CLASS II Device recall · Reported 16 Nov 2016 · FDA Enforcement Report

The surgical table is a stand alone unit recalled

Schaerer Medical USA is recalling The surgical table is a stand alone unit, distributed nationwide in the US. The recall was initiated on 27 Sep 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Codes for the four (4) model 7300 Surgical Tables TFX-1653, TFX1654, TFX1655, TFX1656

Quantity recalled4 surgical tables with defective floor locking cylinders were distributed. Each table contains 3 cylinders for a total of 12 cylinders.

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-0371-2017
FDA event ID: 75288
Recalling firm: Schaerer Medical USA, Cincinnati, OH
Classification: Class II
Status: Terminated
Recall initiated: 27 Sep 2016
FDA classified: 8 Nov 2016
Reported: 16 Nov 2016
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Packaging Defects
Device type: Surgical Instruments

Timeline

27 Sep 2016	Recall initiated by company
8 Nov 2016	Classified by FDA	+42 days
16 Nov 2016	Published 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 floor locking cylinders contained in the base of the Schaerer 7300 model surgical tables were manufactured with the incorrect "O" ring which may cause the cylinder to leak.

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

The surgical table is a stand alone unit. Three (3) floor locking cylinders are attached to the base of the surgical table. The individual cylinders are replaceable. Product Usage: The cylinders are used to lock the surgical table in place.

Where it was distributed

Worldwide Distribution - US Nationwide in the states of: CA, CT, FL, IA, IN, MI, MN, MO, OH, PA, and VA Replcement cylinders wre distributed

Nationwide California Connecticut Florida Iowa Indiana Michigan Minnesota Missouri Ohio Pennsylvania Virginia

Questions about this recall

Is The surgical table is a stand alone unit recalled?

Yes. Schaerer Medical USA recalled The surgical table is a stand alone unit on 27 Sep 2016. The recall is Class II and its status is Terminated. Recall number Z-0371-2017.

Why was it recalled?

The floor locking cylinders contained in the base of the Schaerer 7300 model surgical tables were manufactured with the incorrect "O" ring which may cause the cylinder to leak.

Which lots are affected?

Lot Codes for the four (4) model 7300 Surgical Tables TFX-1653, TFX1654, TFX1655, TFX1656

Where was it sold?

Worldwide Distribution - US Nationwide in the states of: CA, CT, FL, IA, IN, MI, MN, MO, OH, PA, and VA Replcement cylinders wre distributed

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 21 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 Schaerer Medical USA

All 2

Reported	Class	Recall	Company	Reason	Where
16 Nov 2016Device	CLASS II	Replacement floor locking cylinders for the Schaerer recalled	Schaerer Medical USA	Packaging Defects	Nationwide

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