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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.