CLASS II ONGOING Device recall · Reported 6 Aug 2025 · FDA Enforcement Report
Strep Selective II Agar, Product Number R01859 recalled by Remel
Remel is recalling Strep Selective II Agar, Product Number R01859, 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-2224-2025
- 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
Strep Selective II Agar, Product Number R01859
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is Strep Selective II Agar, Product Number R01859 recalled?
Yes. Remel recalled Strep Selective II Agar, Product Number R01859 on 11 Jul 2025. The recall is Class II and its status is Ongoing. Recall number Z-2224-2025.
Why was it recalled?
The products may contain surface and subsurface contamination of Listeria monocytogenes.
Which lots are affected?
UDI-DI: 848838003158; Lot Numbers: 271613
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.
More recalls from Remel
All 86| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | GC Agar Base R04030 recalled by Remel | Remel | Other | Nationwide |
| Device | CLASS II | Yeastone Broth, 10/BOX YY3462 recalled by Remel | Remel | Mold | Nationwide |
| Device | CLASS II | Campy CVA Medium, R01272 recalled by Remel | Remel | Other | Nationwide |
| 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 |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |