Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840144Q; 2) OPEN HEART, Model Number: CDS840150W; 3) OP... — FDA record Z-2453-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date May 6, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840144Q; 2) OPEN HEART, Model Number: CDS840150W; 3) OPEN HEART ADULT, Model Number: CDS840396AA; 4) CABG A CDS, Model Number: CDS982269N; 5) OPEN HEART ANESTHESIA PACK, Model Number: CDS983849G; 6) OPEN HEART ACCESSORY CDS, Model Number: CDS984289L; 7) OPEN HEART A, Model Number: CDS985105Q; 8) OPEN HEART PART 2, Model Number: DYNJ901075R; 9) VPH OPEN HEART, Model Number: DYNJ902664L; 10) HEART A, Model Number: DYNJ903465I; 11) HEART, Model Number: DYNJ903822F; 12) OPEN HEART BASIC B, Model Number: DYNJ904311F; 13) SM OPEN HEART PACK A&B, Model Number: DYNJ904749J; 14) OPEN HEART ANESTHESIA ICC-B, Model Number: DYNJ905567B; 15) SILVER CROSS OPEN HEART, Model Number: DYNJ906102K; 16) ANESTHESIA OPEN HEART, Model Number: DYNJ906225I; 17) OPEN HEART COMBO, Model Number: DYNJ907400F; 18) CARDIAC CABG B, Model Number: DYNJ908121C; 19) FS OPEN HEART, Model Number: DYNJ908308A; 20) OPEN HEART SUPPLEMENT, Model Number: DYNJ909116D; 21) MEM CARDIAC, Model Number: DYNJ9622573AP; 22) OPEN HEART A & B PACK, Model Number: DYNJ9718008AT
Reason
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.
Classification
Class I
Recalling firm
Medline Industries, LP
Quantity
6775 units
Agency-reported status
Ongoing
Source record identifier
Z-2453-2026

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicability1) CDS840144Q, UDI-DI: 10195327263102(each), 40195327263103(case), Lot Number: 24LBH805; 2) CDS840144Q, UDI-DI: 10195327263102(each), 40195327263103(case), Lot Number: 24HBM100; 3) CDS840144Q, UDI-DI: 10195327263102(each), 40195327263103(case), Lot Number: 25ABR195; 4) CDS840144Q, UDI-DI: 10195327263102(each), 40195327263103(case), Lot Number: 25EBS810; 5) CDS840144Q, UDI-DI: 10195327263102(each), 40195327263103(case), Lot Number: 25FBS936; 6) CDS840144Q, UDI-DI: 10195327263102(each), 40195327263103(case), Lot Number: 25GBX096; 7) CDS840144Q, UDI-DI: 10195327263102(each), 40195327263103(case), Lot Number: 25IBT859; 8) CDS840144Q, UDI-DI: 10195327263102(each), 40195327263103(case), Lot Number: 24KBE879; 9) CDS840144R, UDI-DI: 10198459561627(each), 40198459561628(case), Lot Number: 26DBF234; 10) CDS840144R, UDI-DI: 10198459561627(each), 40198459561628(case), Lot Number: 26ABG176; 11) CDS840144R, UDI-DI: 10198459561627(each), 40198459561628(case), Lot Number: 26ABK484; 12) CDS840150W, UDI-DI: 10195327648046(each), 40195327648047(case), Lot Number: 24HBQ201; 13) CDS840150X, UDI-DI: 10198459112386(each), 40198459112387(case), Lot Number: 25CBD369; 14) CDS840150X, UDI-DI: 10198459112386(each), 40198459112387(case), Lot Number: 25DBL498; 15) CDS840150X, UDI-DI: 10198459112386(each), 40198459112387(case), Lot Number: 24LBD200; 16) CDS840150X, UDI-DI: 10198459112386(each), 40198459112387(case), Lot Number: 24LBD223; 17) CDS840150X, UDI-DI: 10198459112386(each), 40198459112387(case), Lot Number: 24LBR405; 18) CDS840150X, UDI-DI: 10198459112386(each), 40198459112387(case), Lot Number: 24JBX455; 19) CDS840150Y, UDI-DI: 10198459303029(each), 40198459303020(case), Lot Number: 25FBD604; 20) CDS840150Y, UDI-DI: 10198459303029(each), 40198459303020(case), Lot Number: 25FBT739; 21) CDS840150Y, UDI-DI: 10198459303029(each), 40198459303020(case), Lot Number: 