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 Freeman Pancreatic Flexi-Stent Kit Device label display an incorrect expiration date, extends the shelf life of the product. Class IIFDA’s classOct 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Freeman Pancreatic Flexi-Stent Kits: Single Pigtail Device label display an incorrect expiration date, extends the shelf life of the product. Class IIFDA’s classOct 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Freeman Pancreatic Flexi-Stent Kits: Single Pigtail (containing 6544) Device label display an incorrect expiration date, extends the shelf life of the product. Class IIFDA’s classOct 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Freeman Pancreatic Flexi-Stent Kit (containing 6533) Device label display an incorrect expiration date, extends the shelf life of the product. Class IIFDA’s classOct 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Freeman Pancreatic Flexi-Stent Kit (containing 6566) Device label display an incorrect expiration date, extends the shelf life of the product. Class IIFDA’s classOct 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Freeman Pancreatic Flexi-Stent Kit (containing 6567) Device label display an incorrect expiration date, extends the shelf life of the product. Class IIFDA’s classOct 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Freeman Pancreatic Flexi-Stent Kit (containing 6568) Device label display an incorrect expiration date, extends the shelf life of the product. Class IIFDA’s classOct 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Freeman Pancreatic Flexi-Stent Device label display an incorrect expiration date, extends the shelf life of the product. Class IIFDA’s classOct 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Freeman Pancreatic Flexi-Stent Device label display an incorrect expiration date, extends the shelf life of the product. Class IIFDA’s classOct 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Freeman Pancreatic Flexi-Stent Device label display an incorrect expiration date, extends the shelf life of the product. Class IIFDA’s classOct 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Freeman Pancreatic Flexi-Stent Device label display an incorrect expiration date, extends the shelf life of the product. Class IIFDA’s classOct 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Freeman Pancreatic Flexi-Stent Device label display an incorrect expiration date, extends the shelf life of the product. Class IIFDA’s classOct 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Freeman Pancreatic Flexi-Stent Device label display an incorrect expiration date, extends the shelf life of the product. Class IIFDA’s classOct 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Freeman Pancreatic Flexi-Stent Device label display an incorrect expiration date, extends the shelf life of the product. Class IIFDA’s classOct 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Freeman Pancreatic Flexi-Stent Device label display an incorrect expiration date, extends the shelf life of the product. Class IIFDA’s classOct 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Freeman Pancreatic Flexi-Stent Device label display an incorrect expiration date, extends the shelf life of the product. Class IIFDA’s classOct 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Freeman Pancreatic Flexi-Stent Device label display an incorrect expiration date, extends the shelf life of the product. Class IIFDA’s classOct 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Freeman Pancreatic Flexi-Stent Device label display an incorrect expiration date, extends the shelf life of the product. Class IIFDA’s classOct 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Freeman Pancreatic Flexi-Stent (contained in kit 6501) Device label display an incorrect expiration date, extends the shelf life of the product. Class IIFDA’s classOct 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Hobbs Medical Polypectomy Snare Device label display an incorrect expiration date, extends the shelf life of the product. Class IIFDA’s classOct 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Hobbs Medical Polypectomy Snare Device label display an incorrect expiration date, extends the shelf life of the product. Class IIFDA’s classOct 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Hobbs Medical Polypectomy Snare Device label display an incorrect expiration date, extends the shelf life of the product. Class IIFDA’s classOct 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Hobbs Medical Polypectomy Snare Device label display an incorrect expiration date, extends the shelf life of the product. Class IIFDA’s classOct 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall COVID Test Kit Nonsterile Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 device. Class IIFDA’s classOct 19, 2022in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedOct 19, 2022ClassClass IIStatusOngoingWherePennsylvania
- Medical device recall Berkeley VC-10 Vacuum Curettage System Update to the Instruction for Use (IFU): Olympus is adding a new warning against the use of accessories which are not listed in the IFU. Class IIFDA’s classOct 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle The scalpel holder may separate from the handle for certain lots. Class IIFDA’s classOct 19, 2022in FDA’s Enforcement Report5 statesnamed in where it went PublishedOct 19, 2022ClassClass IIStatusTerminatedWhereIllinois, Massachusetts, North Carolina, South Carolina and Tennessee
