# FDA recall Z-1330-2024

> **Covidien** · Class II · device recall initiated 2024-02-21.

## Product

Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1

## Reason for recall

Packs including 5 laparotomy sponges may contain incorrect product with a blue loop,  X-ray detectable feature, and ethylene oxide treatment; however, this incorrect product wasn't steam pre-treated prior to sterilization, and has no RF tag, which if non-sterile, may lead to infection, tissue trauma, and sepsis, and if in the scannable area, would lead a "CLEAR" display.

## Distribution

US Nationwide distribution including in the states of AK, AL, AZ, CA, CO, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, PA, RI, TN, TX, UT, VA, WA, WI, WV.

## Key facts

- **Recall number:** Z-1330-2024
- **Recalling firm:** Covidien
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-02-21
- **Report date:** 2024-03-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lafayette, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1330-2024

## Citation

> AI Analytics. FDA recall Z-1330-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1330-2024. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*