Surgical Kit Sterile-Kits containing the Devon Light Glove Catalog… — Class II medical device recall Z-2112-2015
Terminated recall by Covidien LLC, reported 2015-07-29, distributed nationwide. Devon Light Gloves contain splits or holes compromising the sterility
| Recall number | Z-2112-2015 |
|---|---|
| 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 | 114,813 kits |
| Reason classes | sterility |
Product
Surgical Kit Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 573326 7497-HLS Surgical Kit 573328 7437-NRF SURGICAL ASC KIT 573343 7499-88 SURGICAL KIT with Light Gloves 573346 7499-TLG Surgical Kit with Edge 573359 7499-HLW Surgical KIT 573368 7494-CAB2 SURGICAL KIT 573776 7520-BHP SURGICAL KIT 573777 7527-BHB SURGICAL KITS 573798 7496-8KB Surgical KIT 31144507 7519 Minor Surgical Kit 31175089 7497-8T6 Surgical Kit 31321097 7697 Surgical Set Up Kit 31451480 7493-SFW SURGICAL KIT 31460432 7596-SHH Surgical KIT 50000947 7413-CAD Surgical KIT 50001029 7417-PCP Surgical KIT 50001052 7427-CFS Surgical 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-2112-2015. 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.