Laparotomy Sponge — Class II medical device recall Z-0681-2019
Terminated recall by Medical Action Industries Inc, reported 2019-01-02, distributed in MA, MI, MN, NY, WA. Potential compromise of product sterility due to breach of sterile barrier.
| Recall number | Z-0681-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medical Action Industries Inc, Arden, NC, United States |
| Recall initiated | 2018-11-27 |
| Classified | 2018-12-22 |
| Reported by FDA | 2019-01-02 |
| Terminated | 2019-02-08 |
| Distributed | MA, MI, MN, NY, WA |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10809160000113, 50809160000111 |
| Lot numbers | 1806JK305A |
| Model numbers | 403 |
| Expiration dates | 2023-06-20 |
Product
Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with bands without handles, 5 sponges/pack, 40 packs/case. X-Ray Detectable, 1 Non-Absorbent outer wrap. intended use: Laparotomy sponges are intended for use inside the body, surgical incision, or for application to internal organs or structure to control bleeding, absorb fluid, or protect organs or structures from abrasions, drying, or contamination.
Reason for recall
Potential compromise of product sterility due to breach of sterile barrier.
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-0681-2019. 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.