RecallRadar

FDA Device recall Z-2628-2024

See RES description

On 2024-09-04 the FDA classified a Class II recall of See RES description by Medline Industries Northfield, citing medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that m….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2628-2024
ClassificationClass II
Statusongoing
Initiated2024-04-08
Published2024-09-04
Last updated2026-09-13 11:57 UTC
CompanyMedline Industries Northfield
Distributionn/a

Product

See RES description

Reason

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Identifiers

code_info
00-398650AJ, Lot Number 23ABN193 ; 00-398650AJ, Lot Number 23ABN291 ; 00-398650AJ, Lot Number 23EBQ823 ; 00-398650AJ…00-398650AJ, Lot Number 23ABN193 ; 00-398650AJ, Lot Number 23ABN291 ; 00-398650AJ, Lot Number 23EBQ823 ; 00-398650AJ, Lot Number 23FBJ579 ; 00-398650AJ, Lot Number 23FBT136 ; 00-398650AJ, Lot Number 23IBB919 ; 00-398650AJ, Lot Number 23KBE097 ; 00-398650AJ, Lot Number 23LBS258 ; 00-398725AL, Lot Number 19BBA371 ; 00-398725AL, Lot Number 19CBE645 ; 00-398725AL, Lot Number 19DBR240 ; 00-398725AL, Lot Number 19EBK403 ; 00-398725AL, Lot Number 19FBU700 ; 00-398725AL, Lot Number 19GBR148 ; 00-398725AN, Lot Number 21FBS869 ; 00-398725AN, Lot Number 21JBN432 ; 00-398725AN, Lot Number 21LBK643 ; 00-398725AN, Lot Number 22ABX426 ; 00-398725AN, Lot Number 22BBR469 ; 00-398725AN, Lot Number 22CBU793 ; 00-398725AN, Lot Number 22OBM117 ; 00-398725AN, Lot Number 22EBK111 ; 00-398725AN, Lot Number 22GBJ289 ; 00-398725AN, Lot Number 22IBU378 ; 00-398725AN, Lot Number 22JBV752 ; 00-398725AN, Lot Number 22LBE100 ; 00-398725AN, Lot Number 23ABO369 ; 00-398725AN, Lot Number 23BB

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2628-2024%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.