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
Nov 4, 2013 Stryker brand EXCELSIOR 1018 PRE-SHAPED 45 150CM, Catalog Number: M0031441900... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand COMPLIANT 4MM X 15MM, Catalog Number: M003SRC04150; Product is... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand EXCELSIOR SL-10 PRE-SHAPED 90 150CM, Catalog Number: M003168191... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand SUPER COMPLIANT 4MM X 7MM, Catalog Number: M003SSC04070; Prod... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand EXCELSIOR SL-10 PRE-SHAPED S 15OCM; Catalog Number: M0031441920... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand GDC VORTX 2MM X 3MM, Catalog Number: M00335302340; Product is ... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand COMPLIANT 5MM X 15MM, Catalog Number: M003SRC05150; Product i... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand EXCELSIOR SL-10 PRE-SHAPED 45 150CM, Catalog Number: M003168190... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand EXCELSIOR SL-10 PRE-SHAPED J 15OCM; Catalog Number: M0031441930... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand EXCELSIOR SL-10 PRE-SHAPED J 15OCM, Catalog Number: M0031681920... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand GDC-10 ULTRA SOFT 2MM X 3CM, Catalog Number: M0033432030; Pro... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand COMPLIANT 4MM X 10MM, Catalog Number: M003SRC04100; Product is... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand COMPLIANT 5MM X 30MM, Catalog Number: M003SRC05300; Product i... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand COMPLIANT 4MM X 20MM, Catalog Number: M003SRC04200; Product is... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand GDC-18 360 18MM X 30CM, Catalog Number: M00334818300; Product... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand EXCELSIOR SL-10 150CM 2 TIP, Catalog Number: M0031681890, Produ... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand SUPER COMPLIANT 7MM X 15MM, Catalog Number: M003SSC07150; Pro... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 4, 2013 Stryker brand COMPLIANT 4MM X 30MM, Catalog Number: M003SRC04300; Product is... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... Class II Stryker Neurovascular
Nov 1, 2013 Salter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors. Rx onl... It has been determined that three lots of model number 4515-15-25 CO2 Sample Line 15' tube, male ... Class II SALTER LABS
Oct 29, 2013 MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed)... Via one (1) consumer complaint and in-house testing has confirmed that the product does not meet ... Class III Thermofisher Scientive
Oct 28, 2013 Titan 3T MRI System, MRT-3010A/5. Product Usage: Usage: MRI system. Toshiba America Medical Systems, Inc. is recalling due to a potential problem with Specific Absor... Class II Toshiba American Medical Systems Inc
Oct 24, 2013 Fixed Offset Adapter, A-642100. The Offset Adapter is a fixed modular comp... Ossur inititated a voluntary recall of the A-642100 Fixed Offset Adapter because it can develop f... Class II Ossur North America Inc
Oct 24, 2013 C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelera... This correction is to notify users that a solution to a previous correction has been developed an... Class II Varian Medical Systems, Inc.
Oct 24, 2013 Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, an... The recall was initiated because there is a potential for malfunction of the OsseoCare Pro when u... Class II Nobel Biocare Usa Llc
Oct 23, 2013 Product Brand Name(s): Alere Cholestech LDX¿ Lipid Profile"GLU Test Cassette,... Alere initiated a recall of Cholestech LDX Lipid Profile-GLU test cassettes, Catalog Number 10-99... Class III Alere San Diego, Inc.
Oct 23, 2013 SIEMENS brand ONCOR series Linear Accelerator Linac systems with component: a... A safety risk regarding a potentially existing dark current radiation phenomenon on the Linear Ac... Class II Siemens Medical Solutions USA, Inc
Oct 23, 2013 Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, ... The user database delivered for download contained an erroneous value. Specifically the "aO" cons... Class II Carl Zeiss Meditec, Inc.
Oct 23, 2013 Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, ... The user database delivered for download contained an erroneous value. Specifically the "aO" cons... Class II Carl Zeiss Meditec, Inc.
