Device recall: Diversatek Healthcare Viper 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08
Class II FDA enforcement event 98649. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
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
Diversatek Healthcare started this device recall on 18 Mar 2026. The firm address in the FDA record is in Milwaukee, WI. FDA put the recall in Class II. FDA event 98649 has 4 product records. The first FDA enforcement report date is 29 Apr 2026. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US: MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL, Brazil, Belgium
Recalling firm
Diversatek Healthcare, Milwaukee, WI.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
4 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1938-2026 | Diversatek Healthcare Viper 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08 | 15 units | Class II | Ongoing | 29 Apr 2026 |
| Z-1939-2026 | Diversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15 | 527 units | Class II | Ongoing | 29 Apr 2026 |
| Z-1940-2026 | Diversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18 | 250 units | Class II | Ongoing | 29 Apr 2026 |
| Z-1941-2026 | Diversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20 | 1383 units | Class II | Ongoing | 29 Apr 2026 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2026
- 572
- Share of these events in Class II
- 87%
- Product records in this event
- 4Median of the firm: 1
- Events of the firm on the register
- 4
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 4 Jun 2025 | Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10 | Device | Class III | 1 |
| 25 Jul 2023 | ZVU Functional GI Software, REF: ZVU-3 | Device | Class III | 1 |
| 29 Oct 2021 | Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity 5 EA/u. Used to endoscopically retrieve sev | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-1938-2026The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 98649. https://recallregister.com/fda/ii/98649/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US: MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL, Brazil, Belgium
- What quantity of product is in FDA event 98649?
- The event has 4 product records. The first record gives this quantity:
15 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2026 have the same class?
- 87% of the 572 device events that started in 2026 are in Class II.