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U.S. Department of Health and Human Services

Class 2 Device Recall Diversatek Healthcare Viper

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 Class 2 Device Recall Diversatek Healthcare Vipersee related information
Date Initiated by FirmMarch 18, 2026
Date PostedApril 23, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1941-2026
Recall Event ID 98649
Product Classification Dilator, esophageal - Product Code KNQ
ProductDiversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20
Code Information UDI/DI 00816734021804, Lot Numbers: 004947, 004950, 005311, 005397, 005484, 005574
FEI Number 2183446
Recalling Firm/
Manufacturer		 Diversatek Healthcare
102 E Keefe Ave
Milwaukee WI 53212-1535
For Additional Information ContactLaura L. Boll
414-265-7620
Manufacturer 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.
FDA Determined
Cause 2		Labeling Change Control
ActionDiversatek 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 lboll@diversatek.com 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 lboll@diversatek.com.
Quantity in Commerce1383 units
DistributionUS: MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL, Brazil, Belgium
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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