Medical devices, 2022
Shortlist up to four to read them side by side.
2,192 medical device recalls FDA’s Enforcement Report published in 2022, 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.
2,192of 2,192 medical device recallsshown with your filters
The list
- Medical device recall MiniMed 780G Insulin Pump (O.U.S Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of… Class IIFDA’s classJul 20, 2022in FDA’s Enforcement Report53 statesnamed in where it went PublishedJul 20, 2022ClassClass IIStatusOngoingWhereAlaska, 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, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) Isopure received a report of a hazardous incident involving a device which had experienced an electrical short that resulted in a thermal event, damaging some… Class IIFDA’s classJul 20, 2022in FDA’s Enforcement Report23 statesnamed in where it went PublishedJul 20, 2022ClassClass IIStatusOngoingWhereAlabama, Arizona, Colorado, Delaware, Florida, Georgia, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New York, Oklahoma, Pennsylvania, Texas, Utah, Virginia and West Virginia
- Medical device recall ComposiTCP 30 Interference screw D 7- L:25 mm Mislabeled product. Class IIFDA’s classJul 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2022ClassClass IIStatusCompletedWhereNationwide
- Medical device recall Pressure Monitoring Set, Single-lumen uncoated central venous catheter The products may contain excess coating material on the outside and/or interior of the needle component. Class IIFDA’s classJul 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2022ClassClass IIStatusCompletedWhereNationwide
- Medical device recall PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035” Delivery System Potential for stent dislodgement and associated failures related to two specific sizes of the device. Class IIFDA’s classJul 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedJul 20, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall AquaBplus Water Purification System AquaBplus HF module on the AquaBplus 2000 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring mains, may… Class IIFDA’s classJul 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 20, 2022ClassClass IIStatusTerminatedWhereNationwide, and North Carolina and West Virginia named
- Medical device recall Draeger Globe-Trotter and Globe-Trotter IC The firm has initiated this recall to replace component on devices distributed containing a component within the oxygen supply system that is not rated to the… Class IIFDA’s classJul 20, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 20, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Wright EVOLVE TRIAD Plate Cutter The plate cutter is unable to meet sterilization requirements when it is sterilized in a double-wrapped configuration according to the Option 1 Steam… Class IIFDA’s classJul 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 20, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic… On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU). Class IIFDA’s classJul 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Peak Universal Bond Self-Etch Bottle Kit, Part: 4541 SE primer may be missing some or all of the resin portion of the chemistry. Class IIFDA’s classJul 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJul 20, 2022ClassClass IIStatusCompletedWhereNationwide, and Arkansas, Colorado, Florida, Iowa, Maine, Michigan, Minnesota, Nevada, Puerto Rico, Tennessee, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Invacare Platinum 5NXG Oxygen Concentrator Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the “Rx Only” statement as required. Class IIIFDA’s classJul 20, 2022in FDA’s Enforcement Report18 statesnamed in where it went PublishedJul 20, 2022ClassClass IIIStatusOngoingWhereAlaska, Arizona, California, Colorado, Georgia, Iowa, Idaho, Kansas, Kentucky, Michigan, Minnesota, Missouri, North Carolina, New York, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing extracorporeal bicarbonate… Alternate Bottle Caps labeled with “Sealed for your Protection” on the foil not qualified for use Class IIFDA’s classJul 20, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 20, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate… Alternate Bottle Caps labeled with “Sealed for your Protection” on the foil not qualified for use Class IIFDA’s classJul 20, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 20, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall epoc BGEM Test Card 25 Test Cards/box Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support. Class IIFDA’s classJul 20, 2022in FDA’s Enforcement Report10 statesnamed in where it went PublishedJul 20, 2022ClassClass IIStatusOngoingWhereAlabama, California, Colorado, Florida, Iowa, Idaho, Kansas, New Mexico, Oklahoma and Texas
- Medical device recall Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03… Due to latex gloves being include in Custom Pak. Class IIFDA’s classJul 20, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 20, 2022ClassClass IIStatusOngoingWhereArizona, California, Missouri and New York
- Medical device recall Ventana HE 600 System, automated slide preparer, for use in laboratories. There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire Class IIFDA’s classJul 20, 2022in FDA’s Enforcement Report40 statesnamed in where it went PublishedJul 20, 2022ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive The Cathcart Ball has an inherent +5mm offset which is not currently specified in its Instructions for Use or Surgical Technique Guide. Class IIFDA’s classJul 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large… There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. Class IIFDA’s classJul 20, 2022in FDA’s Enforcement Report15 statesnamed in where it went PublishedJul 20, 2022ClassClass IIStatusOngoingWhereAlabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Minnesota, Nevada, New York, Ohio, Tennessee, Texas and Washington
- Medical device recall Endo Model Modular Femur and Tibia, PorEx. orthopedic prosthesis. Model Nos.: X-Small, Right 15-3815/11,… There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. Class IIFDA’s classJul 20, 2022in FDA’s Enforcement Report15 statesnamed in where it went PublishedJul 20, 2022ClassClass IIStatusOngoingWhereAlabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Minnesota, Nevada, New York, Ohio, Tennessee, Texas and Washington
- Medical device recall Tibial Component There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. Class IIFDA’s classJul 20, 2022in FDA’s Enforcement Report15 statesnamed in where it went PublishedJul 20, 2022ClassClass IIStatusOngoingWhereAlabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Minnesota, Nevada, New York, Ohio, Tennessee, Texas and Washington
- Medical device recall Tibial Component Modular There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. Class IIFDA’s classJul 20, 2022in FDA’s Enforcement Report15 statesnamed in where it went PublishedJul 20, 2022ClassClass IIStatusOngoingWhereAlabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Minnesota, Nevada, New York, Ohio, Tennessee, Texas and Washington
- Medical device recall Ivenix Infusion System (IIS) Downstream occlusion alarm is sometimes immediately followed by a pump problem alarm. Class IIFDA’s classJul 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 20, 2022ClassClass IIStatusTerminatedWhereNationwide, and New Jersey and Wisconsin named
