TX1 Tissue Removal System — Class II medical device recall Z-1552-2014
Terminated recall by Tenex Health Inc, reported 2014-05-14, distributed nationwide. The sterile barrier in the packaging may be compromised due to cracks in the thermoform tray that may occur du
| Recall number | Z-1552-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tenex Health Inc, Lake Forest, CA, United States |
| Recall initiated | 2014-04-14 |
| Classified | 2014-05-06 |
| Reported by FDA | 2014-05-14 |
| Terminated | 2014-07-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | PA, SG |
| Quantity | 9,927 units |
| Reason classes | sterility, packaging |
| Lot numbers | 00614-03, 00713-06, 00814-02, 01114-02, 01514-03, 01714-04, 01813-02, 02314-08, 02413-04, 02714-02, 02914-01, 03014-02, 03113-02, 03114-02, 03414-03, 03514-05, 03714-03, 03814-06, 04114-02, 04213-01, 04214-05, 04414-03, 04514-02, 04814-07, 05014-02, 05113-01, 05113-02, 05114-09, 05514-01, 05614-04, 05713-03, 05714-10, 06313-05, 06314-04, 06513-02, 06514-02, 06914-01, 07213-04, 07713-18, 08113-04 and 62 more |
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.
Reason for recall
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.
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-1552-2014. 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.