BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm)… recallZ-1061-2026 · Hangzhou Bever Medical Devices CO., Ltd. · initiated Nov 29, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Hangzhou Bever Medical Devices CO., Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Labeling error, Incorrect expiration date
FDA root cause category: Labeling Change Control
What the company is doing
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.
Recall details
- Recall number
- Z-1061-2026
- Status
- Open, Classified
- Initiated by the company
- Nov 29, 2025
- Posted by the FDA
- Jan 12, 2026
- Recalling firm
- Hangzhou Bever Medical Devices CO., Ltd.
- Quantity
- 149310 units
- Product code
- GBM
- FDA submissions
- K192468
- Distribution
- US Nationwide distribution in the state of GA.
Product description
BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F
Code information (models, lots, serial numbers)
UDI: (01)06948796204063/Lot # T21823
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BD Intermittent RTU14FHangzhou Bever Medical Devices Co., Ltd. · Catheter, Urethral1 recall3 reports
Other devices under the same FDA submission
6 devices cleared under K192468 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- BD Intermittent RTU16CHangzhou Bever Medical Devices Co., Ltd. · Catheter, Urethral7 reports
- BD Intermittent RTU16MHangzhou Bever Medical Devices Co., Ltd. · Catheter, Urethral4 reports
- BD Intermittent RTU14CHangzhou Bever Medical Devices Co., Ltd. · Catheter, Urethral3 reports
- BD Intermittent RTU14MHangzhou Bever Medical Devices Co., Ltd. · Catheter, Urethral2 reports
- BD Intermittent RTU12MHangzhou Bever Medical Devices Co., Ltd. · Catheter, Urethral1 report
- BD Intermittent RTU12CHangzhou Bever Medical Devices Co., Ltd. · Catheter, Urethral1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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