Class IIOngoingZ-1835-2026

Medline Industries, LP recalls Medline Kits: 1) CATH LAB CDS

Medline Industries, LPNorthfield, IL, United StatesReported Apr 29, 2026 · 2 months ago

Legal News Analyst · Apr 29, 2026

Reason for recall

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

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.

Medline Kits: 1) CATH LAB CDS, Model Number: CDS840228F; 2) IR PACK, Model Number: DYNDH2104; 3) CARDIAC CATH PACK-LF, Model Number: DYNJT2164M; 4) ANGIOGRAPHY TRAY, Model Number: DYNJT3078; 5) CATH PACK, Model Number: DYNJT4190; 6) ANGIO VASCULAR PACK, Model Number: DYNJT5717; 7) HEART CATH PACK, Model Number: DYNJ0381139R; 8) CARDIAC CATH PACK, Model Number: DYNJ04529L; 9) CUSTOM RADIOLOGY PACK, Model Number: DYNJ07955L; 10) STVZ CARDIAC CATH PACK, Model Number: DYNJ24619J; 11) CATH TRAY #2, Model Number: DYNJ24706D; 12) CATH LAB PACK, Model Number: DYNJ24802Q; 13) CATH PACK, Model Number: DYNJ30268K; 14) HEART CATHETERIZATION PACK, Model Number: DYNJ30927R; 15) HEART CATH TRAY PACK-LF, Model Number: DYNJ31944D; 16) CATH PACK-LF, Model Number: DYNJ33061D; 17) CATH PACK, Model Number: DYNJ34638K; 18) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJ38120C; 19) CATH PACK, Model Number: DYNJ40904G; 20) CARDIAC CATH-LF, Model Number: DYNJ41057D; 21) CATH LAB PACK, Model Number: DYNJ41172; 22) ANGIOGRAPHY PACK, Model Number: DYNJ42134G; 23) CATH LAB DRAPE PACK, Model Number: DYNJ42455B; 24) ANGIOGRAPHY PACK, Model Number: DYNJ42543B; 25) CATH LAB PACK, Model Number: DYNJ42900D; 26) ANGIOGRAPHY PACK NO SYR, Model Number: DYNJ43009K; 27) CATH PACK (WITH MANIFOLD), Model Number: DYNJ44515L; 28) ANGIO IR DRAPE PACK 319696, Model Number: DYNJ44593I; 29) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJ44850J; 30) CATH LAB PACK, Model Number: DYNJ45296; 31) ANGIO PACK, Model Number: DYNJ50739J; 32) CARDIAC CATH PACK, Model Number: DYNJ51103F; 33) IR ANGIO BODY, Model Number: DYNJ51765D; 34) INTERVENTIONAL TRAY, Model Number: DYNJ52501C; 35) CARDIAC CATH IMF 86040- LF, Model Number: DYNJ53947J; 36) CARDIAC CATH PACK, Model Number: DYNJ54101I; 37) ANGIO KIT, Model Number: DYNJ55686C; 38) CATH LAB PACK, Model Number: DYNJ56141B; 39) ANGIO NEURO PACK, Model Number: DYNJ57685D; 40) CATH PACK, Model Number: DYNJ57729F; 41) CATH PACK, Model Number: DYNJ59632F; 42) CATH LAB PACK WITH NAMIC, Model Number: DYNJ60853D; 43) ANGIO PACK ALEX, Model Number: DYNJ63539C; 44) ANGIOGRAPHY CV RAD PACK, Model Number: DYNJ64936B; 45) CATH LAB PACK, Model Number: DYNJ65185D; 46) CATH PACK, Model Number: DYNJ65619A; 47) CATH I W SPLIT DRAPE PACK, Model Number: DYNJ66182; 48) CATH PACK SHD, Model Number: DYNJ68384B; 49) CATH LAB PACK, Model Number: DYNJ69094B; 50) CATH LAB ACCESSORIES, Model Number: DYNJ69213B; 51) REYES CATH PACK, Model Number: DYNJ69345A; 52) TMH ANGIOGRAPHY TRAY, Model Number: DYNJ80054A; 53) ANGIOGRAPHY TRAY, Model Number: DYNJ80156; 54) CATH PACK, Model Number: DYNJ80516C; 55) CATH PACK, Model Number: DYNJ80730; 56) ANGIO DRAPE PACK 2 WINDOW, Model Number: DYNJ81066B; 57) OR ANGIOGRAM PACK, Model Number: DYNJ81435F; 58) HEART CATH PACK, Model Number: DYNJ81527B; 59) HEART CATH PACK, Model Number: DYNJ83764D; 60) CATH LAB PACK, Model Number: DYNJ84048A; 61) ANGIO TRAY NO LIDO, Model Number: DYNJ85557B; 62) CARDIAC CATH PACK, Model Number: DYNJ85746B; 63) ANGIOGRAPHY PACK, Model Number: DYNJ86313; 64) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJ86787; 65) CATH PACK, Model Number: DYNJ87098A; 66) CATH LAB TAVR PACK, Model Number: DYNJ88532; 67) SMT LEFT HEART CATH, Model Number: DYNJ89274; 68) VASCULAR CATH PACK, Model Number: DYNJ89352; 69) CATH LAB PACK, Model Number: DYNJ89805; 70) CARDIAC CATH MERCY WASHINGTON, Model Number: DYNJ89934; 71) ANGIO, Model Number: DYNJ900278G; 72) TAVR ICC VER. F, Model Number: DYNJ904401F; 73) TAVR, Model Number: DYNJ908646C; 74) LHK-UPMC CHILDRENS MAIN OR 2, Model Number: NAM0009; 75) KIT ANGIO CSTM-EVERGREEN, Model Number: NAM0020; 76) GP-CARDIAC CATH PACK-LF, Model Number: PHS397170009D; 77) LEFT HEART KIT - MARION, Model Number: VASC1073A; 78) RHK - VAMC RICHMOND, Model Number: VASC1185B; 79) LHK-MEADOWVIEW REG, Model Number: VASC1263; 80) LHK - BSC 3V ON S10RA, Model Number: VASC1269; 81) LHK - BSC 3V ON S10MLL, Model Number: VASC1270; 82

