Situate Laparotomy Sponge — Class II medical device recall Z-1330-2024
Ongoing recall by Covidien, reported 2024-03-27, distributed nationwide. Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detectable feature,
| Recall number | Z-1330-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien, Lafayette, CO, United States |
| Recall initiated | 2024-02-21 |
| Classified | 2024-03-21 |
| Reported by FDA | 2024-03-27 |
| Distributed | Nationwide (US) |
| Quantity | 755,800 |
| Reason classes | chemical contamination, sterility |
| UPC / GTIN / UDI-DI | 10884521700956, 20884521700953 |
| Lot numbers | 220903KF, 221102KF, 230504KF |
| Model numbers | L1818-04P01C-1 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1330-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.