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 | 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 | Morphine Strip (300); 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 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 | Dengue IgG/IgM; 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 Ab 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 | Malaria pf/pan 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 | Malaria pf 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 | 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 | Malaria pf Antigen Test Card; Flumiquil, 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 (300); 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 (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 | Legionella 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 | THC 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 | Methadone 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 | Methylphenidate 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 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 | Salmonella typhi 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 | Tramadol 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 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 | Dengue NS1 Ag/IgG/M Ab Duo 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 | Methylphenidate 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 | Oxycodone 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 | Ketamine 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 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 | EDDP 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 | Morphine Strips (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 | Cocaine 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 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 | Benzodiazepine 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 | Adenovirus 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. |
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.