FDA Device recall Z-1266-2016
The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit)
- FDA Device
- Class II
- terminated
- Published 2016-04-06
On 2016-04-06 the FDA classified a Class II recall of The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit) by Pmbs, citing water retention issues. Units with filters that remain wet after the sterilization may compromised sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1266-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-13 |
| Published | 2016-04-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Pmbs |
| Distribution | FL, GA, MN, NY, OH, OR, SC, TN |
Product
The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit)
Reason
Water retention issues. Units with filters that remain wet after the sterilization may compromised sterility.
Identifiers
| code_info | ALL distributed S.C.O.R.E.S. units are affected. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1266-2016%22
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