Skip to content

Medline Convenience Kits recallZ-3060-2026 · Medline Industries, LP · initiated Jun 12, 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 kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

FDA root cause category: Nonconforming Material/Component

What the company is doing

An URGENT MEDICAL DEVICE RECALL notification letter dated 6/12/25 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. Website link: https://recalls.medline.com Recall Reference #: R-26-097-FGX1 Recall Code: 3. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. 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. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected].

Recall details

Recall number
Z-3060-2026
Status
Open, Classified
Initiated by the company
Jun 12, 2026
Posted by the FDA
Aug 31, 2026
Recalling firm
Medline Industries, LP
Quantity
352 kits
Product code
OHM
Distribution
US Nationwide distribution.

Product description

Medline Convenience Kits: 1) C-SECTION PREP, Model Number: DYNJ32702B

Code information (models, lots, serial numbers)

1) DYNJ32702B, UDI-DI: 10193489431070(each), 40193489431071(case), Lot Number: 25BBG443; 2) DYNJ32702B, UDI-DI: 10193489431070(each), 40193489431071(case), Lot Number: 25EBL829; 3) DYNJ32702B, UDI-DI: 10193489431070(each), 40193489431071(case), Lot Number: 24EBR761; 4) DYNJ32702B, UDI-DI: 10193489431070(each), 40193489431071(case), Lot Number: 24GBC622; 5) DYNJ32702B, UDI-DI: 10193489431070(each), 40193489431071(case), Lot Number: 24GBX458; 6) DYNJ32702B, UDI-DI: 10193489431070(each), 40193489431071(case), Lot Number: 23LBT973

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 99334).

Sources and updates

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