FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: Medline EYE PACK, REF LYN036EPESB; medical procedure convenience kit
- Recall number
- Z-0180-2025
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline EYE PACK, REF LYN036EPESB; medical procedure convenience kit
- Status
- Open, Classified
- Initiated
- 2024-09-04
- Posted
- 2024-10-23
- Terminated
- not on file
- Reason
- It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
- Root cause
- Under Investigation by firm
- Action
- Medline issued a MEDICAL DEVICE RECALL notice to its consignees on 09/05/2024 via email and USPS. The notice explained the issue, hazard, and requested the destruction of the affected product. Distributors were directed to notify their consignees.
- Quantity
- 160 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Panama.
- Lot, serial or model codes
- UDI/DI 40889942863304 (each), 10889942863303 (case), Lot Numbers: 24ABA894
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OJK
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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