CLASS II ONGOING Device recall · Reported 11 Jan 2023 · FDA Enforcement Report
Bioball K.rhizophila recalled by Biomerieux
Biomerieux is recalling Bioball K.rhizophila, distributed nationwide in the US. The recall was initiated on 9 Nov 2022 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-0832-2023
- FDA event ID
- 91148
- Recalling firm
- Biomerieux, Hazelwood, MO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Nov 2022
- FDA classified
- 4 Jan 2023
- Reported
- 11 Jan 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Temperature Abuse
- Device type
- Other Medical Devices
Timeline
| 9 Nov 2022 | Recall initiated by company | |
| 4 Jan 2023 | Classified by FDA | +56 days |
| 11 Jan 2023 | 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
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
BIOBALL K.RHIZOPHILA (30X20), CATALOG 412690
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is Bioball K.rhizophila recalled?
Yes. Biomerieux recalled Bioball K.rhizophila on 9 Nov 2022. The recall is Class II and its status is Ongoing. Recall number Z-0832-2023.
Why was it recalled?
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Which lots are affected?
UDI/DI 03573026381103, Batch Numbers: 7408
Where was it sold?
US Nationwide distribution.
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 21 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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