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 6, 2014 Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate... AMO has received complaints where the finger grip dislodged while depressing the syringe plunger.... Class II Abbott Medical Optics Inc (AMO)
Nov 5, 2014 Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A ... Potential problem with the cardiac function analysis software (CFA). Incorrect analysis results ... Class II Toshiba American Medical Systems Inc
Nov 5, 2014 Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A ... Potential problem with the cardiac function analysis software (CFA). Incorrect analysis results ... Class II Toshiba American Medical Systems Inc
Nov 4, 2014 STERRAD 50, Product Code 10114. The STERRAD Cassettes are used on STERRAD ... Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak i... Class II Advanced Sterilization Products
Nov 4, 2014 STERRAD 100NX, Product Code 10144 The STERRAD Cassettes are used on STERRA... Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak i... Class II Advanced Sterilization Products
Nov 4, 2014 STERRAD 100S, Product Code 10113. The STERRAD Cassettes are used on STERRA... Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak i... Class II Advanced Sterilization Products
Nov 4, 2014 STERRAD 200, Product Code 10118 The STERRAD Cassettes are used on STERRAD ... Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak i... Class II Advanced Sterilization Products
Nov 4, 2014 STERRAD NX, Product Code 10133 The STERRAD Cassettes are used on STERRAD S... Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak i... Class II Advanced Sterilization Products
Nov 4, 2014 Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets; Paradigm Si... Tubing may detach at the connect/disconnect location on the MiniMed Silhouette and MiniMed Sure-T... Class II Medtronic MiniMed Inc.
Nov 3, 2014 8MM, LARGE HEM-O-LOK CLIP APPLIER; Intended to assist in the accurate cont... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM, ATRIAL RETRACTOR SHORT RIGHT ; Intended to assist in the accurate con... Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM FENESTRATED BIPOLAR FORCEPS,; Intended to assist in the accurate contr... Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM,PROGRASP FORCEPS; Intended to assist in the accurate control of Intuit... Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM, SMALL GRASPING RETRACTOR ; Intended to assist in the accurate control... Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM PERMANENT CAUTERY SPATULA,; Intended to assist in the accurate control... Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM,LARGE NEEDLE DRIVER; Intended to assist in the accurate control of Int... Deviations in reprocessing steps from those stated in the reprocessing instructions, can cause su... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM,BLACK DIAMOND MICRO FORCEPS; Intended to assist in the accurate control ... Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM, CURVED BIPOLAR DISSECTOR; Intended to assist in the accurate control ... Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM,MEDIUM-LARGE CLIP APPLIER ; Intended to assist in the accurate control... Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM, DUAL BLADE RETRACTOR; Intended to assist in the accurate control of I... Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM,MARYLAND BIPOLAR FORCEPS; Intended to assist in the accurate control o... Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM, MEGA SUTURECUT ND; Intended to assist in the accurate control of Intu... Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM MONOPOLAR CURVED SCISSORS; Intended to assist in the accurate control... Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM, TENACULUM FORCEPS; Intended to assist in the accurate control of Intu... Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM, TIP-UP FENESTRATED GRASPER; Intended to assist in the accurate contro... Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM,LONG TIP FORCEPS; Intended to assist in the accurate control of Intuit... Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM,POTTS SCISSORS; Intended to assist in the accurate control of Intuitiv... Deviations in reprocessing steps from those stated in the reprocessing instructions, can cause su... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM, CARDIAC PROBE GRASPER; Intended to assist in the accurate control of ... Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM PERMANENT CAUTERY HOOK,; Intended to assist in the accurate control of... Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM,MICRO BIPOLAR FORCEPS; Intended to assist in the accurate control of I... Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... Class II Intuitive Surgical, Inc.
Nov 3, 2014 8MM RESANO FORCEPS,; Intended to assist in the accurate control of Intuiti... Deviations in reprocessing steps from those stated in the reprocessing instructions can cause sur... Class II Intuitive Surgical, Inc.
Oct 31, 2014 CyberKnife Robotic Radiosurgery System with the first generation IRIS Variabl... Software upgrade to correct potential safety issue related to CyberKnife System that occurs when ... Class II Accuray Incorporated
Oct 29, 2014 Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V... If the power supply fan mounting screws are installed incorrectly, the ends of the screws may tou... Class II Respironics California Inc
Oct 24, 2014 Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivi... Product sold after April 1, 2014 were inadvertently filled with hydrogen peroxide teeth whitening... Class II Discus Dental LLC
Oct 22, 2014 Target 360 Standard 12mm x 30cm; Target Detachable Coils are intended to e... Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers... Class II Stryker Neurovascular
Oct 22, 2014 GDC-18 360 20mm x 33cm ; GDC 360¿ Detachable Coils are intended for emboli... Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers... Class II Stryker Neurovascular
Oct 22, 2014 GDC-10 360 10mm x 30cm SR ; GDC 360¿ Detachable Coils are intended for emb... Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers... Class II Stryker Neurovascular
Oct 22, 2014 GDC-10 360 SOFT 3mm x 6cm SR ; GDC 360¿ Detachable Coils are intended for ... Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers... Class II Stryker Neurovascular
Oct 22, 2014 Gateway OTW 2.75mm x 9mm; The Gateway PTA balloon catheter is indicated fo... Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers... Class II Stryker Neurovascular
Oct 20, 2014 MAS CardioImmune XL Cardiac Marker Control; Model: CAI-XL1; intended for ... MAS CardioImmune XL, level 1 (lot CXL16011), is showing vial-to-vial variation for the analytes C... Class II Microgenics Corporation
Oct 20, 2014 ASEPT 2000 ml Drainage Bag, Ref No. 622280 Product Usage: The ASEPT Drain... PFM Medical is recalling catheters and other medical devices because they may exceed USP limits f... Class II Pfm Medical Inc
Oct 20, 2014 ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT ... PFM Medical is recalling catheters and other medical devices because they may exceed USP limits f... Class II Pfm Medical Inc
Oct 20, 2014 Rapid Centesis Catheter, 5 Fr x 7 cm Catheter, Ref No. M7513 Product Usage... PFM Medical is recalling catheters and other medical devices because they may exceed USP limits f... Class II Pfm Medical Inc
Oct 20, 2014 Thoracentesis & Paracentesis Procedure Tray, Ref No. M7553, 850004 Product... PFM Medical is recalling catheters and other medical devices because they may exceed USP limits f... Class II Pfm Medical Inc
Oct 20, 2014 Veta Peritoneal Catheter Kit, Curled, Ref No. M7225 Product Usage: Veta P... PFM Medical is recalling catheters and other medical devices because they may exceed USP limits f... Class II Pfm Medical Inc
Oct 20, 2014 Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage... PFM Medical is recalling catheters and other medical devices because they may exceed USP limits f... Class II Pfm Medical Inc
Oct 20, 2014 ASEPT Peritoneal Drainage System, Ref No. P09080002 Product Usage: The pf... PFM Medical is recalling catheters and other medical devices because they may exceed USP limits f... Class II Pfm Medical Inc
Oct 20, 2014 6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage:The PFM CT P... PFM Medical is recalling catheters and other medical devices because they may exceed USP limits f... Class II Pfm Medical Inc
Oct 20, 2014 ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P090800... PFM Medical is recalling catheters and other medical devices because they may exceed USP limits f... Class II Pfm Medical Inc
Oct 19, 2014 ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D13... The recall was initiated because Biosense Webster is providing additional labeling for the safe a... Class II Biosense Webster, 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.