Z-1552-2014Class II

TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001...

Name: Z-1552-2014 TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001...
Creator: Tenex Health Inc
Published: 2014-04-14
License: https://open.fda.gov/license/

Tenex Health / initiated 2014-04-14 / Terminated / root cause: packaging

FDA source

Tenex Health Inc began a recall of 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... on 2014-04-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1552-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-14
Posted: 2014-05-06
Terminated: 2014-07-16
Recalling firm: Tenex Health
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.
Product code: LFL Instrument, Ultrasonic Surgical
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.
Root cause tag: packaging
FDA root cause: Packaging
Action: Tenex Health sent an Urgent Medical Device Recall notification letter dated April 15, 2014, to all consigness. The letter informed consignees of the recall, manufacturer, product name, product code, reason for recall, recall carried out to the user level, instructions to customers, contact information, label examples, and response form was provided. Consignees were instructed to immediately examine their inventory per the enclosed instructions, if they identify any of the affected product within their inventory, they should segregate the product and immediately return only MicroTips with damaged trays to the address below, using the Tenex Health, Inc. FEDEX account number and referencing the Returned Goods Authorization (RGA) number. RGA# Tenex Health, Inc. 26902 Vista Terrace Lake Forest, CA 92630 Customers were asked to complete and return the enclosed response form as soon as possible. Customers with questions should contact Tenex at (949) 454-7500, ext. 209 or email [email protected]. For questions regarding this recall call (949) 454-7500.
Quantity in commerce: 9,927 units
Distribution: Worldwide Distribution - USA (Nationwide) and Internationally to Panama and Singapore.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1552-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1552-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-14	2014-05-06

Product code LFL

K123640UnclassifiedTx1 Tissue Removal SystemTenex Health / cleared 2013-03-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)