Slush + Warmer Disc Drape — Class II medical device recall Z-1141-2021
Terminated recall by Ecolab Inc, reported 2021-03-03, distributed nationwide. Slits were identified in a low quantity of ORS-320 Slush + Warmer Disc Drapes from a single lot. A source for
| Recall number | Z-1141-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ecolab Inc, Saint Paul, MN, United States |
| Recall initiated | 2021-01-11 |
| Classified | 2021-02-22 |
| Reported by FDA | 2021-03-03 |
| Terminated | 2023-01-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | JP |
| Reason classes | sterility |
| Lot numbers | 132, D192619A |
| Model numbers | ORS-320 |
Product
Slush + Warmer Disc Drape; Model ORS-320 Slush + Warmer Disc Drapes - Product Usage: single-use equipment cover intended for use during various surgeries where warm irrigation, slush and/or cold solution is required.
Reason for recall
Slits were identified in a low quantity of ORS-320 Slush + Warmer Disc Drapes from a single lot. A source for potential manufacturing error was identified and investigation is underway to prevent further recurrence. The slits may lead to a breach in the sterile barrier between fluid in the basin and the slush/warming equipment. This could pose a risk of infection to patients receiving warmed irrigation fluid or surgical slush if used during a procedure.
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-1141-2021. 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.