Class 2 Device Recall Medline Iris Scissors

• Date Initiated by Firm: October 21, 2024
• Date Posted: November 14, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0465-2025
• Recall Event ID: 95671
• Product Classification: Scissors, general, surgical - Product Code LRW
• Product: Medline Iris Scissors, Single-Use, Curved, Standard 4.5 , Model Nos. DYNJ04049 (cases), DYNJ04049H (eaches)
• Code Information: UDI-DI: 10080196847273 Lots 23GBV681 23HBD138 23IBF254 23LBJ787
• FEI Number: 1417592
• Recalling Firm/ Manufacturer: MEDLINE INDUSTRIES, LP - Northfield; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Haley Barclay; 866-359-1704
• Manufacturer Reason for Recall: Tip protector may fall off within the packaging, resulting in compromised sterile barrier system and loss of sterility.
• FDA Determined 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 in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.