Lot / code information

UDI: 10889942778546(each), 40889942778547(case)
Lot #: 25ALA420; 2) CDS840228F
UDI: 10889942778546(each), 40889942778547(case)
Lot #: 25CLA774; 3) CDS840228F
UDI: 10889942778546(each), 40889942778547(case)
Lot #: 24LLA038; 4) DYNDH2104
UDI: 10198459273964(each), 40198459273965(case)
Lot #: 25DBR609; 5) DYNJT2164M
UDI: 10198459003165(each), 40198459003166(case)
Lot #: 24JBT885; 6) DYNJT3078

Additional code information

25EBV367; 362) VASC1325, UDI-DI: 10195327127466(each), 40195327127467(case), Lot Number: 24IBR613; 363) VASC1340, UDI-DI: 10195327160197(each), 40195327160198(case), Lot Number: 22FBG046; 364) VASC1340, UDI-DI: 10195327160197(each), 40195327160198(case), Lot Number: 22IBK994; 365) VASC1340, UDI-DI: 10195327160197(each), 40195327160198(case), Lot Number: 23BBH558; 366) VASC1340, UDI-DI: 10195327160197(each), 40195327160198(case), Lot Number: 23BBI789; 367) VASC1340, UDI-DI: 10195327160197(each), 40195327160198(case), Lot Number: 23CBM020; 368) VASC1340, UDI-DI: 10195327160197(each), 40195327160198(case), Lot Number: 23FBP237; 369) VASC1340, UDI-DI: 10195327160197(each), 40195327160198(case), Lot Number: 23HBA351; 370) VASC1340, UDI-DI: 10195327160197(each), 40195327160198(case), Lot Number: 23IBF804; 371) VASC1340, UDI-DI: 10195327160197(each), 40195327160198(case), Lot Number: 23KBJ680; 372) VASC1340, UDI-DI: 10195327160197(each), 40195327160198(case), Lot Number: 24ABC821; 373) VASC1340, UDI-DI: 10195327160197(each), 40195327160198(case), Lot Number: 24BBI096; 374) VASC1340, UDI-DI: 10195327160197(each), 40195327160198(case), Lot Number: 24DBW081; 375) VASC1340, UDI-DI: 10195327160197(each), 40195327160198(case), Lot Number: 24GBI591; 376) VASC1340, UDI-DI: 10195327160197(each), 40195327160198(case), Lot Number: 24HBS193; 377) VASC1340, UDI-DI: 10195327160197(each), 40195327160198(case), Lot Number: 24JBC754; 378) VASC1340, UDI-DI: 10195327160197(each), 40195327160198(case), Lot Number: 24KBR290; 379) VASC1340, UDI-DI: 10195327160197(each), 40195327160198(case), Lot Number: 24LBF931; 380) VASC1340, UDI-DI: 10195327160197(each), 40195327160198(case), Lot Number: 25ABN410; 381) VASC1340, UDI-DI: 10195327160197(each), 40195327160198(case), Lot Number: 25ABS437; 382) VASC1340, UDI-DI: 10195327160197(each), 40195327160198(case), Lot Number: 25EBS376; 383) VASC1340, UDI-DI: 10195327160197(each), 40195327160198(case), Lot Number: 22KBE304; 384) VASC1340, UDI-DI: 10195327160197(each), 40195327160198(case), Lot Number: 24CBJ019; 385) VASC1340, UDI-DI: 10195327160197(each), 40195327160198(case), Lot Number: 25GBJ908; 386) VASC1366, UDI-DI: 10195327242701(each), 40195327242702(case), Lot Number: 24LBE764; 387) VASC1395, UDI-DI: 10195327336707(each), 40195327336708(case), Lot Number: 23IBH009; 388) VASC1395, UDI-DI: 10195327336707(each), 40195327336708(case), Lot Number: 23EBG672; 389) VASC1406A, UDI-DI: 10195327563288(each), 40195327563289(case), Lot Number: 25GBJ756; 390) VASC1416, UDI-DI: 10195327409609(each), 40195327409600(case), Lot Number: 23HBT638; 391) VASC1416, UDI-DI: 10195327409609(each), 40195327409600(case), Lot Number: 24LBL698; 392) VASC1416, UDI-DI: 10195327409609(each), 40195327409600(case), Lot Number: 25ABE332; 393) VASC1416, UDI-DI: 10195327409609(each), 40195327409600(case), Lot Number: 25CBU962; 394) VASC1416, UDI-DI: 10195327409609(each), 40195327409600(case), Lot Number: 25EBA222; 395) VASC1416, UDI-DI: 10195327409609(each), 