Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2324-2025 — Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10

U.S. FDA — Device Enforcement · United States · 2025-06-04 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2324-2025
Date of alert
2025-06-04
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Diversatek Healthcare
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00816734022863
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.