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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Device
Medical Devices/Diagnostic Equipment

Zvu Anorectal Manometry Kits Recalled for Mislabeled Expiration Date

Agency Publication Date: August 14, 2025
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Summary

Diversatek Healthcare has recalled eight Zvu Anorectal Manometry Procedure Kits (REF: HRAM-PROC-10) because the outer label displays an incorrect expiration date. The manufacturer mistakenly printed the manufacturing date in the expiration date field on the external packaging, although the individual components inside the kit display the correct expiration dates. No injuries or incidents have been reported in connection with this labeling error.

Risk

Using medical components that are past their intended shelf life may result in the use of products that are no longer sterile or functional. No injuries have been reported, and the correct expiration information is available on the inner packaging.

What You Should Do

  1. This recall affects Zvu Anorectal Manometry Procedure Kits (REF: HRAM-PROC-10) with UDI-DI 00816734022863 and lot number 24752.
  2. Identify affected kits by checking the outer label for lot number 24752; the expiration date on the outer box will incorrectly match the manufacturing date.
  3. Stop using the recalled kits immediately.
  4. Contact Diversatek Healthcare or your medical equipment distributor to arrange for a return, replacement, or correction of the mislabeled kits.
  5. For additional questions, call the FDA at 1-888-463-6332.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Zvu Anorectal Manometry Procedure Kit
Model / REF:
HRAM-PROC-10
Lot Numbers:
24752
UDI:
00816734022863

Recall number Z-2324-2025. Total of 8 units affected.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97282
Status: Active
Manufacturer: Diversatek Healthcare
Sold By: Diversatek Healthcare
Manufactured In: United States
Units Affected: 8
Distributed To: New Mexico, Massachusetts, Colorado, Ohio

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.