Z-0844-2024Class II

Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK...

Name: Z-0844-2024 Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK...
Creator: Covidien LP
Published: 2023-12-21
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2023-12-21 / Open, Classified / root cause: manufacturing process

FDA source

Covidien LP began a recall of 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... on 2023-12-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0844-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-21
Posted: 2024-01-29
Recalling firm: Medtronic, Inc.
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
Product code: GAR Suture, Nonabsorbable, Synthetic, Polyamide
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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 [email protected] 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.
Quantity in commerce: 46,812 US; 68,976 OUS
Distribution: Worldwide US Nationwide distribution including in the states of AL, AZ, CA, FL, GA, HI, IA, IL, IN, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, PR, TN, TX, VA, WA, WV and the countries of Australia, Bahrain, Belgium, Bulgaria, Canary Islands, China, Cyprus, Czech Republic, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Korea, Republic Of Kosovo, Mongolia, Netherlands, New Zealand, Panama, Poland, Portugal, Puerto Rico, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0844-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0844-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-29
Z-0845-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-29

Product code GAR

K981582Class IISurgilon, Dermalon, & OphthalonDavis & Geck, Inc. / cleared 1998-07-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)