Recall archive / FDA device enforcement
Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR GS-24 90CM X36 (CG-915), CHR... — FDA record Z-1388-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 1, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR GS-24 90CM X36 (CG-915), CHROMIC GUT 4-0 75CM V20 (GG-121), CHROMIC GUT 3-0 75CM V20 X36 (GG-122), CHROMIC GUT 2-0 75CM V20 X36 (GG-123), CHROMIC GUT 2-0 75CM V26 (GG-127), CHROMIC GUT 4-0 45CM P12 X36 (SG-5637), CHROMIC GUT 5-0 45CM P-13 X12 (SG-5687G), CHROMIC GUT 5-0 75CM CV23 (UG-202), CHROMIC GUT 4-0 75CM CV23 X36 (UG-203)
- Reason
- Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified infection or, in the case of sutures used in the eye, pose a loss of vision risk.
- Classification
- Class II
- Recalling firm
- Covidien, LP
- Quantity
- 36204 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1388-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | GTIN: 20884521054001, 20884521054056, 20884521054889, 20884521054896, 20884521054896, 20884521054902, 20884521054902, 10884521054905, 20884521054940, 20884521055688, 20884521055770, 20884521056135, 10884521056145, 20884521056142, 20884521056142, 20884521056142; Lot: D2H1593ZY D2H1022ZY D2F1106ZY D2H1607ZY D2H1609ZY D2H0819ZY D2H2053ZY D2H2053ZY D2H2055ZY D2H1435FZY D2H0829FZY D2H0830FZY D2H0381ZY D2H1523ZY D2H1584ZY D2H1584ZY D2H1587ZY D2H1589ZY |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide Distribution: US (nationwide) to States of: AR, CA, FL, GA, LA, MA, NC, NY, OH, WA; and countries of: Canada, Colombia, El Salvador, Indonesia, Nepal, Puerto Rico, Taiwan, and Thailand.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Apr 19, 2023
- Recall initiation date
- Mar 1, 2023
- Center classification date
- Apr 12, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.