40195327409600(case), Lot Number: 25EBH282; 396) VASC1416, UDI-DI: 10195327409609(each), 40195327409600(case), Lot Number: 25EBP333; 397) VASC1424, UDI-DI: 10195327417475(each), 40195327417476(case), Lot Number: 24LBQ573; 398) VASC1433, UDI-DI: 10195327436964(each), 40195327436965(case), Lot Number: 23JBP992; 399) VASC1445, UDI-DI: 10195327469122(each), 40195327469123(case), Lot Number: 25HBV179; 400) VASC1456, UDI-DI: 10195327501228(each), 40195327501229(case), Lot Number: 24LBQ327; 401) VASC1458A, UDI-DI: 10198459030444(each), 40198459030445(case), Lot Number: 25GBN426; 402) VASC1472, UDI-DI: 10195327541347(each), 40195327541348(case), Lot Number: 25EBB614; 403) VASC1474, UDI-DI: 10195327544058(each), 40195327544059(case), Lot Number: 25DBU129; 404) VASC1474, UDI-DI: 10195327544058(each), 40195327544059(case), Lot Number: 25EBJ096; 405) VASC1474, UDI-DI: 10195327544058(each), 40195327544059(case), Lot Number: 25CBU804; 406) VASC1476, UDI-DI: 10195327555450(each), 40195327555451(case), Lot Number: 24CBL307; 407) VASC1486, UDI-DI: 10195327581916(each), 40195327581917(case), Lot Number: 25EBG340; 408) VASC1486, UDI-DI: 10195327581916(each), 40195327581917(case), Lot Number: 25EBB574; 409) VASC1489A, UDI-DI: 10198459155024(each), 40198459155025(case), Lot Number: 24JBX902; 410) VASC1489A, UDI-DI: 10198459155024(each), 40198459155025(case), Lot Number: 25ABK840; 411) VASC1489A, UDI-DI: 10198459155024(each), 40198459155025(case), Lot Number: 25BBN319; 412) VASC1505, UDI-DI: 10195327673826(each), 40195327673827(case), Lot Number: 25HBV570; 413) VASC1516A, UDI-DI: 10198459150708(each), 40198459150709(case), Lot Number: 25CBO552; 414) VASC1516A, UDI-DI: 10198459150708(each), 40198459150709(case), Lot Number: 25DBL094; 415) VASC1528, UDI-DI: 10198459021107(each), 40198459021108(case), Lot Number: 24GBL420; 416) VASC1528, UDI-DI: 10198459021107(each), 40198459021108(case), Lot Number: 24HBX102; 417) VASC1528, UDI-DI: 10198459021107(each), 40198459021108(case), Lot Number: 24IBV647; 418) VASC1528, UDI-DI: 10198459021107(each), 40198459021108(case), Lot Number: 24JBP816; 419) VASC1528, UDI-DI: 10198459021107(each), 40198459021108(case), Lot Number: 24JBS223; 420) VASC1528, UDI-DI: 10198459021107(each), 40198459021108(case), Lot Number: 25CBB663; 421) VASC1528, UDI-DI: 10198459021107(each), 40198459021108(case), Lot Number: 25DBD834; 422) VASC1528, UDI-DI: 10198459021107(each), 40198459021108(case), Lot Number: 25EBF084; 423) VASC1528, UDI-DI: 10198459021107(each), 40198459021108(case), Lot Number: 25HBO061; 424) VASC1603, UDI-DI: 10198459142260(each), 40198459142261(case), Lot Number: 24KMD745; 425) VASC1604, UDI-DI: 10198459142321(each), 40198459142322(case), Lot Number: 25DBL601; 426) VASC1608, UDI-DI: 10198459143519(each), 40198459143510(case), Lot Number: 25CBS980; 427) VASC1625, UDI-DI: 10198459161698(each), 40198459161699(case), Lot Number: 25BBT179; 428) VASC1628, UDI-DI: 10198459167492(each), 40198459167493(case), Lot Number: 24KBD713; 429) VASC1628, UDI-DI: 10198459167492(each), 40198459167493(case), Lot Number: 25ABP307; 430) VASC1628, UDI-DI: 10198459167492(each), 40198459167493(case), Lot Number: 25DBB874; 431) VASC1628, UDI-DI: 10198459167492(each), 40198459167493(case), Lot Number: 25DBK489; 432) VASC1628, UDI-DI: 10198459167492(each), 40198459167493(case), Lot Number: 25DBS122; 433) VASC1628, UDI-DI: 10198459167492(each), 40198459167493(case), Lot Number: 25EBK745; 434) VASC1628, UDI-DI: 