Class II — STERILMED, INC.
| Recalling firm | STERILMED, INC. |
|---|---|
| Registered facility | STERILMED, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Sterilmed, Inc. is recalling its reprocessed Zimmer Tourniquet Cuff, Part #ZIM60-7075-106, lot number 1846885 due to mislabeling. The affected reprocessed product is labeled as single hose devices but the devices inside the packaging are dual hose devices. |
| Product | Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (PLC), 34", Model (Reprocessor) Number: ZIM60-7075-106, Reprocessed by Sterilmed. Products are individually packaged in a Tyvek®/poly pouch. There are 5 pouches placed inside a casepack box. Each sales unit (casepack) contains 5 devices. |
| Quantity | 43 |
| Distribution | US Nationwide Distribution in the states of CA, KY, MI, OH, UT and WI. |
| Initiated | 2015-08-24 |
| Classified | 2015-09-28 |
| Terminated | 2016-03-11 |
| Recall number | Z-2819-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — STERILMED, INC. (Z-2819-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72035/
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