Single Basin Kits — Class II medical device recall Z-2115-2015
Terminated recall by Covidien LLC, reported 2015-07-29, distributed nationwide. Devon Light Gloves contain splits or holes compromising the sterility
| Recall number | Z-2115-2015 |
|---|---|
| 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 | 77,588 kits |
| Reason classes | sterility |
Product
Single Basin Kits, Sterile-.Kits containing the Devon Light Glove Catalog Number/Description: 573509 7696-GSL-VL SINGLE BASIN KIT 573558 7665-CPB SINGLE BASIN KIT 573561 7696-KSC SINGLE BASIN KIT 31145645 7608 Single Basin KIT 31153060 7697-T4 Single Basin Kit 50000568 7605-SEC Single Basin Kit 50000599 7694-ADA Single Basin Kit 50007698 7698-T4 Single Basin Kit 50007699 7699-T4 Single Basin 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-2115-2015. 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.