MEDLINE Medical Procedure Kits labeled as: 1) BR L&D PACK, Medline Kit Number/SKU DYNJ47625B; 2) GYN VAGINAL, Medline Kit Number/SKU DYNJ912219; 3) KIT MAJ VAG SET UP, Medline Kit Number/SKU DYNJ907033B; 4) MINOR VAG PACK, Medline Kit Number/SKU DYNJ68663B; 5) OB DELIVERY PACK, Medline Kit Number/SKU DYNJ14099F; 6) OB DELIVERY PACK, Medline Kit Number/SKU DYNJ14099G; 7) OB PACK, Medline Kit Number/SKU DYNJ03387B; 8) OB PACK, Medline Kit Number/SKU DYNJ03387C; 9) OB PACK, Medline Kit Number/SKU DYNJ53543B; 10) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645D; 11) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645F; 12) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645G; 13) VAGINAL DELIVERY PACK, Medline Kit Number/SKU DYNJ04454K; 14) VAGINAL DELIVERY PACK, Medline Kit Number/SKU DYNJ04454L; 15) VAGINAL PACK, Medline Kit Number/SKU DYNJ01830G.

Class II

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 DYNJ47625B, UDI/DI 10889942182589 (each), 40889942182580 (case), Lot Number 21LBI584; Medline Kit Number/SKU DYNJ912219, UDI/DI 10198459676048 (each), 40198459676049 (case), Lot Number 26BBQ085; Medline Kit Number/SKU DYNJ907033B, UDI/DI 10195327205980 (each), 40195327205981 (case), Lot Number 23BBK437; Medline Kit Number/SKU DYNJ907033B, UDI/DI 10195327205980 (each), 40195327205981 (case), Lot Number 22LBP927; Medline Kit Number/SKU DYNJ907033B, UDI/DI 10195327205980 (each), 40195327205981 (case), Lot Number 22KBA970; Medline Kit Number/SKU DYNJ907033B, UDI/DI 10195327205980 (each), 40195327205981 (case), Lot Number 22JBH943; Medline Kit Number/SKU DYNJ907033B, UDI/DI 10195327205980 (each), 40195327205981 (case), Lot Number 22HBR879; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 25ABD038; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 24IBP599; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 24HBT938; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 24GBB724; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 24DBK110; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 24ABN322; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 23LBB050; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 23KBB963; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 23HBG577; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 23GBV662; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 23FBC135; Medline Kit Number/SKU DYNJ68663B, UDI/DI 10195327408886 (each), 40195327408887 (case), Lot Number 23EBI988; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 23EMG547; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 23DME985; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 23BMA262; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 23AMC310; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 22LMG249; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 22JMG781; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 22HME796; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 22FBW026; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 22DBS732; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 22OBD819; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 22BBR963; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 21JBP278; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 21IBJ988; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 21HBF040; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 21GBE751; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 21DBJ299; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 21CBS171; Medline Kit Number/SKU DYNJ14099F,
Units affected: 24388 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-2501-2026
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

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