ClearanceBrief
Recall Z-0465-2025 ยท LRW Scissors, General, Surgical

MEDLINE INDUSTRIES, LP - Northfield

Medline Iris Scissors, Single-Use, Curved, Standard 4.5 , Model Nos. DYNJ04049 (cases), DYNJ04049H (eaches)

DateNov 14, 2024 (initiated Oct 21, 2024)
StatusOpen, Classified
ReasonTip protector may fall off within the packaging, resulting in compromised sterile barrier system and loss of sterility.
Root causeUnder Investigation by firm
ActionThis 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.
Quantity69,611
DistributionUS 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.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.