The Recall Desk

Manufacturer

Diversatek Healthcare

7 recalls in our database name Diversatek Healthcare as the manufacturing or recalling firm.

What the numbers show

Total
7
Critical
0
Severe
0
Most recent
2026-04-29

Of the 7 recalls from Diversatek Healthcare we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–7 of 7

  • HighFDA (Devices)·Z-1938-2026·2026-04-29

    Diversatek Healthcare Viper Balloon Dilator Inflation Tag Labeling Error

    Diversatek Healthcare is recalling Viper 3-Stage Fixed Wire Balloon Dilators because the catheter inflation tag may contain incorrect part numbers and balloon diameter and pressure specifications.

    Product
    Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-1940-2026·2026-04-29

    Diversatek Viper balloon dilator tags may show incorrect inflation parameters

    Diversatek Viper 3-Stage Wire Guided Balloon Dilators are being recalled because the catheter inflation tag may show an incorrect part number with wrong balloon diameters and pressures.

    Product
    Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-1939-2026·2026-04-29

    Diversatek Healthcare Viper Balloon Dilator catheter inflation tag error

    Diversatek Healthcare is recalling Viper 3-Stage Wire Guided Balloon Dilators because the catheter inflation tag may contain an incorrect part number with wrong balloon diameter sizes and inflation pressures.

    Product
    Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-1941-2026·2026-04-29

    Diversatek Viper Wire Guided Balloon Dilator Inflation Tag Incorrect

    Diversatek Healthcare is recalling Viper 3-Stage Wire Guided Balloon Dilators because the attached inflation tag may contain an incorrect part number with wrong balloon diameter sizes and inflation pressures.

    Product
    Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-2324-2025·2025-08-20

    Anorectal manometry kit outer label shows the manufacturing date as expiry

    Zvu Anorectal Manometry Procedure Kits are being recalled because the outer kit label carries an incorrect expiration date, with the manufacturing date used in its place. 8 kits are affected.

    Product
    Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2521-2023·2023-09-13

    ZVU Functional GI Software Recall for Incorrect Software Revision Labeling

    ZVU Functional GI Software labeled as revision 3.3.0 is incorrectly labeled; it actually contains revision 3.2.0. The mislabeling affects 20 units distributed from May to July 2023.

    Product
    ZVU Functional GI Software, REF: ZVU-3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1771-2022·2022-09-28

    Diversatek M-Catch Retrieval Nets: incorrect inner polybag labeling

    Diversatek Healthcare is recalling M-Catch Retrieval Nets (Part Number REF 1175-01, Lot Number 001919) due to incorrect inner polybag labeling. 245 devices were distributed nationwide between September and October 2021.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide