FDA Medical Device Recalls (openFDA)
Medline Industries, LP: SCISSORS, OR, SHARP/BLUNT, 5.5", STERILE, Item Number DYND04000
- Recall number
- Z-0921-2026
- Recalling firm
- Medline Industries, LP
- Product
- SCISSORS, OR, SHARP/BLUNT, 5.5", STERILE, Item Number DYND04000
- Status
- Open, Classified
- Initiated
- 2025-11-13
- Posted
- 2025-12-12
- Terminated
- not on file
- Reason
- The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized.
- Root cause
- Packaging process control
- Action
- An URGENT MEDICAL DEVICE RECALL notification letter dated 11/13/25 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed on the enclosed response form. Quarantine all affected product. Upon completion of the below actions, please destroy affected product. 2. Please complete and return the enclosed response form listing the quantity of affected product you have in inventory. Even if you do not have any affected product in inventory, please complete and return the response form. 3. Your account will receive credit once the response form is submitted, if applicable. 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
- 56 units
- Distribution
- US Nationwide distribution in the states CA, CO, IL, KS, and MI.
- Lot, serial or model codes
- DYND04000, UDI-DI: 10193489191349(each), 20193489191346(case), Lot Number: 2023102590
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRW
- 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