Class 2 Device Recall Hydrophilic Catheter

• Date Initiated by Firm: November 29, 2025
• Date Posted: January 12, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1061-2026
• Recall Event ID: 98147
• 510(K)Number: K192468
• Product Classification: Catheter, urethral - Product Code GBM
• Product: BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F
• Code Information: UDI: (01)06948796204063/Lot # T21823
• Recalling Firm/ Manufacturer: HANGZHOU BEVER MEDICAL DEVICES CO., LTD.; Building 2, No. 1-1, Houmuqiao, Yongle Village, Cangqian Street; Yuhang; Hangzhou China
• For Additional Information Contact: Mr. Allyson Zhou; +8657188616630
• Manufacturer Reason for Recall: Labeling error, Incorrect expiration date
• FDA Determined Cause: Labeling Change Control
• Action: On November 29, 2025, Hangzhou Bever Medical Devices issued a "Medical Device Recall" Notification via E-Mail. Hangzhou asked consignees to take the following actions: 1) Immediately discontinue the distribution of the RTU14F product (Lot Number T21823), and isolate the products of this lot in inventory to avoid incorrect shipment or use. 2) Discard the affected devices in compliance with local, state, and federal medical waste regulations. 3.If no alternative products are available currently, you may contact your sales representative to inquire about temporary alternative devices or solutions. 4) After receiving this letter, please fill in the attached Recall Return Response Form, and return to us via email to confirm receipt of the recall notice. 5) Forward the Customer Notification Letter and the Recall Return Response Form and to downstream customers, 6) Handle all replacement requests from your downstream customers and coordinate the delivery of replacement units to your downstream customers once received from Bever.
• Quantity in Commerce: 149310 units
• Distribution: US Nationwide distribution in the state of GA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = GBM