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U.S. Department of Health and Human Services

Class 2 Device Recall ARTOURA Breast Tissue Expanders

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 Class 2 Device Recall ARTOURA Breast Tissue Expanderssee related information
Date Initiated by FirmFebruary 18, 2026
Date PostedMarch 27, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1687-2026
Recall Event ID 98482
510(K)NumberK161176 
Product Classification Tissue expander and accessories - Product Code LCJ
ProductArtoura 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
Code Information UDI(s): 10081317028182 10081317028205 10081317028212 10081317028229 10081317028236 10081317028281
FEI Number 1000118360
Recalling Firm/
Manufacturer		 Mentor Texas, LP.
3041 Skyway Cir N
Irving TX 75038-3524
For Additional Information ContactMentor Resource Department
7200-636-8678
Manufacturer Reason
for Recall		Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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 ethicon3910@sedgwick.com 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
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LCJ
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