30inch Dual Port/Single Bladder Disposable Tourniquet Cuff with PLC — Class II medical device recall Z-2349-2015
Terminated recall by Zimmer Surgical Inc, reported 2015-08-12, distributed in AL, AR, AZ, CA, CO, CT, DC, FL…. The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings.
| Recall number | Z-2349-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Recalling firm | Zimmer Surgical Inc, Dover, OH, United States |
| Recall initiated | 2015-06-24 |
| Classified | 2015-08-06 |
| Reported by FDA | 2015-08-12 |
| Terminated | 2016-11-04 |
| Distributed | AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY |
| Countries outside the US | CA |
| Quantity | 330 units |
| Lot numbers | Z000002535, Z000002541 |
| Model numbers | 60707010500 |
Product
30inch Dual Port/Single Bladder Disposable Tourniquet Cuff with PLC, Zimmer Surgical, Inc. Tourniquets are intended to be used by qualified medical professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field. Single bladder tourniquet cuffs are generally used for operations lasting less than 90 minutes.
Reason for recall
The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings.
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-2349-2015. 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.