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 Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20 Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida, Illinois, Indiana, Massachusetts, Mississippi, Nevada, Ohio, Tennessee, Texas and Washington named
- Medical device recall IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers… Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit lots; control level one may result outside of published ranges;… Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IMMULITE 2000 Thyroglobulin (OUS) Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit lots; control level one may result outside of published ranges;… Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR All lots of BIOSTOP G Bioresorbable Cement Restrictor are being removed as a precautionary measure because tested endotoxin levels were higher than recommended… Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall cobas infinity central lab, Material Number 07154003001 A complaint investigation revealed that an incorrect behavior relating to the rejection of orders capability of the Host Connectivity Agent (HCA) could occur… Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall RadiaLux Lighted Retractor (Pink) Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection. Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE Specific lots of FLXfit implants have internal components that may have been manufactured using stainless steel rather than the specified titanium alloy. Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation The product is labeled with the incorrect expiration date. Class IIFDA’s classJan 18, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 18, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall 9 Gauge Disposable Trocars with Blunt Pushers for Use with Subcutaneous Implants No expiration dates printed on the packaging Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Programmable Diagnostic Computer The firm will be performing a software update to address a software error which affects the listed products. Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system An app, part of a continuous glucose monitoring system, for use with smartphone devices may automatically log out from CareLink, then the app is not able to… Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall BECKMAN COULTER IRISpec CA/CB/CC control Beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB glucose control false positive results when used… Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedJan 11, 2023ClassClass IIStatusOngoingWherePuerto Rico
- Medical device recall VERIFY Dual Species Self-Contained Biological Indicators, 50 per box Biological indicator (BI) used to promote growth of the G. Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Biological indicator (BI) used to promote growth of the G. Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VERIFY Steam Test Pack Biological indicator (BI) used to promote growth of the G. Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VERIFY Steam Test Pack Biological indicator (BI) used to promote growth of the G. Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight Packaging sterile barrier has been compromised. Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall API LISTERIA 10 STRIPS+10 MEDIA 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 API 20 E 25 STRIPS 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 API 20 C AUX 25 STRIPS+25 MEDIA 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 API STAPH 25 STRIPS+25 MEDIA 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 VITEK 2 REAGENT GN TEST KIT VTK2 20 CARDS 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 VITEK 2 REAGENT GP TEST KIT VTK2 20 CARDS 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 VITEK 2 REAGENT YST TEST KIT VTK2 20 CARDS 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 VITEK 2 REAGENT BCL TEST KIT VTK2 20 CARDS 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 VITEK 2 REAGENT NH TEST KIT VTK2 20 CARDS 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 VITEK 2 REAGENT AST-GP67 TEST KIT 20 CARDS 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 PREVI COLOR GRAM REAGENT IODINE-B (NA) 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 PREVI COLOR GRAM REAGENT NOZZLE CLEANING SOLUTION (NA) 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 CLINICALVIDAS VARICEL 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 MEASLES IGG 60TESTS 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 RUB IGG 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 LISTERIA 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 VIDAS CLINICAL VIDAS SALMONELLA 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 VIDAS CLINICAL QCV-QUALITY CONTROL VIDAS 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 PPM CLINICAL CRAPONNE CLINICAL CHROMID CANDIDA 20 PLATES 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 CLINICAL CHROMID MRSA 20 PLT 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 PPM CLINICAL CRAPONNE CHROMID VRE 20 PLT 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 PPM CLINICAL CRAPONNE CHROMID C.DIFFICILE 20 PLT 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 BIOBALL A.BRASILIENSIS NCPF 2275 550X20 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 BIOBALL B.SPIZIZENII NCTC 10400 550X20 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 BIOBALL P.AERUGINOSA NCTC 12924 550X20 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 API VP1 VP2 REAGENTS 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 API NIT1 NIT2 REAGENTS 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 API JAMES 2AMP 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 TEMPO REAGENTS TEMPO CONTROL KIT 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 ASTUTE REAGENT ASTUTE ELECTRONIC QUALITY CTRL DEVICE 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 PPM INDUSTRY COMBOURG LPT BROTH 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
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.