# FDA recall Z-0844-2024

> **Covidien LP** · Class II · device recall initiated 2023-12-21.

## Product

Surgilon Braided Nylon sutures:    88861919-31 SURGILON* 4-0 BLK 7X75CMPCT  88861919-41 SURGILON* 3-0 BLK 7X75CMPCT  88861919-51 SURGILON* 2-0 BLK 7X75CMPCT  88861919-71 SURGILON* 1 BLK 7X75CM PCT

## Reason for recall

Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood loss/ bleeding at a critical level.

## Distribution

Worldwide   US Nationwide distribution including in the states of AL, AZ, CA, FL, GA, HI, IA, IL, IN, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, PR, TN, TX, VA, WA, WV and the countries of Australia, Bahrain, Belgium, Bulgaria, Canary Islands, China, Cyprus, Czech Republic, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Korea, Republic Of Kosovo, Mongolia, Netherlands, New Zealand, Panama, Poland, Portugal, Puerto Rico, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom.

## Key facts

- **Recall number:** Z-0844-2024
- **Recalling firm:** Covidien LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-12-21
- **Report date:** 2024-02-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mansfield, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0844-2024

## Citation

> AI Analytics. FDA recall Z-0844-2024. Retrieved 2026-07-03 from https://api.ai-analytics.org/recall/Z-0844-2024. Source: US FDA. Licensed CC0.

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