Premier Guard Drape — Class II medical device recall Z-1409-2017
Terminated recall by Covidien LLC, reported 2017-03-15, distributed nationwide. Sterility compromised due to breach in sterile barrier
| Recall number | Z-1409-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien LLC, North Haven, CT, United States |
| Recall initiated | 2017-01-23 |
| Classified | 2017-03-04 |
| Reported by FDA | 2017-03-15 |
| Terminated | 2019-08-07 |
| Distributed | Nationwide (US) |
| Quantity | 42,750 units |
| Reason classes | sterility |
| Lot numbers | 1410577-4, 1605778 |
| Model numbers | 01-0037 |
Product
Premier Guard Drape, Sterile. For Use with Verisphere (01-0035) and ArQ.Sphere (01-0044) Item Number: 01-0037 Used in conjunction RF Surgical Gauze detection systems to protect scanning device from contamination during various surgical procedures
Reason for recall
Sterility compromised due to breach in sterile barrier
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-1409-2017. 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.