Browse Device Recalls

1,001 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,001 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 1,001 FDA device recalls.

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DateProductReasonClassFirm
Dec 23, 2024 CENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7; Infusion Cathete... Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were ei... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 23, 2024 MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containi... Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were ei... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 16, 2024 Medline Fluid Delivery Set with Drip Chamber: 1) FDS,135,CHMN,W/F,MLL,RC(2... Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the req... Class I MEDLINE INDUSTRIES, LP - Northfield
Dec 16, 2024 Medline Fluid Delivery Set with Drip Chamber: 1) MTO,135,YELLOW,MICRO,SPK-... Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the req... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 21, 2024 Medline custom medical procedure kits labeled as: 1) PANENDOSCOPY-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) UMC DR. BAKER SUPPLEM... 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 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) CRANI, REF CDS780089V;... 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) FREE FLAP BASIC SET-U... 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) ENDOSCOPIC SKULL BASE... 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) NEURO BASIN PACK-LF, ... 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) NASAL PACK, REF DYNJ6... 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) 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 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 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
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 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 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

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.