FDAClass II · Medical device · Recalled June 24, 2026

MEDLINE Medical Procedure Kits labeled as recall — Medline Industries, LP

Hazard: During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2488-2026
Brand: Medline Industries
Classification: Class II
Units affected: 1248 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

MEDLINE Medical Procedure Kits labeled as: 1) BNT CV PACK, Medline Kit Number/SKU DYNJ912271; 2) CV PACK PART 1, Medline Kit Number/SKU DYNJ31204D; 3) KIT PERIPHERAL VASCULAR MMC, Medline Kit Number/SKU DYNJ905368D; 4) KIT PERIVASCULAR MMC, Medline Kit Number/SKU DYNJ905368B; 5) VP SHUNT PACK, Medline Kit Number/SKU DYNJ46530I.

Affected products

MEDLINE Medical Procedure Kits labeled as

Companies & origin

Recalling firm location: Northfield, IL, United States
Firm address: 3 Lakes Dr, 60093-2753

Identifying details (verbatim from the notice)

Product codes / lots: Medline Kit Number/SKU DYNJ912271: UDI/DI 10198459688324 (each), 40198459688325 (case), Lot Number 26CBQ109; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 25FBO720; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 24KBO387; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 24KBO015; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 24KBD819; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 24KBA736; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 24FBG144; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 24DBO838; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 24BBC453; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 24ABM118; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 23KBS950; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 23IBC670; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 22LBN883; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 22KBF121; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 22IBN293; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 22FBO695; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 22OBH349; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 21JBY498; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 21JBY507; Medline Kit Number/SKU DYNJ31204D: UDI/DI 10193489957990 (each), 40193489957991 (case), Lot Number 21JBH105; Medline Kit Number/SKU DYNJ905368D: UDI/DI 10198459698149 (each), 40198459698140 (case), Lot Number 26DBE022; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 25GBD045; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 25EBN367; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 25CBR397; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 25BBK435; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 25ABR151; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 24JBU152; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 24IBD106; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 24HBI890; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 24GBS879; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 24EBB182; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 24CBT638; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 24CBN624; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 23KBU577; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 23IBS119; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 23GBV028; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 23HBO351; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 23BBL739; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 23BBL740; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 23ABS355; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 23ABG430; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 22GBG375; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 22GBG376; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 22GBG377; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 22EBM264; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 22EBL230; Medline Kit Number/SKU DYNJ905368B: UDI/DI 10195327047917 (each), 40195327047918 (case), Lot Number 21LBV309; Medline Kit Number/SKU DYNJ46530I: UDI/DI 10193489338843 (each), 40193489338844 (case), Lot Number 21IMB152; Medline Kit Number/SKU DYNJ46530I: UDI/DI 10193489338843 (each), 40193489338844 (case), Lot Number 21HMD185; Medline Kit Number/SKU DYNJ46530I: UDI/DI 10193489338843 (each), 40193489338844 (case), Lot Number 21DMA957; Medline Kit Number/SKU DYNJ46530I: UDI/DI 10193489338843 (each), 40193489338844 (case), Lot Number 21BME627; Medline Kit Number/SKU DYNJ46530I: UDI/DI 10193489338843 (each), 40193489338844 (case), Lot Number 21BMC286.
Distribution: Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
Firm notified the public via: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
FDA event ID: 98994
Recall initiated: May 4, 2026
FDA classified: June 17, 2026
FDA report date: June 24, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.

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