MEDLINE Medical Procedure Kits labeled as CLOVIS HYSTEROSCOPY, CSC-N PELVISCOPY, D AND C PACK, D&C HYSTER PACK, FLWR ... — FDA record Z-2505-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date May 4, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
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)
Reason
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.
Classification
Class II
Recalling firm
Medline Industries, LP
Quantity
37324 units
Agency-reported status
Ongoing
Source record identifier
Z-2505-2026

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityMedline 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; Medline Kit Number/SKU DYNJ50874D: UDI/DI 10195327165383 (each), 40195327165384 (case), Lot Number 24BBQ334; Medline Kit Number/SKU DYNJ50874D: UDI/DI 10195327165383 (each), 40195327165384 (case), Lot Number 24ABY235; Medline Kit Number/SKU DYNJ50874D: UDI/DI 10195327165383 (each), 40195327165384 (case), Lot Number 23KBJ941; Medline Kit Number/SKU DYNJ50874D: UDI/DI 10195327165383 (each), 40195327165384 (case), Lot Number 23IBS067; Medline Kit Number/SKU DYNJ50874D: UDI/DI 10195327165383 (each), 40195327165384 (case), Lot Number 23GBP406; Medline Kit Number/SKU DYNJ50874D: UDI/DI 10195327165383 (each), 40195327165384 (case), Lot Number 23FBQ543; Medline Kit Number/SKU DYNJ50874D: UDI/DI 10195327165383 (each), 40195327165384 (case), Lot Number 23EBS415; Medline Kit Number/SKU DYNJ50874D: UDI/DI 10195327165383 (each), 40195327165384 (case), Lot Number 23CBS427; Medline Kit Number/SKU DYNJ50874D: UDI/DI 10195327165383 (each), 40195327165384 (case), Lot Number 23ABJ828; Medline Kit Number/SKU DYNJ50874D: UDI/DI 10195327165383 (each), 40195327165384 (case), Lot Number 22KBW049; Medline Kit Number/SKU DYNJ50874D: UDI/DI 10195327165383 (each), 40195327165384 (case), Lot Number 22JBI320; Medline Kit Number/SKU DYNJ50874D: UDI/DI 10195327165383 (each), 40195327165384 (case), Lot Number 22IBI371; Medline Kit Number/SKU DYNJ50874D: UDI/DI 10195327165383 (each), 40195327165384 (case), Lot Number 22GBU123; Medline Kit Number/SKU DYNJ50874D: UDI/DI 10195327165383 (each), 40195327165384 (case), Lot Number 22GBQ055; Medline Kit Number/SKU DYNJ50874D: UDI/DI 10195327165383 (each), 40195327165384 (case), Lot Number 22EBL631; Medline Kit Number/SKU DYNJ41314A: UDI/DI 10193489981728 (each), 40193489981729 (case), Lot Number 25IBQ005; Medline Kit Number/SKU DYNJ41314A: UDI/DI 10193489981728 (each), 40193489981729 (case), Lot Number 25HBG376; Medline Kit Number/SKU DYNJ41314A: UDI/DI 10193489981728 (each), 40193489981729 (case), Lot Number 25FBG238; Medline Kit Number/SKU DYNJ41314A: UDI/DI 10193489981728 (each), 40193489981729 (case), Lot Number 25CBM513; Medline Kit Number/SKU DYNJ41314A: UDI/DI 10193489981728 (each), 40193489981729 (case), Lot Number 24KBF334; Medline Kit Number/SKU DYNJ41314A: UDI/DI 10193489981728 (each), 40193489981729 (case), Lot Number 24JBO045; Medline Kit Number/SKU DYNJ41314A: UDI/DI 10193489981728 (each), 40193489981729 (case), Lot Number 24EBJ820; Medline Kit Number/SKU DYNJ41314A: UDI/DI 10193489981728 (each), 40193489981729 (case), Lot Number 24DBV669; Medline Kit Number/SKU DYNJ41314A: UDI/DI 10193489981728 (each), 40193489981729 (case), Lot Number 24CBA141; Medline Kit Number/SKU DYNJ41314A: UDI/DI 10193489981728 (each), 40193489981729 (case), Lot Number 23KBW912; Medline Kit Number/SKU DYNJ41314A: UDI/DI 10193489981728 (each), 40193489981729 (case), Lot Number 23JBF766; Medline Kit Number/SKU DYNJ41314A: UDI/DI 10193489981728 (each), 40193489981729 (case), Lot Number 23HBB542; Medline Kit Number/SKU DYNJ41314A: UDI/DI 10193489981728 (each), 40193489981729 (case), Lot Number 23DBG665; Medline Kit Number/SKU DYNJ41314A: UDI/DI 10193489981728 (each), 40193489981729 (case), Lot Number 22IBT653; Medline Kit Number/SKU DYNJ41314A: UDI/DI 10193489981728 (each), 40193489981729 (case), Lot Number 22GBF328; Medline Kit Number/SKU DYNJ41314A: UDI/DI 10193489981728 (each), 40193489981729 (case), Lot Number 22DBS952; Medline Kit Number/SKU DYNJ41314A: UDI/DI 10193489981728 (each), 40193489981729 (case), Lot Number 22BBZ007; Medline Kit Number/SKU DYNJ41314A: UDI/DI 10193489981728 (each), 40193489981729 (case), Lot Number 22BBP519; Medline Kit Number/SKU DYNJ41314A: UDI/DI 10193489981728 (each), 40193489981729 (case), Lot Number 21KBB533; Medline Kit Number/SKU DYNJ41314A: UDI/DI 10193489981728 (each), 40193489981729 (case), Lot Number 21HBR847; Medline Kit Number/SKU