# FDA recall Z-1697-2024

> **Covidien, LP** · Class II · device recall initiated 2024-01-25.

## Product

Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of natural silk fibers, for use in soft tissue approximation and/or ligation.

## Reason for recall

One lot of product was exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles. This may decrease the tensile strength of the sutures over time, which could result in harms such as wound dehiscence, hemorrhage, blood loss, bleeding, tissue breakdown, peritonitis, unspecified infection, vision loss (when used in ophthalmic application), and/or prolonged surgery.

## Distribution

International distribution in the countries of Portugal and Italy.

## Key facts

- **Recall number:** Z-1697-2024
- **Recalling firm:** Covidien, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-01-25
- **Report date:** 2024-05-08

- **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-1697-2024

## Citation

> AI Analytics. FDA recall Z-1697-2024. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-1697-2024. Source: US FDA. Licensed CC0.

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