FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: Medline Iris Scissors, Single-Use, Curved, Standard 4.5 , Model Nos. DYNJ04049 (cases), DYNJ04049H (eaches)
- Recall number
- Z-0465-2025
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline Iris Scissors, Single-Use, Curved, Standard 4.5 , Model Nos. DYNJ04049 (cases), DYNJ04049H (eaches)
- Status
- Open, Classified
- Initiated
- 2024-10-21
- Posted
- 2024-11-14
- Terminated
- not on file
- Reason
- Tip protector may fall off within the packaging, resulting in compromised sterile barrier system and loss of sterility.
- Root cause
- Under Investigation by firm
- Action
- This is an expansion of recall RES 92881, which was originally initiated on April 30, 2024. Additional impacted customers were identified and notified on October 7, 2024. Customers were instructed to destroy any affected product on hand. The firm will issue credit for affected product.
- Quantity
- 69,611
- Distribution
- US Nationwide distributions in the states of AL, AR, CO, CT, FL, IA, IN, KS, LA, MA, MO, NC, NY, OK, OR, RI, TN, TX, VA, WA, WY.
- Lot, serial or model codes
- UDI-DI: 10080196847273 Lots 23GBV681 23HBD138 23IBF254 23LBJ787
- 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