Browse Device Recalls

80 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 80 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 80 FDA device recalls.

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DateProductReasonClassFirm
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 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.
Mar 4, 2014 Syphilis 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 Card Whole Blood(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 Propoxyphene 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 Methamphetamine 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 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 H. Pylori Antibody 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 Rotavirus 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 Tramadol 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 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 Troponin I 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 CK-MB 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 PSA 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 Clonazepam 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 Ketamine 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 Tuberculosis Antibody 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.

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.