FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: Centurion STERILE ROUND EAR SPECULUM SET (3, 4, 5), Product Code I68505
- Recall number
- Z-1433-2024
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Centurion STERILE ROUND EAR SPECULUM SET (3, 4, 5), Product Code I68505
- Status
- Open, Classified
- Initiated
- 2024-02-23
- Posted
- 2024-03-29
- Terminated
- not on file
- Reason
- Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- Root cause
- Process control
- Action
- Medline Industries, LP, issued a Medical Device Recall notice to its consignees on 02/27/2024 via email and USPS First Class mail. The notice explained the problem with the devices, risk, and requested that the products be destroyed at the consignee. Distributors were directed to notify their customers.
- Quantity
- 440 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Panama, Canada.
- Lot, serial or model codes
- UDI/DI 00653160294453 (case), 10653160294450 (unit), Lot Numbers: 2023090190, 2023101190
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EPY
- 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