Medline Iris Scissors, Single-Use, Curved, Standard 4.5 , Model Nos. DYNJ04049 (cases), DYNJ04049H (eaches)
FDA device recall Z-0465-2025 · posted 2024-11-14 · Open, Classified
Recall details
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Reason for recall
- Tip protector may fall off within the packaging, resulting in compromised sterile barrier system and loss of sterility.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- LRW
- Quantity affected
- 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.
- Date initiated
- 2024-10-21
- Date posted
- 2024-11-14
- Location
- Northfield, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.