CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers:… — Class II medical device recall Z-1681-2026
Ongoing recall by Mentor Texas, LP., reported 2026-04-08, distributed nationwide. Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
| Recall number | Z-1681-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mentor Texas, LP., Irving, TX, United States |
| Recall initiated | 2026-02-18 |
| Classified | 2026-03-27 |
| Reported by FDA | 2026-04-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BG, CA, CH, CZ, DE, DK, ES, FI, FR, GB, HR, IE, IS, IT, NO, PK, PL, RO, SA, SE, SG, SI, SK, TW |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00081317006671, 00081317006794, 00081317006800 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1681-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.