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Open, Classified

Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28

FDA Recall Z-2400-2026 · Posted 2026-06-10

Recalling FirmInter-Med Llc
Recall StatusOpen, Classified
Product CodeMVL
Date Initiated2026-05-27
Product Quantity500

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.

Firm Action

On 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.

Root Cause

Labeling mix-ups

Distribution Pattern

US Nationwide distribution in the states of Tennessee and Missouri.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K190220Vista FS, Vista FS LiquidInter-Med/Vista Dental Products · 2019-06-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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