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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall where incorrect labelled inflation parameters could lead to the wrong diameter or pressure being used, a risk of harm with no injuries reported.
Plain-English summary
The Diversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 15 mm-16.5 mm-18 mm, REF 1205-18, UDI/DI 00816734021798, lot 005985, is being recalled. The action covers 250 units.
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. The tag is what the operator uses to set inflation for each stage of dilation. The FDA classified the action as Class II.
Distribution was within the United States across a large number of states, and internationally including Brazil and Belgium. The dilators are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the REF number, UDI/DI and lot number above, quarantine it, and follow the instructions issued by Diversatek.
The recalled product
- Product
- Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18
- Manufacturer
- Diversatek Healthcare
- Category
- Medical Device — Balloon dilator
- Affected units
- 250
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 00816734021798
- Lot Numbers: 005985
Distribution
Part of a larger recall action
This product is one of 4 recalled by Diversatek Healthcare under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Diversatek Healthcare
See all →- HighDiversatek Viper Wire Guided Balloon Dilator Inflation Tag Incorrect
FDA (Devices) · 2026-04-29
- HighDiversatek Healthcare Viper Balloon Dilator catheter inflation tag error
FDA (Devices) · 2026-04-29
- HighDiversatek Healthcare Viper Balloon Dilator Inflation Tag Labeling Error
FDA (Devices) · 2026-04-29
- ModerateAnorectal manometry kit outer label shows the manufacturing date as expiry
FDA (Devices) · 2025-08-20
- ModerateZVU Functional GI Software Recall for Incorrect Software Revision Labeling
FDA (Devices) · 2023-09-13
Same hazard · mislabeling
See all →- ModerateOrthofix MINIRAIL External Fixation Devices Incorrectly Labeled
FDA (Devices) · 2026-07-22
- ModerateWise Onion Rings recalled for undeclared food color additives
FDA (Food) · 2026-07-15
- HighBakr Brown Butter Chocolate Chunk Cookie Dough Recalled for Undeclared Soy
FDA (Food) · 2026-07-15
- HighStapes prosthesis pistons carry an incorrect functional length on labeling
FDA (Devices) · 2026-06-10
- HighMedline eye trays contain insulin syringes labeled as tuberculin syringes
FDA (Devices) · 2026-06-03
Similar recalls
- ModerateOlympus Endoscopic Balloon Dilator Recalled for Incorrect Inflation Chart Label
FDA (Devices) · 2026-09-30
- HighBard Conquest 40 PTA Dilation Catheter Recalled for Packaging Error
FDA (Devices) · 2020-02-05
- LowMedtronic Everest 20cc Inflation Device Recalled for Incorrect Master Label
FDA (Devices) · 2014-03-05
- ModerateBard Vaccess PTA Balloon Catheters Recalled for Incorrect Diameter Labeling
FDA (Devices) · 2013-06-19
- ModerateC.R. Bard Recalls X-Force Nephrostomy Balloon Dilation Catheter Kits
FDA (Devices) · 2016-11-16
- ModerateCook Inc. Recalls Advance 35LP Balloon Catheters Due to Labeling Error
FDA (Devices) · 2018-05-02