DYNJ53973B: UDI/DI 10193489951127 (each), 40193489951128 (case), Lot Number 21HMF197; Medline Kit Number/SKU DYNJ65924B: UDI/DI 10195327057459 (each), 40195327057450 (case), Lot Number 23EBF963; Medline Kit Number/SKU DYNJ65924B: UDI/DI 10195327057459 (each), 40195327057450 (case), Lot Number 23BBO640; Medline Kit Number/SKU DYNJ65924B: UDI/DI 10195327057459 (each), 40195327057450 (case), Lot Number 23ABF644; Medline Kit Number/SKU DYNJ65924B: UDI/DI 10195327057459 (each), 40195327057450 (case), Lot Number 22JBY795; Medline Kit Number/SKU DYNJ65924B: UDI/DI 10195327057459 (each), 40195327057450 (case), Lot Number 22GBN556; Medline Kit Number/SKU DYNJ65924B: UDI/DI 10195327057459 (each), 40195327057450 (case), Lot Number 21LBD073; Medline Kit Number/SKU DYNJ65924C: UDI/DI 10195327480844 (each), 40195327480845 (case), Lot Number 24IBB319; Medline Kit Number/SKU DYNJ65924C: UDI/DI 10195327480844 (each), 40195327480845 (case), Lot Number 24HBS826; Medline Kit Number/SKU DYNJ65924C: UDI/DI 10195327480844 (each), 40195327480845 (case), Lot Number 24CBC660; Medline Kit Number/SKU DYNJ65924C: UDI/DI 10195327480844 (each), 40195327480845 (case), Lot Number 24CBD844; Medline Kit Number/SKU DYNJ65924C: UDI/DI 10195327480844 (each), 40195327480845 (case), Lot Number 23LBM268; Medline Kit Number/SKU DYNJ65924C: UDI/DI 10195327480844 (each), 40195327480845 (case), Lot Number 23JBS750; Medline Kit Number/SKU DYNJ65924C: UDI/DI 10195327480844 (each), 40195327480845 (case), Lot Number 23HBN031; Medline Kit Number/SKU DYNJ900273G: UDI/DI 10198459569562 (each), 40198459569563 (case), Lot Number 26CMC505; Medline Kit Number/SKU DYNJ900273G: UDI/DI 10198459569562 (each), 40198459569563 (case), Lot Number 26BMK391; Medline Kit Number/SKU CDS985238G: UDI/DI 10193489985085 (each), 40193489985086 (case), Lot Number 23HBR949; Medline Kit Number/SKU DYNJ906281B: UDI/DI 10193489827798 (each), 40193489827799 (case), Lot Number 23EMK256; Medline Kit Number/SKU DYNJ906281B: UDI/DI 10193489827798 (each), 40193489827799 (case), Lot Number 23CMF074; Medline Kit Number/SKU DYNJ906281B: UDI/DI 10193489827798 (each), 40193489827799 (case), Lot Number 23BMF765; Medline Kit Number/SKU DYNJ906281B: UDI/DI 10193489827798 (each), 40193489827799 (case), Lot Number 23BMA621; Medline Kit Number/SKU DYNJ906281B: UDI/DI 10193489827798 (each), 40193489827799 (case), Lot Number 22JMD716; Medline Kit Number/SKU DYNJ906281B: UDI/DI 10193489827798 (each), 40193489827799 (case), Lot Number 22IMC576; Medline Kit Number/SKU DYNJ906281B: UDI/DI 10193489827798 (each), 40193489827799 (case), Lot Number 22GBP730; Medline Kit Number/SKU DYNJ906281B: UDI/DI 10193489827798 (each), 40193489827799 (case), Lot Number 22DBS800; Medline Kit Number/SKU DYNJ906281B: UDI/DI 10193489827798 (each), 40193489827799 (case), Lot Number 22OBM242; Medline Kit Number/SKU DYNJ906281B: UDI/DI 10193489827798 (each), 40193489827799 (case), Lot Number 22BBT587; Medline Kit Number/SKU DYNJ906281B: UDI/DI 10193489827798 (each), 40193489827799 (case), Lot Number 22BBO316; Medline Kit Number/SKU DYNJ906281B: UDI/DI 10193489827798 (each), 40193489827799 (case), Lot Number 21LBH693; Medline Kit Number/SKU DYNJ906281B: UDI/DI 10193489827798 (each), 40193489827799 (case), Lot Number 21KBP605; Medline Kit Number/SKU DYNJ906281C: UDI/DI 10195327399399 (each), 40195327399390 (case), Lot Number 24LMD080; Medline Kit Number/SKU DYNJ906281C: UDI/DI 10195327399399 (each), 40195327399390 (case), Lot Number 24HMI599; Medline Kit Number/SKU DYNJ906281C: UDI/DI 10195327399399 (each), 40195327399390 (case), Lot Number 24GMG958; Medline Kit Number/SKU DYNJ906281C: UDI/DI 10195327399399 (each), 40195327399390 (case), Lot Number 24FMD774; Medline Kit Number/SKU DYNJ906281C: UDI/DI 10195327399399 (each), 40195327399390 (case), Lot Number 24BMF595; Medline Kit Number/SKU DYNJ906281C: UDI/DI 10195327399399 (each), 40195327399390 (case), Lot Number 23LMF486; Medline Kit Number/SKU DYNJ906281C: UDI/DI 10195327399399 (each), 40195327399390 (case), Lot Number 23KMA901; Medline Kit Number/SKU DYNJ906281C: UDI/DI 10195327399399 (each), 40195327399390 (case), Lot Number 23JMC383; Medline Kit Number/SKU DYNJ906281C: UDI/DI 10195327399399 (each), 40195327399390 (case), Lot ...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Jun 24, 2026
Recall initiation date
May 4, 2026
Center classification date
Jun 17, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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