Z-0558-2025Class II

ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Medline Convenience Kits containing...

Name: Z-0558-2025 ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Medline Convenience Kits containing...
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2024-10-25
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-10-25 / Open, Classified / root cause: labeling and UDI

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Medline Convenience Kits containing Single Use Biopsy Valve MAJ-1555 on 2024-10-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0558-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-25
Posted: 2024-11-26
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Medline Convenience Kits containing Single Use Biopsy Valve MAJ-1555
Product code: FDE Laparoscopy Kit
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: 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].
Quantity in commerce: 100
Distribution: US Nationwide distribution in the state of NY.
Product codes and lots: UDI-DI: 10193489844115 (each), 40193489844116 (case); Lot Number 22EBD372

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0558-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0558-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-26

Product code FDE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)