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
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.