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 5, 2026.
2,908of 2,908 medical device recallsshown with your filters
The list
- Medical device recall Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800 It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. Class IIFDA’s classDec 31, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 31, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Draeger Vapor 2000 A certain component of affected devices was not delivered within specification and contained impurities. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 31, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedDec 31, 2025ClassClass IStatusOngoingWhereNationwide, and Alaska, California, Florida, Iowa, Kansas, Maryland, Maine, Minnesota, New York, Ohio, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas and Utah named
- Medical device recall Draeger Vapor 3000 A certain component of affected devices was not delivered within specification and contained impurities. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 31, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedDec 31, 2025ClassClass IStatusOngoingWhereNationwide, and Alaska, California, Florida, Iowa, Kansas, Maryland, Maine, Minnesota, New York, Ohio, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas and Utah named
- Medical device recall Brand Name: Alcon Laboratories, Inc Ophthalmic procedure packs may have incomplete seals affecting sterility. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 31, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedDec 31, 2025ClassClass IStatusOngoingWhereNationwide, and California, North Dakota and Utah named
- Medical device recall BD Pyxis MedStation ES Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which caused a Cubie Insert event which prompts software to generate a… Class IIFDA’s classDec 31, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 54 states named PublishedDec 31, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, American Samoa, 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, 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 The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB)… When the device is activated during surgery, the device software issues an error message “Instrument Face Mask (6001385000000) is not valid for this… Class IIFDA’s classDec 31, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 31, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall da Vinci 5, Surgeon Console Column Motor Connector Surgical system Error 23062 due to connector1) Partially damaged “Potential problem with ergonomics: Disable - Retry “ or 2) Failed “Disable Ergonomics:… Class IIFDA’s classDec 31, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedDec 31, 2025ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Minnesota, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia named
- Medical device recall LifeShield Drug Library Management (DLM) For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Class IIFDA’s classDec 31, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedDec 31, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Iowa, Louisiana, New York, Pennsylvania, Tennessee and Virginia named
- Medical device recall LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02 Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). Class IIFDA’s classDec 31, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedDec 31, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Iowa, Kentucky, Louisiana, Maryland, Mississippi, New York, Pennsylvania, Tennessee and Virginia named
- Medical device recall Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Class IIFDA’s classDec 31, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedDec 31, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Florida, Indiana, Kentucky, Massachusetts, Missouri, Montana, North Carolina, New Mexico, Rhode Island, Texas and Utah named
- Medical device recall Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Class IIFDA’s classDec 31, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedDec 31, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Florida, Indiana, Kentucky, Massachusetts, Missouri, Montana, North Carolina, New Mexico, Rhode Island, Texas and Utah named
- Medical device recall Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Class IIFDA’s classDec 31, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedDec 31, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Florida, Indiana, Kentucky, Massachusetts, Missouri, Montana, North Carolina, New Mexico, Rhode Island, Texas and Utah named
- Medical device recall Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Class IIFDA’s classDec 31, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedDec 31, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Florida, Indiana, Kentucky, Massachusetts, Missouri, Montana, North Carolina, New Mexico, Rhode Island, Texas and Utah named
- Medical device recall Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Class IIFDA’s classDec 31, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedDec 31, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Florida, Indiana, Kentucky, Massachusetts, Missouri, Montana, North Carolina, New Mexico, Rhode Island, Texas and Utah named
- Medical device recall Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Class IIFDA’s classDec 31, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedDec 31, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Florida, Indiana, Kentucky, Massachusetts, Missouri, Montana, North Carolina, New Mexico, Rhode Island, Texas and Utah named
- Medical device recall Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Class IIFDA’s classDec 31, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedDec 31, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Florida, Indiana, Kentucky, Massachusetts, Missouri, Montana, North Carolina, New Mexico, Rhode Island, Texas and Utah named
- Medical device recall Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Class IIFDA’s classDec 31, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedDec 31, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Florida, Indiana, Kentucky, Massachusetts, Missouri, Montana, North Carolina, New Mexico, Rhode Island, Texas and Utah named
- Medical device recall Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Class IIFDA’s classDec 31, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedDec 31, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Florida, Indiana, Kentucky, Massachusetts, Missouri, Montana, North Carolina, New Mexico, Rhode Island, Texas and Utah named
- Medical device recall Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Class IIFDA’s classDec 31, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedDec 31, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Florida, Indiana, Kentucky, Massachusetts, Missouri, Montana, North Carolina, New Mexico, Rhode Island, Texas and Utah named
- Medical device recall Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Class IIFDA’s classDec 31, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedDec 31, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Florida, Indiana, Kentucky, Massachusetts, Missouri, Montana, North Carolina, New Mexico, Rhode Island, Texas and Utah named
- Medical device recall Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Class IIFDA’s classDec 31, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedDec 31, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Florida, Indiana, Kentucky, Massachusetts, Missouri, Montana, North Carolina, New Mexico, Rhode Island, Texas and Utah named