25HBT720; 22) CDS840150Y, UDI-DI: 10198459303029(each), 40198459303020(case), Lot Number: 25JBE191; 23) CDS840150Y, UDI-DI: 10198459303029(each), 40198459303020(case), Lot Number: 25JBW220; 24) CDS840150Y, UDI-DI: 10198459303029(each), 40198459303020(case), Lot Number: 26ABP964; 25) CDS840150Y, UDI-DI: 10198459303029(each), 40198459303020(case), Lot Number: 26BBD028; 26) CDS840150Y, UDI-DI: 10198459303029(each), 40198459303020(case), Lot Number: 26BBF355; 27) CDS840150Y, UDI-DI: 10198459303029(each), 40198459303020(case), Lot Number: 26CBB249; 28) CDS840396AA, UDI-DI: 10198459348686(each), 40198459348687(case), Lot Number: 25FBD477; 29) CDS840396AA, UDI-DI: 10198459348686(each), 40198459348687(case), Lot Number: 25HBM750; 30) CDS840396AB, UDI-DI: 10198459468742(each), 40198459468743(case), Lot Number: 25IBD204; 31) CDS840396AB, UDI-DI: 10198459468742(each), 40198459468743(case), Lot Number: 25JBQ605; 32) CDS840396AB, UDI-DI: 10198459468742(each), 40198459468743(case), Lot Number: 25KBK109; 33) CDS840396AB, UDI-DI: 10198459468742(each), 40198459468743(case), Lot Number: 26ABD873; 34) CDS840396AB, UDI-DI: 10198459468742(each), 40198459468743(case), Lot Number: 26ABT718; 35) CDS840396AC, UDI-DI: 10198459639494(each), 40198459639495(case), Lot Number: 26DLA888; 36) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 25BBG163; 37) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 25BBP788; 38) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 25CBD493; 39) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 25CBK781; 40) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24KBK977; 41) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24IBK539; 42) CDS980952AN, UDI-DI: 10198459022531(each), 40198459022532(case), Lot Number: 25BBB644; 43) CDS980952AN, UDI-DI: 10198459022531(each), 40198459022532(case), Lot Number: 25BBR673; 44) CDS980952AN, UDI-DI: 10198459022531(each), 40198459022532(case), Lot Number: 24LBM011; 45) CDS980952AN, UDI-DI: 10198459022531(each), 40198459022532(case), Lot Number: 24LBR411; 46) CDS980952AN, UDI-DI: 10198459022531(each), 40198459022532(case), Lot Number: 24HBW376; 47) CDS980952AN, UDI-DI: 10198459022531(each), 40198459022532(case), Lot Number: 24JBW880; 48) CDS980952AO, UDI-DI: 10198459245237(each), 40198459245238(case), Lot Number: 25DBP914; 49) CDS980952AO, UDI-DI: 10198459245237(each), 40198459245238(case), Lot Number: 25EBO343; 50) CDS980952AO, UDI-DI: 10198459245237(each), 40198459245238(case), Lot Number: 25FBN895; 51) CDS980952AO, UDI-DI: 10198459245237(each), 40198459245238(case), Lot Number: 25FBO022; 52) CDS980952AO, UDI-DI: 10198459245237(each), 40198459245238(case), Lot Number: 25FBS633; 53) CDS980952AP, UDI-DI: 10198459370991(each), 40198459370992(case), Lot Number: 25HBD136; 54) CDS980952AQ, UDI-DI: 10198459478420(each), 40198459478421(case), Lot Number: 25IBN076; 55) CDS980952AQ, UDI-DI: 10198459478420(each), 40198459478421(case), Lot Number: 25IBN339; 56) CDS980952AR, UDI-DI: 10198459520440(each), 40198459520441(case), Lot Number: 25LBC894; 57) CDS980952AR, UDI-DI: 10198459520440(each), 40198459520441(case), Lot Number: 26ABP940; 58) CDS980952AR, UDI-DI: 10198459520440(each), 40198459520441(case), Lot Number: 26CBI600; 59) CDS982269N, UDI-DI: 10195327352998(each), 40195327352999(case), Lot Number: 25HBH657; 60) CDS982269N, UDI-DI: 10195327352998(each), 40195327352999(case), Lot Number: 25IBM477; 61) CDS982269N, UDI-DI: 