Milwaukee, WI, United States
Diversatek Healthcare recalls
4 recalls recorded since 2018, most recently on 18 March 2026. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)3
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 18 March 2026
- Reason
- The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
- Distribution
- US: MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL, Brazil, Belgium
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1940-2026, Z-1939-2026, Z-1941-2026, Z-1938-2026
- Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18
- Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15
- Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20
- Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08
Ongoing Class III Medical devices
- Recall started
- 4 June 2025
- Reason
- Anorectal manometry procedure kit outer kit label is mislabeled with an incorrect expiration date; the manufacturing date was used in place of the expiration date. All inner labels on kit components display the correct expiration date.
- Distribution
- Worldwide - US Nationwide distribution in the states of NM, MA, CO, OH and the countries of Mongolia, South Korea.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2324-2025
- Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
Ongoing Class III Medical devices
- Recall started
- 25 July 2023
- Reason
- GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.
- Distribution
- worldwide - US Nationwide distribution in the states of NJ, MN, TN, WA, KY, OR, FL, GA, NY, TX, CO, KS and the countries of Japan, Saudi Arabia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2521-2023
- ZVU Functional GI Software, REF: ZVU-3
Terminated Class II Medical devices
- Recall started
- 29 October 2021
- Terminated
- 10 April 2024
- Reason
- M-Catch Retrieval Nets, Part Number 1175-01 / Lot Number 001919, that were shipped between 9-27-2021 and 10-22-2021, may contain incorrect inner polybag labeling. The outer package labeling is correct.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1771-2022
- Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity 5 EA/u. Used to endoscopically retrieve severed polyps, tissue samples, food bolus, and foreign bodies in the gastrointestinal tract.
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.