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 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. |
| 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 | Heart Mate II Pocket Controllers removed from packaging Product Usage: ... | Discovery of serious injuries and deaths associated with the process of changing from a primary S... | Class I | Thoratec Corporation |
| 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 | HeartMate II LVAD Pump and Pock Controller Kit; Product Usage: HeartMat... | Discovery of serious injuries and deaths associated with the process of changing from a primary S... | Class I | Thoratec Corporation |
| Mar 4, 2014 | HeartMate II System Controller Product Usage: HeartMate II is a mechanica... | Discovery of serious injuries and deaths associated with the process of changing from a primary S... | Class I | Thoratec Corporation |
| 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. |
| Mar 3, 2014 | Morph AccessPro Steerable Introducer; 6F Introducer, 45 cm working length S... | Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable I... | Class II | Biocardia, Inc. |
| Mar 3, 2014 | FIBERNET Embolic Protection System: Recommended Vessel Diameter 3.5 0 5.0 mm... | Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System... | Class II | Medtronic Vascular, 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.