Summary
The FDA issued a Class II for Blood/MacConkey Biplate 100/PK, Product Number R02049 by Remel, Inc. Reason: The products may contain surface and subsurface contamination of Listeria monocytogenes..
Details
Source
Device Recall
External ID
Z-2226-2025
Action Date
2025-08-06
Status
Ongoing
Category
device
Product Description
Blood/MacConkey Biplate 100/PK, Product Number R02049
Lot/Code Info: UDI-DI: 848838003684; Lot Numbers: 274194
Quantity Affected: 611 untis
Reason for Recall
The products may contain surface and subsurface contamination of Listeria monocytogenes.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-11
Company
Lenexa, KS
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 157 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Remel, Inc has 25 FDA actions in our database, including 25 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Remel, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Remel, Inc have FDA actions?
Remel, Inc has 25 FDA actions in our database, including 25 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2226-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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