Volcano R100 Sterile Equipment Cover — Class II medical device recall Z-1041-2016
Terminated recall by Volcano Corporation, reported 2016-03-09, distributed nationwide. Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Covers may have
| Recall number | Z-1041-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Volcano Corporation, Rancho Cordova, CA, United States |
| Recall initiated | 2016-02-05 |
| Classified | 2016-03-03 |
| Reported by FDA | 2016-03-09 |
| Terminated | 2017-03-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, JP, NZ, PY, ZA |
| Quantity | 1,355 total |
| Reason classes | labeling, sterility |
Product
Volcano R100 Sterile Equipment Cover; Sterile; General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be used in the sterile surgical field but cannot be sterilized. The sterile drapes are put over this equipment in case any sterile items may come into contact with them.
Reason for recall
Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Covers may have the incorrect expiry date on the outer shipping box; individually wrapped inner product bears the correct expiry date.
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-1041-2016. 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.