Medline Industries, LP: 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

Recall number

Z-2453-2026

Recalling firm

Medline Industries, LP

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

Status

Open, Classified

Initiated

2026-05-06

Posted

2026-06-24

Terminated

not on file

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.

Root cause

Nonconforming Material/Component

Action

An URGENT MEDICAL DEVICE RECALL notification letter dated 5/6/26 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. Website link: https://recalls.medline.com Recall Reference #: R-26-078-FG-FGX3 Recall Code: 3. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. 4. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.

Quantity

6775 units

Distribution

US Nationwide.

Lot, serial or model codes

1) 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).40195327461295(case), Lot Number: 25KBH512; 134) DYNJ902879T, UDI-DI: 10195327461294(each), 40195327461295(case), Lot Number: 24KBJ173; 135) DYNJ902879T, UDI-DI: 10195327461294(each), 40195327461295(case), Lot Number: 24LBN817; 136) DYNJ902879T, UDI-DI: 10195327461294(each), 40195327461295(case), Lot Number: 24GBL698; 137) DYNJ902879T, UDI-DI: 10195327461294(each), 40195327461295(case), Lot Number: 24HBN007; 138) DYNJ902879T, UDI-DI: 10195327461294(each), 40195327461295(case), Lot Number: 24IBE657; 139) DYNJ902879T, UDI-DI: 10195327461294(each), 40195327461295(case), Lot Number: 24IBQ479; 140) DYNJ902879T, UDI-DI: 10195327461294(each), 40195327461295(case), Lot Number: 24JBM236; 141) DYNJ902879T, UDI-DI: 10195327461294(each), 40195327461295(case), Lot Number: 24JBQ858; 142) DYNJ902879U, UDI-DI: 10198459629525(each), 40198459629526(case), Lot Number: 25LBK265; 143) DYNJ902879U, UDI-DI: 10198459629525(each), 40198459629526(case), Lot Number: 26ABI879; 144) DYNJ902879U, UDI-DI: 10198459629525(each), 40198459629526(case), Lot Number: 26ABK604; 145) DYNJ902879U, UDI-DI: 10198459629525(each), 40198459629526(case), Lot Number: 26CBJ681; 146) DYNJ903465I, UDI-DI: 10195327678395(each), 40195327678396(case), Lot Number: 24HDA682; 147) DYNJ903465I, UDI-DI: 10195327678395(each), 40195327678396(case), Lot Number: 24JDA680; 148) DYNJ903465I, UDI-DI: 10195327678395(each), 40195327678396(case), Lot Number: 24KDB293; 149) DYNJ903465I, UDI-DI: 10195327678395(each), 40195327678396(case), Lot Number: 24LDB086; 150) DYNJ903465J, UDI-DI: 10198459255045(each), 40198459255046(case), Lot Number: 25BDB377; 151) DYNJ903465K, UDI-DI: 10198459292743(each), 40198459292744(case), Lot Number: 26DDA021; 152) DYNJ903465K, UDI-DI: 10198459292743(each), 40198459292744(case), Lot Number: 25CDA729; 153) DYNJ903465K, UDI-DI: 10198459292743(each), 40198459292744(case), Lot Number: 25EDA907; 154) DYNJ903465K, UDI-DI: 10198459292743(each), 40198459292744(case), Lot Number: 25GDB257; 155) DYNJ903465K, UDI-DI: 10198459292743(each), 40198459292744(case), Lot Number: 25JDC094; 156) DYNJ903465K, UDI-DI: 10198459292743(each), 40198459292744(case), Lot Number: 