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 6, 2026.
2,477of 2,477 medical device recallsshown with your filters
The list
- Medical device recall LINK SLED Knee System: ENDO Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System ENDO Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System ENDO Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System ENDO Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System ENDO Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System ENDO Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System ENDO Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System ENDO Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System ENDO Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System ENDO Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System ENDO Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, SMALL Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM SMALL Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, LARGE Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System POREX ENDO Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System POREX ENDO Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System POREX ENDO Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System POREX ENDO Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System POREX ENDO Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System POREX ENDO Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System POREX ENDO Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System POREX ENDO Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System POREX ENDO Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System POREX ENDO Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System POREX ENDO Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System POREX ENDO Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall VITROS XT 7600 Integrated System - For use in the in vitro quantitative, semi-quantitative, and qualitative… MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS¿ 5600 and XT 7600 Integrated Systems, results may be delayed… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitative… MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS¿ 5600 and XT 7600 Integrated Systems, results may be delayed… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall VITROS 5600 Integrated System - Refurbished MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS¿ 5600 and XT 7600 Integrated Systems, results may be delayed… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard. Class IIFDA’s classMay 10, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Input Output Module (IOM) FLX-201-Laboratory Automation system Brand names of the same product: FlexLab… Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Class IIFDA’s classMay 10, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Storage and Retrieval Module (SRM)-Laboratory Automation system Brand names of the same product: FlexLab… Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Class IIFDA’s classMay 10, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PVT Interface Module (PVT)-Laboratory Automation system Brand names of the same product: FlexLab (FLX),… Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Class IIFDA’s classMay 10, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Vesmatic Cube 80 Interface Module (VMC)-Laboratory Automation system Brand names of the same product: FlexLab… Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Class IIFDA’s classMay 10, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Alinity h Interface Module (HSQ)-Laboratory Automation system Brand names of the same product: FlexLab (FLX),… Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Class IIFDA’s classMay 10, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall (1) Carefusion V A portion of the two products were incorrectly marked (etched) and packaged resulting in a product mismatch. Class IIFDA’s classMay 3, 2023in FDA’s Enforcement Report36 statesnamed in where it went PublishedMay 3, 2023ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051 Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. Class IIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 3, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051 Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. Class IIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 3, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 8735.685 Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. Class IIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 3, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall FLEX. GRASP. FORCEPS 6.6FR WL 550MM, Product Number 8736.685 Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. Class IIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 3, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE SMALL JULIET Lateral Lumbar Ti-Life Plate, a component of the JULIET Ti Lateral Lumbar Cage, may disassemble during the preparation stage before implantation, or… Class IIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedMay 3, 2023ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Illinois, North Carolina, New Hampshire, Rhode Island, Texas and Virginia named
- Medical device recall HAMILTON-C6, REF: 160021 Software error causes, safety ventilation, in which ventilation continues in the “safety ventilation” mode with audible/visible alarm - patient inputs are not… Class IIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedMay 3, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Idaho, Kansas, Massachusetts, Missouri, North Carolina, New Mexico, Nevada, New York, Pennsylvania, South Carolina, Virginia and Wyoming named
- Medical device recall Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full… Mislabeled: Product is marked with GTIN # 04046955299592 however; the correct GTIN # is 04046955299607. Class IIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedMay 3, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Nebraska, New Hampshire, Ohio, Pennsylvania and Texas named
- Medical device recall Sterile surgical convenience kits: 1 The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. Class IIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 3, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida and Missouri named
- Medical device recall Sterile surgical convenience kits: 1 The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. Class IIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 3, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida and Missouri named
- Medical device recall Sterile surgical convenience kit: regard The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. Class IIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 3, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida and Missouri named
- Medical device recall Sterile surgical convenience kit: regard The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. Class IIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 3, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida and Missouri named
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.