Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit recallZ-2400-2026 · Inter-Med Llc · initiated May 27, 2026
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 Inter-Med Llc 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
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 root cause category: Labeling mix-ups
What the company is doing
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.
Recall details
- Recall number
- Z-2400-2026
- Status
- Open, Classified
- Initiated by the company
- May 27, 2026
- Posted by the FDA
- Jun 10, 2026
- Recalling firm
- Inter-Med Llc
- Quantity
- 500
- Product code
- MVL
- FDA submissions
- K190220
- Distribution
- US Nationwide distribution in the states of Tennessee and Missouri.
Product description
Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28
Code information (models, lots, serial numbers)
Model No. 504600-28; UDI-DI 00371347008104; Lot Number 2026-0204
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Advance Dental Products 504600-28The Atlanta Dental Supply Company · CORD, RETRACTION1 recall0 reports
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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