Blood/EMB, Levine 100/PK, Product Number R02041 recallZ-2225-2025 · Remel, Inc · initiated Jul 11, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Remel, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The products may contain surface and subsurface contamination of Listeria monocytogenes.
FDA root cause category: Under Investigation by firm
What the company is doing
An Urgent: Medical Device Recall notification letter dated 7/11/25 was sent to customers. ACTIONS TO BE TAKEN BY THE CUSTOMER: Our records indicate that you have received above products. Accordingly, in keeping with our Quality Policy, we request that you please notify any personnel who need to be aware of the potential for visible contamination of products listed above and destroy any remaining inventory of lots listed above and complete the accompanying Acknowledgement form. Return the completed form indicating number of units destroyed via email to [email protected] in order for your replacement/credit to be processed. Complete and return the response form even if you no longer have the affected product on hand. Please keep this notification on file. This notice needs to be passed on to all who need to be aware within your organization or to any organization where the potentially affected products have been transferred. If you have any questions, please contact our Technical Services Department at 800-255-6730 (US) or email [email protected]. TYPE OF ACTION BY THE MANUFACTURER: Remel Inc., part of Thermo Fisher Scientific, is investigating the root cause and will implement corrective and preventive actions to prevent future recurrence.
Recall details
- Recall number
- Z-2225-2025
- Status
- Open, Classified
- Initiated by the company
- Jul 11, 2025
- Posted by the FDA
- Jul 31, 2025
- Recalling firm
- Remel, Inc
- Quantity
- 750 units
- Product code
- JSI
- Distribution
- US Nationwide distribution.
Product description
Blood/EMB, Levine 100/PK, Product Number R02041
Code information (models, lots, serial numbers)
UDI-DI: 848838003684; Lot Numbers: 274194
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- REMEL R02041Remel, Inc. · Culture Media, Selective And Differential3 recalls0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 97224).
- Z-2223-2025 · Open, ClassifiedBlood Agar,5% Sheep Blood 100/PK, Product Number R01202
- Z-2224-2025 · Open, ClassifiedStrep Selective II Agar, Product Number R01859
- Z-2226-2025 · Open, ClassifiedBlood/MacConkey Biplate 100/PK, Product Number R02049
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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