FDA Medical devices recall ·
Medline Iris Scissors, Single-Use, Curved, Standard 4.5 , Model Nos recall
- Recall number
- Z-0465-2025
- Date
- (initiated October 21, 2024)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 69,611
- Hazard tags
- Sterility Fall
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medline Iris Scissors, Single-Use, Curved, Standard 4.5 , Model Nos. DYNJ04049 (cases), DYNJ04049H (eaches)
Why was it recalled?
Tip protector may fall off within the packaging, resulting in compromised sterile barrier system and loss of sterility.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 10080196847273 Lots 23GBV681 23HBD138 23IBF254 23LBJ787
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.
States: Alabama Arkansas Colorado Connecticut Florida Iowa Indiana Kansas Louisiana Massachusetts Missouri North Carolina New York Oklahoma Oregon Rhode Island Tennessee Texas Virginia Washington Wyoming
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0465-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.