Zimmer — Class II medical device recall Z-0404-2016
Terminated recall by STERILMED, INC., reported 2015-12-16, distributed nationwide. Sterilmed, Inc. is voluntarily recalling all unexpired Reprocessed Tourniquet Cuffs. Sterilmed cannot assure t
| Recall number | Z-0404-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | STERILMED, INC., Maple Grove, MN, United States |
| Recall initiated | 2015-11-13 |
| Classified | 2015-12-10 |
| Reported by FDA | 2015-12-16 |
| Terminated | 2016-12-12 |
| Distributed | Nationwide (US) |
| Quantity | 174,960 |
| Reason classes | sterility |
| Lot numbers | 1720009, 1757854, 1758629, 1768646, 1774412, 1784664, 1786626, 1795911, 1797605, 1800714, 1801676, 1802271, 1805472, 1807344, 1807744, 1809011, 1809184, 1809195, 1809910, 1810063, 1812006, 1812312, 1812365, 1812545, 1812561, 1812567, 1812740, 1812883, 1813141, 1813511, 1813959, 1814040, 1814199, 1814219, 1814223, 1814231, 1814651, 1814671, 1814751, 1814989 and 460 more |
Product
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
Reason for recall
Sterilmed, Inc. is voluntarily recalling all unexpired Reprocessed Tourniquet Cuffs. Sterilmed cannot assure the sterility of all units in the recalled lots. The introduction of non-sterile product into a sterile operative field raises the risk of potential infection. Sterilmed has not received any reports of Adverse Events for this issue.
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-0404-2016. 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.