FDA Device recall Z-1474-2022

Medline Convenience kits labeled as: a. MAJOR VASCULAR CDS, b. POST OP KIT, c. KIT NEURO FUS LUM POST SANSUR, d. KIT NEURO FUS LUM POST SAN…

FDA Device
Class II
ongoing
Published 2022-08-03

On 2022-08-03 the FDA classified a Class II recall of Medline Convenience kits labeled as: a. MAJOR VASCULAR CDS, b. POST OP KIT, c. KIT NEURO FUS LUM POST SANSUR, d. KIT NEURO FUS LUM POST SAN… by Medline Industries Spt, citing kits contain leaking bottles of isopropyl alcohol.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1474-2022
Classification	Class II
Status	ongoing
Initiated	2022-06-06
Published	2022-08-03
Last updated	2026-09-13 11:56 UTC
Company	Medline Industries Spt
Distribution	US

Product

Medline Convenience kits labeled as: a. MAJOR VASCULAR CDS, b. POST OP KIT, c. KIT NEURO FUS LUM POST SANSUR, d. KIT NEURO FUS LUM POST SANSUR , e. PRE-OP ACCESSORY KIT CHOICE, f. DEEP BRAIN STIMULATION PACK, g. DEEP BRAIN STIMULATION PACK, h. MINIMALLY INVASIVE PACK-LF, i. EVLP Pack/Kit, j. GENERAL PURPOSE CV, k. GENERAL PURPOSE CV, l. KIT GERMANTOWN CABG, m. KIT GERMANTOWN CABG, n. DENTAL RESTORATIONS, o. ALCOHOL PREP PACK, p. ALCOHOL PREP PACK, q. MATRIXECTOMY PACK-LF Model/Catalog Number: a. CDS981543D, b. DYKM1875, c. DYKMBNDL142A, d. DYKMBNDL142A, e. DYKS1185A, f. DYNJ0842793F, g. DYNJ0842793F, h. DYNJ0843063J, i. DYNJ901205C, j. DYNJ904395F, k. DYNJ904395F, l. DYNJ905855, m. DYNJ905855, n. DYNJ906653A, o. P922260, p. P922260, q. PHS110395003

Reason

Kits contain leaking bottles of isopropyl alcohol

Identifiers

code_info	Lot Code: a. Model Number CDS981543D, Lot Numbers: 19HBK745; b. Model Number DYKM1875, Lot Numbers: 22ABK810, 22ABO5… Lot Code: a. Model Number CDS981543D, Lot Numbers: 19HBK745; b. Model Number DYKM1875, Lot Numbers: 22ABK810, 22ABO583, 21LBB378; c. Model Number DYKMBNDL142A, Lot Numbers: 22OBJ742, 22ABY101, 21FBQ232, 21HBG594, 21JBA902, 21VBC259, 21DBE917; d. Model Number DYKS1185A, Lot Numbers: 21LBX041, 22CBO060, 21HBI534, 21HBQ840, 21CBT064, 21CBZ524; e. Model Number DYNJ0842793F, Lot Numbers: 22BDB295, 22DDA792, 21EDA769, 21GDB289, 21HDC822; f. Model Number DYNJ0843063J, Lot Numbers: 22CDB166, 22ADC136, 21LDA151, 21EDC220, 21GDC682, 21IDA570, 21JDA064; g. Model Number DYNJ901205C, Lot Numbers: 19HBE998; h. Model Number DYNJ904395F, Lot Numbers: 22DBG340, 22DBH356, 22DBI433, 21GBM221, 21LBO497, 21LBO625, 21DBJ932; i. Model Number DYNJ905855, Lot Numbers: 22DBK812, 22NBE430, 21GBC672, 21GBI192, 21IBT387, 21VBB580, 21DBV520, 21FBG162; j. Model Number DYNJ906653A, Lot Numbers: 22CDB173, 21CDC622; k. Model Number P922260, Lot Numbers: 22DMB774, 22BBK027, 21GBQ268, 21KBS110, 21

code_info

Lot Code: a. Model Number CDS981543D, Lot Numbers: 19HBK745; b. Model Number DYKM1875, Lot Numbers: 22ABK810, 22ABO5…

Lot Code: a. Model Number CDS981543D, Lot Numbers: 19HBK745; b. Model Number DYKM1875, Lot Numbers: 22ABK810, 22ABO583, 21LBB378; c. Model Number DYKMBNDL142A, Lot Numbers: 22OBJ742, 22ABY101, 21FBQ232, 21HBG594, 21JBA902, 21VBC259, 21DBE917; d. Model Number DYKS1185A, Lot Numbers: 21LBX041, 22CBO060, 21HBI534, 21HBQ840, 21CBT064, 21CBZ524; e. Model Number DYNJ0842793F, Lot Numbers: 22BDB295, 22DDA792, 21EDA769, 21GDB289, 21HDC822; f. Model Number DYNJ0843063J, Lot Numbers: 22CDB166, 22ADC136, 21LDA151, 21EDC220, 21GDC682, 21IDA570, 21JDA064; g. Model Number DYNJ901205C, Lot Numbers: 19HBE998; h. Model Number DYNJ904395F, Lot Numbers: 22DBG340, 22DBH356, 22DBI433, 21GBM221, 21LBO497, 21LBO625, 21DBJ932; i. Model Number DYNJ905855, Lot Numbers: 22DBK812, 22NBE430, 21GBC672, 21GBI192, 21IBT387, 21VBB580, 21DBV520, 21FBG162; j. Model Number DYNJ906653A, Lot Numbers: 22CDB173, 21CDC622; k. Model Number P922260, Lot Numbers: 22DMB774, 22BBK027, 21GBQ268, 21KBS110, 21

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1474-2022%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.