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MEDLINE Medical Procedure Kits labeled as recallZ-2501-2026 · Medline Industries, LP · initiated May 4, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medline Industries, LP or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

Medline Industries issued two URGENT MEDICAL DEVICE RECALL notice on 5/4/2026 to its consignees, one to its catheter and catheter tray consignees, and the other to the kit consignees via USPS and email. Both notices explained the issue and potential risk. The catheter and catheter tray consignees were directed to respond to the notice and destroy the affected products. The kit consignees were directed to respond to the notice and apply additional labeling (over-labels) to affix to the kits which instruct the user to remove and destroy the affected component. Both notices direct distributors or those who further distributing the products to notify their customers. For questions, contact the Recall Department at 866-359-1704 or [email protected].

Recall details

Recall number
Z-2501-2026
Status
Open, Classified
Initiated by the company
May 4, 2026
Posted by the FDA
Jun 17, 2026
Recalling firm
Medline Industries, LP
Quantity
24388 units
Product code
MLS
Distribution
Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.

Product description

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.

Code information (models, lots, serial numbers)

Show the full code information (14k characters)

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.UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 21BBO974; Medline Kit Number/SKU DYNJ14099F, UDI/DI 10193489352504 (each), 40193489352505 (case), Lot Number 21ABH741; Medline Kit Number/SKU DYNJ14099G, UDI/DI 10195327446635 (each), 40195327446636 (case), Lot Number 24IMB312; Medline Kit Number/SKU DYNJ14099G, UDI/DI 10195327446635 (each), 40195327446636 (case), Lot Number 24HMA611; Medline Kit Number/SKU DYNJ14099G, UDI/DI 10195327446635 (each), 40195327446636 (case), Lot Number 24FMA120; Medline Kit Number/SKU DYNJ14099G, UDI/DI 10195327446635 (each), 40195327446636 (case), Lot Number 24DMG080; Medline Kit Number/SKU DYNJ14099G, UDI/DI 10195327446635 (each), 40195327446636 (case), Lot Number 24CMJ181; Medline Kit Number/SKU DYNJ14099G, UDI/DI 10195327446635 (each), 40195327446636 (case), Lot Number 24CMI617; Medline Kit Number/SKU DYNJ14099G, UDI/DI 10195327446635 (each), 40195327446636 (case), Lot Number 24BMH160; Medline Kit Number/SKU DYNJ14099G, UDI/DI 10195327446635 (each), 40195327446636 (case), Lot Number 23LMG041; Medline Kit Number/SKU DYNJ14099G, UDI/DI 10195327446635 (each), 40195327446636 (case), Lot Number 23JMH222; Medline Kit Number/SKU DYNJ14099G, UDI/DI 10195327446635 (each), 40195327446636 (case), Lot Number 23JMF601; Medline Kit Number/SKU DYNJ14099G, UDI/DI 10195327446635 (each), 40195327446636 (case), Lot Number 23HMG202; Medline Kit Number/SKU DYNJ14099G, UDI/DI 10195327446635 (each), 40195327446636 (case), Lot Number 23HMD732; Medline Kit Number/SKU DYNJ14099G, UDI/DI 10195327446635 (each), 40195327446636 (case), Lot Number 23GMD596; Medline Kit Number/SKU DYNJ03387B, UDI/DI 10195327191092 (each), 40195327191093 (case), Lot Number 25FBI444; Medline Kit Number/SKU DYNJ03387B, UDI/DI 10195327191092 (each), 40195327191093 (case), Lot Number 25BBO923; Medline Kit Number/SKU DYNJ03387B, UDI/DI 10195327191092 (each), 40195327191093 (case), Lot Number 24LBG789; Medline Kit Number/SKU DYNJ03387B, UDI/DI 10195327191092 (each), 40195327191093 (case), Lot Number 24LBA767; Medline Kit Number/SKU DYNJ03387B, UDI/DI 10195327191092 (each), 40195327191093 (case), Lot Number 24JBO026; Medline Kit Number/SKU DYNJ03387B, UDI/DI 10195327191092 (each), 40195327191093 (case), Lot Number 24IBI662; Medline Kit Number/SKU DYNJ03387B, UDI/DI 10195327191092 (each), 40195327191093 (case), Lot Number 24FBK362; Medline Kit Number/SKU DYNJ03387B, UDI/DI 10195327191092 (each), 