Hand Pack — Class II medical device recall Z-2013-2015
Completed recall by Stradis Healthcare, LLC., reported 2015-07-15, distributed nationwide. Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light
| Recall number | Z-2013-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stradis Healthcare, LLC., Lawrenceville, GA, United States |
| Recall initiated | 2015-04-20 |
| Classified | 2015-07-07 |
| Reported by FDA | 2015-07-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 3 |
Product
Hand Pack - contains Devon Light Glove Used during surgery
Reason for recall
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
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-2013-2015. 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.