CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314...
FDA Device Recall #Z-1681-2026 — Class II — February 18, 2026
Recall Summary
| Recall Number | Z-1681-2026 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 18, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Mentor Texas, LP. |
| Location | Irving, TX |
| Product Type | Devices |
Product Description
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc)
Reason for Recall
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Distribution Pattern
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.
Lot / Code Information
00081317006671 00081317006794 00081317006800
Other Recalls from Mentor Texas, LP.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1684-2026 | Class II | CPX 4 US Breast Tissue Expanders with Suture Ta... | Feb 18, 2026 |
| Z-1686-2026 | Class II | Artoura Breast Tissue Expanders Reference Numb... | Feb 18, 2026 |
| Z-1682-2026 | Class II | CPX 4 US Breast Tissue Expanders with Suture Ta... | Feb 18, 2026 |
| Z-1683-2026 | Class II | CPX 4 US Breast Tissue Expanders with Suture Ta... | Feb 18, 2026 |
| Z-1685-2026 | Class II | Artoura Breast Tissue Expanders Reference Numb... | Feb 18, 2026 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.