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 |
|---|---|---|---|---|
| Mar 20, 2014 | On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type... | Varian has identified a failure with the shaft of the Type 01 elbow motor for Exact arms used in ... | Class II | Varian Medical Systems, Inc. |
| Mar 20, 2014 | Alere Triage BNP Test for the Beckman Coulter Access Family of Immunoassay Sy... | These lots may not recover within range when tested using certain commercially available controls. | Class II | Alere San Diego, Inc. |
| Mar 20, 2014 | FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for d... | Obsolete versions of the Laser Treatment Settings card for the Fraxel DUAL 1550/1927 Laser system... | Class II | Solta Medical, Inc. |
| Mar 19, 2014 | SmartSite Extension Set, Model No. 20029E, intravascular administration set. | Disconnections and leakages at the connection of the smallbore tubing and the SmartSite Y-port. | Class II | CareFusion 303, Inc. |
| Mar 14, 2014 | K-Lite Knee 2 Stays with Visco, Model No. 122015. Product Usage: The prod... | Breg is recalling the Economy Elastic Knee Sleeve Open and K-Lite Knee 2 Stays with Visco because... | Class II | Breg Inc |
| Mar 14, 2014 | Alcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation o... | Alcon LenSx received reports of unexpected downward motion of the gantry. | Class II | Alcon LenSx, Inc. |
| Mar 14, 2014 | Economy Elastic Knee Sleeve Open, Model No. 121414 and 121415. Product Usa... | Breg is recalling the Economy Elastic Knee Sleeve Open and K-Lite Knee 2 Stays with Visco because... | Class II | Breg Inc |
| Mar 13, 2014 | Medtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm models: MMT-5... | Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion Pumps because they have re... | Class II | Medtronic MiniMed Inc. |
| Mar 13, 2014 | 5X300 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, mode... | Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curv... | Class II | Intuitive Surgical, Inc. |
| Mar 13, 2014 | 5X250 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, mode... | Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curv... | Class II | Intuitive Surgical, Inc. |
| Mar 13, 2014 | 5X250 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, mode... | Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curv... | Class II | Intuitive Surgical, Inc. |
| Mar 13, 2014 | 5X300 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, mode... | Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curv... | Class II | Intuitive Surgical, Inc. |
| Mar 7, 2014 | Siemens Medical Solutions, ACUSON P300 Ultrasound system with P300 PA 230E c... | ACUSON P300 ultrasound systems using the PA230 transducer with a user-defined preset which includ... | Class II | Siemens Medical Solutions USA, Inc. |
| Mar 7, 2014 | Halogen Lamp component in RetCam 3 System - Clarity Medical Systems, Inc... | One lot of Halogen lamps have the potential to fail sooner than the expected life of the lamp whi... | Class II | Clarity Medical Systems Inc |
| Mar 4, 2014 | Methadone Test Strip; LumiQuick,. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... | Class II | LumiQuick Diagnostics Inc. |
| Mar 4, 2014 | PCP Test (Strip); LumiQuick, Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... | Class II | LumiQuick Diagnostics Inc. |
| Mar 4, 2014 | Alcohol Test, Urine; LumiQuick,. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... | Class II | LumiQuick Diagnostics Inc. |
| Mar 4, 2014 | THC Strip; LumiQuick,. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... | Class II | LumiQuick Diagnostics Inc. |
| Mar 4, 2014 | Adeno/Rota Combo Test Card; LumiQuick, Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... | Class II | LumiQuick Diagnostics Inc. |
| Mar 4, 2014 | Cocaine Strip; LumiQuick. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... | Class II | LumiQuick Diagnostics Inc. |
| Mar 4, 2014 | Myoglobin Test Card (Serum); LumiQuick,. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... | Class II | LumiQuick Diagnostics Inc. |
| Mar 4, 2014 | Syphilis Test Strip (Serum) LumiQuick, Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... | Class II | LumiQuick Diagnostics Inc. |
