Browse Device Recalls
3,367 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,367 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 3,367 FDA device recalls in IL.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 10, 2026 | Medline convenience kits containing Healthmark Instrument Channel Brushes. SI... | Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due t... | Class II | Medline Industries, LP |
| Aug 3, 2026 | Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Numb... | Contamination within the release test equipment flow path could have affected the accuracy of the... | Class II | Baxter Healthcare Corporation |
| Jul 31, 2026 | Convenience kits CATARACT PACK DYNJ59881A | Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterilit... | Class II | Medline Industries, LP |
| Jul 31, 2026 | Convenience kits MINOR PACK DYNJ58421A SPRINGHILL MINOR PACK DYN... | Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterilit... | Class II | Medline Industries, LP |
| Jul 31, 2026 | Enterprise Archive V8, software product for receiving, archiving, and sending... | Under certain conditions historical imaging data migrated from a legacy system may become incorre... | Class II | GE Healthcare |
| Jul 31, 2026 | Workflow Core Services V8, intended to provide set of services for storage an... | Under certain conditions historical imaging data migrated from a legacy system may become incorre... | Class II | GE Healthcare |
| Jul 31, 2026 | Core Services Hub V8, a set of backend services including Cross Enterprise (X... | Under certain conditions historical imaging data migrated from a legacy system may become incorre... | Class II | GE Healthcare |
| Jul 31, 2026 | Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925A | Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterilit... | Class II | Medline Industries, LP |
| Jul 31, 2026 | Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A | Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterilit... | Class II | Medline Industries, LP |
| Jul 31, 2026 | Centricity Enterprise Archive V2, V3, and V4, software product for receiving,... | Under certain conditions historical imaging data migrated from a legacy system may become incorre... | Class II | GE Healthcare |
| Jul 31, 2026 | Centricity PACS V2, V3, V4, V6, V7, software product is intended for the stor... | Under certain conditions historical imaging data migrated from a legacy system may become incorre... | Class II | GE Healthcare |
| Jul 31, 2026 | Centricity PACS Server V7, intended for managing digital medical images and a... | Under certain conditions historical imaging data migrated from a legacy system may become incorre... | Class II | GE Healthcare |
| Jul 29, 2026 | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... | The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... | Class II | Cardinal Health 200, LLC |
| Jul 29, 2026 | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... | The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... | Class II | Cardinal Health 200, LLC |
| Jul 29, 2026 | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... | The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... | Class II | Cardinal Health 200, LLC |
| Jul 29, 2026 | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... | The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... | Class II | Cardinal Health 200, LLC |
| Jul 29, 2026 | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... | The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... | Class II | Cardinal Health 200, LLC |
| Jul 29, 2026 | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... | The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... | Class II | Cardinal Health 200, LLC |
| Jul 29, 2026 | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... | The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... | Class II | Cardinal Health 200, LLC |
| Jul 29, 2026 | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... | The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... | Class II | Cardinal Health 200, LLC |
| Jul 29, 2026 | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... | The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... | Class II | Cardinal Health 200, LLC |
| Jul 29, 2026 | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... | The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... | Class II | Cardinal Health 200, LLC |
| Jul 29, 2026 | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... | The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... | Class II | Cardinal Health 200, LLC |
| Jul 29, 2026 | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... | The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... | Class II | Cardinal Health 200, LLC |
| Jul 23, 2026 | Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N | The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for... | Class II | Medline Industries, LP |
| Jul 20, 2026 | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... | Class II | Medline Industries, LP |
| Jul 20, 2026 | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... | Class II | Medline Industries, LP |
| Jul 20, 2026 | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... | Class II | Medline Industries, LP |
| Jul 20, 2026 | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... | Class II | Medline Industries, LP |
| Jul 20, 2026 | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... | Class II | Medline Industries, LP |
| Jul 20, 2026 | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... | Class II | Medline Industries, LP |
| Jul 20, 2026 | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... | Class II | Medline Industries, LP |
| Jul 20, 2026 | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... | Class II | Medline Industries, LP |
| Jul 20, 2026 | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... | Class II | Medline Industries, LP |
| Jul 20, 2026 | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... | Class II | Medline Industries, LP |
| Jul 20, 2026 | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... | Class II | Medline Industries, LP |
| Jul 20, 2026 | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... | Class II | Medline Industries, LP |
| Jul 20, 2026 | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... | Class II | Medline Industries, LP |
| Jul 14, 2026 | Cardinal Health Presource Kits: 1) BASIC PACK , Catalog N... | Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected v... | Class II | Cardinal Health 200, LLC |
| Jul 14, 2026 | Cardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Nu... | Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected v... | Class II | Cardinal Health 200, LLC |
| Jul 14, 2026 | Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB | Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected v... | Class II | Cardinal Health 200, LLC |
| Jul 14, 2026 | Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Nu... | Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected v... | Class II | Cardinal Health 200, LLC |
| Jul 14, 2026 | Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Nu... | Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected v... | Class II | Cardinal Health 200, LLC |
| Jul 14, 2026 | Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog N... | Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected v... | Class II | Cardinal Health 200, LLC |
| Jul 14, 2026 | Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog N... | Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected v... | Class II | Cardinal Health 200, LLC |
| Jul 14, 2026 | Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Nu... | Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected v... | Class II | Cardinal Health 200, LLC |
| Jul 13, 2026 | Medline breathing circuits labeled as: 1) MEDLINE HUDSON RCI, CIRCUIT, NEO... | Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wi... | Class II | Medline Industries, LP |
| Jul 13, 2026 | Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product ... | Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wi... | Class II | Medline Industries, LP |
| Jul 13, 2026 | Medline breathing circuits labeled as: 1) HUDSON RCI, CIRCUIT, HTD, DL, NE... | Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wi... | Class II | Medline Industries, LP |
| Jul 10, 2026 | Medline convenience kits labeled as: 1) LAVH, Medline Kit SKU CDS982273U; ... | Kits contain a potentially contaminated component which were recalled by the manufacturer | Class II | Medline Industries, LP |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.