10195327352998(each), 40195327352999(case), Lot Number: 26BBG451; 62) CDS983849G, UDI-DI: 10195327650148(each), 40195327650149(case), Lot Number: 25ABO737; 63) CDS983849G, UDI-DI: 10195327650148(each), 40195327650149(case), Lot Number: 25BBM406; 64) CDS983849G, UDI-DI: 10195327650148(each), 40195327650149(case), Lot Number: 25CBL909; 65) CDS983849G, UDI-DI: 10195327650148(each), 40195327650149(case), Lot Number: 25EBN768; 66) CDS983849G, UDI-DI: 10195327650148(each), 40195327650149(case), Lot Number: 25GBC295; 67) CDS983849G, UDI-DI: 10195327650148(each), 40195327650149(case), Lot Number: 25HBJ455; 68) CDS983849G, UDI-DI: 10195327650148(each), 40195327650149(case), Lot Number: 25JBJ254; 69) CDS983849G, UDI-DI: 10195327650148(each), 40195327650149(case), Lot Number: 25LBJ730; 70) CDS983849G, UDI-DI: 10195327650148(each), 40195327650149(case), Lot Number: 25LBQ452; 71) CDS983849G, UDI-DI: 10195327650148(each), 40195327650149(case), Lot Number: 24LBB436; 72) CDS983849G, UDI-DI: 10195327650148(each), 40195327650149(case), Lot Number: 26ABV988; 73) CDS983849G, UDI-DI: 10195327650148(each), 40195327650149(case), Lot Number: 26CBR016; 74) CDS984289L, UDI-DI: 10195327439064(each), 40195327439065(case), Lot Number: 24FBT233; 75) CDS984289L, UDI-DI: 10195327439064(each), 40195327439065(case), Lot Number: 24HBJ043; 76) CDS984289M, UDI-DI: 10198459118548(each), 40198459118549(case), Lot Number: 24KBN423; 77) CDS984289M, UDI-DI: 10198459118548(each), 40198459118549(case), Lot Number: 24LBA755; 78) CDS984289M, UDI-DI: 10198459118548(each), 40198459118549(case), Lot Number: 24IBH401; 79) CDS984289M, UDI-DI: 10198459118548(each), 40198459118549(case), Lot Number: 24JBM195; 80) CDS984289M, UDI-DI: 24KBA684(each), 10198459118548(case), Lot Number: 40198459118549; 81) CDS984289N, UDI-DI: 25BBR524(each), 10198459256769(case), Lot Number: 40198459256760; 82) CDS984289N, UDI-DI: 10198459256769(each), 40198459256760(case), Lot Number: 25CBG855; 83) CDS984289N, UDI-DI: 10198459256769(each), 40198459256760(case), Lot Number: 25FBD048; 84) CDS984289O, UDI-DI: 10198459418143(each), 40198459418144(case), Lot Number: 25GBY100; 85) CDS984289O, UDI-DI: 10198459418143(each), 40198459418144(case), Lot Number: 25IBB599; 86) CDS984289O, UDI-DI: 10198459418143(each), 40198459418144(case), Lot Number: 25IBC732; 87) CDS984289O, UDI-DI: 10198459418143(each), 40198459418144(case), Lot Number: 25IBL186; 88) CDS984289O, UDI-DI: 10198459418143(each), 40198459418144(case), Lot Number: 25KBB457; 89) CDS984355I, UDI-DI: 10195327569518(each), 40195327569519(case), Lot Number: 24ELA326; 90) CDS984355J, UDI-DI: 10198459096228(each), 40198459096229(case), Lot Number: 25ALA777; 91) CDS984355J, UDI-DI: 10198459096228(each), 40198459096229(case), Lot Number: 25BLA015; 92) CDS984355J, UDI-DI: 10198459096228(each), 40198459096229(case), Lot Number: 25CLA060; 93) CDS984355J, UDI-DI: 10198459096228(each), 40198459096229(case), Lot Number: 24LLA698; 94) CDS984355K, UDI-DI: 10198459258848(each), 40198459258849(case), Lot Number: 25JLA937; 95) CDS984355K, UDI-DI: 10198459258848(each), 40198459258849(case), Lot Number: 26ALA525; 96) CDS984355K, UDI-DI: 10198459258848(each), 40198459258849(case), Lot Number: 26BLA695; 97) CDS984355K, UDI-DI: 10198459258848(each), 40198459258849(case), Lot Number: 26CLA630; 98) CDS985105Q, UDI-DI: 10198459197925(each), 40198459197926(case), Lot Number: 25ABC137; 99) CDS985105Q, UDI-DI: 10198459197925(each), 