Syringe Recall: Mentor LUER Lok 10cc
Announced 2026-07-08 · FDA
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. Distributed worldwide, including the United States, with UDI numbers 10081317028182, 10081317028205, 10081317028212, 10081317028229, 10081317028236, 10081317028281. No corrective action is listed.
| Brand | Mentor Texas, LP. |
|---|---|
| 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 |
| Reason | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. |
| Severity | moderate |
| Units affected | 1401 |
| 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. |
| Agency | FDA |
WHAT YOU SHOULD DO
- Check if you own the recalled syringes by comparing their UDI numbers to the ones listed.
- Contact your supplier or healthcare provider for replacement options or return instructions.
- Do not use recalled syringes; set them aside and dispose of them according to local regulations or facility guidance.
- Refer to the recall for further instructions or questions from the provider or FDA.
How to identify the recalled item
| Lot / date codes | UDI(s): 10081317028182 10081317028205 10081317028212 10081317028229 10081317028236 10081317028281 |
|---|---|
| Lot / date codes | BD Product Code: 302995 Mentor Product Code: B9604 Sales Unit Box UDI-DI/GTIN code: 30382903029952 Individual Unit UDI-DI/GTIN code: 00382903029952 Lot Number: 8298877 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.