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 ARTHROSCOPY SUP JOI PACK Procedure tray Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ARTHO KNEE BAPTIST SOUTH PACK Procedure tray Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ARTHRO KNEE BEACHES PACK BHS- Procedure tray Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BPKN15C KNEE BASIN PACK BHS- Procedure tray Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall FOOT ANKLE-LF Procedure tray Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HAND WRIST FOREARM-LF Procedure tray Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall KNEE SCOPE Procedure tray Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall UPPER EXTREMITY PK, STRL F G Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ACL, ST LUKES METHODIST 1CS Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TOTAL KNEE, ST LUKES Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall KNEE ARTHROSCOPY PACK Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall KNEE ARTHROSCOPY-Procedure Kit Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TOTAL KNEE -Procedure Kit Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TOTAL KNEE -Procedure Kit Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HAND PACK 297829--Procedure Kit Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TOTAL KNEE - 297835-Procedure Kit Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TOTAL KNEE - 297835 -Procedure Kit Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall KNEE ARTHROSCOPY PACK-Procedure Kit Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TOTAL KNEE-Procedure Kit Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HAND DRAPING SJH-Procedure Kit Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall KNEE ARTHROSCOPY-Procedure Kit Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TOTAL KNEE-Procedure Kit Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ARTHROSCOPY PACK-Procedure Kit Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ARTHROSCOPY PACK-Procedure Kit Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TPK ANTERIOR HIP PACK 176483-Procedure Kit Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ACL PACK - 206039-Procedure Kit Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CUSTOM KNEE - 206061-Procedure Kit Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CUSTOM KNEE - 206061-Procedure Kit Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ORIF HIP - IM RODDING FEMUR-Procedure Kit Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HAND PACK-Procedure Kit Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HAND PACK-Procedure Kit Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall KNEE ARTHROSCOPY PACK-Procedure Kit Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VidiaPort carrying arm, mount for auxiliary products Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Trulight 5000/3000 Surgical Light Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall iLED 7 surgical lights Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Vivid Ultrasound products GE HealthCare has become aware of an issue with certain Vivid ultrasound systems where, due to a slow DICOM Worklist response time, incorrect patient name and… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement Report5 statesnamed in where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereIllinois, Massachusetts, New Mexico, New York and Oklahoma
- Medical device recall GE Vivid Ultrasound products GE HealthCare has become aware of an issue with certain Vivid ultrasound systems where, due to a slow DICOM Worklist response time, incorrect patient name and… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement Report5 statesnamed in where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereIllinois, Massachusetts, New Mexico, New York and Oklahoma
- Medical device recall 9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction with an… Due to incorrect milled titanium abutment being packaged and labeled. Class IIFDA’s classJul 17, 2024in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereCalifornia, Missouri and Nevada
- Medical device recall Non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners… Firm received complaints regarding skin irritation when using the gloves, disintegration of the gloves when used with certain cleaning solutions, and… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Colorado, Florida, Georgia, Michigan, Nebraska, New York and Pennsylvania named
- Medical device recall Welch Allyn CP150 Electrocardiograph with Spirometry Option During manufacturing, the step to install an Electromagnetic Interference (EMI) Absorber was omitted. Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedJul 17, 2024ClassClass IIStatusOngoingWhereIllinois
- Medical device recall ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator (AED) is designed for… G5 Semi-Automatic AED is shipped, with a protective film over its front panel, to protect the screen and shock button from cosmetic damage during shipping. Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Kosmos on iOS impacting iOS Ultrasound system has a bug in affected iOS software, which after DICOM export, can cause inaccuracy in postprocessed measurements done in 3rd party software,… Class IIFDA’s classJul 17, 2024in FDA’s Enforcement Report32 statesnamed in where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereAlaska, Alabama, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Tennessee, Texas, Utah, Vermont, Washington and Wisconsin
- Medical device recall Decompression Table This product is being recalled due to potentially insufficient rework on a part (E7130-B) on the lumbar section of the frame on 6 distributed tables. Class IIFDA’s classJul 17, 2024in FDA’s Enforcement Report6 statesnamed in where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereCalifornia, Florida, Georgia, Idaho, Tennessee and Texas
- Medical device recall Presource kits and trays, labeled as: 1) ANGIOGRAPHY PACK Cardinal Health is following the FDA’s recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Presource kits and trays, labeled as: 1) Cardiac Catheterization Kit Cardinal Health is following the FDA’s recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Presource kits and trays, labeled as: 1) Cardiovascular Procedure Kit Cardinal Health is following the FDA’s recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Presource kits and trays, labeled as: 1) Neurological Tray Cardinal Health is following the FDA’s recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Class IIFDA’s classJul 17, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AURORA Surgiscope System Potential sheath damage that could lead to tissue damage and/or track hemorrhage. Class IIFDA’s classJul 17, 2024in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 17, 2024ClassClass IIStatusOngoingWhereDistrict of Columbia, New York and Ohio
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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