Medical devices, 2025
Shortlist up to four to read them side by side.
2,908 medical device recalls FDA’s Enforcement Report published in 2025, 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.
2,908of 2,908 medical device recallsshown with your filters
The list
- Medical device recall epoc NXS Host Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that… Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall epoc NXS Host Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that… Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall epoc NXS Host Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that… Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall epoc NXS Host Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that… Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Galaxy System (GAL-001) Bronchoscopic visualization system power supplies have defective semiconductor components that may fail unexpectedly, which could result in an aborted… Class IIFDA’s classJan 1, 2025in FDA’s Enforcement Report15 statesnamed in where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereCalifornia, Connecticut, Idaho, Indiana, Massachusetts, Maryland, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee and West Virginia
- Medical device recall Clarity Precision Grip Attachments, for use in orthodontic treatment Attachments may not mate with the tooth as intended in the digital treatment design. Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TEMA Elbow - Axle Small Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery. Class IIFDA’s classJan 1, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereFlorida and Texas
- Medical device recall FACSLyric 2L4C Instrument US On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number… Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall Device Description: FACSLyric 2L6C Instrument US On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number… Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall FACSLyric 3L8C Instrument US-IVD On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number… Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall FACSLyric 3L10C Instrument US-IVD On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number… Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall FACSLyric 3L12C Instrument RUO On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number… Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall BYTE Aligner System Virtual-only clinical workflow utilized for dental aligners and impression to approve patients for aligner devices may not be suitable for patients who have… Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate. Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Florida, Georgia, Pennsylvania, Texas and Virginia named
- Medical device recall Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small Stature, T25 Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate. Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Florida, Georgia, Pennsylvania, Texas and Virginia named
- Medical device recall The Merlin PCS 3650 programmer Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific sequence of programmer actions combined with a loss of… Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall STERILE STRT KELLY HEMOSTAT (SK8039S), Medline Weak seals may result in a breach of sterility, which may not be detectable to the user. Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall O.R. SCISSORS, S/B, 5.5 STERILE, Medline Item No. DYND04000 Weak seals may result in a breach of sterility, which may not be detectable to the user. Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ST OR MAYO HEGAR NEEDLEHOLDER 6”(OR2500), Medline Weak seals may result in a breach of sterility, which may not be detectable to the user. Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STERILE MAGILL FORCEP (MAGF9), Medline Weak seals may result in a breach of sterility, which may not be detectable to the user. Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ST REPROCESSED BRUNS CURETTE #00 (BC00), Medline Weak seals may result in a breach of sterility, which may not be detectable to the user. Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ST IUD REMOVAL HOOK 10” Weak seals may result in a breach of sterility, which may not be detectable to the user. Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall RUMMELL, Medline Weak seals may result in a breach of sterility, which may not be detectable to the user. Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product. Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Indiana, Kansas, New York, Texas and Washington named
- Medical device recall MISHA Knee System Implant Small, Left Knee implant may fracture due to a supplier-related issue with one component that has nonconforming geometry at the distal end of the absorber component that… Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, New York, Ohio, Oregon, Texas and Virginia named
- Medical device recall EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE 5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surgical delay to get a new product. Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Iowa, Illinois, Indiana, Maryland, Minnesota, New York, South Carolina, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Magnesium Flex reagent cartridge, 360 tests Siemens Healthcare Diagnostics is recalling two lots of their Dimension Vista¿ Total Magnesium (MG) Flex Reagent Cartridges (lots 24057BB and 24064BC) due to… Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126¿,… Error on the main label and the patient label. Class IIFDA’s classJan 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 1, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama and Florida 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.”
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