Zvu recallZ-2324-2025 · Diversatek Healthcare · initiated Jun 4, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Diversatek Healthcare or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Anorectal manometry procedure kit outer kit label is mislabeled with an incorrect expiration date; the manufacturing date was used in place of the expiration date. All inner labels on kit components display the correct expiration date.
FDA root cause category: Error in labeling
What the company is doing
On 6/4/2025, field safety notices were emailed to GI Lab / Endoscopy Unit Managers who were asked to do the following: Check your inventory for devices with the part and lot numbers listed below. 2. Discard any affected product. 3. Complete and return the attached MEDICAL DEVICE RECALL RETURN RESPONSE form via email to [email protected] If you have questions about this issue, please contact your Sales Representative or the firm at 1-800-558-6408
Recall details
- Recall number
- Z-2324-2025
- Status
- Open, Classified
- Initiated by the company
- Jun 4, 2025
- Posted by the FDA
- Aug 14, 2025
- Recalling firm
- Diversatek Healthcare
- Quantity
- 8
- Product code
- FFX
- FDA submissions
- K190208
- Distribution
- Worldwide - US Nationwide distribution in the states of NM, MA, CO, OH and the countries of Mongolia, South Korea.
Product description
Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
Code information (models, lots, serial numbers)
UDI-DI: 00816734022863, Lot: 24752
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Zvu® HRAM-PROC-10Diversatek Healthcare, Inc. · System, Gastrointestinal Motility (Electrical)1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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