- Medical device recall Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Class IIFDA’s classDec 31, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedDec 31, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Florida, Indiana, Kentucky, Massachusetts, Missouri, Montana, North Carolina, New Mexico, Rhode Island, Texas and Utah named
- Medical device recall Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Class IIFDA’s classDec 31, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedDec 31, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Florida, Indiana, Kentucky, Massachusetts, Missouri, Montana, North Carolina, New Mexico, Rhode Island, Texas and Utah named
- Medical device recall Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Class IIFDA’s classDec 31, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedDec 31, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Florida, Indiana, Kentucky, Massachusetts, Missouri, Montana, North Carolina, New Mexico, Rhode Island, Texas and Utah named
- Medical device recall Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Class IIFDA’s classDec 31, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedDec 31, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Florida, Indiana, Kentucky, Massachusetts, Missouri, Montana, North Carolina, New Mexico, Rhode Island, Texas and Utah named
- Medical device recall Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Class IIFDA’s classDec 31, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedDec 31, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Florida, Indiana, Kentucky, Massachusetts, Missouri, Montana, North Carolina, New Mexico, Rhode Island, Texas and Utah named
- Medical device recall KWIK-STIK 2-Pack, Campylobacter jejuni subsp Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. Class IIFDA’s classDec 31, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 31, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall KWIK-STIK 6-Pack, Campylobacter jejuni subsp Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. Class IIFDA’s classDec 31, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 31, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LYFO DISK, Campylobacter jejuni subsp Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. Class IIFDA’s classDec 31, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 31, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic,… Safety and efficacy of dialysis acid concentrate cannot be assured Class IIFDA’s classDec 31, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedDec 31, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Illinois, Massachusetts, Missouri and Texas named
- Medical device recall Brand Name: Diasol Product Name: 100125-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic,… Safety and efficacy of dialysis acid concentrate cannot be assured Class IIFDA’s classDec 31, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedDec 31, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Illinois, Massachusetts, Missouri and Texas named
- Medical device recall Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic,… Safety and efficacy of dialysis acid concentrate cannot be assured Class IIFDA’s classDec 31, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedDec 31, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Illinois, Massachusetts, Missouri and Texas named
- Medical device recall Brand Name: Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic,… Safety and efficacy of dialysis acid concentrate cannot be assured Class IIFDA’s classDec 31, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedDec 31, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Illinois, Massachusetts, Missouri and Texas named
- Medical device recall Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic,… Safety and efficacy of dialysis acid concentrate cannot be assured Class IIFDA’s classDec 31, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedDec 31, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Illinois, Massachusetts, Missouri and Texas named
- Medical device recall Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic,… Safety and efficacy of dialysis acid concentrate cannot be assured Class IIFDA’s classDec 31, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedDec 31, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Illinois, Massachusetts, Missouri and Texas named
- Medical device recall Flexor Check-Flo Introducers and Sets, Reference Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Class IIFDA’s classDec 31, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 31, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Ring Transjugular Intrahepatic Access Sets, Reference Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Class IIFDA’s classDec 31, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 31, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall R¿sch-Uchida Transjugular Liver Access Sets, Reference Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Class IIFDA’s classDec 31, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 31, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Restore Clinician Programmer Application (CP App) Software issue where a Device Reset message displayed on the app was unable to be cleared. Class IIFDA’s classDec 31, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 31, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BECKMAN COULTER BICARBONATE Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample. Class IIFDA’s classDec 31, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedDec 31, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, 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, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Ivenix Infusion System (IIS), LVP Software LVP-SW-0005 Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 24, 2025in FDA’s Enforcement Report20 statesnamed in where it went PublishedDec 24, 2025ClassClass IStatusOngoingWhereCalifornia, Colorado, Florida, Georgia, Idaho, Illinois, Maryland, Michigan, Minnesota, Mississippi, Nebraska, New Jersey, Nevada, Oklahoma, Oregon, South Carolina, Texas, Virginia, Washington and Wisconsin
- Medical device recall GE Healthcare Carestation anesthesia system, product number and Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall GE Healthcare Carestation anesthesia system, product number and Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU),… Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Hardware configuration of the BeneVision Central Monitoring System (CMS) When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing. Class IIFDA’s classDec 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 24, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SCISSORS, OR, SHARP/BLUNT, 5.5”, STERILE The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is… Class IIFDA’s classDec 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedDec 24, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Illinois, Kansas and Michigan named
- Medical device recall FORCEP, STD STR, STERILE KELLY, 5.5 IN The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is… Class IIFDA’s classDec 24, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedDec 24, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Illinois, Kansas and Michigan named
- Medical device recall Zimmer Air Dermatome The devices may have a misaligned thickness control bar. Class IIFDA’s classDec 24, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 24, 2025ClassClass IIStatusOngoingWhereNo state 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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