- Medical device recall Clip COVID Rapid Antigen Test Kit COVID test kit shelf life was periodically extended, as real-time stability test timepoints passed, without FDA concurrence. Class IIFDA’s classOct 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Prismaflex M Set: M60 (product code 106696), M100 (product code 106697) Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. Class IIFDA’s classOct 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Prismaflex M Set: M150 (product code 109990) Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. Class IIFDA’s classOct 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Prismaflex HF Set: HF1000 (product code 107140), HF1400 (product code 107142) Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. Class IIFDA’s classOct 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Prismaflex ST Set: ST60 (product code 107643), ST100 (product code 107636), ST150 (product code 107640) Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. Class IIFDA’s classOct 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Prismaflex HF20 Set (product code 109841) Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. Class IIFDA’s classOct 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Veritas Advanced Infusion Packs As a result of returned product complaints for Veritas Phaco packs related to broken or cracked irrigation luer due to a manufacturing issue. Class IIFDA’s classOct 19, 2022in FDA’s Enforcement Report25 statesnamed in where it went PublishedOct 19, 2022ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Louisiana, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Tennessee, Texas, Utah, Virginia and Washington
- Medical device recall Positron Emission Tomography and Computed Tomography System The wireless VSM module of a mobile PET/CT system, operating in an environment with strong Wi-Fi signals, may experience ECG signal and respiratory signal loss… Class IIFDA’s classOct 19, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedOct 19, 2022ClassClass IIStatusOngoingWhereCalifornia, Michigan, Texas and Wisconsin
- Medical device recall VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM Impacted Venclose Procedure Packs contain a 12cm introducer/sheath component, either component #128626 - SET INTRO 7FX12CM FITS 0.018 or component #137339 -… Class IIFDA’s classOct 19, 2022in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedOct 19, 2022ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall Ivenix Infusion System (IIS), LVP Software The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 12, 2022in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 12, 2022ClassClass IStatusTerminatedWhereNew Jersey and Wisconsin
- Medical device recall The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with… Excessive ultraviolet-C radiation Class IIFDA’s classOct 12, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 12, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MR Patient Care Portal 5000 (Desktop Unit) Device may intermittently fail to produce audio. Class IIFDA’s classOct 12, 2022in FDA’s Enforcement Report25 statesnamed in where it went PublishedOct 12, 2022ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Minnesota, North Carolina, Nebraska, New Jersey, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Vermont, Washington and Wyoming
- Medical device recall stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm The outer label does not match the device inside the package. Class IIFDA’s classOct 12, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 12, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm The outer label does not match the device inside the package. Class IIFDA’s classOct 12, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 12, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall G7 Acetabular System, Acetabular Shell The outer sterile package cavity has a corner wall thickness that is below the specification. Class IIFDA’s classOct 12, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 12, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Hammertoe Continuous Compression Implant (CCI) Kit Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a packaging error, result in a surgical delay and may cause soft… Class IIFDA’s classOct 12, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 12, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Introcan Safety FEP 14G, 2.2x32MM-US Potential for leakage at the catheter hub. Class IIFDA’s classOct 12, 2022in FDA’s Enforcement Report15 statesnamed in where it went PublishedOct 12, 2022ClassClass IIStatusOngoingWhereArizona, California, Florida, Georgia, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Pennsylvania, Tennessee, Texas and Washington
- Medical device recall Philips Respironics Amara View Minimal Contact Full-Face Mask No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 12, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 12, 2022ClassClass IStatusOngoingWhereNationwide, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Philips Respironics DreamWear Full Face Mask No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 12, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 12, 2022ClassClass IStatusOngoingWhereNationwide, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall DreamWisp Nasal Mask with Over the Nose Cushion No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 12, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 12, 2022ClassClass IStatusOngoingWhereNationwide, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Wisp and Wisp Youth Nasal Mask No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 12, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 12, 2022ClassClass IStatusOngoingWhereNationwide, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Therapy Mask 3100 NC/SP No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 12, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 12, 2022ClassClass IStatusOngoingWhereNationwide, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming 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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