Covidien Devon Light Glove packaged in sterile surgical kits… — Class II medical device recall Z-0364-2017
Terminated recall by Covidien LLC, reported 2016-11-16, distributed nationwide. Added Instructions for Use: After application, inspect the Light Glove for barrier integrity
| Recall number | Z-0364-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien LLC, North Haven, CT, United States |
| Recall initiated | 2016-09-29 |
| Classified | 2016-11-08 |
| Reported by FDA | 2016-11-16 |
| Terminated | 2019-04-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BE, CA, CH, CZ, DE, DK, ES, FI, FR, GB, GR, IE, IL, IT, LU, LV, NL, NO, PL, PT, SA, SE, SI, ZA |
| Quantity | 13,786,893 in |
Product
Covidien Devon Light Glove packaged in sterile surgical kits Reference: 31140208 Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles
Reason for recall
Added Instructions for Use: After application, inspect the Light Glove for barrier integrity
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-0364-2017. 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.