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 Intera 1.5T Omni/Stellar identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to… Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Delaware, Massachusetts, Michigan, Nebraska, New York and South Dakota named
- Medical device recall Intera Achieva 1.5T Pulsar identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to… Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Delaware, Massachusetts, Michigan, Nebraska, New York and South Dakota named
- Medical device recall SmartPath to dStream for 1.5T¿ identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to… Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Delaware, Massachusetts, Michigan, Nebraska, New York and South Dakota named
- Medical device recall BD BBL CultureSwab EZ Collection and Transport System Swabs for specimen collection may be prone to breakage during product usage. Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide, and Maryland named
- Medical device recall MUSE 5 Systems The MUSE Administrator Account active directory or local credential could potentially be used from your local network to log into a GE HealthCare MUSE 5 system… Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Femoral Nail, LEFT T2 GTN 8x300 mm Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was… Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide, and California and Missouri named
- Medical device recall Femoral Nail, RIGHT T2 GTN 8x300 mm Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was… Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide, and California and Missouri named
- Medical device recall Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood Product may have an off color affecting perfomance Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Georgia, Kentucky and Virginia named
- Medical device recall Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetella kit It was determined that there could be a false positive rate of up to 16.7% for the affected lots associated with the Bordetella parapertussis (BPP) results… Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Brand Name: Tecfen Medical Product Name: 15 degree Stab Knife Sterility assurance for Ophthalmic knives. Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide, and Connecticut and Minnesota named
- Medical device recall Brand Name: Tecfen Medical Product Name: 2.2mm Slit Knife, Angled Sterility assurance for Ophthalmic knives. Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide, and Connecticut and Minnesota named
- Medical device recall Brand Name: Tecfen Medical Product Name: 2.4mm Slit Knife, Angled Sterility assurance for Ophthalmic knives. Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide, and Connecticut and Minnesota named
- Medical device recall Brand Name: Tecfen Medical Product Name: 2.8mm Slit Knife, Angled Sterility assurance for Ophthalmic knives. Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide, and Connecticut and Minnesota named
- Medical device recall Brand Name: Tecfen Medical Product Name: 20G Sterility assurance for Ophthalmic knives. Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide, and Connecticut and Minnesota named
- Medical device recall Brand Name: Tecfen Medical Product Name: 2.0mm Crescent Knife Angled Bevel Up Sterility assurance for Ophthalmic knives. Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide, and Connecticut and Minnesota named
- Medical device recall Brand Name: Tecfen Medical Product Name: 3.2mm Slit Knife, Angled Sterility assurance for Ophthalmic knives. Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide, and Connecticut and Minnesota named
- Medical device recall Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution Contact lens insertion solution may lack sterility. Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Florida, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Michigan, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall KWIK-STICK, Quality control kit for culture media Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product containing the wrong microorganism. Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide, and California and Pennsylvania named
- Medical device recall 2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles The replacement rechargeable batteries inserted into the Welch Allyn PocketScope handles have the potential to cause a short circuit in the handle, which can… Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit Due to non-sterile products being labeled as sterile Class IIFDA’s classJun 18, 2025in FDA’s Enforcement Report20 statesnamed in where it went PublishedJun 18, 2025ClassClass IIStatusOngoingWhereAlabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Michigan, North Carolina, New York, Ohio, Oregon, Tennessee, Texas and Virginia
- Medical device recall Baxter Novum IQ Syringe Pump Baxter has identified a design issue which may cause the pump to detect the presence of a syringe flange when no syringe is loaded. Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall iBOT PMD with software version 01.05.24 Software issue that could potentially lead to the device tipping over from Balance Mode. Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Florida, Georgia, Indiana, North Carolina, New Jersey, Ohio, Puerto Rico, Rhode Island, Tennessee, Texas and Virginia named
- Medical device recall Allon 2001. Part Number: 200-00263 An investigation into a report of the patient wrap (ThermoWrap), used with the Allon device, exceeding the set temperature determined that if: 1. Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide, and California, District of Columbia, Louisiana, Massachusetts, New Mexico, Pennsylvania, Texas, Virginia and Washington named
- Medical device recall Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller A software issue where “low” and “terminal” battery alerts did not display on the screen to the user in specific circumstances when the device was not running… Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide, and Connecticut, Florida, Illinois, Pennsylvania and Texas named
