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 In-Line ventilator adaptor There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJun 8, 2022ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall 15 Liters Drain Bag Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error. Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Massachusetts, Maryland, Missouri, New York, Ohio and Texas named
- Medical device recall Locking Cap for PD Catheter Adapter Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error. Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Massachusetts, Maryland, Missouri, New York, Ohio and Texas named
- Medical device recall 5 Prong Manifold Set (with Luer Connectors) Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error. Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Massachusetts, Maryland, Missouri, New York, Ohio and Texas named
- Medical device recall Effluent Sample Bag Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error. Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Massachusetts, Maryland, Missouri, New York, Ohio and Texas named
- Medical device recall 3,65 m Extension Set with Luer-lock Connector Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error. Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Massachusetts, Maryland, Missouri, New York, Ohio and Texas named
- Medical device recall APD Drain Manifold Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error. Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Massachusetts, Maryland, Missouri, New York, Ohio and Texas named
- Medical device recall I.V. Start Kit - Tegaderm Dressing - Catheter Securement - Prevantics Catalog Number: 822 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Procedure Tray Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cervical Tray Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Lumbar Tray Catalog 1091 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Single Shot Epidural Tray Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Single Shot Epidural Tray Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Epidural Tray Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Universal Tray Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Epidural Tray Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Port Tray Catalog 7607 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall I.V. Start Kit Catalog 8172 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Nerve Block Tray Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Single Shot Epidural Tray Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Nerve Block Tray Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Universal Nerve Block Tray Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Universal Nerve Block Tray Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MBB Tray Catalog Number: 9882 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pain Tray Catalog Number: 9883 Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stereo Breast Biopsy Tray Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CVC Dressing Change Kit Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Nerve Block Tray Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cervical Tray Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Single Shot Epidural Tray Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sterile Epidural Tray Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Nerve Block Tray Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Single Shot Epidural Tray Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pump Refill Kit Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Single Shot Epidural Tray - 18G Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Joint Injection Tray Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Core Biopsy Tray Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bone Marrow Biopsy Tray Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Procedural Accessory Kit Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 3.2MM Pellet Insertion Tray Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall “3.2MM Pellet Insertion Tray with Medium Gloves” Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SS 3.5Mm Pellet Insertion Tray with large Gloves Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SS 3.5Mm Pellet Insertion Tray with large Gloves Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SS 3.5MM Pellet Insertion Tray with Medium Gloves Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SS 3.5MM Pellet Insertion Tray with Medium Gloves Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 4.5MM Pellet Insertion Tray with Large Gloves Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 4.5MM Pellet Insertion Tray with Medium Gloves Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SS 4.5MM Pellet Insertion Tray with Large Gloves Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
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.”
Your shortlist0 of 4
Add one more to compare.