CLASS II ONGOING Device recall · Reported 21 Jan 2026 · FDA Enforcement Report
BD Ready-to-Use Hydrophilic Catheter Straight Tip, Coated, Female recalled
Hangzhou Bever Medical Devices is recalling BD Ready-to-Use Hydrophilic Catheter Straight Tip, Coated, Female, distributed nationwide in the US. The recall was initiated on 29 Nov 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1061-2026
- FDA event ID
- 98147
- Recalling firm
- Hangzhou Bever Medical Devices, Hangzhou
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Nov 2025
- FDA classified
- 12 Jan 2026
- Reported
- 21 Jan 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Heart & Vascular Devices
Timeline
| 29 Nov 2025 | Recall initiated by company | |
| 12 Jan 2026 | Classified by FDA | +44 days |
| 21 Jan 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling error, Incorrect expiration date
Product as listed by the FDA
BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F
Where it was distributed
US Nationwide distribution in the state of GA.
Questions about this recall
Why was it recalled?
Labeling error, Incorrect expiration date
Which lots are affected?
UDI: (01)06948796204063/Lot # T21823
Where was it sold?
US Nationwide distribution in the state of GA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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