Covidien, LP: Medical Device Recall in 2023 - (Recall #: Z-1389-2023)

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:

Mild Chromic Gut Absorbable Sutures, CH GUT 5-0 12 UD SS-14 SS-14 (G-1766-K), CHROMIC GUT 6-0 45CM HE-1 X12 (G-1780K)

Product Classification:

Class II

Date Initiated: March 1, 2023

Date Posted: April 19, 2023

Recall Number: Z-1389-2023

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: 960 units

Code Information:

GTIN: 20884521054339, 20884521054438; Lot: D2H0095ZY, D2H0096ZY

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