Hysto Pack — Class II medical device recall Z-2119-2015
Terminated recall by Covidien LLC, reported 2015-07-29, distributed nationwide. Devon Light Gloves contain splits or holes compromising the sterility
| Recall number | Z-2119-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien LLC, North Haven, CT, United States |
| Recall initiated | 2015-04-16 |
| Classified | 2015-07-20 |
| Reported by FDA | 2015-07-29 |
| Terminated | 2017-06-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BG, CA, CH, CR, CZ, DE, DK, ES, FI, FR, GB, IE, IL, IT, JO, KE, KW, LB, LU, NL, NO, NZ, PL, PT, QA, RU, SA, SE, SI, TR, ZA |
| Quantity | 23,560 |
| Reason classes | sterility |
Product
Hysto Pack, Non-sterile Part Number Description SA2059B MAJOR BASIN SA2220 HYSTO PACK SA2220A HYSTO PACK
Reason for recall
Devon Light Gloves contain splits or holes compromising the sterility
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-2119-2015. 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.