Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
FDA Recall Z-2324-2025 · Posted 2025-08-14
Recalling FirmDiversatek Healthcare
Recall StatusOpen, Classified
Product CodeFFX
Date Initiated2025-06-04
Product Quantity8
Reason for Recall
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.
Firm Action
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
Root Cause
Error in labeling
Distribution Pattern
Worldwide - US Nationwide distribution in the states of NM, MA, CO, OH and the countries of Mongolia, South Korea.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.