Medical devices, 2014
Shortlist up to four to read them side by side.
3,059 medical device recalls FDA’s Enforcement Report published in 2014, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 7, 2026.
3,059of 3,059 medical device recallsshown with your filters
The list
- Medical device recall 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) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall 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) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Dengue IgG/IgM Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall 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) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall 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) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Salmonella typhi Antigen Test Card Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall 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) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Adenovirus Antigen Test Card Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Adeno/Rota Combo Test Card Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Legionella Test Card Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall 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) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Strep A Test Card Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Malaria pf Antigen Test Card Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Malaria pf Antigen Test Card Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Malaria pan Antigen Test Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Salmonella typhi/paratyphi Antigen Test Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Salmonella typhi IgG/IgM Duo Test Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Syphilis Test Card (Serum) Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Tuberculosis Antibody Test Card Serum Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Malaria pf/pan Antigen Test Card Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Dengue NS1 Antigen Test Card Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Dengue NS1 Ag/IgG/M Ab Duo Test Card Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Fecal Occult Blood Test Card Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall PSA Test Card (Serum) Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall PSA Test Card (Whole Blood) Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Fecal Occult Blood Test Strip Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Alcohol Test, Saliva Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Tramadol Test Card Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Tramadol Strip Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Drugs of Abuse Panel Test Device Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Amphetamine Strip Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Amphetamine Test Card Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Barbiturate Strip Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Barbiturate Test Card Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Benzodiazepine Strip Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Benzodiazepine Test Card Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Cocaine Strip Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Cocaine Test Card Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall EDDP Strip; LumiQuick. Santa Clara, CA 95054 Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall EDDP Test Card Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall MDMA/Ecstasy Strip Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall MDMA/Ecstasy Test Card Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Methadone Test Strip Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Methadone Test Card Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Methamphetamine Strip Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Methamphetamine Test Card Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Morphine Strip Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
- Medical device recall Morphine Test Card Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. Class IIFDA’s classApr 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 16, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Jersey, New York and Texas
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
Your shortlist0 of 4
Add one more to compare.