25KDA540; 157) DYNJ903465K, UDI-DI: 10198459292743(each), 40198459292744(case), Lot Number: 26ADA464; 158) DYNJ903465K, UDI-DI: 10198459292743(each), 40198459292744(case), Lot Number: 26BDA587; 159) DYNJ903822F, UDI-DI: 10195327355692(each), 40195327355693(case), Lot Number: 25BBG220; 160) DYNJ903822F, UDI-DI: 10195327355692(each), 40195327355693(case), Lot Number: 25DBB263; 161) DYNJ903822F, UDI-DI: 10195327355692(each), 40195327355693(case), Lot Number: 25EBR367; 162) DYNJ903822F, UDI-DI: 10195327355692(each), 40195327355693(case), Lot Number: 25GBI751; 163) DYNJ903822F, UDI-DI: 10195327355692(each), 40195327355693(case), Lot Number: 25HBU086; 164) DYNJ903822F, UDI-DI: 10195327355692(each), 40195327355693(case), Lot Number: 25IBH108; 165) DYNJ903822F, UDI-DI: 10195327355692(each), 40195327355693(case), Lot Number: 25JBL344; 166) DYNJ903822F, UDI-DI: 10195327355692(each), 40195327355693(case), Lot Number: 25KBD169; 167) DYNJ903822F, UDI-DI: 10195327355692(each), 40195327355693(case), Lot Number: 24KBI650; 168) DYNJ903822F, UDI-DI: 10195327355692(each), 40195327355693(case), Lot Number: 24LBP781; 169) DYNJ903822I, UDI-DI: 10198459702860(each), 40198459702861(case), Lot Number: 26CBU152; 170) DYNJ903822I, UDI-DI: 10198459702860(each), 40198459702861(case), Lot Number: 26DBI319; 171) DYNJ903822I, UDI-DI: 10198459702860(each), 40198459702861(case), Lot Number: 26CBR069; 172) DYNJ904311F, UDI-DI: 10195327297077(each), 40195327297078(case), Lot Number: 25GBM249; 173) DYNJ904311F, UDI-DI: 10195327297077(each), 40195327297078(case), Lot Number: 25GBO426; 174) DYNJ904311F, UDI-DI: 10195327297077(each), 40195327297078(case), Lot Number: 25GBW218; 175) DYNJ904311F, UDI-DI: 10195327297077(each), 40195327297078(case), Lot Number: 25LBG055; 176) DYNJ904311F, UDI-DI: 10195327297077(each), 40195327297078(case), Lot Number: 25LBG655; 177) DYNJ904311F, UDI-DI: 10195327297077(each), 40195327297078(case), Lot Number: 25LBH679; 178) DYNJ904311F, UDI-DI: 10195327297077(each), 40195327297078(case), Lot Number: 24FBP491; 179) DYNJ904311F, UDI-DI: 10195327297077(each), 40195327297078(case), Lot Number: 24HBC264; 180) DYNJ904311F, UDI-DI: 10195327297077(each), 40195327297078(case), Lot Number: 24IBI533; 181) DYNJ904311F, UDI-DI: 10195327297077(each), 40195327297078(case), Lot Number: 24JBR690; 182) DYNJ904311F, UDI-DI: 10195327297077(each), 40195327297078(case), Lot Number: 26ABD798; 183) DYNJ904311F, UDI-DI: 10195327297077(each), 40195327297078(case), Lot Number: 26CBC603; 184) DYNJ904749J, UDI-DI: 10195327511142(each), 40195327511143(case), Lot Number: 26DBI408; 185) DYNJ904749J, UDI-DI: 10195327511142(each), 40195327511143(case), Lot Number: 25ABE593; 186) DYNJ904749J, UDI-DI: 10195327511142(each), 40195327511143(case), Lot Number: 25BBG734; 187) DYNJ904749J, UDI-DI: 10195327511142(each), 40195327511143(case), Lot Number: 25EBU720; 188) DYNJ904749J, UDI-DI: 10195327511142(each), 40195327511143(case), Lot Number: 25HBI847; 189) DYNJ904749J, UDI-DI: 10195327511142(each), 40195327511143(case), Lot Number: 25IBQ209; 190) DYNJ904749J, UDI-DI: 10195327511142(each), 40195327511143(case), Lot Number: 25IBU994; 191) DYNJ904749J, UDI-DI: 10195327511142(each), 40195327511143(case), Lot Number: 25KBC533; 192) DYNJ904749J, UDI-DI: 10195327511142(each), 40195327511143(case), Lot Number: 24KBJ796; 193) DYNJ904749J, UDI-DI: 10195327511142(each), 40195327511143(case), Lot Number: 24LBP688; 194) DYNJ904749J, UDI-DI: 10195327511142(each), 40195327511143(case), Lot Number: 26ABM369; 195) DYNJ905567B, UDI-DI: 10198459151163(each), 40198459151164(case), Lot Number: 26DBE950; 196) DYNJ905567B, UDI-DI: 10198459151163(each), 40198459151164(case), Lot Number: 25ABR149; 197) DYNJ905567B, UDI-DI: 10198459151163(each), 40198459151164(case), Lot Number: 25BBE959; 198) DYNJ905567B, UDI-DI: 10198459151163(each), 40198459151164(case), Lot Number: 25CBG599; 199) DYNJ905567B, UDI-DI: 10198459151163(each), 40198459151164(case), Lot Number: 25GBG395; 200) DYNJ905567B, UDI-DI: 10198459151163(each), 40198459151164(case), Lot Number: 25HBT255; 201) DYNJ905567B, UDI-DI: 10198459151163(each), 40198459151164(case), Lot Number: 25IBK707; 202) DYNJ905567B, UDI-DI: 10198459151163(each), 40198459151164(case), Lot Number: 25KBH514; 203) DYNJ905567B, UDI-DI: 10198459151163(each), 40198459151164(case), Lot Number: 25LBU205; 204) DYNJ906102K, UDI-DI: 10198459079733(each), 40198459079734(case), Lot Number: 24KBJ996; 205) DYNJ906102L, UDI-DI: 10198459242564(each), 40198459242565(case), Lot Number: 25GBE498; 206) DYNJ906102M, UDI-DI: 10198459406409(each), 40198459406400(case), Lot Number: 25JBE315; 207) DYNJ906102M, UDI-DI: 10198459406409(each), 40198459406400(case), Lot Number: 25KBI700; 208) DYNJ906102M, UDI-DI: 10198459406409(each), 40198459406400(case), Lot Number: 25KBM827; 209) DYNJ906102M, UDI-DI: 10198459406409(each), 40198459406400(case), Lot Number: 25LBB028; 210) DYNJ906102M, UDI-DI: 10198459406409(each), 40198459406400(case), Lot Number: 26ABH106; 211) DYNJ906102M, UDI-DI: 10198459406409(each), 40198459406400(case), Lot Number: 26CBQ206; 212) DYNJ906225I, UDI-DI: 10195327658328(each), 40195327658329(case), Lot Number: 26DDA781; 213) DYNJ906225I, UDI-DI: 10195327658328(each), 40195327658329(case), Lot Number: 25BDB488; 214) DYNJ906225I, UDI-DI: 10195327658328(each), 40195327658329(case), Lot Number: 25DDA872; 215) DYNJ906225I, UDI-DI: 10195327658328(each), 40195327658329(case), Lot Number: 25DDB818; 216) DYNJ906225I, UDI-DI: 10195327658328(each), 40195327658329(case), Lot Number: 25EDB259; 217) DYNJ906225I, UDI-DI: 10195327658328(each), 40195327658329(case), Lot Number: 25FDA502; 218) DYNJ906225I, UDI-DI: 10195327658328(each), 40195327658329(case), Lot Number: 25FDA669; 219) DYNJ906225I, UDI-DI: 10195327658328(each), 40195327658329(case), Lot Number: 25FDA885; 220) DYNJ906225I, UDI-DI: 10195327658328(each), 40195327658329(case), Lot Number: 25FDB470; 221) DYNJ906225I, UDI-DI: 10195327658328(each), 40195327658329(case), Lot Number: 25GDB124; 222) DYNJ906225I, UDI-DI: 10195327658328(each), 