FDA Medical devices recall ·
BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated… recall
- Recall number
- Z-1061-2026
- Date
- (initiated November 29, 2025)
- Company / brand
- Hangzhou Bever Medical Devices CO., Ltd.
Building 2, No. 1-1, Houmuqiao, Yongle Village, Cangqian Street, Hangzhou, China - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 149310 units
- Hazard tags
- Mislabeling
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F
Why was it recalled?
Labeling error, Incorrect expiration date
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: (01)06948796204063/Lot # T21823
Distribution
US Nationwide distribution in the state of GA.
States: Georgia
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-1061-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.