CLASS II ONGOING Device recall · Reported 6 Nov 2024 · FDA Enforcement Report

Flex Extenders, 5.2" OD ID recalled by Westmed

Westmed is recalling Flex Extenders, 5.2" OD ID, distributed in 30 states. The recall was initiated on 27 Sep 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog 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

Quantity recalled50,050 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0263-2025
FDA event ID: 95453
Recalling firm: Westmed, Tucson, AZ
Classification: Class II
Status: Ongoing
Recall initiated: 27 Sep 2024
FDA classified: 30 Oct 2024
Reported: 6 Nov 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Masks, Gloves & PPE

Timeline

27 Sep 2024	Recall initiated by company
30 Oct 2024	Classified by FDA	+33 days
6 Nov 2024	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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).

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

Alaska California Colorado District of Columbia Florida Georgia Illinois Indiana Kentucky Massachusetts Maryland Maine Michigan Minnesota Missouri North Carolina Nebraska New Hampshire New Jersey Nevada

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Westmed

All 24

Reported	Class	Recall	Company	Reason	Where
6 Jan 2021Device	CLASS II	Disposable Respiratory Products Non-rebreather Mask recalled by Westmed	Westmed	Other	Nationwide
6 Jan 2021Device	CLASS II	REF 0562F, Adult CO2/O2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" recalled	Westmed	Other	Nationwide
6 Jan 2021Device	CLASS II	REF 3102-E, Elongated Oxygen Mask, Adult Oxygen Elongated Mask recalled	Westmed	Other	Nationwide
6 Jan 2021Device	CLASS II	REF 0930 Adult Elongated CO2/O2 Mask, 7' Tubing w/ Threaded Nut recalled	Westmed	Other	Nationwide
6 Jan 2021Device	CLASS II	REF 0562K (Adult Elongated O2/CO2 Mask - Product Usage: intended recalled	Westmed	Other	Nationwide

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