Diversatek Healthcare recalls Zvu Anorectal Manometry Procedure Kit

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.

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 clahr@diversatek.com If you have questions about this issue, please contact your Sales Representative or the firm at 1-800-558-6408

• FDA enforcement recordOfficial FDA database entry for Z-2324-2025
• FDA 510(k) clearance · K190208The device's official FDA premarket clearance record
• FDA device classification · FFXOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.1725The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Diversatek HealthcareSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.