Browse Device Recalls

3,087 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,087 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 3,087 FDA device recalls in IL.

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DateProductReasonClassFirm
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
Nov 6, 2024 Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1... 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) MVFF/FIBU #... Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to cont... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 6, 2024 FESS-MB PACK-LF Convenience kit, SKU DYNJ0888159I. Convenience kits used for... Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to cont... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 6, 2024 DIEP FLAP Convenience kit, SKU DYNJ910120. Convenience kits used for various... 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) CRANIOTOMY,... Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to cont... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 6, 2024 SEPTOPLASTY PACK Convenient kit, SKU DYNJ44759F. Convenience kits used for v... Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to cont... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 6, 2024 KIT,SPINE LH Convenience kit, SKU DYNJ906448A. Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to cont... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 1, 2024 Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT61... Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure speci... Class II Cardinal Health 200, LLC
Nov 1, 2024 Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back,... Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure speci... Class II Cardinal Health 200, LLC
Oct 25, 2024 ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Me... Identified lots of Olympus product may be missing sterile and manufacturing lot numbers and expir... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 23, 2024 URINALYSIS KIT 4, SKU DYLAB1021; Component No. 503581 Specimen container included in kits is labeled as sterile, but has been identified to be non-ster... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 23, 2024 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T... There has been an increase in the number of complaints related to the separation of the female co... Class II Baxter Healthcare Corporation
Oct 23, 2024 URINE KIT W/BD CUP, SKU DYLAB1001A; Component No. 503581 Specimen container included in kits is labeled as sterile, but has been identified to be non-ster... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 23, 2024 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R... There has been an increase in the number of complaints related to the separation of the female co... Class II Baxter Healthcare Corporation
Oct 23, 2024 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R... There has been an increase in the number of complaints related to the separation of the female co... Class II Baxter Healthcare Corporation
Oct 23, 2024 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R... There has been an increase in the number of complaints related to the separation of the female co... Class II Baxter Healthcare Corporation
Oct 23, 2024 URINE KIT, SKU DYKM1845; Component No. 503581 Specimen container included in kits is labeled as sterile, but has been identified to be non-ster... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 23, 2024 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5... There has been an increase in the number of complaints related to the separation of the female co... Class II Baxter Healthcare Corporation
Oct 23, 2024 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R... There has been an increase in the number of complaints related to the separation of the female co... Class II Baxter Healthcare Corporation
Oct 23, 2024 Baxter MiniCap Extended Life PD Transfer Set (long) with Titanium Spike, Par... There has been an increase in the number of complaints related to the separation of the female co... Class II Baxter Healthcare Corporation
Oct 23, 2024 URINE COLLECTION KIT, SKU DYKM1848A DYKM2005 DYKM2151 DYLAB1004 DYLAB1004... Specimen container included in kits is labeled as sterile, but has been identified to be non-ster... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 23, 2024 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5... There has been an increase in the number of complaints related to the separation of the female co... Class II Baxter Healthcare Corporation
Oct 23, 2024 UA KIT, SKU DYKM1690A; Component No. 503581 Specimen container included in kits is labeled as sterile, but has been identified to be non-ster... 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.