CLASS III ONGOING Device recall · Reported 20 Aug 2025 · FDA Enforcement Report

Zvu Anorectal Manometry Procedure Kit recalled by Diversatek Healthcare

Diversatek Healthcare is recalling Zvu Anorectal Manometry Procedure Kit, distributed nationwide in the US. The recall was initiated on 4 Jun 2025 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesUDI-DI: 00816734022863, Lot: 24752

Quantity recalled8

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2324-2025
FDA event ID: 97282
Recalling firm: Diversatek Healthcare, Highlands Ranch, CO
Classification: Class III
Status: Ongoing
Recall initiated: 4 Jun 2025
FDA classified: 14 Aug 2025
Reported: 20 Aug 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

4 Jun 2025	Recall initiated by company
14 Aug 2025	Classified by FDA	+71 days
20 Aug 2025	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

Worldwide - US Nationwide distribution in the states of NM, MA, CO, OH and the countries of Mongolia, South Korea.

Nationwide Colorado Massachusetts New Mexico Ohio

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI-DI: 00816734022863, Lot: 24752

Where was it sold?

Worldwide - US Nationwide distribution in the states of NM, MA, CO, OH and the countries of Mongolia, South Korea.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Diversatek Healthcare

All 7

Reported	Class	Recall	Company	Reason	Where
29 Apr 2026Device	CLASS II	Viper¿ 3-Stage Fixed Wire Balloon Dilator recalled	Diversatek Healthcare	Other	19 states
29 Apr 2026Device	CLASS II	Viper¿ 3-Stage Wire Guided Balloon Dilator recalled	Diversatek Healthcare	Other	19 states
29 Apr 2026Device	CLASS II	Viper¿ 3-Stage Wire Guided Balloon Dilator recalled	Diversatek Healthcare	Other	19 states
29 Apr 2026Device	CLASS II	Viper¿ 3-Stage Wire Guided Balloon Dilator recalled	Diversatek Healthcare	Other	19 states
13 Sep 2023Device	CLASS III	ZVU Functional GI recalled by Diversatek Healthcare	Diversatek Healthcare	Labeling Errors	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide