Z-1941-2026Class II

Diversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20

Name: Z-1941-2026 Diversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20
Creator: Diversatek Healthcare
Published: 2026-03-18
License: https://open.fda.gov/license/

Diversatek Healthcare Inc / initiated 2026-03-18 / Open, Classified / root cause: labeling and UDI

FDA source

Diversatek Healthcare began a recall of Diversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20 on 2026-03-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1941-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-18
Posted: 2026-04-23
Recalling firm: Diversatek Healthcare Inc
Product: Diversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20
Product code: KNQ Dilator, Esophageal
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Diversatek Healthcare issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 3/18/2026 via USPS. The notice explained the problem, risk to health, and requested the consignee discard any affected product. Complete and return the attached MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement and Receipt Form and provide Signature Confirming Customer Receipt to Laura Boll, VP Regulatory Affairs & Quality at [email protected] or 414-755-4806 to receive a replacement order. For questions about this issue, please contact Laura Boll, Vice President - Regulatory Affairs & Quality, at 414-755-4806 or [email protected].
Quantity in commerce: 1383 units
Distribution: US: MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL, Brazil, Belgium
Product codes and lots: UDI/DI 00816734021804, Lot Numbers: 004947, 004950, 005311, 005397, 005484, 005574

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1941-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1938-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-23
Z-1939-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-23
Z-1940-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-23
Z-1941-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-23

Product code KNQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)