| Mar 4, 2014 | H. Pylori Antigen Test Card LumiQuick, Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... | Class II | LumiQuick Diagnostics Inc. |
| Mar 4, 2014 | HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm) w... | Discovery of serious injuries and deaths associated with the process of changing from a primary S... | Class I | Thoratec Corporation |
| Mar 4, 2014 | EDDP Strip; LumiQuick. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... | Class II | LumiQuick Diagnostics Inc. |
| Mar 4, 2014 | Cardiac Panel Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... | Class II | LumiQuick Diagnostics Inc. |
| Mar 4, 2014 | Rickettsia IgG/IgM Test Card LumiQuick, Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... | Class II | LumiQuick Diagnostics Inc. |
| Mar 4, 2014 | Salmonella typhi/paratyphi Antigen Test; LumiQuick. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... | Class II | LumiQuick Diagnostics Inc. |
| Mar 4, 2014 | Dengue NS1 Antigen Test Card; LumiQuick. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... | Class II | LumiQuick Diagnostics Inc. |
| Mar 4, 2014 | Oxycodone Test Card; LumiQuick,. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... | Class II | LumiQuick Diagnostics Inc. |
| Mar 4, 2014 | Buprenorphine Test Card; LumiQuick,. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... | Class II | LumiQuick Diagnostics Inc. |
| Mar 4, 2014 | Amphetamine Test Card; LumiQuick. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... | Class II | LumiQuick Diagnostics Inc. |
| Mar 4, 2014 | Strep A Test Card; LumiQuick, Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... | Class II | LumiQuick Diagnostics Inc. |
| Mar 4, 2014 | MDMA/Ecstasy Test Card; LumiQuick. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... | Class II | LumiQuick Diagnostics Inc. |
| Mar 4, 2014 | Fentanyl Test Card; LumiQuick,. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... | Class II | LumiQuick Diagnostics Inc. |
| Mar 4, 2014 | Fentanyl Test Strip; LumiQuick,. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... | Class II | LumiQuick Diagnostics Inc. |
| Mar 4, 2014 | Malaria pan Antigen Test; LumiQuick, Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... | Class II | LumiQuick Diagnostics Inc. |
| Mar 4, 2014 | MDMA/Ecstasy Strip; LumiQuick. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... | Class II | LumiQuick Diagnostics Inc. |
| Mar 4, 2014 | Barbiturate Test Card; LumiQuick. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... | Class II | LumiQuick Diagnostics Inc. |
| Mar 4, 2014 | Fecal Occult Blood Test Card; LumiQuick. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... | Class II | LumiQuick Diagnostics Inc. |
| Mar 4, 2014 | Cardiac Panel Test (Serum); LumiQuick,. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... | Class II | LumiQuick Diagnostics Inc. |
| Mar 4, 2014 | Benzodiazepine Test Card; LumiQuick. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... | Class II | LumiQuick Diagnostics Inc. |
| Mar 4, 2014 | K2 (synthetic Marijuana) Test card; LumiQuick,. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... | Class II | LumiQuick Diagnostics Inc. |
| Mar 4, 2014 | Myoglobin Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... | Class II | LumiQuick Diagnostics Inc. |
| Mar 4, 2014 | Troponin I test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... | Class II | LumiQuick Diagnostics Inc. |
| Mar 4, 2014 | Salmonella typhi IgG/IgM Duo Test; LumiQuick. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... | Class II | LumiQuick Diagnostics Inc. |
| Mar 4, 2014 | Alcohol Test, Saliva; LumiQuick. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... | Class II | LumiQuick Diagnostics Inc. |
| Mar 4, 2014 | Morphine Test Card (2000); LumiQuick, Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... | Class II | LumiQuick Diagnostics Inc. |
| Mar 4, 2014 | Drugs of Abuse Panel Test Device; LumiQuick. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... | Class II | LumiQuick Diagnostics Inc. |
| Mar 4, 2014 | CK-MB Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054 | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... | Class II | LumiQuick Diagnostics 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.