Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Zvu Anorectal Manometry Procedure Kit Recalled by Diversatek Healthcare Due to Mislabeling

Date: June 4, 2025
Company: Diversatek Healthcare
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Diversatek Healthcare directly.

Affected Products

Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10

Quantity: 8

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Diversatek Healthcare

Diversatek Healthcare has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report