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Medline Kits recallZ-1845-2026 · Medline Industries, LP · initiated Feb 25, 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

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

FDA root cause category: No Marketing Application

What the company is doing

An URGENT MEDICAL DEVICE RECALL dated 2/25/26 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and lot number(s) listed in the recall portal. Quarantine all affected product. 2. Complete your response form. List the quantity of affected product you have in inventory on the form. Even if you do not have any affected product, submit the form to Website link: https://recalls.medline.com Recall Reference #: R-26-020-FGX1 Recall Code: 3. When we receive your response form, we will send over-labels via FedEx overnight to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. 4. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Include your customers quantities on your response form. When we receive your response form, we will send over-labels to provide to your customers. Any questions? Contact the Recall Department at 866-359-1704 or [email protected]. *** An Urgent Medical Device Recall notification letter dated 3/2/26 was sent to customers. This is a follow-up to a Medline notification you may have received on February 25, 2026. New item numbers and lot numbers have been included with this communication. Recipients receiving this notification for the first time were not affected by the original notification. REQUIRED ACTIONS: same as for 2/25/26 letter

Recall details

Recall number
Z-1845-2026
Status
Open, Classified
Initiated by the company
Feb 25, 2026
Posted by the FDA
Apr 17, 2026
Recalling firm
Medline Industries, LP
Quantity
1720 units
Product code
MLS
Distribution
US Nationwide distribution.

Product description

Medline Kits: 1) LABOR PACK-22025208-LF, Model Number: DYNJ44813D

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

1) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 21CBJ477; 2) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 21GBE184; 3) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 21GBJ527; 4) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 21HBL388; 5) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 21IBT013; 6) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 21LBS718; 7) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 22BBD935; 8) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 22CBA262; 9) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 22FBM910; 10) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 22LBQ838; 11) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 23FBS838; 12) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 23IBD099; 13) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 23KBA057; 14) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 24ABJ743; 15) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 24EBG776; 16) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 24FBC225; 17) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 24IBW215; 18) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 24LBU055; 19) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 22HBG782; 20) DYNJ44813D, UDI-DI: 10193489467642(each), 40193489467643(case), Lot Number: 25DBP554

Devices named in this recall

1 device 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 98599).

Sources and updates

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