Major Kit — Class II medical device recall Z-2114-2015
Terminated recall by Covidien LLC, reported 2015-07-29, distributed nationwide. Devon Light Gloves contain splits or holes compromising the sterility
| Recall number | Z-2114-2015 |
|---|---|
| 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 | 5,160 kits |
| Reason classes | sterility |
Product
Major Kit, Sterile-.Kits containing the Devon Light Glove Catalog Number:Description 573831B MAJOR KIT
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-2114-2015. 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.