40195327191093 (case), Lot Number 24DBN071; Medline Kit Number/SKU DYNJ03387B, UDI/DI 10195327191092 (each), 40195327191093 (case), Lot Number 23JBK808; Medline Kit Number/SKU DYNJ03387B, UDI/DI 10195327191092 (each), 40195327191093 (case), Lot Number 23IBS185; Medline Kit Number/SKU DYNJ03387B, UDI/DI 10195327191092 (each), 40195327191093 (case), Lot Number 23HBV579; Medline Kit Number/SKU DYNJ03387B, UDI/DI 10195327191092 (each), 40195327191093 (case), Lot Number 23HBQ803; Medline Kit Number/SKU DYNJ03387B, UDI/DI 10195327191092 (each), 40195327191093 (case), Lot Number 23BBU020; Medline Kit Number/SKU DYNJ03387B, UDI/DI 10195327191092 (each), 40195327191093 (case), Lot Number 23ABJ397; Medline Kit Number/SKU DYNJ03387B, UDI/DI 10195327191092 (each), 40195327191093 (case), Lot Number 22KBG024; Medline Kit Number/SKU DYNJ03387B, UDI/DI 10195327191092 (each), 40195327191093 (case), Lot Number 22JBB063; Medline Kit Number/SKU DYNJ03387B, UDI/DI 10195327191092 (each), 40195327191093 (case), Lot Number 22HBU578; Medline Kit Number/SKU DYNJ03387C, UDI/DI 10198459495823 (each), 40198459495824 (case), Lot Number 26CBV912; Medline Kit Number/SKU DYNJ03387C, UDI/DI 10198459495823 (each), 40198459495824 (case), Lot Number 26CBF051; Medline Kit Number/SKU DYNJ03387C, UDI/DI 10198459495823 (each), 40198459495824 (case), Lot Number 26BBB290; Medline Kit Number/SKU DYNJ03387C, UDI/DI 10198459495823 (each), 40198459495824 (case), Lot Number 25JBG571; Medline Kit Number/SKU DYNJ03387C, UDI/DI 10198459495823 (each), 40198459495824 (case), Lot Number 25IBN493; Medline Kit Number/SKU DYNJ53543B, UDI/DI 10198459572753 (each), 40198459572754 (case), Lot Number 26DBH680; Medline Kit Number/SKU DYNJ53543B, UDI/DI 10198459572753 (each), 40198459572754 (case), Lot Number 26BBC009; Medline Kit Number/SKU DYNJ53543B, UDI/DI 10198459572753 (each), 40198459572754 (case), Lot Number 25LBS233; Medline Kit Number/SKU DYNJ53543B, UDI/DI 10198459572753 (each), 40198459572754 (case), Lot Number 25KBI463; Medline Kit Number/SKU DYNJ62645D, UDI/DI 10195327350635 (each), 40195327350636 (case), Lot Number 23JBV442; Medline Kit Number/SKU DYNJ62645F, UDI/DI 10195327637651 (each), 40195327637652 (case), Lot Number 25FMI215; Medline Kit Number/SKU DYNJ62645F, UDI/DI 10195327637651 (each), 40195327637652 (case), Lot Number 25DMD310; Medline Kit Number/SKU DYNJ62645F, UDI/DI 10195327637651 (each), 40195327637652 (case), Lot Number 25AME268; Medline Kit Number/SKU DYNJ62645F, UDI/DI 10195327637651 (each), 40195327637652 (case), Lot Number 24KMA478; Medline Kit Number/SKU DYNJ62645F, UDI/DI 10195327637651 (each), 40195327637652 (case), Lot Number 24IMJ299; Medline Kit Number/SKU DYNJ62645F, UDI/DI 10195327637651 (each), 40195327637652 (case), Lot Number 24HMB222; Medline Kit Number/SKU DYNJ62645F, UDI/DI 10195327637651 (each), 40195327637652 (case), Lot Number 24FMI268; Medline Kit Number/SKU DYNJ62645F, UDI/DI 10195327637651 (each), 40195327637652 (case), Lot Number 24DBT826; Medline Kit Number/SKU DYNJ62645F, UDI/DI 10195327637651 (each), 40195327637652 (case), Lot Number 24CBL291; Medline Kit Number/SKU DYNJ62645G, UDI/DI 10198459485565 (each), 40198459485566 (case), Lot Number 25KMH729; Medline Kit Number/SKU DYNJ62645G, UDI/DI 10198459485565 (each), 40198459485566 (case), Lot Number 25JMJ897; Medline Kit Number/SKU DYNJ62645G, UDI/DI 10198459485565 (each), 40198459485566 (case), Lot Number 25IMJ310; Medline Kit Number/SKU DYNJ62645G, UDI/DI 10198459485565 (each), 40198459485566 (case), Lot Number 25IMH021; Medline Kit Number/SKU DYNJ04454K, UDI/DI 10193489555820 (each), 40193489555821 (case), Lot Number 22EMC749; Medline Kit Number/SKU DYNJ04454K, UDI/DI 10193489555820 (each), 40193489555821 (case), Lot Number 22DBF817; Medline Kit Number/SKU DYNJ04454K, UDI/DI 10193489555820 (each), 40193489555821 (case), Lot Number 22CBY160; Medline Kit Number/SKU DYNJ04454K, UDI/DI 10193489555820 (each), 40193489555821 (case), Lot Number 