Z-0465-2025 Class II Ongoing
FDA device recall Z-0465-2025 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Oct 21, 2024 and is designated Class II. Reason for recall: Tip protector may fall off within the packaging, resulting in compromised sterile barrier system and loss of sterility. The recall status is ongoing. Affected quantity: 69,611.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 20, 2024
- Initiation Date
- Oct 21, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 69,611
Product Description
Medline Iris Scissors, Single-Use, Curved, Standard 4.5 , Model Nos. DYNJ04049 (cases), DYNJ04049H (eaches)
Reason for Recall
Tip protector may fall off within the packaging, resulting in compromised sterile barrier system and loss of sterility.
Distribution Pattern
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.
Code Information
UDI-DI: 10080196847273 Lots 23GBV681 23HBD138 23IBF254 23LBJ787
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0465-2025
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026