Browse Device Recalls
2,910 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,910 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 2,910 FDA device recalls in IL.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) MICRODISECTOMY PACK, ... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) MEM MAXILLOFACIAL PAC... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) VP SHUNT CDS, REF CDS... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: DEEP BRAIN STIMULATION P... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | See DocMan | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) CERVICAL PACK-LF, REF... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) ENSEMBLE RACHIS-LF, R... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, RE... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 19, 2024 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Pro... | Devices were identified as released after repair without full testing being performed, which incl... | Class II | Baxter Healthcare Corporation |
| Nov 19, 2024 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Pr... | Devices were identified as released after repair without full testing being performed, which incl... | Class II | Baxter Healthcare Corporation |
| Nov 18, 2024 | Medline procedure kits labeled as: 1) SHORT TERM INFUSAPORT ACCESS KIT, Re... | Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 18, 2024 | Medline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5... | Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 18, 2024 | HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; trac... | Complaint defects have been noted regarding the adhesive elements of the device and the frame of ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 18, 2024 | HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF... | Complaint defects have been noted regarding the adhesive elements of the device and the frame of ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 18, 2024 | HUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap, REF... | Complaint defects have been noted regarding the adhesive elements of the device and the frame of ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 18, 2024 | Medline procedure kits labeled as: 1) CENTRAL LINE DRESSING KIT, Reorder n... | Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 18, 2024 | HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4; tra... | Complaint defects have been noted regarding the adhesive elements of the device and the frame of ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 12, 2024 | ST IUD REMOVAL HOOK 10" (504090), Medline Item No. I68785 | Weak seals may result in a breach of sterility, which may not be detectable to the user. This can... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 12, 2024 | STERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No. 66695 | Weak seals may result in a breach of sterility, which may not be detectable to the user. This can... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 12, 2024 | RUMMELL, Medline Item No. ST006ST | Weak seals may result in a breach of sterility, which may not be detectable to the user. This can... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 12, 2024 | O.R. SCISSORS, S/B, 5.5 STERILE, Medline Item No. DYND04000 | Weak seals may result in a breach of sterility, which may not be detectable to the user. This can... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 12, 2024 | STERILE MAGILL FORCEP (MAGF9), Medline Item No. 66790 | Weak seals may result in a breach of sterility, which may not be detectable to the user. This can... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 12, 2024 | ST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Medline Item No. 67870 | Weak seals may result in a breach of sterility, which may not be detectable to the user. This can... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 12, 2024 | ST REPROCESSED BRUNS CURETTE #00 (BC00), Medline Item No. 67600K | Weak seals may result in a breach of sterility, which may not be detectable to the user. This can... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1 ) TRIPLE ENDO PACK, Catalog Number: SBAOCT... | Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog N... | Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) ACDF PACK, Catalog Number: SNEHBACSCA; 2... | Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog Numbe... | Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 0 ) DESCRIPTION Catalog Number: CATALOG #; 1 ... | Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:... | Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1 ) KIT, MAJOR ORAL SURGERY, Catalog Number:... | Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1 ) LARYNGOSCOPY PACK, Catalog Number: SEN11... | Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHI... | Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog N... | Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog N... | Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) CRANIOTOMY PACK, Catalog Number: 2NE69CNK... | Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Nu... | Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY, Catalog Numb... | Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:... | Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951... | Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET09... | Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4... | Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1 ) KIT, FETAL SURGERY, Catalog Number PB11F... | Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) KIT, H N FREE FLAP, Catalog Number: PEHFH... | Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1 ) ANEURYSM PACK , Catalog Number: SCVHFAPB... | Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog N... | Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | Class II | Cardinal Health 200, LLC |
| Nov 6, 2024 | Medline brand, medical procedure convenience kits, labeled as: 1) NEURO CRANI... | Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to cont... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 6, 2024 | MAJOR NEURO PACK-LF Convenience kit, SKU DYNJ0578916X. Convenience kits used ... | Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to cont... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 6, 2024 | Medline brand, medical procedure convenience kits, labeled as: 1) LAMINECTOM... | Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to cont... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
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.