FDA Medical devices recall ·
Arrow Echogenic Introducer Needle recall
- Recall number
- Z-1910-2026
- Date
- (initiated March 11, 2026)
- Company / brand
- Arrow International, LLC
3015 Carrington Mill Blvd, Morrisville, NC, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 85
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 This device is intended for injection or aspiration of fluids. The needle protection device covers the needle after use to help prevent needle sticks.
Why was it recalled?
Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured
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
Product code: ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 Batch Number: 33F25J0347
Distribution
U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.
States: Arizona California Georgia Massachusetts Maine Michigan Oregon Pennsylvania Virginia
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-1910-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.