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Diversatek Healthcare Recalls
7 recalls on record · September 28, 2022 to April 29, 2026 · Medical Devices
Recalls by year
22
23
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
April 29, 2026Medical DevicesFDA
Diversatek Healthcare recalls Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20
Hazard: 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.
April 29, 2026Medical DevicesFDA
Diversatek Healthcare recalls Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18
Hazard: 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.
April 29, 2026Medical DevicesFDA
Diversatek Healthcare recalls Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15
Hazard: 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.
April 29, 2026Medical DevicesFDA
Diversatek Healthcare recalls Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08
Hazard: 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.
August 20, 2025Medical DevicesFDA
Diversatek Healthcare recalls Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
Hazard: 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.
September 13, 2023Medical DevicesFDA
Diversatek Healthcare recalls ZVU Functional GI Software, REF: ZVU-3
Hazard: GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.
September 28, 2022Medical DevicesFDA
Diversatek Healthcare recalls Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity 5 EA/u. Used to endoscopically retrieve s
Hazard: 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.