CLASS II Device recall · Reported 14 May 2014 · FDA Enforcement Report
TX1 Tissue Removal System recalled by Tenex Health
Tenex Health is recalling TX1 Tissue Removal System, distributed nationwide in the US. The recall was initiated on 14 Apr 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1552-2014
- FDA event ID
- 68074
- Recalling firm
- Tenex Health, Lake Forest, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Apr 2014
- FDA classified
- 6 May 2014
- Reported
- 14 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 14 Apr 2014 | Recall initiated by company | |
| 6 May 2014 | Classified by FDA | +22 days |
| 14 May 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - USA (Nationwide) and Internationally to Panama and Singapore.
Questions about this recall
Is TX1 Tissue Removal System recalled?
Yes. Tenex Health recalled TX1 Tissue Removal System on 14 Apr 2014. The recall is Class II and its status is Terminated. Recall number Z-1552-2014.
Why was it recalled?
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.
Which lots are affected?
Lot Numbers: 00614-03, 06513-02, 24913-01, 00713-06, 06514-02, 25313-01, 00814-02, 06914-01, 25513-02, 01114-02, 07213-04, 25613-01, 01514-03, 07713-18, 26113-06, 01714-04, 08113-04, 26313-04, 01813-02, 08413-13, 26713-04, 02314-08, 09313-05, 26813-01, 02413-04, 10213-07, 27013-10, 02714-02, 10613-01, 27613-02, 02914-01, 11213-07, 28013-05, 03014-02, 11613-06, 28313-02, 03113-02, 12113-02, 29513-03, 03114-02, 12713-03, 29713-01, 03414-03, 13413-01, 30913-07, 03514-05, 14413-05, 31113-08, 03714-03, 15013-04, 31513-02, 03814-06, 15413-02, 31713-05, 04114-02, 15413-03, 32213-01, 04213-01, 16513-04, 32413-01, 04214-05, 17013-02, 32613-01, 04414-03, 17013-09, 32913-07, 04514-02, 17613-08, 33613-09, 04814-07, 17913-16, 33813-05, 05014-02, 18413-05, 34013-03, 05113-01, 18413-06, 34313-01, 05113-02, 18613-03, 34413-04, 05114-09, 19213-03, 34513-04, 05514-01, 19713-04, 34713-08, 05614-04, 20713-06, 35113-01, 05713-03, 21813-01, 35213-03, 05714-10, 23913-01, 36013-01, 06313-05, 24113-04, 36113-02, 06314-04, 24213-04, and 36413-05.
Where was it sold?
Worldwide Distribution - USA (Nationwide) and Internationally to Panama and Singapore.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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