Racine, WI, United States
Inter-Med Llc recalls
2 recalls recorded since 2018, most recently on 27 May 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 27 May 2026
- Reason
- 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.
- Distribution
- US Nationwide distribution in the states of Tennessee and Missouri.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2400-2026
- Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28
Terminated Class II Medical devices
- Recall started
- 27 June 2019
- Terminated
- 10 August 2021
- Reason
- The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade due to chemical interaction with the bleach solution.
- Distribution
- US, South Africa, Switzerland, Poland, Italy, Singapore, Australia
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0014-2020, Z-0013-2020, Z-0015-2020, Z-0012-2020, Z-0011-2020, Z-0017-2020, Z-0016-2020
- Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350
- Vista Dental Products Sodium Hypochlorite - 3%, 10 - 12cc Pre-filled Syringes, REF 502315
- Vista Dental Products 3% Sodium Hypochlorite, 10- 3cc Pre-filled Syringes, REF 502355
- Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300
- Vista Dental Products CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-XTRA, 6mL - SmearOFF + 92) + (2) 30ga Irrigation Tips + (1) Micro Aspirator with Tip, REF 504700
- Vista Dental Products Chlor-XTRA - 12mL Prefilled Syringes, QTY: 8, REF 503850
- Vista Dental Products Chlor-XTRA - 3mL Prefilled Syringes, QTY: 12, REF 503825
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.