CLASS II ONGOING Device recall · Reported 30 Jul 2025 · FDA Enforcement Report
BD COR System recalled by Becton Dickinson &
Becton Dickinson is recalling BD COR System, distributed nationwide in the US. The recall was initiated on 23 Jun 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-2162-2025
- FDA event ID
- 97142
- Recalling firm
- Becton Dickinson, Sparks, MD
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Jun 2025
- FDA classified
- 23 Jul 2025
- Reported
- 30 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 23 Jun 2025 | Recall initiated by company | |
| 23 Jul 2025 | Classified by FDA | +30 days |
| 30 Jul 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
BD COR System Software. Model Number: 444829.
Where it was distributed
Worldwide - US Nationwide distribution in the states of Florida, Texas and Michigan. The countries of Sweden and Belgium.
Questions about this recall
Why was it recalled?
Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.
Which lots are affected?
Model Number: 444829. UDI-DI: 00382904448295. Software version 8.80 and above.
Where was it sold?
Worldwide - US Nationwide distribution in the states of Florida, Texas and Michigan. The countries of Sweden and Belgium.
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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