CLASS II Device recall · Reported 16 Jul 2014 · FDA Enforcement Report

Devon Supine, Lithotomy and Trendelenburg Positioning Kit recalled

Covidien is recalling Devon Supine, Lithotomy and Trendelenburg Positioning Kit, distributed nationwide in the US. The recall was initiated on 8 May 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes14085, 14086, 14092, 14095, 14101, 14106 *The original recall submission listed 14084 and 14094, these were reported by Covidien in error on the original submission.

Quantity recalled264 devices

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-1997-2014
FDA event ID: 68243
Recalling firm: Covidien, Mansfield, MA
Classification: Class II
Status: Terminated
Recall initiated: 8 May 2014
FDA classified: 6 Jul 2014
Reported: 16 Jul 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

8 May 2014	Recall initiated by company
6 Jul 2014	Classified by FDA	+59 days
16 Jul 2014	Published in enforcement report	+10 days

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

Reason for recall

Straps may separate from the foam pad.

Product as listed by the FDA

Devon Supine, Lithotomy and Trendelenburg Positioning Kit; Product Code: 31151090 Product Usage: The device is intended to provide padding under the patient, and help maintain the position of an anesthetized patient during surgery.

Where it was distributed

US Nationwide Distribution in the states of NJ, CA, TX, IL, MO, PA, OH, IN, MI, MN, FL, IN, DC, PA, VA, MS, ME, NV, AR, KY, NY, KS, SC

Nationwide Arkansas California District of Columbia Florida Illinois Indiana Kansas Kentucky Maine Michigan Minnesota Missouri Mississippi New Jersey Nevada New York Ohio Pennsylvania South Carolina Texas

Questions about this recall

Is Devon Supine, Lithotomy and Trendelenburg Positioning Kit recalled?

Yes. Covidien recalled Devon Supine, Lithotomy and Trendelenburg Positioning Kit on 8 May 2014. The recall is Class II and its status is Terminated. Recall number Z-1997-2014.

Why was it recalled?

Straps may separate from the foam pad.

Which lots are affected?

14085, 14086, 14092, 14095, 14101, 14106 *The original recall submission listed 14084 and 14094, these were reported by Covidien in error on the original submission.

Where was it sold?

US Nationwide Distribution in the states of NJ, CA, TX, IL, MO, PA, OH, IN, MI, MN, FL, IN, DC, PA, VA, MS, ME, NV, AR, KY, NY, KS, SC

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.

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