FDADecember 2, 2022device
Surgipro Monofilament Polypropylene Sutures Product Description CP-535 SURGIPRO* 1 BLU 100CM GS24 X36 CP-824 SURGIPRO* 1 BLU 150CM GS26 X24 CP-825 SURGIPRO* 2 BLU 150CM GS26 X24 VP-543 SURGIPRO* 2-0 BLU 120CM V20 DA
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
What to do
FDA enforcement status: Ongoing
Brands named
covidien lpcovidiencovidien lp
UPCs
20884521037868208845210365192088452300438720884521036540
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDACovidien Mon-a-Therm General Purpose Temperature Probe REF: 900442026-04-23
- FDACovidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 900502026-04-23
- FDACovidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 900422026-04-23
- FDACovidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;2026-04-15
- FDACOVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in providing tracheal access for airway management. Shiley Tracheostomy Tubes are double cannula tracheostomy tubes with reusable inner cannulae (LPC, FEN, CFS, CFN, L...2026-04-15
- FDAHealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 / 10884521844940 Vital Sync 3.4.1 / 10884521847569 (OUS Only) Vital Sync 3.4.2 / 10884521856127 Product N...2026-01-30
- FDACovidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;2025-09-25
- FDACovidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06170V4;2025-09-25
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