CLASS II ONGOING Device recall · Reported 6 Aug 2025 · FDA Enforcement Report
Blood Agar,5% Sheep Blood, Product Number R01202 recalled by Remel
Remel is recalling Blood Agar,5% Sheep Blood, Product Number R01202, distributed nationwide in the US. The recall was initiated on 11 Jul 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-2223-2025
- FDA event ID
- 97224
- Recalling firm
- Remel, Lenexa, KS
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Jul 2025
- FDA classified
- 31 Jul 2025
- Reported
- 6 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Listeria
- Device type
- Other Medical Devices
Timeline
| 11 Jul 2025 | Recall initiated by company | |
| 31 Jul 2025 | Classified by FDA | +20 days |
| 6 Aug 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The products may contain surface and subsurface contamination of Listeria monocytogenes.
Listeria monocytogenes can grow at refrigerator temperatures. Infection is most dangerous for pregnant women, newborns, older adults and people with weakened immune systems. Symptoms can appear up to 70 days after eating contaminated food.
Product as listed by the FDA
Blood Agar,5% Sheep Blood 100/PK, Product Number R01202
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
The products may contain surface and subsurface contamination of Listeria monocytogenes.
Which lots are affected?
UDI-DI: 848838000645; Lot Numbers: 271595, 271596
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 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.
Other products in this recall event
3 other products · FDA event 97224| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Blood/MacConkey Biplate, Product Number R02049 recalled by Remel | Remel | Listeria | Nationwide | |
| CLASS II | Strep Selective II Agar, Product Number R01859 recalled by Remel | Remel | Listeria | Nationwide | |
| CLASS II | Blood/EMB, Levine, Product Number R02041 recalled by Remel | Remel | Listeria | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | GC Agar Base R04030 recalled by Remel | Remel | Other | Nationwide |
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| Device | CLASS II | Camhb W/lhb, Manual, 10/box Ycp112-10 Brucella Broth, 10/box Yt3450 recalled | Remel | Other | Nationwide |
| Device | CLASS II | Blood/EMB, Levine, Product Number R02041 recalled by Remel | Remel | Listeria | Nationwide |
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