Z-2112-2015Class II

Surgical Kit Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 573326 7497-HLS...

Name: Z-2112-2015 Surgical Kit Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 573326 7497-HLS...
Creator: Covidien LLC
Published: 2015-04-16
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2015-04-16 / Terminated / root cause: manufacturing process

FDA source

Covidien LLC began a recall of Surgical Kit Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 573326 7497-HLS Surgical Kit 573328 7437-NRF SURGICAL ASC KIT 573343... on 2015-04-16. FDA classified it as Class II and gives the reason as "Devon Light Gloves contain splits or holes compromising the sterility". 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-2112-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-16
Posted: 2015-07-20
Terminated: 2017-06-28
Recalling firm: Medtronic, Inc.
Product: Surgical Kit Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 573326 7497-HLS Surgical Kit 573328 7437-NRF SURGICAL ASC KIT 573343 7499-88 SURGICAL KIT with Light Gloves 573346 7499-TLG Surgical Kit with Edge 573359 7499-HLW Surgical KIT 573368 7494-CAB2 SURGICAL KIT 573776 7520-BHP SURGICAL KIT 573777 7527-BHB SURGICAL KITS 573798 7496-8KB Surgical KIT 31144507 7519 Minor Surgical Kit 31175089 7497-8T6 Surgical Kit 31321097 7697 Surgical Set Up Kit 31451480 7493-SFW SURGICAL KIT 31460432 7596-SHH Surgical KIT 50000947 7413-CAD Surgical KIT 50001029 7417-PCP Surgical KIT 50001052 7427-CFS Surgical KIT
Product code: FSY Light, Surgical, Ceiling Mounted
Reason for recall: Devon Light Gloves contain splits or holes compromising the sterility
Root cause tag: manufacturing process
FDA 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 in commerce: 114,813 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.
Product codes and lots: Lot number begins 508xxxx or lower

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2112-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2106-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20
Z-2107-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20
Z-2108-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20
Z-2109-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20
Z-2110-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20
Z-2111-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20
Z-2112-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20
Z-2113-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20
Z-2114-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20
Z-2115-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20
Z-2116-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20
Z-2117-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20
Z-2118-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20
Z-2119-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20

Product code FSY

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)