FDA Medical Device Recalls (openFDA)
Medline Industries, LP: MEDLINE STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D; 2) REF: DYNJ37743F.
- Recall number
- Z-0510-2026
- Recalling firm
- Medline Industries, LP
- Product
- MEDLINE STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D; 2) REF: DYNJ37743F.
- Status
- Open, Classified
- Initiated
- 2025-10-03
- Posted
- 2025-11-14
- Terminated
- not on file
- Reason
- Medline has identified specific sterile eye procedure kits with pouch packaging that may exhibit open seals.
- Root cause
- Other
- Action
- Medline Industries issued an URGENT MEDICAL DEVICE RECALL notice to its consignee on 10/03/2025 via USPS first class mail and email. The notice explained the issue with the product, potential risk to the patient, and requested the following actions: "1.Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. Upon completion of the below actions, please destroy affected product.2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form.Website link: https://recalls.medline.comRecall Reference #: R-25-202-FGRecall Code: 3.Your account will receive credit once the response form is submitted.4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request that customers destroy any affected product. You should include your customers quantities on your response form. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com."
- Quantity
- 1024 units
- Distribution
- US: MO
- Lot, serial or model codes
- 1) REF: DYNJ37743D: UDI/DI 10193489600124 (each), 40193489600125 (case), Lot Number 25EMI333; 2) REF: DYNJ37743F: UDI/DI 10198459390685 (each), 40198459390686 (case), Lot Number 25GMD927.
- 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
- 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