FDADecember 21, 2023device
Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-71 SURGILON* 1 BLK 7X75CM PCT
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood loss/ bleeding at a critical level.
What to do
FDA enforcement status: Ongoing
Brands named
covidien lpcovidien
UPCs
10884521071728208845210717251088452107174220884521071749108845210717662088452107176320884521071794
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
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →