Z-2453-2026Class I

Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840144Q; 2) OPEN HEART, Model Number...

Name: Z-2453-2026 Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840144Q; 2) OPEN HEART, Model Number...
Creator: Medline Industries, LP
Published: 2026-05-06
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-05-06 / Open, Classified / root cause: manufacturing process

FDA source

Medline Industries, LP began a recall of Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840144Q; 2) OPEN HEART, Model Number: CDS840150W; 3) OPEN HEART ADULT, Model Number: CDS840396AA... on 2026-05-06. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2453-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-05-06
Posted: 2026-06-24
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
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
Product code: OEZ Cardiovascular Procedure Kit
Reason for recall: 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 tag: manufacturing process
FDA 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 [email protected].
Quantity in commerce: 6775 units
Distribution: US Nationwide.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2453-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2452-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-24
Z-2453-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-24
Z-2454-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-24
Z-2455-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-24

Product code OEZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)