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 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.