Z-1061-2026Class II

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

Name: Z-1061-2026 BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F
Creator: Hangzhou Bever Medical Devices Co., Ltd.
Published: 2025-11-29
License: https://open.fda.gov/license/

Hangzhou Bever Medical Devices Co., Ltd. / initiated 2025-11-29 / Open, Classified / root cause: labeling and UDI

FDA source

HANGZHOU BEVER MEDICAL DEVICES CO., LTD. began a recall of BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F on 2025-11-29. FDA classified it as Class II and gives the reason as "Labeling error, Incorrect expiration date". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1061-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-11-29
Posted: 2026-01-12
Recalling firm: Hangzhou Bever Medical Devices Co., Ltd.
Product: BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F
Product code: GBM Catheter, Urethral
Reason for recall: Labeling error, Incorrect expiration date
Root cause tag: labeling and UDI
FDA root 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.
Product codes and lots: UDI: (01)06948796204063/Lot # T21823

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1061-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1061-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-12

Product code GBM

K192468Class IIMale, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter; Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter; Male, Olive-Tip Tiemann Ready-to-Use Hydrophilic CatheterHangzhou Bever Medical Devices Co., Ltd. / cleared 2019-11-27

Hollister recalls 2.5 million intermittent catheters over a manufacturing defect11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)