Z-2922-2026Class II

Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX

Name: Z-2922-2026 Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
Creator: Covidien, LP
Published: 2026-06-24
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2026-06-24 / Open, Classified / root cause: manufacturing process

FDA source

Covidien, LP began a recall of Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX on 2026-06-24. FDA classified it as Class II and gives the reason as "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...". 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-2922-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-24
Posted: 2026-08-07
Recalling firm: Medtronic, Inc.
Product: Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
Product code: GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: The firm began notifying consignees on 7/7/26 via email, mail, or electronically. Notices were titled, "URGENT: VOLUNTARY MEDICAL DEVICE RECALL." Customers were informed of the manufacturing nonconformance. If products in scope of this field action have been used in patients under the customer's care, the customer is instructed to monitor for signs of infection or vision issues due to the possibility of biocontamination. Customers were instructed to immediately identify, cease use, and quarantine all unused impacted product. Unused impacted product is to be returned to Medtronic. The recall notice should be passed on to all those who need to be aware within the customer's organization or to any organization where devices have been transferred.
Quantity in commerce: 135,875 total
Distribution: US Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kosovo, Lebanon, Lithuania, Luxembourg, Mexico, Namibia, Netherlands, North Macedonia, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan.
Product codes and lots: S8698GX UDI-DI 20612479214716 Lot D5M3438FY

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2922-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2918-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-19	2026-08-07
Z-2919-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-19	2026-08-07
Z-2920-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-19	2026-08-07
Z-2921-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-19	2026-08-07
Z-2922-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-19	2026-08-07

Product code GAW

K050947Class IIModification to: Modified Uss Polypropylene SutureUnited States Surgical, A Division of Tyco Healthc / cleared 2005-06-01

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)