# FDA recall Z-1388-2023

> **Covidien, LP** · Class II · device recall initiated 2023-03-01.

## 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 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.

## 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.

## Key facts

- **Recall number:** Z-1388-2023
- **Recalling firm:** Covidien, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-03-01
- **Report date:** 2023-04-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** North Haven, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1388-2023

## Citation

> AI Analytics. FDA recall Z-1388-2023. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1388-2023. Source: US FDA. Licensed CC0.

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