Browse Device Recalls
812 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 812 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 812 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 11, 2025 | Medline procedure kits labeled as: 1) ARTHROSCOPY PACK, Pack Number DYNJHS... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) DELIVERY PACK, Pack Number DYNJ09230... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) CLOVIS ROBOTIC-LF, Pack Number DYNJ6... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ800... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) BILATERAL FACET TRAY, Pack Number DYNJ... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) CV NEONATAL PACK, Pack Number DYNJ67356 | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) BILLINGS CLINIC SC HEAD & NECK, Pack ... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) ABLATION PACK, Pack Number DYNJ40629... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) ACOUSTIC NEUROMA PACK-LF, Pack Numbe... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) LACERATION TRAY, Pack Number DYNJ17328B | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) ANGIOGRAPHY SPECIALS | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) AV FISTULA PACK-LF, Pack Number DYNJ... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Number ... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 6, 2025 | Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, M... | Devices may have higher than expected amounts of bacterial endotoxin. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jan 9, 2025 | Medline Convenience Kits for Various Procedures: 1) CLOVIS RESP/INTUB DRAWER... | Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jan 9, 2025 | Medline Convenience Kits for Various Procedures: 1) ADULT INTUBATION TRAY, M... | Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jan 3, 2025 | Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenien... | Medline is recalling medical convenience kits which were assembled with specific Coloplast Foley ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 31, 2024 | Medline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT, Item N... | The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess materia... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 31, 2024 | Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600... | The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess materia... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| 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 |
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.