Vistec X-Ray Detectable Sponges — Class II medical device recall Z-1858-2016
Terminated recall by Covidien LLC, reported 2016-06-08, distributed nationwide. Compromised sterility due to breach of barrier
| Recall number | Z-1858-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien LLC, North Haven, CT, United States |
| Recall initiated | 2016-03-03 |
| Classified | 2016-05-31 |
| Reported by FDA | 2016-06-08 |
| Terminated | 2017-06-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CA, DE, ES, FR, GB, HR, IE, IT, NO, NZ, PL, PT, SA, SE, ZA |
| Quantity | 372,480 |
| Reason classes | sterility |
| Lot numbers | 15J162962X |
| Model numbers | 7319 |
Product
Vistec X-Ray Detectable Sponges, 16 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7319
Reason for recall
Compromised sterility due to breach of 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-1858-2016. 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.