CLASS II Device recall · Reported 28 Jan 2015 · FDA Enforcement Report

Ferno Model 35X PROFlexx Stretchers, one unit per package recalled

Ferno-Washington is recalling Ferno Model 35X PROFlexx Stretchers, one unit per package, distributed in 8 states. The recall was initiated on 3 Dec 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesThe following serial numbers are affected by this recall: 13N272700 13N273357 13N273915 13N274967 13N275720 13N272701 13N273358 13N273916 13N274968 13N275721 13N272702 13N273359 13N273917 13N274969 13N275722 13N272703 13N273360 13N274387 13N274970 13N275723 13N272704 13N273361 13N274388 13N274971 13N275724 13N272705 13N273362 13N274389 13N274972 13N275725 13N273353 13N273363 13N274390 13N274973 13N275726 13N273354 13N273902 13N274391 13N275717 13N273355 13N273913 13N274965 13N275718 13N273356 13N273914 13N274966 13N275719

Quantity recalled46 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-0995-2015
FDA event ID: 69978
Recalling firm: Ferno-Washington, Wilmington, OH
Classification: Class II
Status: Terminated
Recall initiated: 3 Dec 2014
FDA classified: 16 Jan 2015
Reported: 28 Jan 2015
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Packaging Defects
Device type: Wheelchairs, Beds & Lifts

Timeline

3 Dec 2014	Recall initiated by company
16 Jan 2015	Classified by FDA	+44 days
28 Jan 2015	Published in enforcement report	+12 days

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

Reason for recall

The wheel castor assemblies may be loosening on the stretchers.

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

Ferno Model 35X PROFlexx Stretchers, one unit per package

Where it was distributed

The affected product was distributed to the following states: OH, MA, HI, NJ, TN, TX, MO, and GA. The affected product was distributed to the following foreign countries: Canada, Germany and Venezuela.

Georgia Hawaii Massachusetts Missouri New Jersey Ohio Tennessee Texas

Questions about this recall

Why was it recalled?

The wheel castor assemblies may be loosening on the stretchers.

Which lots are affected?

The following serial numbers are affected by this recall: 13N272700 13N273357 13N273915 13N274967 13N275720 13N272701 13N273358 13N273916 13N274968 13N275721 13N272702 13N273359 13N273917 13N274969 13N275722 13N272703 13N273360 13N274387 13N274970 13N275723 13N272704 13N273361 13N274388 13N274971 13N275724 13N272705 13N273362 13N274389 13N274972 13N275725 13N273353 13N273363 13N274390 13N274973 13N275726 13N273354 13N273902 13N274391 13N275717 13N273355 13N273913 13N274965 13N275718 13N273356 13N273914 13N274966 13N275719

Where was it sold?

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.

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