Medical devices, 2023
Shortlist up to four to read them side by side.
2,477 medical device recalls FDA’s Enforcement Report published in 2023, 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.
2,477of 2,477 medical device recallsshown with your filters
The list
- Medical device recall ASTUTE REAGENT NEPHROCHECK LIQUID CONTROLS KIT US As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ETEST CLINICAL COLISTIN CO 256 US B100 As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VIDAS CLINICAL VIDAS HCG 60 TESTS As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VIDAS CLINICAL VIDAS LH 60 TESTS As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VIDAS CLINICAL VIDAS PROGESTERONE 60 TESTS As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VIDAS CLINICAL VIDAS ESTRADIOL II 60 TESTS As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VIDAS CLINICAL VIDAS BRAHMS PROCALCITONIN 60T As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PPM INDUSTRY COMBOURG BACARA 20PLATES 90MM As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PPM LOMBARD PRODUCTS CT&IR&DB-TSA + L & P80 10PLT As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PPM LOMBARD PRODUCTS CT&TI-TSA + L & P80 10PLT As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PPM LOMBARD PRODUCTS TSA 10PLT As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PPM LOMBARD PRODUCTS R2A MEDIUM 10PLT As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PPM LOMBARD PRODUCTS IR&DB - TSA As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PPM LOMBARD PRODUCTS T PHOSPHATE BUFFERSTERILE 20X9ML As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact… Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPTH results- an average -12% shift in patient sample results Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Detect Covid-19 Test Product/Model Number: 21205 There is an increased chance that the tests from affected lots may give false negative results. Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ActiveAid 922, Shower/Commode Chair Device manufactured with a component with affects the foldability of the frame, not allowing it to be secured by the frame strap in the folded position. Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 11, 2023ClassClass IIStatusTerminatedWhereNationwide, and Texas named
- Medical device recall Various Custom Surgical Instrument Disposable Kits Due to Customer Convenience Kits containing 3M Steri-Drape Surgical Drapes that have been recalled by 3M Healthcare. Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Guam, Indiana, North Carolina, New Jersey, Nevada, Oklahoma, Pennsylvania, Tennessee, Texas and Wisconsin named
- Medical device recall Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical… Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low… Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Maine, Missouri, North Carolina, New Jersey, Ohio, Pennsylvania and Tennessee named
- Medical device recall Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on… Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low… Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Maine, Missouri, North Carolina, New Jersey, Ohio, Pennsylvania and Tennessee named
- Medical device recall Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on… Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low… Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Maine, Missouri, North Carolina, New Jersey, Ohio, Pennsylvania and Tennessee named
- Medical device recall DeRoyal Tonsillectomy Tray DeRoyal is recalling certain lots of surgical procedure pack products that contain a ConMed Foot Controlled Electrosurgical Suction Coagulator. Class IIFDA’s classJan 11, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 11, 2023ClassClass IIStatusTerminatedWhereSouth Carolina and Virginia
- Medical device recall Part Number/Part Description: 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose AM-0025-S 25.0mm Acutrak¿ 4/5… Distribution without Pre-Market Clearance Class IIFDA’s classJan 4, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 4, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Acutrak 2 Part Number/Part Description: 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 30-0021-S 25.0mm Acutrak 2¿ -… Distribution without Pre-Market Clearance Class IIFDA’s classJan 4, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 4, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall AcuTwist Acutrak Compression Screws Distribution without Pre-Market Clearance Class IIFDA’s classJan 4, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 4, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Dual-Trak Clavicle Screws Distribution without Pre-Market Clearance Class IIFDA’s classJan 4, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 4, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Remington MEDICAL, Automatic Cutting Needle, 18ga The stylet is longer than specified on the label Class IIFDA’s classJan 4, 2023in FDA’s Enforcement Report6 statesnamed in where it went PublishedJan 4, 2023ClassClass IIStatusTerminatedWhereAlabama, California, North Carolina, Pennsylvania, Texas and West Virginia
- Medical device recall Pilling Wecksorb Cylindrical Sponges Specific lots have not been irradiated to eliminate pyronema and therefore the sterility of the affected products may be compromised. Class IIFDA’s classJan 4, 2023in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 4, 2023ClassClass IIStatusTerminatedWhereIllinois, Mississippi, Pennsylvania and Tennessee
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.”
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