Class IIOngoingZ-2093-2026

Medline Industries, LP recalls See RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS

Medline Industries, LPNorthfield, IL, United StatesReported May 13, 2026 · 2 months ago

Legal News Analyst · May 13, 2026

Reason for recall

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

See RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS, Model Number:CDS840015AQ; 2) OPEN HEART CDS, Model Number:CDS840015AQ; 3) OPEN HEART CDS, Model Number:CDS840023T; 4) OFF PUMP CABG CDS, Model Number:CDS840087AI; 5) OFF PUMP CABG CDS, Model Number:CDS840087AK; 6) OFF PUMP CABG CDS, Model Number:CDS840087AL; 7) OFF PUMP CABG CDS, Model Number:CDS840087AM; 8) OPEN HEART, Model Number:CDS840150S; 9) OPEN HEART, Model Number:CDS840150T;

Lot / code information

UDI: 10195327210144(each), 40195327210145(case)
Lot #: 23FLA191; 2) CDS840015AQ
UDI: 10195327210144(each), 40195327210145(case)
Lot #: 24ILB176; 3) CDS840023T
UDI: 10193489682069(each), 40193489682060(case)
Lot #: 21CKA394; 4) CDS840023T
UDI: 10193489682069(each), 40193489682060(case)
Lot #: 21EBN817; 5) CDS840023T
UDI: 10193489682069(each), 40193489682060(case)
Lot #: 21GBH886; 6) CDS840023T

Additional code information

Lot Number: 21BBS510; 360) CDS985105M, UDI-DI: 10193489229950(each), 40193489229951(case), Lot Number: 21FBE255; 361) CDS985105N, UDI-DI: 10193489902297(each), 40193489902298(case), Lot Number: 21HBD158; 362) CDS985105N, UDI-DI: 10193489902297(each), 40193489902298(case), Lot Number: 21IBO615; 363) CDS985105N, UDI-DI: 10193489902297(each), 40193489902298(case), Lot Number: 21JBZ656; 364) CDS985105N, UDI-DI: 10193489902297(each), 40193489902298(case), Lot Number: 21LBP381; 365) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 22BBS888; 366) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 22DBS062; 367) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 22GBU933; 368) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 22IBE901; 369) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 22IBT102; 370) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 22JBD236; 371) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 22JBP078; 372) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 22LBD272; 373) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 23ABT277; 374) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 23DBR889; 375) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 23EBS635; 376) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 23FBV374; 377) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 23HBP383; 378) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 23JBT159; 379) CDS985105O, UDI-DI: 10195327036249(each), 40195327036240(case), Lot Number: 23KBQ479; 380) CDS985215C, UDI-DI: 10193489780109(each), 40193489780100(case), Lot Number: 21DBH711; 381) CVT159AA, UDI-DI: 10193489457513(each), 40193489457514(case), Lot Number: 22DBL279; 382) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 21FBO379; 383) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 21HBC943; 384) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 21IBQ531; 385) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 21KBI013; 386) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 22BBF497; 387) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 22BBI986; 388) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 22EBS701; 389) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 22GBL773; 390) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 22IBA742; 391) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 22KBA324; 392) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 22LBD173; 393) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 23DBT226; 394) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 23EBO066; 395) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 23GBI903; 396) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 23IBI960; 397) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 23JBP216; 398) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 24BBT324; 399) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 24DBF439; 400) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 24FBJ229; 401) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 24JBH528; 402) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 25ABT077; 403) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 25CBR083; 404) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 25GBL893; 405) DYKE1580B, UDI-DI: 10193489906011(each), 40193489906012(case), Lot Number: 25GMJ942; 406) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21ABI967; 407) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21ABO823; 408) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21BBN597; 409) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21CBF850; 410) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21CBM813; 411) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21CBO740; 412) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21CBS016; 413) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21DBA605; 414) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21DBC538; 415) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21DBN048; 416) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21FBF909; 417) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21FBO542; 418) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21GBJ355; 419) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21GBO480; 420) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21HBL002; 421) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21IBK912; 422) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21IBV599; 423) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21IBW788; 424) DYKMBNDL11, UDI-DI: 10193489478600(each), 40193489478601(case), Lot Number: 21IBW789; 425) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 20XBA425; 426) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 21ABL157; 427) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 21BBF731; 428) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 21BLA306; 429) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 21DLA456; 430) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 21FLA215; 431) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 21GLA161; 432) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 21GLA991; 433) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 21HLB002; 434) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 21KLA410; 435) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22ALA370; 436) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22ALA723; 437) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22BLB034; 438) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22CLA548; 439) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22DLA405; 440) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22ELA030; 441) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22ELB070; 442) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22FLA352; 443) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22FLB050; 444) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 22HLA262; 445) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 22ILA065; 446) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 22ILB112; 447) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 22KLA582; 448) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 23ALA566; 449) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 23BLA828; 450) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 23CLA705; 451) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 23DLA355; 452) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 23ELA838; 453) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 23ELA941; 454) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 23FLA324; 455) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 23ILA666; 456) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 23KLA391; 457) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 23LLA174; 458) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 24CLA833; 459) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 24HLA380; 460) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 24KLB057; 461) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 25BLA585; 462) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 25CLA313; 463) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 25GLA109; 464) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 25HLA331; 465) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 25ILA365; 466) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 25LLA510; 467) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 21ABJ093; 468) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 21BLA317; 469) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 21CLA211; 470) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 21ELA354; 471) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 21FLA091; 472) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 21FLA945; 473) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 21GLB132; 474) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 21HLB003; 475) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 21ILA312; 476) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 21JLA460; 477) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 21JLA983; 478) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 21LLA186; 479) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 21LLA708; 480) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 21LLA903; 481) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 22CBD042; 482) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 22DLA164; 483) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 22ELB071; 484) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 22GLA229; 485) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 22GLB229; 486) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 22HLB104; 487) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 22JLB091; 488) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 22LLA146; 489) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 22LLA597; 490) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 23BLA …

What the firm is doing

An URGENT MEDICAL DEVICE RECALL notification letter dated 1/7/26 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-26-003-FGX1 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. An URGENT MEDICAL DEVICE RECALL notification letter dated 1/14/26 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-26-003-

DistributionShow details

Worldwide - US Nationwide distribution.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus

Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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