Recall of Diversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Diversatek Healthcare is recalling 250 units of their Viper 3-Stage Wire Guided Balloon Dilator due to incorrect part numbers and balloon diameter sizes on the inflation tag.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 8, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Diversatek Healthcare initiated a voluntary recall because the catheter inflation tag on the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
Which Products Are Affected
The affected product is the Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18. Approximately 250 units are involved, with UDI/DI 00816734021798 and Lot Numbers: 005985. The products were distributed to US states including MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL, as well as Brazil and Belgium.
What You Should Do
Consumers who have the affected product should contact Diversatek Healthcare as per the initial firm notification via letter for further instructions.
Why This Matters
This recall involves medical devices that could lead to potential misuse due to inaccurate labeling, emphasizing the need for precise information in healthcare products to ensure patient safety.
Source
Source: FDA Recall Number Z-1940-2026.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,073 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.