FDA Medical Device Recalls (openFDA)
Covidien LLC: 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.
- Recall number
- Z-1997-2014
- Recalling firm
- Covidien LLC
- 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.
- Status
- Terminated
- Initiated
- 2014-05-08
- Posted
- 2014-07-07
- Terminated
- 2015-09-04
- Reason
- Straps may separate from the foam pad.
- 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
- 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
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CCX
- Firm FEI
- 1282497
- Firm city
- Mansfield
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28