- Recalling firm
- Medline Industries, LP
- Reason for recall
- 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.
- Affected products (lot / model / serial)
- 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
- Units affected
- 1248 units
- Distribution pattern
- Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
- Firm location
- Northfield, IL, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2488-2026
- Recall initiated
- May 4, 2026
- FDA classification date
- June 17, 2026
- FDA report date
- June 24, 2026
- FDA event ID
- 98994
- Last updated on HTM Vibe
- July 23, 2026