MEDLINE Medical Procedure Kits labeled as CLOVIS HYSTEROSCOPY, CSC-N PELVISCOPY, D AND C PACK, D&C HYSTER PACK, FLWR GYN PACK, FS LAP TUBAL LIGATION, HILLSDALE D&C / HYSTEROSCOPY, LAVH NEW BRAUNFELS,TVH PACK, etc (see recall documents for a full list of affected products)

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 DYNJ61063A: UDI/DI 10193489640458 (each), 40193489640459 (case), Lot Number 21KBV571; Medline Kit Number/SKU DYNJ61063B: UDI/DI 10195327193478 (each), 40195327193479 (case), Lot Number 23EBU351; Medline Kit Number/SKU DYNJ61063B: UDI/DI 10195327193478 (each), 40195327193479 (case), Lot Number 23DBQ190; Medline Kit Number/SKU DYNJ61063B: UDI/DI 10195327193478 (each), 40195327193479 (case), Lot Number 23BBE364; Medline Kit Number/SKU DYNJ61063B: UDI/DI 10195327193478 (each), 40195327193479 (case), Lot Number 22IBW094; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 26CMK666; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 26BMG709; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 26AMI644; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 25KMD133; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 25JMA568; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 25IMF717; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 25HMJ595; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 25FMH149; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 25EME964; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 25DMG466; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 25CMH227; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 25CMC736; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 25BMB744; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 24LMB964; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 24JMB516; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 24JMA159; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 24EMI862; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 24DMG741; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 24CBP782; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 24CMI475; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 24BBU531; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 24BBB690; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 23LBH349; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 23JBP275; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 23IBU481; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 23GBW750; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 23GBB691; Medline Kit Number/SKU DYNJ50874C: UDI/DI 10195327024963 (each), 40195327024964 (case), Lot Number 22ABS574; Medline Kit Number/SKU DYNJ50874C: UDI/DI 10195327024963 (each), 40195327024964 (case), Lot Number 22ABI415; Medline Kit Number/SKU DYNJ50874C: UDI/DI 10195327024963 (each), 40195327024964 (case), Lot Number 21KBN568; Medline Kit Number/SKU DYNJ50874D: UDI/DI 10195327165383 (each), 40195327165384 (case), Lot Number 24CBV299; Medl
Units affected: 37324 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-2505-2026
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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