FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049
- Recall number
- Z-2595-2023
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049
- Status
- Open, Classified
- Initiated
- 2023-08-03
- Posted
- 2023-09-18
- Terminated
- not on file
- Reason
- 4.5" Iris Scissors, Sterile, Curved (DYNJ04049) are being recalled due to the potential of the tip protector to fall off. The sharp tip of the scissors could compromise the sterile barrier system by puncturing large and/or small holes that may not be visible to the user.
- Root cause
- Under Investigation by firm
- Action
- Medline Industries issued a recall notice to its consignees by email on 08/03/2023. The notice explained the problem with the device, the potential hazard, and requested the following: Immediately check your stock for the affected item number and the affected lot numbers listed on the recall portal. Destroy affected product. Distributors or those who resold or transferred the product were directed to notify their customers and have them destroy any affected product. If you have any questions, please contact the Recall Department at 866-359-1704.
- Quantity
- 324,451 devices
- Distribution
- Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Canada, Hong Kong, Taiwan, Singapore
- Lot, serial or model codes
- UDI/DI 10080196847273, all lots
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JOK
- 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