40195327658329(case), Lot Number: 25IDA895; 223) DYNJ906225I, UDI-DI: 10195327658328(each), 40195327658329(case), Lot Number: 25KDA349; 224) DYNJ906225I, UDI-DI: 10195327658328(each), 40195327658329(case), Lot Number: 26ADA530; 225) DYNJ906225I, UDI-DI: 10195327658328(each), 40195327658329(case), Lot Number: 26CDA583; 226) DYNJ906225I, UDI-DI: 10195327658328(each), 40195327658329(case), Lot Number: 26CDB312; 227) DYNJ907400F, UDI-DI: 10195327694579(each), 40195327694570(case), Lot Number: 25BBN388; 228) DYNJ907400F, UDI-DI: 10195327694579(each), 40195327694570(case), Lot Number: 25EBA952; 229) DYNJ907400F, UDI-DI: 10195327694579(each), 40195327694570(case), Lot Number: 25EBP655; 230) DYNJ907400F, UDI-DI: 10195327694579(each), 40195327694570(case), Lot Number: 25FBG002; 231) DYNJ907400F, UDI-DI: 10195327694579(each), 40195327694570(case), Lot Number: 25GBC367; 232) DYNJ907400G, UDI-DI: 10198459440656(each), 40198459440657(case), Lot Number: 26DBM514; 233) DYNJ907400G, UDI-DI: 10198459440656(each), 40198459440657(case), Lot Number: 25HBO685; 234) DYNJ907400G, UDI-DI: 10198459440656(each), 40198459440657(case), Lot Number: 25IBB659; 235) DYNJ907400G, UDI-DI: 10198459440656(each), 40198459440657(case), Lot Number: 25IBH530; 236) DYNJ908121C, UDI-DI: 10198459024863(each), 40198459024864(case), Lot Number: 26DBP621; 237) DYNJ908121C, UDI-DI: 10198459024863(each), 40198459024864(case), Lot Number: 25CBQ702; 238) DYNJ908121C, UDI-DI: 10198459024863(each), 40198459024864(case), Lot Number: 25DBN708; 239) DYNJ908121C, UDI-DI: 10198459024863(each), 40198459024864(case), Lot Number: 25EBH917; 240) DYNJ908121C, UDI-DI: 10198459024863(each), 40198459024864(case), Lot Number: 25GBH817; 241) DYNJ908121C, UDI-DI: 10198459024863(each), 40198459024864(case), Lot Number: 25JBM106; 242) DYNJ908121C, UDI-DI: 10198459024863(each), 40198459024864(case), Lot Number: 25KBG673; 243) DYNJ908121C, UDI-DI: 10198459024863(each), 40198459024864(case), Lot Number: 26ABD610; 244) DYNJ908121C, UDI-DI: 10198459024863(each), 40198459024864(case), Lot Number: 26CBM190; 245) DYNJ908308A, UDI-DI: 10198459287213(each), 40198459287214(case), Lot Number: 25DBG598; 246) DYNJ908308A, UDI-DI: 10198459287213(each), 40198459287214(case), Lot Number: 25FBU833; 247) DYNJ908308A, UDI-DI: 10198459287213(each), 40198459287214(case), Lot Number: 25HBP099; 248) DYNJ909116D, UDI-DI: 10198459055355(each), 40198459055356(case), Lot Number: 25JBM466; 249) DYNJ9622573AP, UDI-DI: 10193489462821(each), 40193489462822(case), Lot Number: 25CBJ587; 250) DYNJ9622573AP, UDI-DI: 10193489462821(each), 40193489462822(case), Lot Number: 25DBV374; 251) DYNJ9622573AP, UDI-DI: 10193489462821(each), 40193489462822(case), Lot Number: 25FBJ227; 252) DYNJ9622573AP, UDI-DI: 10193489462821(each), 40193489462822(case), Lot Number: 25GBF521; 253) DYNJ9622573AP, UDI-DI: 10193489462821(each), 40193489462822(case), Lot Number: 25HBU890; 254) DYNJ9622573AP, UDI-DI: 10193489462821(each), 40193489462822(case), Lot Number: 25IBN994; 255) DYNJ9622573AP, UDI-DI: 