Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
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).
Why it was recalled
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.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
Catalog Number: S6411P UDI-DI codes: Each: 00709078012488 Case: 10709078012485 Lot Numbers: 0004294660 0004289136 0004291318 0004295361 Catalog Number: 7 5132 UDI-DI codes: Each: 00709078008405 Case: 10709078008402 Lot Numbers: 0004289133 0004289134 0004289135 0004289735 0004289736 0004289737 0004290327 0004290328 0004291315 0004291316 0004291317 0004291790 0004291791 0004292272 0004292273 0004292275 0004292717 0004293127 0004294432 0004294433 0004295069 0004295358 0004295458
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
U.S.: 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, and WV O.U.S.: N/A
Recall record
- Recalling firm
- Westmed, Inc.
- Product type
- Devices
- Recall number
- Z-0263-2025
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Tucson, AZ
- Recall initiated
- 2024-09-27
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-0263-2025 · Source: openFDA enforcement.