10198459167492(each), 40198459167493(case), Lot Number: 25GBJ696; 435) VASC1633, UDI-DI: 10198459180309(each), 40198459180300(case), Lot Number: 24LBC090; 436) VASC1633, UDI-DI: 10198459180309(each), 40198459180300(case), Lot Number: 25EBB507; 437) VASC1633, UDI-DI: 10198459180309(each), 40198459180300(case), Lot Number: 25EBV466; 438) VASC1633, UDI-DI: 10198459180309(each), 40198459180300(case), Lot Number: 25GBJ765; 439) VASC1655, UDI-DI: 10198459218491(each), 40198459218492(case), Lot Number: 25ABG238; 440) VASC1655, UDI-DI: 10198459218491(each), 40198459218492(case), Lot Number: 25CBA276; 441) VASC1655, UDI-DI: 10198459218491(each), 40198459218492(case), Lot Number: 25GBS583; 442) VASC1673, UDI-DI: 10198459246944(each), 40198459246945(case), Lot Number: 25BBD501; 443) VASC1673, UDI-DI: 10198459246944(each), 40198459246945(case), Lot Number: 25HBM036; 444) VASC1678, UDI-DI: 10198459241468(each), 40198459241469(case), Lot Number: 25BBJ631; 445) VASC1678, UDI-DI: 10198459241468(each), 40198459241469(case), Lot Number: 25CBJ145; 446) VASC1678, UDI-DI: 10198459241468(each), 40198459241469(case), Lot Number: 25DBI494; 447) VASC1679, UDI-DI: 10198459242151(each), 40198459242152(case), Lot Number: 25CBD675; 448) VASC1679, UDI-DI: 10198459242151(each), 40198459242152(case), Lot Number: 25CBI195; 449) VASC1679, UDI-DI: 10198459242151(each), 40198459242152(case), Lot Number: 25CBJ039; 450) VASC1679, UDI-DI: 10198459242151(each), 40198459242152(case), Lot Number: 25DBT853; 451) VASC1679, UDI-DI: 10198459242151(each), 40198459242152(case), Lot Number: 25GBS586; 452) VASC1681, UDI-DI: 10198459243837(each), 40198459243838(case), Lot Number: 25CBA812; 453) VASC1681, UDI-DI: 10198459243837(each), 40198459243838(case), Lot Number: 25CBG063; 454) VASC1681, UDI-DI: 10198459243837(each), 40198459243838(case), Lot Number: 25CBK100; 455) VASC1681, UDI-DI: 10198459243837(each), 40198459243838(case), Lot Number: 25DBF823; 456) VASC1707, UDI-DI: 10198459269349(each), 40198459269340(case), Lot Number: 25CBQ372; 457) VASC1707, UDI-DI: 10198459269349(each), 40198459269340(case), Lot Number: 25CBS015; 458) VASC1717, UDI-DI: 10198459285387(each), 40198459285388(case), Lot Number: 25EBC181; 459) VASC1747, UDI-DI: 10198459329388(each), 40198459329389(case), Lot Number: 25EMG054; 460) VASC1751, UDI-DI: 10198459337222(each), 40198459337223(case), Lot Number: 25EMH057; 461) VASC1757, UDI-DI: 10198459347832(each), 40198459347833(case), Lot Number: 25FBA376; 462) VASC1787, UDI-DI: 10198459386015(each), 40198459386016(case), Lot Number: 25HBL457; 463) VASC1802, UDI-DI: 10198459401626(each), 40198459401627(case), Lot Number: 25IBF016; 464) 60033123, UDI-DI: 10193489042436(each), 40193489042437(case), Lot Number: 25DBC934; 465) 60033123, UDI-DI: 10193489042436(each), 40193489042437(case), Lot Number: 25DBT579; 466) 6010108121, UDI-DI: 10193489104929(each), 40193489104920(case), Lot Number: 25CBC919; 467) 6010108121, UDI-DI: 10193489104929(each), 40193489104920(case), Lot Number: 24JBD975; 468) 601832314, UDI-DI: 10193489095173(each), 40193489095174(case), Lot Number: 25DBC058; 469) 601832314, UDI-DI: 10193489095173(each), 40193489095174(case), Lot Number: 25DBS920; 470) 601832314, UDI-DI: 10193489095173(each), 40193489095174(case), Lot Number: 25EBB562; 471) 601832314, UDI-DI: 10193489095173(each), 40193489095174(case), Lot Number: 25EBJ329; 472) 60232091, UDI-DI: 10193489053258(each), 40193489053259(case), Lot Number: 25GBS552

