ARTHROSCOPY Convenience kit used for surgical procedures… recallZ-0350-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Oct 4, 2024

Open, Classified

Is my device affected?

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.
If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
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

Products within a Medline pack may be impacted by a packaging error in which an incomplete seal has formed on the packaging thereby creating a packaging seal gap.

FDA root cause category: Nonconforming Material/Component

What the company is doing

An URGENT MEDICAL DEVICE NOTIFICATION dated 10/4/24 was sent to the customer. REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. Quarantine all affected product immediately.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 response form.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 the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable.The login for completing the response form is:Website link: https://recalls.medline.comRecall Reference #: R-24-207-FGX1Recall Code: 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. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected].

Recall details

Recall number: Z-0350-2025
Status: Open, Classified
Initiated by the company: Oct 4, 2024
Posted by the FDA: Nov 8, 2024
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Quantity: 80 units
Product code: OJH
Distribution: US Nationwide distribution in the state of TN.

Product description

ARTHROSCOPY Convenience kit used for surgical procedures, SKU SYNJ910004C

Code information (models, lots, serial numbers)

UDI-DI: 10195327246747; Lot Numbers: 24GBI464 24HBO800

Devices named in this recall

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

Medline Industries, Inc. SYNJ910004C
Medline Industries, Inc. · Orthopedic tray
2 recalls0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 95563).

Z-0349-2025 · Open, Classified
CARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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