FDA Medical Device Recalls (openFDA)
Covidien LLC: Surgical Set Up kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 31144895 7614-T4 Single Basin Set Up Kit 31144960 7693-T4 Single Basin Set Up Kit 31144978 7766 Double Basin Set Up Kit 31145215 7896 Double Basin Set Up Kit 31145231 7897 Double Basin Set Up Kit 31145249 7897-T8 Double Basin Set Up Kit 31145298 7896-T8 Double Basin Set Up Kit 31145496 7696-T4 Single Basin Set Up Kit 31145520 7614 Single Basin Set Up Kit 31145546 7693 Single Basin Set Up Kit 31145629 7696 Single Basin Set Up Kit 31153938 7756-KST Surgical Set Up Kit 31154266 7656-KST Surgical Set Up Kit 31321097 7697 Surgical Set Up Kit 31324299 7830-HOH Surgical Set Up Kit 31451092 7600-DNV Surgical Set Up Kit 31453098 7682-MHP Surgical Set Up Kit
- Recall number
- Z-2110-2015
- Recalling firm
- Covidien LLC
- Product
- Surgical Set Up kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 31144895 7614-T4 Single Basin Set Up Kit 31144960 7693-T4 Single Basin Set Up Kit 31144978 7766 Double Basin Set Up Kit 31145215 7896 Double Basin Set Up Kit 31145231 7897 Double Basin Set Up Kit 31145249 7897-T8 Double Basin Set Up Kit 31145298 7896-T8 Double Basin Set Up Kit 31145496 7696-T4 Single Basin Set Up Kit 31145520 7614 Single Basin Set Up Kit 31145546 7693 Single Basin Set Up Kit 31145629 7696 Single Basin Set Up Kit 31153938 7756-KST Surgical Set Up Kit 31154266 7656-KST Surgical Set Up Kit 31321097 7697 Surgical Set Up Kit 31324299 7830-HOH Surgical Set Up Kit 31451092 7600-DNV Surgical Set Up Kit 31453098 7682-MHP Surgical Set Up Kit
- Status
- Terminated
- Initiated
- 2015-04-16
- Posted
- 2015-07-20
- Terminated
- 2017-06-28
- Reason
- Devon Light Gloves contain splits or holes compromising the sterility
- Root cause
- Process control
- Action
- Medtronic/Covidien initiated recall on April 16, 2015 via FedEx and certified mail Customers were instructed to discontinue use of the product and return all inventory and kits to Medtronic (Covidien) -Attention: Devon" Light Glove 110 Kendall Park Lane. Atlanta, GA 30336. If you have any questions contact your Medtronic representative or Medtronic Customer Service, Monday through Friday, 8am to 6:30pm ET, at (800) 882-5878.
- Quantity
- 33,256 kits
- Distribution
- Worldwide Distribution-US (nationwide) including the Virgin Islands and the countries of Canada, Australia, New Zealand, Costa Rica, Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland , France, Germany, Netherlands, Sweden, Ireland, ISRAEL,Spain, Italy, Jordan, Kenya, Kuwait, United Kingdom, Lebanon, Liechtenstein, Luxembourg, Monaco, South Africa, Norway, Poland, Portugal, Qatar, Russia, Saudi Arabia, Slovenia, Switzerland, Turkey, and UAE.
- Lot, serial or model codes
- Lot number begins 508xxxx or lower
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FSY
- Firm FEI
- 1219930
- Firm city
- North Haven
- Firm state
- CT
- 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