FDA Device recall Z-2118-2015
Non Sterile Subassembly: Catalog Number/Description: SA1008 NONSTERILE SUBASSEMBLY SA1578 NO-STERILE SUBASSEMBLY SA2000 NON STERILE SUBASSE…
- FDA Device
- Class II
- terminated
- Published 2015-07-29
On 2015-07-29 the FDA classified a Class II recall of Non Sterile Subassembly: Catalog Number/Description: SA1008 NONSTERILE SUBASSEMBLY SA1578 NO-STERILE SUBASSEMBLY SA2000 NON STERILE SUBASSE… by Covidien, citing devon Light Gloves contain splits or holes compromising the sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2118-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-16 |
| Published | 2015-07-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Covidien |
| Distribution | US |
Product
Non Sterile Subassembly: Catalog Number/Description: SA1008 NONSTERILE SUBASSEMBLY SA1578 NO-STERILE SUBASSEMBLY SA2000 NON STERILE SUBASSEMBLY SA2001 NON STERILE SUBASSEMBLY SA2002 NON STERILE SUBASSEMBLY SA2004 NON STERILE SUBASSEMBLY SA2005 NON STERILE SUBASSEMBLY SA2006 NON STERILE SUBASSEMBLY SA2007 NON STERILE SUBASSEMBLY SA2008 SA-7457-R NS SUBASSEMBLY SA2032B NSSA SA2038A NSSA SA2042 SA2042 SUBASSEMBLY NS SA2049 SA2049 NON STERILE SUBASSEMBLY SA2058B NSSA SA2074 SA2074 NON STERILE SUBASSEMBLY SA2075 SA2075 NON STERILE SUBASSEMBLY SA2109 SA2109 NON STERILE SUBASSY SA2119 SA2119 NON STERILE SUBASSY SA2120 SA2120 NON STERILE SUBASSY SA2121 NON STERILE SUBASSY SA2122 SA2122 NON STERILE SUBASSY SA2164A NSSA SA2172A NSSA SA2172B NSSA SA2173C NSSA SA2174B NSSA SA2185 SRM800 NSSA SA2198D NSSA SA2199 SA2199 NON STERILE SUBASSY SA2219 NSSA SA3011 SA3011 NON STERILE SUBASSY SA3013 SA3013 NON STERILE SUBASSY SA3018 SA3018 NON STERILE SUBASSY SA3040 SA3040 NON STERILE SUBASSY SA3045 NSSA SA3060 SA3060 NON STERILE SUBASSY SA3062A NSSA SUBASSEMBLY SA3068 SA3068 NON STERILE SUBASSY SA3069 SA3069 NON STERILE SUBASSY SA3071 SA3071 NON STERILE SUBASSY SA3076 NSSA SA3076A NSSA SA3077 NSSA BUTTON SA3078 NSSA ROCKER SA3080 NSSA SA4003 NON STERILE SUBASSEMBLY SA4003A NON STERILE SUBASSEMBLY SA4013 NSSA SA4014 NSSA SA4015 NSSA SA5006 NSSA SA5015 NSSA SA5017 NON STERILE SUBASSEMBLY SA2140 SA2140 NON STERILE SUBASSY
Reason
Devon Light Gloves contain splits or holes compromising the sterility
Identifiers
| code_info | Lot number begins 508xxxx or lower |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2118-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.