Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28
FDA device recall Z-2400-2026 · posted 2026-06-10 · Open, Classified
Recall details
- Recalling firm
- Inter-Med Llc
- 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.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- MVL
- Quantity affected
- 500
- Distribution
- US Nationwide distribution in the states of Tennessee and Missouri.
- Date initiated
- 2026-05-27
- Date posted
- 2026-06-10
- Location
- Racine, WI
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Vista FS, Vista FS Liquid (K190220) | Inter-Med/Vista Dental Products | 2019-06-10 |