ENDO KIT, Medline Kit SKU DYKE1577A, Component Number… recallZ-0558-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Oct 25, 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
Identified lots of Olympus product may be missing sterile and manufacturing lot numbers and expiration dates on the sterile packaging. The information can be found on the outer box or zipper bag label. Medline is recalling its kits which utilize affected product as a component.
FDA root cause category: Labeling Change Control
What the company is doing
On October 25, 2024, the firm notified customers of the recall via letters titled "Olympus America, Inc. IMMEDIATE ACTION REQUIRED RECALL". Customers were informed that the specified lot of kits may contain the affected lot of Single Use Biopsy Valve MAJ-1555 recalled by Olympus. The missing sterile and manufacturing lot numbers and expiration dates can be found on the outer box or zipper bag label. Affected product should not be used if you are unable to determine the expiration date. Customers should locate and quarantine all product from affected lot. Customers should complete the response form provided by the firm. Upon receipt of the completed form, the firm will provide over-labels to place on affected inventory, with instructions for staff to remove the affected component prior to using the kit. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected].
Recall details
- Recall number
- Z-0558-2025
- Status
- Open, Classified
- Initiated by the company
- Oct 25, 2024
- Posted by the FDA
- Nov 26, 2024
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 100
- Product code
- FDE
- Distribution
- US Nationwide distribution in the state of NY.
Product description
ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Medline Convenience Kits containing Single Use Biopsy Valve MAJ-1555
Code information (models, lots, serial numbers)
UDI-DI: 10193489844115 (each), 40193489844116 (case); Lot Number 22EBD372
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Medline Industries, Inc. DYKE1577AMedline Industries, Inc. · laparoscopy kit1 recall0 reports
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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