22CBJ210; Medline Kit Number/SKU DYNJ04454K, UDI/DI 10193489555820 (each), 40193489555821 (case), Lot Number 22ABJ981; Medline Kit Number/SKU DYNJ04454K, UDI/DI 10193489555820 (each), 40193489555821 (case), Lot Number 21KBW225; Medline Kit Number/SKU DYNJ04454K, UDI/DI 10193489555820 (each), 40193489555821 (case), Lot Number 21JBQ328; Medline Kit Number/SKU DYNJ04454K, UDI/DI 10193489555820 (each), 40193489555821 (case), Lot Number 21HBR630; Medline Kit Number/SKU DYNJ04454K, UDI/DI 10193489555820 (each), 40193489555821 (case), Lot Number 21GBF157; Medline Kit Number/SKU DYNJ04454K, UDI/DI 10193489555820 (each), 40193489555821 (case), Lot Number 21DKA599; Medline Kit Number/SKU DYNJ04454L, UDI/DI 10195327188221 (each), 40195327188222 (case), Lot Number 26CMK043; Medline Kit Number/SKU DYNJ04454L, UDI/DI 10195327188221 (each), 40195327188222 (case), Lot Number 26BMI532; Medline Kit Number/SKU DYNJ04454L, UDI/DI 10195327188221 (each), 40195327188222 (case), Lot Number 26AMA922; Medline Kit Number/SKU DYNJ04454L, UDI/DI 10195327188221 (each), 40195327188222 (case), Lot Number 25JMA933; Medline Kit Number/SKU DYNJ04454L, UDI/DI 10195327188221 (each), 40195327188222 (case), Lot Number 25IMA699; Medline Kit Number/SKU DYNJ04454L, UDI/DI 10195327188221 (each), 40195327188222 (case), Lot Number 25GMB964; Medline Kit Number/SKU DYNJ04454L, UDI/DI 10195327188221 (each), 40195327188222 (case), Lot Number 25EMF424; Medline Kit Number/SKU DYNJ04454L, UDI/DI 10195327188221 (each), 40195327188222 (case), Lot Number 25DMF069; Medline Kit Number/SKU DYNJ04454L, UDI/DI 10195327188221 (each), 40195327188222 (case), Lot Number 25CMA039; Medline Kit Number/SKU DYNJ04454L, UDI/DI 10195327188221 (each), 40195327188222 (case), Lot Number 25AMC467; Medline Kit Number/SKU DYNJ04454L, UDI/DI 10195327188221 (each), 40195327188222 (case), Lot Number 24JMB289; Medline Kit Number/SKU DYNJ04454L, UDI/DI 10195327188221 (each), 40195327188222 (case), Lot Number 24HMI938; Medline Kit Number/SKU DYNJ04454L, UDI/DI 10195327188221 (each), 40195327188222 (case), Lot Number 24FMH964; Medline Kit Number/SKU DYNJ04454L, UDI/DI 10195327188221 (each), 40195327188222 (case), Lot Number 24DMH198; Medline Kit Number/SKU DYNJ04454L, UDI/DI 10195327188221 (each), 40195327188222 (case), Lot Number 24BMG306; Medline Kit Number/SKU DYNJ04454L, UDI/DI 10195327188221 (each), 40195327188222 (case), Lot Number 23KMI243; Medline Kit Number/SKU DYNJ04454L, UDI/DI 10195327188221 (each), 40195327188222 (case), Lot Number 23JMA024; Medline Kit Number/SKU DYNJ04454L, UDI/DI 10195327188221 (each), 40195327188222 (case), Lot Number 23HMG712; Medline Kit Number/SKU DYNJ04454L, UDI/DI 10195327188221 (each), 40195327188222 (case), Lot Number 23GMA293; Medline Kit Number/SKU DYNJ04454L, UDI/DI 10195327188221 (each), 40195327188222 (case), Lot Number 23EMI664; Medline Kit Number/SKU DYNJ04454L, UDI/DI 10195327188221 (each), 40195327188222 (case), Lot Number 23BMA722; Medline Kit Number/SKU DYNJ04454L, UDI/DI 10195327188221 (each), 40195327188222 (case), Lot Number 23AMA041; Medline Kit Number/SKU DYNJ04454L, UDI/DI 10195327188221 (each), 40195327188222 (case), Lot Number 22JMD634; Medline Kit Number/SKU DYNJ04454L, UDI/DI 10195327188221 (each), 40195327188222 (case), Lot Number 22HME067; Medline Kit Number/SKU DYNJ04454L, UDI/DI 10195327188221 (each), 40195327188222 (case), Lot Number 22GMF232; Medline Kit Number/SKU DYNJ01830G, UDI/DI 10889942572595 (each), 40889942572596 (case), Lot Number 21EMF514; Medline Kit Number/SKU DYNJ01830G, UDI/DI 10889942572595 (each), 40889942572596 (case), Lot Number 21EMB753; Medline Kit Number/SKU DYNJ01830G, UDI/DI 10889942572595 (each), 40889942572596 (case), Lot Number 21CMD016; Medline Kit Number/SKU DYNJ01830G, UDI/DI 10889942572595 (each), 40889942572596 (case), Lot Number 21BMC555.

Devices named in this recall

11 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 98994).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page