Recall Z-0189-2027 ยท KCY Tourniquet, Pneumatic
Medline Industries, LP
Medline convenience kit labeled as: FOOT ANKLE. Medline Kit SKU DYNJ65395A
| Date | Oct 15, 2026 (initiated Sep 11, 2026) |
| Status | Open, Classified |
| Reason | Discrepancy in the shelf-life of a component |
| Root cause | Labeling Change Control |
| Action | Medline Industries, LP issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 9/11/2026 via email and USPS First Class Mail. The letter explained the issue, potential risk, and requested the following: "REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected prod |
| Quantity | 30 kits |
| Distribution | US Nationwide distribution in the state of NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.