1) Flex Extenders — Class II medical device recall Z-0263-2025
Ongoing recall by Westmed, Inc., reported 2024-11-06, distributed in AK, CA, CO, DC, FL, GA, IL, IN…. Due to connector within the circuit flex extender not meeting specifications resulting in a low connection for
| Recall number | Z-0263-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Westmed, Inc., Tucson, AZ, United States |
| Recall initiated | 2024-09-27 |
| Classified | 2024-10-30 |
| Reported by FDA | 2024-11-06 |
| Distributed | AK, CA, CO, DC, FL, GA, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OR, PA, SC, TX, VA, VT, WA, WV |
| Quantity | 50,050 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00709078008405, 00709078012488, 10709078008402, 10709078012485 |
| Lot numbers | 0004289133, 0004289134, 0004289135, 0004289136, 0004289735, 0004289736, 0004289737, 0004290327, 0004290328, 0004291315, 0004291316, 0004291317, 0004291318, 0004291790, 0004291791, 0004292272, 0004292273, 0004292275, 0004292717, 0004293127, 0004294432, 0004294433, 0004294660, 0004295069, 0004295358, 0004295361, 0004295458 |
| Model numbers | 5132, 6411P, S6411P |
Product
1) Flex Extenders, 5.2" x 15mm OD x 15mm ID REF S6411P 2) Flex Extender, 5.2" x 15mm OD x 22/15mm ID REF 7 5132 The Westmed Flex Extenders are non invasive, single use/disposable, large bore, corrugated plastic tubes that provide a flexible, low resistance lightweight connection between breathing circuits and patient interface (tracheal tube, tracheostomy tube, or mask).
Reason for recall
Due to connector within the circuit flex extender not meeting specifications resulting in a low connection force and as a result, the connector may leak or disconnect and may cause life threating conditions or death.
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-0263-2025. 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.