Recall Z-1687-2026
Mentor Texas, LP. · initiated February 18, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: UDI(s): 10081317028182 10081317028205 10081317028212 10081317028229 10081317028236 10081317028281
Reason for recall
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
FDA-determined cause: Under Investigation by firm
Action taken
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 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
Details
- Recall number
- Z-1687-2026
- Initiated
- February 18, 2026
- Posted by FDA
- March 27, 2026
- Product code
- LCJ – Tissue Expander And Accessories
- 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.
- Recalling firm
- Mentor Texas, LP., Irving, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1681-2026 Class II | CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313…Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | 02/18/2026Open, Classified |
| Z-1682-2026 Class II | CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth…Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | 02/18/2026Open, Classified |
| Z-1683-2026 Class II | CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH…Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | 02/18/2026Open, Classified |
| Z-1684-2026 Class II | CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH…Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | 02/18/2026Open, Classified |
| Z-1685-2026 Class II | Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH…Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | 02/18/2026Open, Classified |
| Z-1686-2026 Class II | Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H…Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | 02/18/2026Open, Classified |