CLASS II ONGOING Device recall · Reported 17 Jun 2026 · FDA Enforcement Report
Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit recalled
Inter-Med is recalling Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, distributed nationwide in the US. The recall was initiated on 27 May 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2400-2026
- FDA event ID
- 99105
- Recalling firm
- Inter-Med, Racine, WI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 May 2026
- FDA classified
- 10 Jun 2026
- Reported
- 17 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 27 May 2026 | Recall initiated by company | |
| 10 Jun 2026 | Classified by FDA | +14 days |
| 17 Jun 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28
Where it was distributed
US Nationwide distribution in the states of Tennessee and Missouri.
Questions about this recall
Why was it 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.
Which lots are affected?
Model No. 504600-28; UDI-DI 00371347008104; Lot Number 2026-0204
Where was it sold?
US Nationwide distribution in the states of Tennessee and Missouri.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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