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U.S. Department of Health and Human Services

Class 2 Device Recall Advance Dental Products

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 Class 2 Device Recall Advance Dental Productssee related information
Date Initiated by FirmMay 27, 2026
Date PostedJune 10, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2400-2026
Recall Event ID 99105
510(K)NumberK190220 
Product Classification Cord, retraction - Product Code MVL
ProductAdvance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28
Code Information Model No. 504600-28; UDI-DI 00371347008104; Lot Number 2026-0204
FEI Number 3000209941
Recalling Firm/
Manufacturer		 Inter-Med Llc
2200 South St
Racine WI 53404-1510
For Additional Information ContactAlex Johnson
201-569-0050
Manufacturer Reason
for Recall		Some units of Aluminum Chloride Gel contain the package insert for Ferric Sulfate Gel. The incorrect insert misidentifies the product and contains different first aid instructions, most critically in that the Ferric Sulfate insert instructs users to induce vomiting in the case of ingestion, while the correct Aluminum Chloride insert instructs users not to induce vomiting.
FDA Determined
Cause 2		Labeling mix-ups
ActionOn 5/27/2026, firm notified consignees via email. Consignees were instructed to return all units from Lot 2026-0204 to Inter-Med, Inc. Inter-Med, Inc. will provide prepaid return shipping labels. All returned product will be replaced with correctly packaged product at no charge, or a credit may be issued at the customer's preference. Customers must also notify any downstream dental practices or end users who received product from this lot and instruct them to return product.
Quantity in Commerce500
DistributionUS Nationwide distribution in the states of Tennessee and Missouri.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MVL
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