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 6, 2026.
2,908of 2,908 medical device recallsshown with your filters
The list
- Medical device recall Welch Allyn CONNEX Accessory Power Management Stand There were customer reports of devices which experienced battery-related fires. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Welch Allyn CP150 Electrocardiograph There were customer reports of devices which experienced battery-related fires. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel The devices are missing the laser marked depth markings. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Indiana, Maine and Minnesota named
- Medical device recall Welch Allyn Connex Integrated Wall System Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Welch Allyn Welch Allyn Connex Spot Monitor Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Welch Allyn Connex Vital Signs Monitor Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Welch Allyn Spot Vital Signs 4400 Device Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Welch Allyn Green Series 777 Wall System Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff labeled as: 1) WELCH ALLYN… Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1 Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall restor3d Cordera Hip System The hip cup liner that was packaged with the incorrect labeling. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Nevada and Tennessee named
- Medical device recall HeartMate Mobile Power Unit Left Ventricular Assist System Mobile Power Unit (MPU) may have electrical component that may cause MPU not to turn on, unprompted shut down, or turning… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedApr 23, 2025ClassClass IStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Maquet VH-3010 Power Supply Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro 2 to not adequately heat up. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Texas, Utah, Virginia, Wisconsin and West Virginia named
- Medical device recall Brand Name: Rover Product Name: Mobile X-ray System Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide, and California, New Jersey and Puerto Rico named
- Medical device recall Brand Name: Rover Product Name: Mobile X-ray System Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load on the anode. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide, and California, New Jersey and Puerto Rico named
- Medical device recall Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Due to evaporator gasket not sealing which can cause liquid nitrous oxide to drip/leak from the bottom of the device handle during treatment or after treatment… Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maryland, Missouri, North Carolina, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island, Tennessee and Texas named
- Medical device recall Medline Convenience kits used for various procedures: 1) INTUBATION TRAY There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience kits used for various procedures: 1) PAIN PACK There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience kits used for various procedures: 1) CUSTOM BLOCK KEMP PACK-LF There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience kits used for various procedures: 1) ANGIO CONSOLIDATED PACK There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience kits used for various procedures: 1) ANGIOGRAPHY DRAPE PACK There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience kits used for various procedures: 1) DR There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience kits used for various procedures: 1) LINE INSERTION PACK There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience kits used for various procedures: 1) LARGE BIOPSY PACK NTX There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience kits used for various procedures: 1) DENTAL PACK-LF There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience kits used for various procedures: 1) T A PACK There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Refer to RES There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience kits used for various procedures: 1) T&A ENDO PACK There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience kits used for various procedures: 1) OCULOPLASTIC PICK PACK There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience kits used for various procedures: 1) MINOR BASIN -SMH There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Refer to RES There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience kits used for various procedures: 1) PRECIP TRAY There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience kits used for various procedures: 1) IV PACK SOUTH There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience kits used for various procedures: 1) NAIL PACK There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience kits used for various procedures: 1) SKIN LESION SET There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience kits used for various procedures: 1) CSTM PACEMAKER DRAPE PACK There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience kits used for various procedures: 1) UNIVERSAL DRAPE PACK There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience kits used for various procedures: 1) HERNIA REPAIR TOTE There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience kits used for various procedures: 1) NEURO PACK WRO-LF There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience kits used for various procedures: 1) LABOR AND DELIVERY PACK-LF There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass 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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