Covidien LLC: Medical Device Recall in 2015 - (Recall #: Z-2111-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

ASC (Breast) Kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Decription: 573328 7437-NRF SURGICAL ASC KIT 50000511 7516-UNI Universal ASC Kit 50000512 7557-UNI Universal ASC Kit 50000515 7667-BRT Breast ASC Kit

Product Classification:

Class II

Date Initiated: April 16, 2015

Date Posted: July 29, 2015

Recall Number: Z-2111-2015

Event ID: 71113

Reason for Recall:

Devon Light Gloves contain splits or holes compromising the sterility

Status: Terminated

Product Quantity: 4,136 kits

Code Information:

Lot number begins 508xxxx or lower

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated