MEDICAL DEVICE RECALLCRITICAL

Medline CV Anesthesia Room Setup Kits

Medline recalls CV Anesthesia Room Setup kits due to quality issues with included lidocaine and bupivacaine injections.

What to do

Consumers should stop using the affected kits and contact Medline for instructions on returning the product and obtaining a replacement.

Recalled

2026-05-06

Listed

2026-06-24

Updated

2026-09-03

Recall No.

Z-2452-2026

Agency

FDA

Firm

Medline Industries, LP

Recall ID

99043

Status

ONGOING

Why it was recalled

Medline is recalling two convenience kits used for cardiovascular anesthesia room setup because they contain Arrow kits and sets with Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP that were recalled due to quality issues identified during an FDA inspection of the supplier.

Is mine affected?

This recall covers 30 products. Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

Product	Lot code	Model	UDI-DI
CV ANESTHESIA - ROOM SET UP	24GBR740, 24JBP984	DYNJ905503F	10193489967272
OPEN HEART CDS	24LBH805, 24HBM100, 25ABR195, 25EBS810, 25FBS936, 25GBX096, 25IBT859, 24KBE879	CDS840144Q	10195327263102
OPEN HEART	24HBQ201	CDS840150W	10195327648046
OPEN HEART ADULT	25FBD477, 25HBM750	CDS840396AA	10198459348686
CABG A CDS	25HBH657, 25IBM477, 26BBG451	CDS982269N	10195327352998
OPEN HEART ANESTHESIA PACK	25ABO73725BBM40625CBL90925EBN76825GBC29525HBJ45525JBJ25425LBJ73025LBQ45224LBB43626ABV98826CBR016	CDS983849G	10195327650148
OPEN HEART ACCESSORY CDS	24FBT233, 24HBJ043	CDS984289L	10195327439064
OPEN HEART A	25ABC137, 25BBD104, 25CBD560, 25DBS683, 25FBI319, 25GBJ383, 25HBJ140	CDS985105Q	10198459197925

Show all 30 products

Product	Lot code	Model	UDI-DI
CV ANESTHESIA - ROOM SET UP	26DBJ11025ABJ06925ABL74925CBB76225DBG79925EBM99425GBW22625LBA95025LBT01926ABH51926ABT31526BBQ338	DYNJ905503G	10198459200397
OPEN HEART PART 2	25CBE435, 25EBS829, 25IBG152, 24KBJ878, 24JBD229, 26CBF249	DYNJ901075R	10198459047947
VPH OPEN HEART	25CLA878, 24ELA957, 24GLA394, 24ILA830	DYNJ902664L	10195327537883
HEART A	24HDA682, 24JDA680, 24KDB293, 24LDB086	DYNJ903465I	10195327678395
HEART	25BBG22025DBB26325EBR36725GBI75125HBU08625IBH10825JBL34425KBD16924KBI65024LBP781	DYNJ903822F	10195327355692
OPEN HEART BASIC B	25GBM24925GBO42625GBW21825LBG05525LBG65525LBH67924FBP49124HBC26424IBI53324JBR69026ABD79826CBC603	DYNJ904311F	10195327297077
SM OPEN HEART PACK A&B	26DBI40825ABE59325BBG73425EBU72025HBI84725IBQ20925IBU99425KBC53324KBJ79624LBP68826ABM369	DYNJ904749J	10195327511142
OPEN HEART ANESTHESIA ICC-B	26DBE95025ABR14925BBE95925CBG59925GBG39525HBT25525IBK70725KBH51425LBU205	DYNJ905567B	10198459151163
SILVER CROSS OPEN HEART	24KBJ996	DYNJ906102K	10198459079733
ANESTHESIA OPEN HEART	26DDA78125BDB48825DDA87225DDB81825EDB25925FDA50225FDA66925FDA88525FDB47025GDB12425IDA89525KDA34926ADA53026CDA58326CDB312	DYNJ906225I	10195327658328
OPEN HEART COMBO	25BBN388, 25EBA952, 25EBP655, 25FBG002, 25GBC367	DYNJ907400F	10195327694579
CARDIAC CABG B	26DBP62125CBQ70225DBN70825EBH91725GBH81725JBM10625KBG67326ABD61026CBM190	DYNJ908121C	10198459024863
FS OPEN HEART	25DBG598, 25FBU833, 25HBP099	DYNJ908308A	10198459287213
OPEN HEART SUPPLEMENT	25JBM466	DYNJ909116D	10198459055355
MEM CARDIAC	25CBJ58725DBV37425FBJ22725GBF52125HBU89025IBN99425JBM12125JBP61425LBM80024LBO07524JBW89624JBY03824KBE874	DYNJ9622573AP	10193489462821
OPEN HEART A & B PACK	24LLA953, 25ALA273, 25ALA353, 25BLA453, 25CLA742, 25CLA982, 24KLA590	DYNJ9718008AT	10198459133978
DRAWER 6 CENTRAL LINE INSERTIO	26DDA462, 26DDA547	ACC011142	10198459721342
CENTRAL AND ARTERIAL LINE TOTE	26DBB599	DYNJ8407	10198459704543
DRAWER 6A ADULT CENTRAL LINE	25BDA811, 25DDB415, 25DDC095	ACC010890	10198459139833
OPEN HEART A OVERHEAD	25ADB324, 25FDB473, 25GDA336, 24FDB427	DYNJ910066	10195327565596
OPEN HEART	25ABH622, 25CBA788, 25CBF665, 25DBR616, 25FBA415, 25HBT666	DYNJ9855016V	10198459019951
OPEN HEART	25KBO109	DYNJ9855016X	10198459571374

Where it was sold

Distributed nationwide.

Timeline

2026-05-06Firm initiated recall
2026-06-24Publicly announced
2026-06-25Listed on Recall Canary
2026-09-03Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification