Browse Device Recalls
474 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 474 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 474 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 20, 2026 | Fisher Scientific Sure-Vue Urine hCG Strip, Model/ Part: FHC-101/23900527; M... | hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result... | Class II | Alere San Diego, Inc. |
| Aug 20, 2026 | McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001; Alere hCG C... | hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result... | Class II | Alere San Diego, Inc. |
| Aug 20, 2026 | Fisher Scientific Sure-Vue Urine hCG, Model/ Part: FHC-102/23900526; Henry S... | hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result... | Class II | Alere San Diego, Inc. |
| Aug 18, 2026 | Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT,... | The kits contain tube sets with handpieces that may leak during use. The impacted devices can hav... | Class II | Cardinal Health 200, LLC |
| Aug 18, 2026 | Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT,... | The kits contain tube sets with handpieces that may leak during use. The impacted devices can hav... | Class II | Cardinal Health 200, LLC |
| Aug 18, 2026 | Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT,... | The kits contain tube sets with handpieces that may leak during use. The impacted devices can hav... | Class II | Cardinal Health 200, LLC |
| Aug 18, 2026 | Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT,... | The kits contain tube sets with handpieces that may leak during use. The impacted devices can hav... | Class II | Cardinal Health 200, LLC |
| Aug 10, 2026 | Presource Convenience Kits: 1) KIT, USGPIV , Catalog Numbe... | The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the ... | Class II | Cardinal Health 200, LLC |
| Aug 10, 2026 | Presource Convenience Kits: 1) KIT, PRE OP , Catalog Numbe... | The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the ... | 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 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 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 |
| May 21, 2026 | A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgica... | Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the d... | Class I | Windstone Medical Packaging, Inc. |
| May 21, 2026 | A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgi... | Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the d... | Class I | Windstone Medical Packaging, Inc. |
| May 21, 2026 | A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, ... | Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the d... | Class I | Windstone Medical Packaging, Inc. |
| May 21, 2026 | A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgi... | Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the d... | Class I | Windstone Medical Packaging, Inc. |
| Apr 10, 2026 | Medline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ2... | Specific Medline Kits contain Cardinal Health Monoject 1mL Luer Lock Syringes, Tuberculin Print, ... | Class II | Medline Industries, LP |
| Mar 16, 2026 | Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Mar 16, 2026 | Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Mar 16, 2026 | Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Mar 16, 2026 | Medline or Centurion medical convenience kits, containing Webcol Large Alcoho... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Mar 16, 2026 | Medline and Centurion medical convenience kits, containing Webcol Large Alcoh... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Mar 16, 2026 | Medline and Centurion medical convenience kits, containing Webcol Large Alcoh... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Mar 16, 2026 | Medline medical convenience kits, containing Webcol Large Alcohol Prep Pads, ... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Feb 27, 2026 | Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1... | The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Sy... | Class II | Cardinal Health 200, LLC |
| Jan 30, 2026 | Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) ... | The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and acce... | Class II | Medline Industries, LP |
| Dec 26, 2025 | Chest Drainage Units and Accessories: Product Code Description 1. 88885... | The firm is updating the IFU to clarify the intended patient population for the identified chest ... | Class II | Cardinal Health 200, LLC |
| Nov 12, 2025 | ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Co... | Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-l... | Class II | Cardinal Health 200, LLC |
| Sep 18, 2025 | Salem Sump PVC Tubes: Product Code/Product Name: 266122 Salem Sump" Stoma... | Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force du... | Class II | Cardinal Health 200, LLC |
| Sep 18, 2025 | Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SAL... | Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force du... | Class II | Cardinal Health 200, LLC |
| Sep 18, 2025 | Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-... | Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force du... | Class II | Cardinal Health 200, LLC |
| Sep 18, 2025 | Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" P... | Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force du... | Class II | Cardinal Health 200, LLC |
| Sep 18, 2025 | Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stoma... | Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force du... | Class II | Cardinal Health 200, LLC |
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.