Oct 23, 2013 SIEMENS brand ARTISTE Linear Accelerator Linac systems with component: any ph... A safety risk regarding a potentially existing dark current radiation phenomenon on the Linear Ac... Class II Siemens Medical Solutions USA, Inc
Oct 21, 2013 Applied Medical's Inzii¿ 12/15mm Retrieval System. Applieds Inzii Tissue ... Applied Medical is conducting a voluntary recall of the Inzii¿ 12/15mm retrieval system. During s... Class II Applied Medical Resources Corp
Oct 21, 2013 da Vinci Vision System Cart, a component of the da Vinci Si Surgical System ... Intuitive has identified that the metalized coating on the IS3000 HD lamp module may be incompati... Class III Intuitive Surgical, Inc.
Oct 18, 2013 Sterrad 100NX, Product Code: 10104. Used to sterilize heat and moisture se... Advanced Sterilization Products (ASP) is recalling the Sterrad 100NX Sterilizer some healthcare w... Class II Advanced Sterilization Products
Oct 16, 2013 Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog... Microgenics Corp., part of Thermo Fisher Scientific, is recalling CEDIA Tobramycin II Assay (Lot ... Class II Microgenics Corp
Oct 16, 2013 Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio fr... Cutera received two adverse events associated with the edge of the electrode, when it was pressed... Class II Cutera, Inc.
Oct 14, 2013 Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a... Philips Healthcare became aware of a software problem with the IntelliSpace PACS system, in that ... Class II Philips Healthcare Informatics, Inc.
Oct 13, 2013 Sterile Disposable Kit ( Contains Skin Tensioner ASY-25067; Three Mark Needl... Reports of discoloration (residue) on the pins of the skin tensioner have been received by severa... Class II Restoration Robotics
Oct 13, 2013 ARTAS Disposable and Reuseable Kit ( Contains Skin Tensioner FP-45384; Inn... Reports of discoloration (residue) on the pins of the skin tensioner have been received by severa... Class II Restoration Robotics
Oct 13, 2013 ARTAS Disposable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Va... Reports of discoloration (residue) on the pins of the skin tensioner have been received by severa... Class II Restoration Robotics
Oct 13, 2013 Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma. Turns Red if ster... Reports of discoloration (residue) on the pins of the skin tensioner have been received by severa... Class II Restoration Robotics
Oct 10, 2013 Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary Mini Type No 58 ... Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Mini Temporary Type, a... Class II Mizuho America, Inc.
Oct 10, 2013 Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary and permanent ... Specific item numbers form Lots 27-J and 29-J of Sugita T2 Aneurysm Clips. Mini Temporary Type, a... Class II Mizuho America, Inc.
Oct 7, 2013 Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm; Sten... A small number of units in lot number 0006573585 of the Resolute Integrity Zotarolimus-Eluting Co... Class II Medtronic Vascular, Inc.
Oct 3, 2013 STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product cod... Advanced Sterilization Products (ASP) is recalling the SteriTite containers because they do not ... Class III Advanced Sterilization Products
Oct 3, 2013 Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control ... Product catalog # A68825 Norbuprenorphine 13 ng/mL Level 2 Controls gives a decreased concentrati... Class III Lin-Zhi International Inc
Oct 2, 2013 Single Site Bipolar Maryland Forceps Intuitive Surgical, Sunnyvale, CA. 94... A limited number of FDA-cleared instruments for da Vinci Single Site use, Bipolar Maryland and cu... Class II Intuitive Surgical, Inc.
Oct 2, 2013 Single Site Curved Needed Driver Intuitive Surgical, Sunnyvale, CA. 94086 ... A limited number of FDA-cleared instruments for da Vinci Single Site use, Bipolar Maryland and cu... Class II Intuitive Surgical, Inc.
Oct 2, 2013 Access Immunoassay Systems Reaction Vessels. The Access Immunoassay System... Beckman Coulter is initiating a recall for the Access Immunoassay Systems Reaction Vessels, inclu... Class II Beckman Coulter Inc.
Oct 1, 2013 TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System; TXS-101/R Aquil... Toshiba intitiated this recall because their investigation revealed that due to a problem of the ... Class II Toshiba American Medical Systems Inc
Oct 1, 2013 Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3 InHealth Technologies (IHT) is recalling the Blom-Singer Adjustable Tracheostoma Valve II (ATSV I... Class III Helix Medical LLC
Sep 26, 2013 Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160. The Di... Distal Access Catheters were shipped to US customers with the Directions for Use that included in... Class II Concentric Medical 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.