Skip to content

Medline surgical convenience kits labeled as: OPEN HEART… recallZ-0178-2027 · Medline Industries, LP · initiated Sep 2, 2026

Open, Classified All recalls posted in October 2026

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

Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

FDA root cause category: Under Investigation by firm

What the company is doing

Medline Industries issued a MEDICAL DEVICE RECALL notice to its consignees on 9/2/2026 via USPS first class mail and email. The notice explained the issue, potential risk, and requested the following: "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-26-201-FG, 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." Those consignees who further distributed the product were directed to notify the parties to whom the affected product was distributed. For questions, contact the Recall Department at 866-359-1704 or [email protected].

Recall details

Recall number
Z-0178-2027
Recall class
Not yet classified by the FDA
Status
Open, Classified
Initiated by the company
Sep 2, 2026
Posted by the FDA
Oct 15, 2026
Recalling firm
Medline Industries, LP
Quantity
165 kits
Product code
OJK
Distribution
US Nationwide distribution.

Product description

Medline surgical convenience kits labeled as: OPEN HEART, Medline Product Number/SKU DYNJ902898D

Code information (models, lots, serial numbers)

UDI/DI 10195327369743 (each) 40195327369744 (case). Lot Numbers: 23GBD734, 23EBQ512

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 99886).

Sources and updates

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