FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Medline Convenience Kits containing Single Use Biopsy Valve MAJ-1555
- Recall number
- Z-0558-2025
- 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
- Status
- Open, Classified
- Initiated
- 2024-10-25
- Posted
- 2024-11-26
- Terminated
- not on file
- Reason
- 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
- 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 recalls@medline.com.
- Quantity
- 100
- Distribution
- US Nationwide distribution in the state of NY.
- Lot, serial or model codes
- UDI-DI: 10193489844115 (each), 40193489844116 (case); Lot Number 22EBD372
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FDE
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28