REMEL R02041Recalls & reported problems
Remel, Inc. · Blood/EMB,Levine Biplate 100/PK · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
3 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 3
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
3 FDA recall records name this device's identifier, 3 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- Jul 11, 2025Open, Classified
The products may contain surface and subsurface contamination of Listeria monocytogenes.
Z-2225-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jul 11, 2025Open, Classified
The products may contain surface and subsurface contamination of Listeria monocytogenes.
Z-2226-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Feb 13, 2025Open, Classified
Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate.
Z-1201-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Other Culture Media, Selective And Differential devices
- BD BBL™ MacConkey II Agar 221270Becton, Dickinson And Company · CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL1 recall64 reports
- CHROMID® Candida AgarBiomerieux SA · CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL1 recall28 reports
- CHROMID® C. difficileBiomerieux SA · CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL1 recall3 reports
- Strep Selective II Agar R01859Remel, Inc. · Culture Media, Selective And Differential1 recall0 reports
- REMEL R02049Remel, Inc. · Culture Media, Selective And Differential1 recall0 reports
- BD BBL™ CHROMagar™ Candida 254093Becton, Dickinson And Company · CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL29 reports
- CHROMID® S. aureus Elite agarBiomerieux SA · CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL9 reports
- BD BBL™ Hektoen Enteric Agar 221365Becton, Dickinson And Company · CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL6 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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