Covidien Vistec" X-Ray Detectable Sponges — Class II medical device recall Z-0534-2018
Terminated recall by Covidien LP, reported 2018-02-14, distributed in CO, PA, PR. Medtronic is voluntarily recalling two production lots of its Covidien Vistec" x-ray detectable sponges de to
| Recall number | Z-0534-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien LP, Augusta, GA, United States |
| Recall initiated | 2017-07-17 |
| Classified | 2018-02-08 |
| Reported by FDA | 2018-02-14 |
| Terminated | 2018-09-14 |
| Distributed | CO, PA, PR |
| Quantity | 33,280 |
| Reason classes | chemical contamination |
| UPC / GTIN / UDI-DI | 10884527016990, 20884527016997 |
| Lot numbers | 17E121262, 17E121362 |
Product
Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Sponges Sponge. product Usage: Vistec X-Ray Detectable Sponges are medical absorbent devices intended to be used internally within the body cavity to control bleeding or for applying medication. These sponges contain unique dual-colored elements that combines blue radiopaque strand with white strand, which is visible when sponge is saturated with blood.
Reason for recall
Medtronic is voluntarily recalling two production lots of its Covidien Vistec" x-ray detectable sponges de to possible contamination with human blood caused by handling of the product during the manufacturing process and prior to final packaging and Ethylene Oxide sterilization.
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-0534-2018. 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.