Microtek Medical — Class II medical device recall Z-2793-2015
Terminated recall by Ecolab Inc, reported 2015-09-30, distributed in DC, PR. The sterile packaging may contain small (less than 250 microns wide) channels in the seal of the pouch. If cha
| Recall number | Z-2793-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ecolab Inc, Saint Paul, MN, United States |
| Recall initiated | 2015-08-18 |
| Classified | 2015-09-18 |
| Reported by FDA | 2015-09-30 |
| Terminated | 2017-08-09 |
| Distributed | DC, PR |
| Countries outside the US | CA, DE, HK, JP, LB, SA, SG |
| Quantity | 5,172,816 units |
| Reason classes | sterility, packaging |
| Model numbers | ORS-100, ORS-110, ORS-130, ORS-2200, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 |
Product
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
Reason for recall
The sterile packaging may contain small (less than 250 microns wide) channels in the seal of the pouch. If channels are present, the package integrity is compromised and there is a remote chance that a non-sterile drape may be used during a surgical 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-2793-2015. 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.