Z-1997-2014Class II

Devon Supine, Lithotomy and Trendelenburg Positioning Kit

Name: Z-1997-2014 Devon Supine, Lithotomy and Trendelenburg Positioning Kit
Creator: Covidien LLC
Published: 2014-05-08
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2014-05-08 / Terminated / root cause: manufacturing process

FDA source

Covidien LLC began a recall of Devon Supine, Lithotomy and Trendelenburg Positioning Kit; Product Code: 31151090 Product Usage: The device is intended to provide padding under the patient... on 2014-05-08. FDA classified it as Class II and gives the reason as "Straps may separate from the foam pad". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1997-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-08
Posted: 2014-07-07
Terminated: 2015-09-04
Recalling firm: Medtronic, Inc.
Product: 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.
Product code: CCX Support, Patient Position
Reason for recall: Straps may separate from the foam pad.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Covidien Sales Representatives notified customers in person by beginning May 8, 2014. The Sales Representative will provided a copy of the Recall letter (attachment 4), and collect any remaining product at the site. The notification and recovery of the product is expected to be complete no later than May 14, 2014.
Quantity in commerce: 264 devices
Distribution: 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
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1997-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1997-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-16	2014-07-06

Product code CCX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)