What the firm is doing

An URGENT MEDICAL DEVICE RECALL dated 2/25/26 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and lot number(s) listed in the recall portal. Quarantine all affected product. 2. Complete your response form. List the quantity of affected product you have in inventory on the form. Even if you do not have any affected product, submit the form to Website link: https://recalls.medline.com Recall Reference #: R-26-020-FGX1 Recall Code: 3. When we receive your response form, we will send over-labels via FedEx overnight to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. 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. Include your customers quantities on your response form. When we receive your response form, we will send over-labels to provide to your customers. Any questions? Contact the Recall Department at 866-359-1704 or recalls@medline.com. *** An Urgent Medical Device Recall notification letter dated 3/2/26 was sent to customers. This is a follow-up to a Medline notification you may have received on February 25, 2026. New item numbers and lot numbers have been included with this communication. Recipients receiving this notification for the first time were not affected by the original notification. REQUIRED ACTIONS: same as for 2/25/26 letter

DistributionShow details

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.

More Class II recalls

Class IIOngoingZ-2674-2026

Zimmer Surgical Inc recalls Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems S…

Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find anot…

Pneumatic Tourniquet
Under Investigation by firm

Zimmer Surgical IncOHJul 8, 2026

Class IIOngoingZ-2673-2026

Zimmer Surgical Inc recalls Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems D…

Pneumatic Tourniquet
Under Investigation by firm

Zimmer Surgical IncOHJul 8, 2026

Class IIOngoingZ-2672-2026

W L Gore & Associates, Inc. recalls GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Re…

Due to catheter separation

Aortic Aneurysm Treatment Endovascular Graft System
Under Investigation by firm

W L Gore & Associates,…AZJul 8, 2026