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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Oct 17, 2014 | Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL R... | Product was improperly labeled leading to improper storage. | Class II | Mallinckrodt Manufacturing LLC |
| Oct 17, 2014 | Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapi... | An increase in false positive susceptible results on Rapid Neg BP Combo Panel Type 3 and Rapid Ne... | Class I | Siemens Healthcare Diagnostics, Inc. |
| Oct 17, 2014 | Rapid Neg Urine Combo Panel Type 1; Catalog number B 1017-167; Siemens Mater... | An increase in false positive susceptible results on Rapid Neg BP Combo Panel Type 3 and Rapid Ne... | Class I | Siemens Healthcare Diagnostics, Inc. |
| Oct 6, 2014 | UniCel DxC 600i SYNCHRON Access Clinical Analyzer, Catalog No. A25640, Instru... | Beckman Coulter is recalling the Small Form Factor Console PC (SFF PC) (B23083) for use with the ... | Class II | Beckman Coulter Inc. |
| Oct 6, 2014 | Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Us... | Beckman Coulter is recalling the Small Form Factor Console PC (SFF PC) (B23083) for use with the ... | Class II | Beckman Coulter Inc. |
| Oct 1, 2014 | Spline Twist Implant, HA 3.25mmD X 15mmL; Part No. 2135. Zimmer Dental Spl... | Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was pr... | Class II | Zimmer Dental Inc |
| Oct 1, 2014 | Tapered Screw-Vent Implant, MTX, 4.1mmD X 10mmL X 3.5mm Platform Part No. TS... | Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was pr... | Class II | Zimmer Dental Inc |
| Sep 30, 2014 | Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-li... | Firm has identified a small number of Oximetry Cables with crossed-internal wires. The effect on... | Class II | Masimo Corporation |
| Sep 23, 2014 | ArcPoint Labs 5 Panel Dip Drug Screen, Part No. APD-5M. The ArcPoint Labs ... | Ameditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpreta... | Class II | Ameditech Inc |
| Sep 23, 2014 | ArcPoint Labs 10 Panel Dip Screen (OXY), Part No. APD-10MO. The ArcPoint L... | Ameditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpreta... | Class II | Ameditech Inc |
| Sep 23, 2014 | ArcPoint Labs 10 Panel Dip Screen (BAR), Part No. APD-10M. The ArcPoint La... | Ameditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpreta... | Class II | Ameditech Inc |
| Sep 20, 2014 | Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. ... | TriVascular has identified select lots of Ovation Prime 29mm Aortic Body stent grafts that may be... | Class I | Trivascular, Inc |
| Sep 18, 2014 | EndoWrist Stapler 45 instrument for the da Vinci Si System Model Number: I... | Intuitive is issuing an urgent product notice to all users of the EndoWrist Stapler 45 to discont... | Class II | Intuitive Surgical, Inc. |
| Sep 18, 2014 | Calcitonin ELISA Kit, Code No. 7024, 7024BU. Intended use of this product ... | A potential issue with false high values. | Class II | Biomerica |
| Sep 17, 2014 | EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical... | Intuitive Surgical is initiating a voluntary correction relating to the labeling and software ass... | Class II | Intuitive Surgical, Inc. |
| Sep 17, 2014 | Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Gene... | A failure of a specific component may prevent the ventilators from operating on AC power or trans... | Class I | Respironics California 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.