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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.