- Medical device recall Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller A software update corrected an issue where “low” and “terminal” battery alerts did not display on the screen to the user in specific circumstances when the… Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide, and Connecticut, Florida, Illinois, Pennsylvania and Texas named
- Medical device recall Azurion R1.x and R2.x systems A software issue was identified in the internal communication process between the system software and the X-ray generator firmware. Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2… Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male… Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Guam, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BD Texium Needle-Free Syringe: 3 mL Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male… Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Guam, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BD Texium: 3 mL Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male… Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Guam, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male… Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Guam, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male… Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Guam, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly Potential that the blade can unintentionally cut tissue prior to the user deploying the blade. Class IIFDA’s classJun 18, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 18, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Kits containing Codman Disposable Perforator 14 mm: 1 Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 11, 2025in FDA’s Enforcement Report13 statesnamed in where it went PublishedJun 11, 2025ClassClass IStatusOngoingWhereCalifornia, Florida, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Minnesota, New York, Texas, Vermont, Washington and Wisconsin
- Medical device recall Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 11, 2025in FDA’s Enforcement Report13 statesnamed in where it went PublishedJun 11, 2025ClassClass IStatusOngoingWhereCalifornia, Florida, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Minnesota, New York, Texas, Vermont, Washington and Wisconsin
- Medical device recall Medline Kits containing Codman Disposable Perforator 14 mm: 1 Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 11, 2025in FDA’s Enforcement Report13 statesnamed in where it went PublishedJun 11, 2025ClassClass IStatusOngoingWhereCalifornia, Florida, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Minnesota, New York, Texas, Vermont, Washington and Wisconsin
- Medical device recall Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 11, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Lazervida 10W diode laser cutter and engraver with Lazervida shield. Lazervida 10W Diode Laser Engraver does not fully meet current Federal performance standards in certain areas. Class IIFDA’s classJun 11, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 11, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Palindrome Precision Chronic Hemodialysis Catheter Sport Pack Potential breach of sterile barrier packaging. Class IIFDA’s classJun 11, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack Potential breach of sterile barrier packaging. Class IIFDA’s classJun 11, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack Potential breach of sterile barrier packaging. Class IIFDA’s classJun 11, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack Potential breach of sterile barrier packaging. Class IIFDA’s classJun 11, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MAHURKAR Chronic Hemodialysis Catheter Sport Pack Potential breach of sterile barrier packaging. Class IIFDA’s classJun 11, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall FoundationOne Companion Diagnostic (F1CDx) Two (2) reports were sent to customers with an incorrect negative claim on the claims page; the device variant information was displayed correctly in the tumor… Class IIFDA’s classJun 11, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 11, 2025ClassClass IIStatusOngoingWhereNationwide, and Michigan named
- Medical device recall FoundationOne Companion Diagnostic (F1CDx) An incorrect negative claim was identified on the claims page; the device variant information was displayed correctly in the tumor profiling section of the… Class IIFDA’s classJun 11, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 11, 2025ClassClass IIStatusOngoingWhereNationwide, and Wisconsin named
- Medical device recall BX2 Needle Guide During the attachment of the needle guide to the covered probe, the tight tolerance and fit of the needle guide can cause a pinhole breach in the transducer… Class IIFDA’s classJun 11, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 11, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Signature Laparoscopic Instruments, Dolphin Nose Grasper with Rotating Shaft and Monopolar Electrosurgical… Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to… Class IIFDA’s classJun 11, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedJun 11, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Hawaii, Iowa, Idaho, Illinois, Michigan, Mississippi, North Dakota, New Jersey, Oregon, Texas, Virginia and West Virginia named
- Medical device recall Signature Laparoscopic Instruments, Allis Clamp Grasper with Rotating Shaft and Monopolar Electrosurgical… Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to… Class IIFDA’s classJun 11, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedJun 11, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Hawaii, Iowa, Idaho, Illinois, Michigan, Mississippi, North Dakota, New Jersey, Oregon, Texas, Virginia and West Virginia named
- Medical device recall Signature Laparoscopic Instruments, Debakey Grasper with Rotating Shaft and Monopolar Electrosurgical… Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to… Class IIFDA’s classJun 11, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedJun 11, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Hawaii, Iowa, Idaho, Illinois, Michigan, Mississippi, North Dakota, New Jersey, Oregon, Texas, Virginia and West Virginia 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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