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 |
|---|---|---|---|---|
| Apr 1, 2017 | Healon Pro, Part No. 10270012 | Remote possibility that certain solutions in these lots may contain microscopic glass particles d... | Class II | Abbott Medical Optics Inc. (AMO) |
| Apr 1, 2017 | Healon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014 | Remote possibility that certain solutions in these lots may contain microscopic glass particles d... | Class II | Abbott Medical Optics Inc. (AMO) |
| Mar 31, 2017 | da Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument; PN 480299-03; and ... | Intuitive Surgical has become aware that in specific scenarios with system software P6 and the da... | Class II | Intuitive Surgical, Inc. |
| Mar 30, 2017 | Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: T... | Medtronic is issuing a voluntary field corrective action for all its Newport" HT70 and Newport" H... | Class I | Newport Medical Instruments Inc |
| Mar 30, 2017 | HeartMate¿ II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PC... | St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with ne... | Class I | Thoratec Corporation |
| Mar 30, 2017 | If Hip, Sterile Polar Dressing P/N 10680 Product Usage: These products ar... | They may not have been sealed prior to sterilization. Products with unsealed pouches will be non... | Class II | Breg Inc |
| Mar 30, 2017 | HeartMate¿ II LVAS with Pocket Controller; 106762 - HMII POCKET CONTROLLER,... | St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with ne... | Class I | Thoratec Corporation |
| Mar 30, 2017 | HeartMate¿ II LVAS with Pocket Controller; 107801 - HMII PUMP & POCKET CTRL... | St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with ne... | Class I | Thoratec Corporation |
| Mar 30, 2017 | AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cut... | Packaging error. 20GA Vitrectomy Cutters may be found in a 25GA package and 25GA Vitrectomy Cut... | Class II | Abbott Medical Optics Inc. (AMO) |
| Mar 30, 2017 | Dressing Rect L, P/N 02428 Product Usage: These products are sterile dres... | They may not have been sealed prior to sterilization. Products with unsealed pouches will be non... | Class II | Breg Inc |
| Mar 30, 2017 | Dressing Shldr, P/N 04908 Product Usage: These products are sterile dress... | They may not have been sealed prior to sterilization. Products with unsealed pouches will be non... | Class II | Breg Inc |
| Mar 30, 2017 | 18L6 HD transducer on the ACUSON S Family ultrasound systems with software ve... | When scanning with the 18L6 HD transducer on the ACUSON HELX" Evolution with Touch Control, the u... | Class II | Siemens Medical Solutions USA, Inc. |
| Mar 30, 2017 | Dressing Knee/Shldr, P/N 02328 Product Usage: These products are sterile ... | They may not have been sealed prior to sterilization. Products with unsealed pouches will be non... | Class II | Breg Inc |
| Mar 30, 2017 | Dressing Back, P/N 09810 Product Usage: These products are sterile dressi... | They may not have been sealed prior to sterilization. Products with unsealed pouches will be non... | Class II | Breg Inc |
| Mar 30, 2017 | Dressing, Knee L/XL, P/N 04708 Product Usage: These products are sterile ... | They may not have been sealed prior to sterilization. Products with unsealed pouches will be non... | Class II | Breg Inc |
| Mar 30, 2017 | Dressing M/U XL, P/N 02344 Product Usage: These products are sterile dres... | They may not have been sealed prior to sterilization. Products with unsealed pouches will be non... | Class II | Breg Inc |
| Mar 30, 2017 | Dressing Shldr XL, P/N 04918 Product Usage: These products are sterile dr... | They may not have been sealed prior to sterilization. Products with unsealed pouches will be non... | Class II | Breg Inc |
| Mar 29, 2017 | Refinity Rotational Intravascular Ultrasound (IVUS) Catheter; Product number... | High complaint rates of kinking near the junction of the proximal shaft to telescope section of t... | Class II | Volcano Corporation |
| Mar 29, 2017 | Refinity Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter; Prod... | High complaint rates of kinking near the junction of the proximal shaft to telescope section of t... | Class II | Volcano Corporation |
| Mar 28, 2017 | 216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frame... | Mizuho has discovered that the 5319-37 Wilson Frame Pads have a design deficiency in the construc... | Class II | Mizuho OSI |
| Mar 23, 2017 | Toshiba Medical Radrex - i Digital Radiography X-ray system Radrex-i is in... | It was discovered during a procedure that when the operator made an exposure on the wireless x-ra... | Class II | Toshiba American Medical Systems |
| Mar 22, 2017 | Wingman 35 Crossing Catheter, 65cm, Model Numbers: WGM35065US WGM35065... | ReFlow Medical is recalling the Wingman 35 Crossing Catheter because it may be prone to tip detac... | Class I | ReFlow Medical |
| Mar 22, 2017 | NC Tenku RX PTCA Balloon Catheter, Part No. 1012448-08T, 1012448-12T, 101244... | Products from the identified lots may exhibit difficulty in removing the protective balloon sheat... | Class I | Abbott Vascular |
| Mar 22, 2017 | NC Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 1013152-15... | Products from the identified lots may exhibit difficulty in removing the protective balloon sheat... | Class I | Abbott Vascular |
| Mar 22, 2017 | NC Trek RX Coronary Dilatation Catheter, Part No. 1012448-06, 1012448-08, 101... | Products from the identified lots may exhibit difficulty in removing the protective balloon sheat... | Class I | Abbott Vascular |
