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 28, 2015 Fiber Stripper, 910¿m, Autoclavable; The Fiber Stripper is a tool provided... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Tool, Stripper W/BLD, 28S, Nonautoclavable; The Fiber Stripper is a tool p... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Fiber Stripper, 273¿m, Autoclavable; The Fiber Stripper is a tool provided... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Stripper, 0.3mm Disposable EndoStat Fiber, The Fiber Stripper is a tool p... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Stripper, 0.6mm Disposable EndoStat Fiber, The Fiber Stripper is a tool p... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Tool, Stripper W/BLD, 18S, Autoclavable; The Fiber Stripper is a tool prov... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Tool, Stripper W/BLD, 12S, Nonautoclavable; The Fiber Stripper is a tool p... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Sureflex 550 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are inten... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Tool, Stripper W/BLD, 14S, Autoclavable; The Fiber Stripper is a tool prov... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Sureflex 910 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are inten... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 1X1 Cleaving Tiles; The Fiber Cleaver is a reusable and sterilizable to... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Fiber Stripper, 365¿m, Autoclavable; The Fiber Stripper is a tool provided... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 365¿M Lithotripsy Fiber- Reusable; Sure F!ex laser fibers are intended for... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Sureflex 273 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are inten... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 200¿M Lithotripsy Fiber- Reusable; Sure F!ex laser fibers are intended for... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Tool, Stripper W/BLD, 14S, Nonautoclavable; The Fiber Stripper is a tool p... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Tool, Stripper W/BLD, 28S, Autoclavable; The Fiber Stripper is a tool prov... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Tool, Stripper W/BLD, 44S, Nonautoclavable; The Fiber Stripper is a tool p... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Tool, Stripper W/BLD, 12S, Autoclavable; The Fiber Stripper is a tool prov... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Fiber Stripper, 550¿m, Autoclavable; The Fiber Stripper is a tool provided... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Tool, StripperW/BLD, 10S, Autoclavable; The Fiber Stripper is a tool prov... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Fiber Stripper, 150¿m, Autoclavable; The Fiber Stripper is a tool provided... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Stripper, 0.4mm Disposable EndoStat Fiber, The Fiber Stripper is a tool p... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Tool, Stripper W/BLD, 44S, Autoclavable; The Fiber Stripper is a tool prov... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Fiber Cleaver; Fiber Cleaver is also used to score the outer jacket on Endo... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 28, 2015 Tool, Stripper W/BLD, 18S, Nonautoclavable; The Fiber Stripper is a tool p... validation data related to cleaning instructions and sterilization methods and the methods define... Class II American Medical Systems Innovation Center - Si...
May 21, 2015 Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surg... The coating of the 5 mm Thoracic Grasper main tube may experience damage with the possibility of ... Class II Intuitive Surgical, Inc.
May 18, 2015 ClearSight, Model No. EVHRS Heart Reference Sensor. The EV1000 Clinical Plat... Edward Lifesciences is recalling the ClearSight System because the finger component of the Heart ... Class II Edwards Lifesciences, LLC
May 18, 2015 ActCel advanced bleeding control Topical Hemostatic Dressing 2in X 2in (5... Coreva Health Science, LLC. is recalling ActCel Hemostatic Dressing due to customer literature an... Class II Coreva Health Science LLC
May 13, 2015 StoneLight 30 Laser System (NS3000). For use in surgical procedures using ... During internal testing a situation was discovered where when changing the settings, a new settin... Class II New Star Lasers, Inc.
May 13, 2015 Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Us... An issue with the cancel functionality used during atypical infusion programming to cancel user i... Class II CareFusion 303, Inc.
May 11, 2015 EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. The ASP... Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor ... Class II Advanced Sterilization Products
May 11, 2015 EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. ... Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor ... Class II Advanced Sterilization Products
May 8, 2015 Toshiba Aquilion CT System TSX-301B If two specific operations are performed in multi-phase helical scanning, the acquired raw data m... Class II Toshiba American Medical Systems Inc
May 8, 2015 Celesteion PCA-9000A/2 PET/CT System It was found that if specific operations are performed in multi-phase helical scanning, the acqui... Class II Toshiba American Medical Systems Inc
May 8, 2015 Toshiba Aquilion CT System TSX-101A If two specific operations are performed in multi-phase helical scanning, the acquired raw data m... Class II Toshiba American Medical Systems Inc
May 8, 2015 Toshiba Aquilion CT System TSX-302A If two specific operations are performed in multi-phase helical scanning, the acquired raw data m... Class II Toshiba American Medical Systems Inc
May 8, 2015 Toshiba Aquilion CT System TSX-301A If two specific operations are performed in multi-phase helical scanning, the acquired raw data m... Class II Toshiba American Medical Systems Inc
May 8, 2015 Toshiba Aquilion CT System TSX-303A If two specific operations are performed in multi-phase helical scanning, the acquired raw data m... Class II Toshiba American Medical Systems Inc
May 8, 2015 Toshiba Aquilion CT System TSX-301C If two specific operations are performed in multi-phase helical scanning, the acquired raw data m... Class II Toshiba American Medical Systems Inc
May 6, 2015 D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA ... Firm discovered that incorrect Instructions for Use were shipped with one lot of D2-40. Class III Biocare Medical, LLC
May 5, 2015 Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. F... The product failed to meet the internal established statistical test requirement for heparin acti... Class II Edwards Lifesciences, LLC
Apr 28, 2015 RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product U... Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's ... Class III Acclarent, Inc.
Apr 20, 2015 98" (249 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon ... ICU Medical is recalling MicroClave T-Connectors because they have potential connection separatio... Class II ICU Medical, Inc.
Apr 20, 2015 119" (302 cm) Transfer Set w/MicroClave T-Connector, Smallbore Quadfuse Ext S... ICU Medical is recalling MicroClave T-Connectors because they have potential connection separatio... Class II ICU Medical, Inc.
Apr 20, 2015 108" (274 cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon... ICU Medical is recalling MicroClave T-Connectors because they have potential connection separatio... Class II ICU Medical, Inc.
Apr 20, 2015 127" (323cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon ... ICU Medical is recalling MicroClave T-Connectors because they have potential connection separatio... Class II ICU Medical, Inc.
Apr 20, 2015 104" (264 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Smallbore T... ICU Medical is recalling MicroClave T-Connectors because they have potential connection separatio... Class II ICU Medical, Inc.
Apr 20, 2015 113" (287cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon ... ICU Medical is recalling MicroClave T-Connectors because they have potential connection separatio... Class II ICU Medical, Inc.
Apr 20, 2015 107" (272 cm) Ext Set w/2 Check Valves, MicroClave T-Connector, Clamp, Rotati... ICU Medical is recalling MicroClave T-Connectors because they have potential connection separatio... Class II ICU 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.