The S — Class II medical device recall Z-1266-2016
Terminated recall by PMBS, LLC, reported 2016-04-06, distributed in FL, GA, MN, NY, OH, OR, SC, TN. Water retention issues. Units with filters that remain wet after the sterilization may compromised sterility.
| Recall number | Z-1266-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PMBS, LLC, Stockton, NJ, United States |
| Recall initiated | 2016-01-13 |
| Classified | 2016-03-25 |
| Reported by FDA | 2016-04-06 |
| Terminated | 2017-09-27 |
| Distributed | FL, GA, MN, NY, OH, OR, SC, TN |
| Quantity | 58 units |
| Reason classes | sterility |
Product
The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit)
Reason for recall
Water retention issues. Units with filters that remain wet after the sterilization may compromised sterility.
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-1266-2016. 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.