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 PrisMax V3 control Unit-US, Hemodialysis Delivery System Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or difficulty normalizing the Blood Leak Detector (BLD) leading to… Class IIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 3, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall TherMax Blood Warmer Unit-US, PrisMax Accessory Thermax System may be unable to detect the presence of a bag on the Thermax Blood Warmer Unit leading to difficulty setting up therapy, or PrisMax System alarm… Class IIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 3, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Orascoptic Superior Visualization Custom loupes with Dragonfly frames Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. Class IIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedSep 3, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Wisconsin, West Virginia and Wyoming named
- Medical device recall Orascoptic Superior Visualization Custom loupes configured with Phantom Frames Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. Class IIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedSep 3, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Wisconsin, West Virginia and Wyoming named
- Medical device recall Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side… Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. Class IIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedSep 3, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Wisconsin, West Virginia and Wyoming named
- Medical device recall Orascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw, lens cleaning wipe, side… Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. Class IIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedSep 3, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Wisconsin, West Virginia and Wyoming named
- Medical device recall Orascoptic Superior Visualization Dragonfly Nose Pad Accessory Kit ( nose pad and screw) 1 pk and 20 pk. Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. Class IIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedSep 3, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Wisconsin, West Virginia and Wyoming named
- Medical device recall Orascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad and screw) 1 pk Due to complaints, loupe nose pads containing nickel may cause an allergic reaction. Class IIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedSep 3, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Wisconsin, West Virginia and Wyoming named
- Medical device recall Akreos, SKU: AO60P0300. Akreos intraocular lenses An off-power error was identified, which resulted in a diopter of 16, rather than the intended 3 diopter. Class IIIFDA’s classSep 3, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 3, 2025ClassClass IIIStatusOngoingWhereArizona and California
- Medical device recall The Medline General Surgery Tray is customized to meet requirements of the hospitals and health care… Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs. Class IIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedSep 3, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Iowa and Texas named
- Medical device recall BD PhaSeal Injector Luer (N30C) Closed system drug transfer devices were shipped to the U.S. Class IIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedSep 3, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Medline ReNewal Reprocessed St Specific lots of reprocessed electrophysiology catheters may contain small residual particulates. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall IPC Powerease System Due to out of the box wobble of the driver. Class IIFDA’s classSep 3, 2025in FDA’s Enforcement Report25 statesnamed in where it went PublishedSep 3, 2025ClassClass IIStatusOngoingWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, South Carolina, Tennessee and Texas
- Medical device recall Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc… Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine and may include pelvic or abdominal pain, flank… Class IIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedSep 3, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Florida, Georgia, Hawaii, Iowa, Indiana, Massachusetts, Maryland, Minnesota, Oklahoma, Oregon, Pennsylvania and West Virginia named
- Medical device recall Brand Name: HOMEDICS Product Name: Air Compression Leg Massager Regulatory documentation error and misleading color packaging claim. Class IIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947 During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components… Class IIFDA’s classSep 3, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 3, 2025ClassClass IIStatusOngoingWhereIllinois and Louisiana
- Medical device recall AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components… Class IIFDA’s classSep 3, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 3, 2025ClassClass IIStatusOngoingWhereIllinois and Louisiana
- Medical device recall AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) CYSTO During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components… Class IIFDA’s classSep 3, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 3, 2025ClassClass IIStatusOngoingWhereIllinois and Louisiana
- Medical device recall AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK - 205946 During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components… Class IIFDA’s classSep 3, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 3, 2025ClassClass IIStatusOngoingWhereIllinois and Louisiana
- Medical device recall AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI PACK (PS 132432) During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components… Class IIFDA’s classSep 3, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 3, 2025ClassClass IIStatusOngoingWhereIllinois and Louisiana
- Medical device recall AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components… Class IIFDA’s classSep 3, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 3, 2025ClassClass IIStatusOngoingWhereIllinois and Louisiana
- Medical device recall AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components… Class IIFDA’s classSep 3, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 3, 2025ClassClass IIStatusOngoingWhereIllinois and Louisiana
- Medical device recall AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ROBOT HYST PACK During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components… Class IIFDA’s classSep 3, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 3, 2025ClassClass IIStatusOngoingWhereIllinois and Louisiana
- Medical device recall AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components… Class IIFDA’s classSep 3, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 3, 2025ClassClass IIStatusOngoingWhereIllinois and Louisiana
- Medical device recall STA Satellite Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. Class IIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedSep 3, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Louisiana, Maryland, Maine, Minnesota, Missouri, Montana, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Vermont, Wisconsin and Wyoming named
