Browse Device Recalls
5,321 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,321 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 5,321 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 4, 2025 | Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm ... | product mix-up; Vascular stent labeled as one size but contains a different size. | Class II | Cordis US Corp |
| Mar 4, 2025 | Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm ... | product mix-up; Vascular stent labeled as one size but contains a different size. | Class II | Cordis US Corp |
| Feb 27, 2025 | NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-co... | The "Use with plate 7, 8, 9, 10" compatibility statement on top of the label does not match with ... | Class II | Zimmer, Inc. |
| Feb 24, 2025 | Medline medical convenience kits labeled as: 1) NEONATAL INTUBATION TRAY, ... | Specific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 21, 2025 | Medline medical procedure kits, containing Medtronic Aortic Root Cannula, lab... | Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the p... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 21, 2025 | Medline medical procedure kits, containing Medtronic Aortic Root Cannula, lab... | Medline medical procedure kits, containing Medtronic Aortic Root Cannula | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 21, 2025 | Medline medical procedure kits, containing Medtronic Aortic Root Cannula, lab... | Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the p... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 21, 2025 | Medline medical procedure kits, containing Medtronic Aortic Root Cannula, lab... | Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the p... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 20, 2025 | Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device,... | The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on th... | Class II | Orthofix U.S. LLC |
| Feb 19, 2025 | CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended fo... | Aspiration system, for endoscopic examination/treatment of urinary tract and kidney interior, to ... | Class I | Calyxo, Inc. |
| Feb 19, 2025 | Lazervida 10W diode laser cutter and engraver with Lazervida shield. | Lazervida 10W Diode Laser Engraver does not fully meet current Federal performance standards in ... | Class II | Flux Technology Inc. |
| Feb 14, 2025 | Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 12... | A problem was discovered during the scanning process of the outer carton label because of an inco... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Feb 14, 2025 | Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13... | A problem was discovered during the scanning process of the outer carton label because of an inco... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Feb 14, 2025 | Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 1... | A problem was discovered during the scanning process of the outer carton label because of an inco... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Feb 13, 2025 | Proxima Drape labeled as FACE LIFT. Sterile surgical drape. | Potential breach in pouch packaging which could lead to loss of sterility. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 13, 2025 | Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,1... | Potential breach in pouch packaging which could lead to loss of sterility. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 13, 2025 | Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape. | Potential breach in pouch packaging which could lead to loss of sterility. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 13, 2025 | Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape. | Potential breach in pouch packaging which could lead to loss of sterility. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 13, 2025 | Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY ... | Potential breach in pouch packaging which could lead to loss of sterility. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 13, 2025 | Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape. | Potential breach in pouch packaging which could lead to loss of sterility. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 13, 2025 | Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PAC... | Potential breach in pouch packaging which could lead to loss of sterility. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 13, 2025 | Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; P... | Potential breach in pouch packaging which could lead to loss of sterility. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 12, 2025 | namic convenience kits labeled as: KIT,ARTERIAL,60,(152CM),PG; medical con... | The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess ma... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 12, 2025 | namic convenience kits labeled as: MTS,COLOR,PML,KIT,-,FRENCH HOSPITAL PG;... | The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess ma... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 12, 2025 | namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 8064172... | The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess ma... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 12, 2025 | namic convenience kits labeled as: 1) MTS,4 VALVE,LFT,HRT,KIT-AHS-A*,NW, R... | The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess ma... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) ANGIO DRAPE PACK (DRLUL)-LF, Pack Nu... | 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) BREAST PACK-LF, Pack Number DYNJ0956... | 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 SECTION, Pack Number DYNJ57622; ... | 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) L S GYN PACK, Pack Number DYNJ65616C... | 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) ANGIO PACK, Pack Number DYNJ50624A; ... | 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) CT BIOPSY PACK, Pack Number DYNJ6273... | 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) ACL ARTHROSCOPY PACK, Pack Number DYN... | 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) A & A KNEE PACK-LF, Pack Number DYNJH... | 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) GENERAL ENDOSCOPY PACK, Pack Number ... | 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 SECTION, Pack Number DYNJ909098 | 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) CSMC/ABDOMINAL HYST PACK-LF, Pack Nu... | 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) AOP/BASIC EYE PACK-LF, Pack Number D... | 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) EYE PACK, Pack Number VAL038BSCLC | 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) 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 |
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.