Surgilon Sutures (Unknown) – gamma radiation strength issue (2023)
Excessive gamma sterilization can decrease suture strength, risking surgical complications.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Lot Codes / Batch Numbers
Model 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT UDI-DI 10884521071728
Products Sold
Model 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT UDI-DI 10884521071728, 20884521071725 Lots D1L1929RY D2B2243RY Model 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT UDI-DI 10884521071742, 20884521071749 Lot D2B0176RY Model 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT UDI-DI 10884521071766 Lots D2D2437RY UDI-DI 20884521071763 Lots D2D2437RY D2E0905RY D2E0916RY Model 88861919-71 SURGILON* 1 BLK 7X75CM PCT UDI-DI 20884521071794 Lots D1M0640RY D1M1494RY
A medical device manufacturer is recalling Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 B due to Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the su. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On December 21, the firm notified affected consignees via URGENT MEDICAL DEVICE RECALL letters. Customers were instructed to identify, quarantine, and return all unused, non-expired affected sutures to Medtronic. Please contact rs.covidienfeedbackcustomerservice@medtronic.com for the Return Good Authorization (RGA). Customers will receive credit for returned affected product. If purchased from a distributor, please contact your distributor directly to arrange for the return of product back to your distributor. Pass on the recall notice to all those who need to be aware within your organization, or to any organization where the affected sutures have been transferred or distributed. If you have questions regarding this recall, please call Medtronic Quality Assurance at 800-255-6774 option 1, then option 1 ***Updated 4/1/2024*** Firm identified additional models and lots affected by the gamma radiation issue and sent additional notification to customers on January 25, 2024.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026