10193489462821(each), 40193489462822(case), Lot Number: 25JBM121; 256) DYNJ9622573AP, UDI-DI: 10193489462821(each), 40193489462822(case), Lot Number: 25JBP614; 257) DYNJ9622573AP, UDI-DI: 10193489462821(each), 40193489462822(case), Lot Number: 25LBM800; 258) DYNJ9622573AP, UDI-DI: 10193489462821(each), 40193489462822(case), Lot Number: 24LBO075; 259) DYNJ9622573AP, UDI-DI: 10193489462821(each), 40193489462822(case), Lot Number: 24JBW896; 260) DYNJ9622573AP, UDI-DI: 10193489462821(each), 40193489462822(case), Lot Number: 24JBY038; 261) DYNJ9622573AP, UDI-DI: 10193489462821(each), 40193489462822(case), Lot Number: 24KBE874; 262) DYNJ9622573AQ, UDI-DI: 10198459682421(each), 40198459682422(case), Lot Number: 26CBR084; 263) DYNJ9718008AS, UDI-DI: 10193489263121(each), 40193489263122(case), Lot Number: 24GLB178; 264) DYNJ9718008AS, UDI-DI: 10193489263121(each), 40193489263122(case), Lot Number: 24ILA162; 265) DYNJ9718008AS, UDI-DI: 10193489263121(each), 40193489263122(case), Lot Number: 24ILA474; 266) DYNJ9718008AT, UDI-DI: 10198459133978(each), 40198459133979(case), Lot Number: 24LLA953; 267) DYNJ9718008AT, UDI-DI: 10198459133978(each), 40198459133979(case), Lot Number: 25ALA273; 268) DYNJ9718008AT, UDI-DI: 10198459133978(each), 40198459133979(case), Lot Number: 25ALA353; 269) DYNJ9718008AT, UDI-DI: 10198459133978(each), 40198459133979(case), Lot Number: 25BLA453; 270) DYNJ9718008AT, UDI-DI: 10198459133978(each), 40198459133979(case), Lot Number: 25CLA742; 271) DYNJ9718008AT, UDI-DI: 10198459133978(each), 40198459133979(case), Lot Number: 25CLA982; 272) DYNJ9718008AT, UDI-DI: 10198459133978(each), 40198459133979(case), Lot Number: 24KLA590; 273) DYNJ9718008AU, UDI-DI: 10198459291579(each), 40198459291570(case), Lot Number: 26DLA248; 274) DYNJ9718008AU, UDI-DI: 10198459291579(each), 40198459291570(case), Lot Number: 26DLB039; 275) DYNJ9718008AU, UDI-DI: 10198459291579(each), 40198459291570(case), Lot Number: 25FLA478; 276) DYNJ9718008AU, UDI-DI: 10198459291579(each), 40198459291570(case), Lot Number: 25FLA656; 277) DYNJ9718008AU, UDI-DI: 10198459291579(each), 40198459291570(case), Lot Number: 25GLA353; 278) DYNJ9718008AU, UDI-DI: 10198459291579(each), 40198459291570(case), Lot Number: 25GLA499; 279) DYNJ9718008AU, UDI-DI: 10198459291579(each), 40198459291570(case), Lot Number: 25HLA068; 280) DYNJ9718008AU, UDI-DI: 10198459291579(each), 40198459291570(case), Lot Number: 26ALA729; 281) DYNJ9718008AU, UDI-DI: 10198459291579(each), 40198459291570(case), Lot Number: 26BLA613; 282) DYNJ9718008AU, UDI-DI: 10198459291579(each), 40198459291570(case), Lot Number: 26CLA783; 283) DYNJ9855016AA, UDI-DI: 10198459687617(each), 40198459687618(case), Lot Number: 26CBD676; 284) DYNJ9855016AA, UDI-DI: 10198459687617(each), 40198459687618(case), Lot Number: 26CBT699

510(k) numbers

not on file

PMA numbers

not on file

Product code

OEZ

Firm FEI

1417592

Firm city

Northfield

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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