CLASS II Device recall · Reported 2 Sep 2015 · FDA Enforcement Report

Wheel caster set screw for Ferno iNX Wheeled Stretcher recalled

Ferno-Washington is recalling Wheel caster set screw for Ferno iNX Wheeled Stretcher, distributed in 7 states. The recall was initiated on 1 May 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial numbers: 15F001703, 15F001704, 15F001705, 15F001706, 15F001707, 15F001708, 15F001709, 15F001710, 15F001711, 15F001712, 15F001713, 15F001714, 15F001715, 15F001716, 15F001717, 15F001719, 15F001720, 15F001721, 15F001722, 15F001723, 15F001724, 15F001725, 15F001726, 15F001727, 15F001729 & 15F001730.
Quantity recalled26 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-2461-2015
FDA event ID
71556
Recalling firm
Ferno-Washington, Wilmington, OH
Classification
Class II
Status
Terminated
Recall initiated
1 May 2015
FDA classified
25 Aug 2015
Reported
2 Sep 2015
Type
Voluntary: Firm initiated
Customers notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category
Other Reasons

Timeline

1 May 2015Recall initiated by company
25 Aug 2015Classified by FDA+116 days
2 Sep 2015Published in enforcement report+8 days

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

Reason for recall

The firm discovered an improperly installed set screw in one caster arm assembly on a unit in production. The screw assists in preventing the bearing cup on the caster assembly from backing out of the caster arm during use.

Product as listed by the FDA

Wheel caster set screw for Ferno iNX Wheeled Stretcher. Ferno iNX Wheeled Stretcher for pre-hospital patient transport.

Where it was distributed

Distributed in the states of AZ, CO, IA, MD, OH, PA & WA, and the countries of Australia, Canada & United Kingdom.

ArizonaColoradoIowaMarylandOhioPennsylvaniaWashington

Questions about this recall

Why was it recalled?

The firm discovered an improperly installed set screw in one caster arm assembly on a unit in production. The screw assists in preventing the bearing cup on the caster assembly from backing out of the caster arm during use.

Which lots are affected?

Serial numbers: 15F001703, 15F001704, 15F001705, 15F001706, 15F001707, 15F001708, 15F001709, 15F001710, 15F001711, 15F001712, 15F001713, 15F001714, 15F001715, 15F001716, 15F001717, 15F001719, 15F001720, 15F001721, 15F001722, 15F001723, 15F001724, 15F001725, 15F001726, 15F001727, 15F001729 & 15F001730.

Where was it sold?

Distributed in the states of AZ, CO, IA, MD, OH, PA & WA, and the countries of Australia, Canada & United Kingdom.

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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