Recall Z-1061-2026— HANGZHOU BEVER MEDICAL DEVICES CO., LTD.

Name: FDA recall Z-1061-2026
Creator: U.S. Food and Drug Administration
Published: 2025-11-29

Class II · Ongoing

Class II FDA medical device recall by HANGZHOU BEVER MEDICAL DEVICES CO., LTD., initiated 2025-11-29. It names one FDA 510(k) clearance: K192468. Product: BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F. Reason: Labeling error, Incorrect expiration date.

Recalling firm: HANGZHOU BEVER MEDICAL DEVICES CO., LTD.
Classification: Class II
Status: Ongoing
Initiated: 2025-11-29
Firm location: Hangzhou, China

510(k) clearances named in this recall

1 on FDA's record

K192468 — Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter +4 moreHangzhou Bever Medical Devices Co., Ltd.·cleared 2019-11-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F

Reason for recall

Labeling error, Incorrect expiration date

Data sourced from openFDA. This site is unofficial and independent of the FDA.