| Mar 20, 2017 | Tapered SwissPlus Implant System, Model No. SPB10 | It was manufactured with the minor diameter of the internal thread that is below specification. | Class II | Zimmer Dental Inc |
| Mar 15, 2017 | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... | Intuitive Surgical has become aware and further investigation has determined that misinterpretati... | Class II | Intuitive Surgical, Inc. |
| Mar 15, 2017 | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... | Intuitive Surgical has become aware and further investigation has determined that misinterpretati... | Class II | Intuitive Surgical, Inc. |
| Mar 15, 2017 | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... | Intuitive Surgical has become aware and further investigation has determined that misinterpretati... | Class II | Intuitive Surgical, Inc. |
| Mar 15, 2017 | Toshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System Mo... | The issue was identified as a firmware problem with the generator. | Class II | Toshiba American Medical Systems Inc |
| Mar 15, 2017 | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... | Intuitive Surgical has become aware and further investigation has determined that misinterpretati... | Class II | Intuitive Surgical, Inc. |
| Mar 15, 2017 | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... | Intuitive Surgical has become aware and further investigation has determined that misinterpretati... | Class II | Intuitive Surgical, Inc. |
| Mar 15, 2017 | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... | Intuitive Surgical has become aware and further investigation has determined that misinterpretati... | Class II | Intuitive Surgical, Inc. |
| Mar 15, 2017 | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... | Intuitive Surgical has become aware and further investigation has determined that misinterpretati... | Class II | Intuitive Surgical, Inc. |
| Mar 15, 2017 | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... | Intuitive Surgical has become aware and further investigation has determined that misinterpretati... | Class II | Intuitive Surgical, Inc. |
| Mar 15, 2017 | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... | Intuitive Surgical has become aware and further investigation has determined that misinterpretati... | Class II | Intuitive Surgical, Inc. |
| Mar 15, 2017 | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... | Intuitive Surgical has become aware and further investigation has determined that misinterpretati... | Class II | Intuitive Surgical, Inc. |
| Mar 15, 2017 | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... | Intuitive Surgical has become aware and further investigation has determined that misinterpretati... | Class II | Intuitive Surgical, Inc. |
| Mar 15, 2017 | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... | Intuitive Surgical has become aware and further investigation has determined that misinterpretati... | Class II | Intuitive Surgical, Inc. |
| Mar 15, 2017 | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... | Intuitive Surgical has become aware and further investigation has determined that misinterpretati... | Class II | Intuitive Surgical, Inc. |
| Mar 15, 2017 | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... | Intuitive Surgical has become aware and further investigation has determined that misinterpretati... | Class II | Intuitive Surgical, Inc. |
| Mar 15, 2017 | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... | Intuitive Surgical has become aware and further investigation has determined that misinterpretati... | Class II | Intuitive Surgical, Inc. |
| Mar 15, 2017 | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number... | Intuitive Surgical has become aware and further investigation has determined that misinterpretati... | Class II | Intuitive Surgical, Inc. |
| Mar 13, 2017 | Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Proble... | The Pause function on central monitors will not automatically resume when connected to a Life Sco... | Class II | Nihon Kohden America Inc |
| Mar 10, 2017 | Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C | Beckman Coulter is recalling the Access Ferritin Calibrators kit because it contains a calibratio... | Class II | Beckman Coulter Inc. |
| Mar 7, 2017 | Access 2 Immunoassay Systems, Part No. 81600N Product Usage: The Access 2... | Beckman Coulter is recalling the Access 2 Family of Immunoassay Systems because a circuit board t... | Class II | Beckman Coulter Inc. |
| Mar 7, 2017 | UniCel DxC 600i SYNCHRON Access Clinical System, Part No. A25637, A25638 P... | Beckman Coulter is recalling the Access 2 Family of Immunoassay Systems because a circuit board t... | Class II | Beckman Coulter Inc. |
| Mar 7, 2017 | Access 2 assay Immunoassay System, Remanufactured, Part No. 386220 Product... | Beckman Coulter is recalling the Access 2 Family of Immunoassay Systems because a circuit board t... | Class II | Beckman Coulter Inc. |
| Mar 3, 2017 | ImplantDirect, Dental implants intended for use in partially and fully edentu... | The main vial label lists the incorrect part number, but the cap label is correct. | Class II | Implant Direct Sybron Manufacturing, LLC |
| Feb 27, 2017 | Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Nu... | Medtronic is initiating a voluntary Urgent Medical Device Recall for a subset of Endurant/ Endura... | Class II | Medtronic Vascular, 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.