CLASS II ONGOING Device recall · Reported 29 Apr 2026 · FDA Enforcement Report

Viper¿ 3-Stage Wire Guided Balloon Dilator recalled

Diversatek Healthcare is recalling Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, distributed in 19 states. The recall was initiated on 18 Mar 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI 00816734021781, Lot Numbers: 004758, 005124, 005309, 005629

Quantity recalled527 units

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-1939-2026
FDA event ID: 98649
Recalling firm: Diversatek Healthcare, Milwaukee, WI
Classification: Class II
Status: Ongoing
Recall initiated: 18 Mar 2026
FDA classified: 23 Apr 2026
Reported: 29 Apr 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

18 Mar 2026	Recall initiated by company
23 Apr 2026	Classified by FDA	+36 days
29 Apr 2026	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15

Where it was distributed

US: MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL, Brazil, Belgium

Alabama Arizona California Florida Iowa Illinois Kansas Louisiana Michigan Missouri Mississippi North Carolina New Jersey New York Ohio Pennsylvania Rhode Island Texas Virginia

Questions about this recall

Is Viper¿ 3-Stage Wire Guided Balloon Dilator recalled?

Yes. Diversatek Healthcare recalled Viper¿ 3-Stage Wire Guided Balloon Dilator on 18 Mar 2026. The recall is Class II and its status is Ongoing. Recall number Z-1939-2026.

Why was it recalled?

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.

Which lots are affected?

UDI/DI 00816734021781, Lot Numbers: 004758, 005124, 005309, 005629

Where was it sold?

US: MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL, Brazil, Belgium

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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Diversatek Healthcare

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Reported	Class	Recall	Company	Reason	Where
29 Apr 2026Device	CLASS II	Viper¿ 3-Stage Fixed Wire Balloon Dilator recalled	Diversatek Healthcare	Other	19 states
29 Apr 2026Device	CLASS II	Viper¿ 3-Stage Wire Guided Balloon Dilator recalled	Diversatek Healthcare	Other	19 states
29 Apr 2026Device	CLASS II	Viper¿ 3-Stage Wire Guided Balloon Dilator recalled	Diversatek Healthcare	Other	19 states
20 Aug 2025Device	CLASS III	Zvu Anorectal Manometry Procedure Kit recalled by Diversatek Healthcare	Diversatek Healthcare	Labeling Errors	Nationwide
13 Sep 2023Device	CLASS III	ZVU Functional GI recalled by Diversatek Healthcare	Diversatek Healthcare	Labeling Errors	Nationwide

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