Class II — Tenex Health Inc
| Recalling firm | Tenex Health |
|---|---|
| Registered facility | TENEX HEALTH (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The sterile barrier in the packaging may be compromised due to cracks in the thermoform tray that may occur during transport of the product in extreme cold weather conditions, in conjunction with mechanical impact. |
| Product | TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the TX System Console as an ultrasonic surgical aspirator of soft tissue. |
| Quantity | 9,927 units |
| Distribution | Worldwide Distribution - USA (Nationwide) and Internationally to Panama and Singapore. |
| Initiated | 2014-04-14 |
| Classified | 2014-05-06 |
| Terminated | 2014-07-16 |
| Recall number | Z-1552-2014 |
| 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 — Tenex Health Inc (Z-1552-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68074/
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