Professional Hospital Supply — Class II medical device recall Z-0366-2017
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-0366-2017 |
|---|---|
| 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 | 4,950 units |
Product
Professional Hospital Supply, Inc Custom Packaging containing the Devon Light Glove Item Number Description 380789003 SURE SET SINGLE BASIN PACK 400383006 MAJOR BASIN PACK 400383007 MAJOR BASIN PACK 618275004 BASIN PACK 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-0366-2017. 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.