Covidien
6044 Longbow Court, BOULDER, CO, US
Registered product codes
10 product codes
Recent MDR events
181,626 on file
- PolysorbJul 31, 2026Malfunction1219930-2026-04734
- PolysorbJul 31, 2026Malfunction1219930-2026-04735
- PolysorbJul 31, 2026Malfunction1219930-2026-04736
- Endo GIAJul 31, 2026Malfunction1219930-2026-04737
- FORTREX 0.035 OTW PTA BALLOON CATHETERJul 31, 2026Malfunction2183870-2026-00349
- RAPIDCROSSJul 31, 2026Malfunction2183870-2026-00350
- CLOSUREFAST 6FR CATHETERJul 31, 2026Malfunction9610849-2026-00155
- Endo GIAJul 31, 2026Malfunction2647580-2026-02197
- 840 VentilatorJul 31, 2026Malfunction8020893-2026-00128
- V-Loc 180Jul 31, 2026Malfunction1219930-2026-04741
Recalls
739 on file
- Open, ClassifiedAug 14, 2026
Due to products are incorrectly flagged as expired due to the system's 24-hour usage limit, rendering the product unavailable for clinical procedures.
View FDA record ↗ - Open, ClassifiedAug 7, 2026
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
View FDA record ↗ - Open, ClassifiedAug 7, 2026
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
View FDA record ↗ - Open, ClassifiedAug 7, 2026
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
View FDA record ↗ - Open, ClassifiedAug 7, 2026
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
View FDA record ↗ - Open, ClassifiedAug 7, 2026
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
View FDA record ↗ - Open, ClassifiedJul 2, 2026
Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.
View FDA record ↗ - Open, ClassifiedJun 1, 2026
The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure.
View FDA record ↗ - Open, ClassifiedMay 29, 2026
Due to customer complaint regarding incorrect display box labeling.
View FDA record ↗ - Open, ClassifiedMay 29, 2026
Temperature probe devices lack FDA clearance.
View FDA record ↗
Compliance history
Matched by FEI 1717344.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.