Class II — Customed, Inc
| Recalling firm | CUSTOMED, INC. |
|---|---|
| Registered facility | CUSTOMED, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. |
| Product | LEGGINGS W/7" CUFF 30" x 42" 30/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . |
| Quantity | 300 |
| Distribution | Distributed Only in Puerto Rico. |
| Initiated | 2015-07-10 |
| Classified | 2015-09-03 |
| Terminated | 2017-04-12 |
| Recall number | Z-2594-2015 |
| 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 — Customed, Inc (Z-2594-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71721/
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