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 Medicina Oral Tip Syringe 0.5ml Code: OT005 Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification Class IIFDA’s classOct 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medicina Oral Tip Syringe 1ml Code: OT01 Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification Class IIFDA’s classOct 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medicina Oral Tip Syringe 2.5ml Code: OT25 Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification Class IIFDA’s classOct 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medicina Reusable Oral syringe 1ml Code: OTH01 Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification Class IIFDA’s classOct 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medicina Reusable Oral syringe 5ml Code: OTH05 Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification Class IIFDA’s classOct 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medicina Reusable Oral syringe 2.5ml Code: OTH25 Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification Class IIFDA’s classOct 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G4 Clip Delivery System NT… An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Class IIFDA’s classOct 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 26, 2022ClassClass 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, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR, MitraClip NTR Clip Delivery System… An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Class IIFDA’s classOct 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 26, 2022ClassClass 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, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Product/Part: MitraClip G4 CDS NT REPAIR-MR Clinical/CDS0704-NT, MitraClip G4 CDS NTW REPAIR-MR… An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Class IIFDA’s classOct 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 26, 2022ClassClass 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, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Jiangsu Well Biotech Co.,Ltd Distribution of COVID-19 Ag Rapid Test kits in the U.S. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 19, 2022in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedOct 19, 2022ClassClass IStatusOngoingWhereCalifornia
- Medical device recall Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures 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 Spray Catheter: The Mistifier: 2.6mm 165cm Disposable For endoscopy procedures 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 Flex-Ez Guide Wire Disposable For endoscopy procedures 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 Cytology Brush 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 Cytology Brush 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 Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe 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 Transbronchial Aspiration Needle 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 Scope Introducer 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 Posi-Stop Injection Needle 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 Posi-Stop Injection Needle 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 Posi-Stop Injection Needle 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 Posi-Stop Injection Needle 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 Posi-Stop Injection Needle 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 Posi-Stop Injection Needle 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 Helical Retrieval Basket 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 Helical Retrieval Basket 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 Helical Retrieval Basket 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 Helical Retrieval Basket 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 Helical Retrieval Basket 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 Helical Retrieval Basket 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 Helical Retrieval Basket 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 Helical Retrieval Basket 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 Grasping Forceps 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 Grasping Forceps 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 Retrieval Forceps 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 Biliary Pigtail Stent Kits (containing 3412) 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 Biliary Pigtail Stent Kits (containing 3412) 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 Biliary Pigtail Stent Kits (containing 6105) 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 Biliary Pigtail Stent Kits (containing 3412) 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 Biliary Pigtail Stent Kits (contains 3412) 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 Biliary Pigtail Stent Kits (containing 3412) 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 Biliary Pigtail Stent Kits 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 Biliary Pigtail Stent Kits 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 Biliary Pigtail Stent Kits 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 6352) 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 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
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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