40198459197926(case), Lot Number: 25BBD104; 100) CDS985105Q, UDI-DI: 10198459197925(each), 40198459197926(case), Lot Number: 25CBD560; 101) CDS985105Q, UDI-DI: 10198459197925(each), 40198459197926(case), Lot Number: 25DBS683; 102) CDS985105Q, UDI-DI: 10198459197925(each), 40198459197926(case), Lot Number: 25FBI319; 103) CDS985105Q, UDI-DI: 10198459197925(each), 40198459197926(case), Lot Number: 25GBJ383; 104) CDS985105Q, UDI-DI: 10198459197925(each), 40198459197926(case), Lot Number: 25HBJ140; 105) CDS985105R, UDI-DI: 10198459501661(each), 40198459501662(case), Lot Number: 26DBE048; 106) CDS985105R, UDI-DI: 10198459501661(each), 40198459501662(case), Lot Number: 26DBP065; 107) CDS985105R, UDI-DI: 10198459501661(each), 40198459501662(case), Lot Number: 25JBT358; 108) CDS985105R, UDI-DI: 10198459501661(each), 40198459501662(case), Lot Number: 25LBE124; 109) CDS985105R, UDI-DI: 10198459501661(each), 40198459501662(case), Lot Number: 26ABO369; 110) DYNJ901075R, UDI-DI: 10198459047947(each), 40198459047948(case), Lot Number: 25CBE435; 111) DYNJ901075R, UDI-DI: 10198459047947(each), 40198459047948(case), Lot Number: 25EBS829; 112) DYNJ901075R, UDI-DI: 10198459047947(each), 40198459047948(case), Lot Number: 25IBG152; 113) DYNJ901075R, UDI-DI: 10198459047947(each), 40198459047948(case), Lot Number: 24KBJ878; 114) DYNJ901075R, UDI-DI: 10198459047947(each), 40198459047948(case), Lot Number: 24JBD229; 115) DYNJ901075R, UDI-DI: 10198459047947(each), 40198459047948(case), Lot Number: 26CBF249; 116) DYNJ902664L, UDI-DI: 10195327537883(each), 40195327537884(case), Lot Number: 25CLA878; 117) DYNJ902664L, UDI-DI: 10195327537883(each), 40195327537884(case), Lot Number: 24ELA957; 118) DYNJ902664L, UDI-DI: 10195327537883(each), 40195327537884(case), Lot Number: 24GLA394; 119) DYNJ902664L, UDI-DI: 10195327537883(each), 40195327537884(case), Lot Number: 24ILA830; 120) DYNJ902664M, UDI-DI: 10198459349126(each), 40198459349127(case), Lot Number: 25ILA177; 121) DYNJ902664M, UDI-DI: 10198459349126(each), 40198459349127(case), Lot Number: 25KLA500; 122) DYNJ902664N, UDI-DI: 10198459675287(each), 40198459675288(case), Lot Number: 26BLA783; 123) DYNJ902879T, UDI-DI: 10195327461294(each), 40195327461295(case), Lot Number: 25BBL963; 124) DYNJ902879T, UDI-DI: 10195327461294(each), 40195327461295(case), Lot Number: 25CBI916; 125) DYNJ902879T, UDI-DI: 10195327461294(each), 40195327461295(case), Lot Number: 25CBO345; 126) DYNJ902879T, UDI-DI: 10195327461294(each), 40195327461295(case), Lot Number: 25DBF270; 127) DYNJ902879T, UDI-DI: 10195327461294(each), 40195327461295(case), Lot Number: 25FBQ497; 128) DYNJ902879T, UDI-DI: 10195327461294(each), 40195327461295(case), Lot Number: 25HBN030; 129) DYNJ902879T, UDI-DI: 10195327461294(each), 40195327461295(case), Lot Number: 25IBI197; 130) DYNJ902879T, UDI-DI: 10195327461294(each), 40195327461295(case), Lot Number: 25IBL774; 131) DYNJ902879T, UDI-DI: 10195327461294(each), 40195327461295(case), Lot Number: 25JBH529; 132) DYNJ902879T, UDI-DI: 10195327461294(each), 40195327461295(case), Lot Number: 25KBB119; 133) DYNJ902879T, UDI-DI: 10195327461294(each...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

US Nationwide.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Jul 1, 2026
Recall initiation date
May 6, 2026
Center classification date
Jun 24, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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