Covidien, LP: Medical Device Recall in 2023 - (Recall #: Z-1388-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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)

Product Classification:

Class II

Date Initiated: March 1, 2023

Date Posted: April 19, 2023

Recall Number: Z-1388-2023

Event ID: 91873

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 36204 units

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated