Medical devices, 2024
Shortlist up to four to read them side by side.
3,394 medical device recalls FDA’s Enforcement Report published in 2024, 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 6, 2026.
3,394of 3,394 medical device recallsshown with your filters
The list
- Medical device recall Shoulder, SESH18I ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide, and Massachusetts, Minnesota, Missouri, Nebraska and Ohio named
- Medical device recall Bilateral Tubal Ligation Pack, FHBT3T ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide, and Massachusetts, Minnesota, Missouri, Nebraska and Ohio named
- Medical device recall Paracentesis Thoracente, SLPT76H ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide, and Massachusetts, Minnesota, Missouri, Nebraska and Ohio named
- Medical device recall IR Procedure Pack, CEAT19W ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide, and Massachusetts, Minnesota, Missouri, Nebraska and Ohio named
- Medical device recall Neuro Vascular, ANKV91A ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide, and Massachusetts, Minnesota, Missouri, Nebraska and Ohio named
- Medical device recall Hand Pack, AKHD97C ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide, and Massachusetts, Minnesota, Missouri, Nebraska and Ohio named
- Medical device recall Vaginal Delivery, ASDV25B ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide, and Massachusetts, Minnesota, Missouri, Nebraska and Ohio named
- Medical device recall Cath Lab Pack, CECL02P ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide, and Massachusetts, Minnesota, Missouri, Nebraska and Ohio named
- Medical device recall Essentia MAJ Laparotomy Std Pack, ESLT53B ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide, and Massachusetts, Minnesota, Missouri, Nebraska and Ohio named
- Medical device recall ENT, COEN27N ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide, and Massachusetts, Minnesota, Missouri, Nebraska and Ohio named
- Medical device recall Nasal Sinus Pack, MTSN26B ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide, and Massachusetts, Minnesota, Missouri, Nebraska and Ohio named
- Medical device recall Cysto, FTCY03L ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide, and Massachusetts, Minnesota, Missouri, Nebraska and Ohio named
- Medical device recall Pacemaker, COPM11B ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide, and Massachusetts, Minnesota, Missouri, Nebraska and Ohio named
- Medical device recall LINK Universal Handle, with quick coupling, Stainless Steel, straight Some lots of the LINK Universal Handle, with quick coupling, Stainless Steel, straight may suffer an immediate material failure intraoperatively when the… Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide, and Florida, Kansas, Michigan, New Jersey and Virginia named
- Medical device recall BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility… Escherichia coli (E. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of… Escherichia coli (E. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and… Identified an issue with Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software when used in combination with C-View software in which the quality of… Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number… During a production process, Philips became aware of one IntelliVue power supply with a broken ground bolt upon disconnection of the ground cable from the… Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Biodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or… Products expire prior to the expiration date printed on the product labeling Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or… Products expire prior to the expiration date printed on the product labeling Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Biodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal or… Products expire prior to the expiration date printed on the product labeling Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or… Products expire prior to the expiration date printed on the product labeling Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Biodesign Fistula Plug C-FPS-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or… Products expire prior to the expiration date printed on the product labeling Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Biodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or… Products expire prior to the expiration date printed on the product labeling Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or… Products expire prior to the expiration date printed on the product labeling Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or… Products expire prior to the expiration date printed on the product labeling Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce soft tissue for repair of… Products expire prior to the expiration date printed on the product labeling Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue for repair of… Products expire prior to the expiration date printed on the product labeling Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce soft tissue for repair of… Products expire prior to the expiration date printed on the product labeling Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair… Products expire prior to the expiration date printed on the product labeling Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended… Due to a software issue, affected devices that are set up with High Pressure Oxygen (HPO), if the flow alignment alarm occurs, the device will deliver room air… Class IIFDA’s classOct 2, 2024in FDA’s Enforcement Report29 statesnamed in where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereArizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Dakota, Texas, Utah, Virginia and Washington
- Medical device recall eakin Cohesive seal, small On lot of cartons of Eakin Cohesive small seals, Model Number 839002 may contain blistered seals labelled as 839005. Class IIIFDA’s classOct 2, 2024in FDA’s Enforcement ReportKentuckythe one state its words name PublishedOct 2, 2024ClassClass IIIStatusOngoingWhereKentucky
- Medical device recall Stryker TMJ Unilateral Implant Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide, and Minnesota named
- Medical device recall WALLFLEX FC ESO STENT RMV 18X103MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent… WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall WALLFLEX FC ESO STENT RMV 18X123MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent… WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall WALLFLEX FC ESO STENT RMV 18X153MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent… WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall WALLFLEX FC ESO STENT RMV 23X105MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent… WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall WALLFLEX FC ESO STENT RMV 23X125MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent… WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall WALLFLEX FC ESO STENT RMV 23X155MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent… WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall WALLFLEX FC ESO STENT RMV LL 18X103- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent… WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall WALLFLEX FC ESO STENT RMV LL 23X105- Intended for maintaining esophageal luminal patency in esophageal… WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall WALLFLEX FC ESO STENT RMV LL 23X125-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent… WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall WALLFLEX FC ESO STENT RMV LL 23X155- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent… WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall WALLFLEX ESOPHAGEAL FC 18/23-25MMX10CM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC)… WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall WALLFLEX ESOPHAGEAL FC 18/23-25MMX12CM-- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC)… WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall WALLFLEX ESOPHAGEAL FC 18/23-25MMX15CM- Agile Esophageal Partially Covered and Fully Covered OTW Stent System… WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall WALLFLEX ESOPHAGEAL FC 23/28MMX10CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is… WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall WALLFLEX ESOPHAGEAL FC 23/28MMX12CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is… WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass 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.”
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