Z-1687-2026Class II

Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH...

Name: Z-1687-2026 Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH...
Creator: Mentor Texas, LP.
Published: 2026-02-18
License: https://open.fda.gov/license/

Mentor / initiated 2026-02-18 / Open, Classified

FDA source

Mentor Texas, LP. began a recall of Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth Ultra High Profile Tissue Expander... on 2026-02-18. FDA classified it as Class II and gives the reason as "Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1687-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-18
Posted: 2026-03-27
Recalling firm: Mentor
Product: Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth Ultra High Profile Tissue Expander, 350cc, 455cc, 535cc, 650cc, 700cc, 850cc
Product code: LCJ Tissue Expander And Accessories
Reason for recall: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
FDA root cause: Under Investigation by firm
Action: On March 2, 2026, Mentor Worldwide LLC issued a updated "Urgent Medical Device Recall (Removal). The initial notification was issued on February 18, 2026. Mentor is asking consignees to take the following actions: 1. Examine your inventory and quarantine immediately any affected products. 2. Please maintain a copy of the notice with the quarantined product. 3. Notify all personnel who need to be made aware of the recall. 4. Complete the Business Reply Form of this notice and fax 877-223-7559 or email [email protected] to Sedgwick within 3 business days. 5. If you require any assistance with returning product, please contact Sedgwick at 877-546-7680 and reference Event # 3910
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Albania, Australia, Austria, Belgium, Bulgaria, Croatia, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, Norway, Pakistan, Poland, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, United Kingdom, Czech Republic.
Product codes and lots: UDI(s): 10081317028182 10081317028205 10081317028212 10081317028229 10081317028236 10081317028281

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1687-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1681-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-27
Z-1682-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-27
Z-1683-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-27
Z-1684-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-27
Z-1685-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-27
Z-1686-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-27
Z-1687-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-27

Product code LCJ

K161176UnclassifiedARTOURA Breast Tissue Expanders with Smooth SurfaceMentor Worldwide, LLC / cleared 2016-05-23

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)