- Medical device recall Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of… A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into a failure AND the instructions to monitor a ventilator… Class IIFDA’s classJul 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM. Class IIFDA’s classJul 20, 2022in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 20, 2022ClassClass IIStatusTerminatedWhereAlaska and Texas
- Medical device recall Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A Label provided for substrate vail contained incorrect expiration date. Class IIIFDA’s classJul 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 20, 2022ClassClass IIIStatusOngoingWhereNationwide, and New York and Virginia named
- Medical device recall HAMILTON-H900 Humidifier, Models: 950001, 950004 When starting a humidifier, intended for respiratory gas conditioning during invasive and noninvasive mechanical ventilation, with an empty chamber, and water… Class IIIFDA’s classJul 20, 2022in FDA’s Enforcement Report6 statesnamed in where it went PublishedJul 20, 2022ClassClass IIIStatusCompletedWhereCalifornia, Florida, Nevada, Pennsylvania, Texas and Wisconsin
- Medical device recall Clean Catch Urine Kit NS 178489, AHMU58A Affected products were assembled off-site by individuals who may not have been properly trained. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 13, 2022in FDA’s Enforcement ReportMinnesotathe one state its words name PublishedJul 13, 2022ClassClass IStatusOngoingWhereMinnesota
- Medical device recall Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312,… Affected products were assembled off-site by individuals who may not have been properly trained. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 13, 2022in FDA’s Enforcement ReportMinnesotathe one state its words name PublishedJul 13, 2022ClassClass IStatusOngoingWhereMinnesota
- Medical device recall NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging. Class IIFDA’s classJul 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 13, 2022ClassClass IIStatusTerminatedWhereNationwide, and Louisiana and Texas named
- Medical device recall Palindrome Precision Chronic Catheter, Sterile, Single Use There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedJul 13, 2022ClassClass IStatusOngoingWhereNationwide, 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, 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 Palindrome Precision H Chronic Catheter, Sterile, Single Use There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedJul 13, 2022ClassClass IStatusOngoingWhereNationwide, 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, 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 Palindrome Precision SI Chronic Catheter, Sterile, Single Use There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedJul 13, 2022ClassClass IStatusOngoingWhereNationwide, 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, 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 Palindrome Precision HSI Chronic Catheter, Sterile, Single Use There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedJul 13, 2022ClassClass IStatusOngoingWhereNationwide, 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, 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 Palindrome Chronic Catheter, Sterile, Single Use There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedJul 13, 2022ClassClass IStatusOngoingWhereNationwide, 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, 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 Palindrome H Chronic Catheter, Sterile, Single Use There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedJul 13, 2022ClassClass IStatusOngoingWhereNationwide, 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, 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 Palindrome SI Chronic Catheter, Sterile, Single Use There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedJul 13, 2022ClassClass IStatusOngoingWhereNationwide, 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, 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 Palindrome HSI Chronic Catheter, Sterile, Single Use There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedJul 13, 2022ClassClass IStatusOngoingWhereNationwide, 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, 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 Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedJul 13, 2022ClassClass IStatusOngoingWhereNationwide, 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, 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 ABL800 Flex Analyzer There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+. Class IIFDA’s classJul 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedJul 13, 2022ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall EEA Autosuture Circular Stapler with DST Series Technology, 25mm The affected staplers have the potential for the staple guide to not be securely attached to the instrument. Class IIFDA’s classJul 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use with autograft when… Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and Patient Labels. Class IIFDA’s classJul 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated for use with autograft when… Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and Patient Labels. Class IIFDA’s classJul 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents. Due to receiving complaints related to broken (cracked) prosthetic foot with failures occurring in situations where sudden high impact twisting or bending is… Class IIFDA’s classJul 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 13, 2022ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Omnera 400T Digital Radiographic System There is the potential for the X-Ray system to short circuit due to an ingress of liquid in the display handles which may result in uncontrolled movement of… Class IIFDA’s classJul 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedJul 13, 2022ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Colorado, Delaware, Florida, Illinois, Indiana, Louisiana, Michigan, Missouri, New Mexico, Nevada, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia, Vermont and Washington named
- Medical device recall Omnera 400A Digital Radiographic System There is the potential for the X-Ray system to short circuit due to an ingress of liquid in the display handles which may result in uncontrolled movement of… Class IIFDA’s classJul 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedJul 13, 2022ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Colorado, Delaware, Florida, Illinois, Indiana, Louisiana, Michigan, Missouri, New Mexico, Nevada, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia, Vermont and Washington named
- Medical device recall GE Centricity Universal Viewer Zero Footprint Potential to display inaccurate measurements on images in Centricity Universal Viewer Zero Footprint Client (ZFP) Class IIFDA’s classJul 13, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 13, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Verigene CDF Nucleic Acid Test There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab. Class IIFDA’s classJul 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VERIGENE Enteric Pathogens Nucleic Acid Test There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab. Class IIFDA’s classJul 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2022ClassClass 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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