- Medical device recall STA-Liquid Anti-Xa 4 Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. Class IIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedSep 3, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Louisiana, Maryland, Maine, Minnesota, Missouri, Montana, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Vermont, Wisconsin and Wyoming named
- Medical device recall STA-Liquid Anti-Xa 8 Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. Class IIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedSep 3, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Louisiana, Maryland, Maine, Minnesota, Missouri, Montana, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Vermont, Wisconsin and Wyoming named
- Medical device recall STA - Fibrinogen 5 Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. Class IIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedSep 3, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Louisiana, Maryland, Maine, Minnesota, Missouri, Montana, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Vermont, Wisconsin and Wyoming named
- Medical device recall BD Pyxis Product Name / UDI-DI code / Antivirus software was not consistently installed on impacted devices during the implementation process. Class IIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 54 states named PublishedSep 3, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Northern Mariana Islands, Mississippi, Montana, North Carolina, North Dakota, 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 Medline Kits containing BD SureStep Foley Tray Systems Kits contain SureStep Foley Tray Systems recalled by BD that include incorrect product information insert sheets. Class IIFDA’s classSep 3, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 3, 2025ClassClass IIStatusOngoingWhereFlorida and Illinois
- Medical device recall ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT) Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 27, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 27, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator… Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 27, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 27, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent Defibrillator… Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 27, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 27, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator… A mechanical defect on a printed circuit board (PCB) as a result of PCB separating process. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 27, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 27, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Pentax Medical Video Processor During endoscopic procedures using a combination of the video processor EPK-i8020c and i20c series video endoscope, the observed image can become reddish or… Class IIFDA’s classAug 27, 2025in FDA’s Enforcement Report20 statesnamed in where it went PublishedAug 27, 2025ClassClass IIStatusOngoingWhereArizona, California, District of Columbia, Florida, Iowa, Idaho, Illinois, Kansas, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, New Mexico, New York, Oklahoma, Pennsylvania, Texas and Washington
- Medical device recall Brand Name: Q-Stop Product Name: Suture Retention Device XXX Class IIFDA’s classAug 27, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 27, 2025ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California and New York named
- Medical device recall Injection needle, bayonet, Luer-Lock, 1 Affected product show elevated cytotoxicity values. Class IIFDA’s classAug 27, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedAug 27, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Missouri and Ohio named
- Medical device recall VITROS Chemistry Products Ca Slides Generations 67 and above of VITROS Ca Slides are experiencing an increased occurrence of Condition Code TH4-63J during calibration on VITROS XT 3400 and VITROS… Class IIFDA’s classAug 27, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 27, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagnostic manual… Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability or rarely give falsely low patient… Class IIFDA’s classAug 27, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 27, 2025ClassClass IIStatusOngoingWhereNationwide, and North Carolina named
- Medical device recall Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived Due to a classification error in the inventory management system, specific medical devices were shipped to customers that did not have the requisite license to… Class IIFDA’s classAug 27, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 27, 2025ClassClass IIStatusOngoingWhereNationwide, and Georgia named
- Medical device recall Electrosurgical, Cutting and Coagulation and Accessories Potential for the ESG-410 Electrosurgical Generator to display an error message: “E0662 System Error”, followed by either automatic single reboots of the… Class IIFDA’s classAug 27, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 27, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Electrosurgical, Cutting and Coagulation and Accessories Potential for the ESG-410 Electrosurgical Generator to display an error message: “E0662 System Error”, followed by either automatic single reboots of the… Class IIFDA’s classAug 27, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 27, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Burr Hole Cover Kit Resistance and difficulties could occur while closing the retaining clip locking mechanism, which is part of a burr hole cover kit, which is part of a Deep… Class IIFDA’s classAug 27, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedAug 27, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall OtoLase Starter Kit The potential for unsterilized product within finished product labeled as sterile. Class IIFDA’s classAug 27, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 27, 2025ClassClass IIStatusOngoingWherePennsylvania and Wisconsin
- Medical device recall Dynex Agility Sample Tips The internal label affixed to the sample tip rack is incorrectly labeled as reagent tip racks. Class IIFDA’s classAug 27, 2025in FDA’s Enforcement Report5 statesnamed in where it went PublishedAug 27, 2025ClassClass IIStatusOngoingWhereCalifornia, Florida, North Carolina, New Jersey and New York
- Medical device recall Baxter Novum IQ Large Volume Pump Baxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) due to the potential for underinfusion when transitioning from a… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 20, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult Potential for the manometer port being blocked rendering the manometer non-functional. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 20, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall DreamStation Auto CPAP Devices may possess a programming error resulting in an incorrect device configuration. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedAug 20, 2025ClassClass IStatusOngoingWhereNationwide, and Alabama, California, Colorado, District of Columbia, Florida, Georgia, Indiana, Louisiana, Maryland, Nebraska, New Jersey, New York, Pennsylvania and Texas 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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