015 Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF... One Distal Access Catheter intended for distribution in Korea, was found at a US location. Class II Concentric Medical Inc
Aug 19, 2015 ACUSON SC2000 Ultrasound System with software versions VB10B and lower; Mode... The ACUSON SC2000 ultrasound system considers uppercase/lowercase differences in the same patient... Class II Siemens Medical Solutions USA, Inc.
Aug 18, 2015 Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid... Some devices exhibit backup VVI operation due to a backup reset. Class II St Jude Medical Cardiac Rhythm Management Division
Aug 17, 2015 da Vinci Xi Surgical System P4 software;with Xi Stapler; model number IS4000 ... Complaints regarding the Exposed Knife Blade recoverable fault for the Xi Stapler with Xi System ... Class II Intuitive Surgical, Inc.
Aug 14, 2015 INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems When a fontal DA (Digital Angiography) acquisition was done, scattered x-ray came into the dose m... Class II Toshiba American Medical Systems Inc
Aug 12, 2015 FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter:... The expiration date was incorrectly printed on the pouch/box labels of 19 products that were ship... Class III Abbott Electrophysiology
Aug 10, 2015 CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reproc... Advanced Sterilization Products (ASP) is reminding all CIDEX OPA Solution customers to follow the... Class II Advanced Sterilization Products
Aug 8, 2015 Crocodile Grasper; used with the da Vinci Si Surgical System (IS3000); Model... In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip ... Class II Intuitive Surgical, Inc.
Aug 8, 2015 Maryland Bipolar Forceps; used with the da Vinci Si Surgical System (IS3000);... In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip ... Class II Intuitive Surgical, Inc.
Aug 8, 2015 Curved Needle Driver; used with the da Vinci Si Surgical System (IS3000); Mo... In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip ... Class II Intuitive Surgical, Inc.
Aug 8, 2015 Needle Driver; used with the da Vinci Si Surgical System (IS3000); Model num... In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip ... Class II Intuitive Surgical, Inc.
Aug 8, 2015 Maryland Dissector; used with the da Vinci Si Surgical System (IS3000); Mode... In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip ... Class II Intuitive Surgical, Inc.
Aug 8, 2015 Fenestrated Bipolar Forceps; used with the da Vinci Si Surgical System (IS300... In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip ... Class II Intuitive Surgical, Inc.
Aug 8, 2015 Cadiere Forceps; used with the da Vinci Si Surgical System (IS3000); Model n... In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip ... Class II Intuitive Surgical, Inc.
Aug 8, 2015 Medium -Large Clip Applier; used with the da Vinci Si Surgical System (IS3000... In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip ... Class II Intuitive Surgical, 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.