Anorectal Manometry Procedure Kit Recalled for Mislabeled Expiration Date
Diversatek Healthcare is recalling the Zvu Anorectal Manometry Procedure Kit (Lot 24752) because the outer kit label displays an incorrect expiration date using the manufacturing date instead. The correct expiration date appears on inner kit labels.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This Class III recall is classified as Moderate due to the minor labeling error on the outer packaging. The source explicitly states no illnesses or injuries have been reported, and the correct expiration date is displayed on all inner kit labels, mitigating the risk of misuse.
Plain-English summary
Diversatek Healthcare is recalling the Zvu Anorectal Manometry Procedure Kit, model REF: HRAM-PROC-10 (Lot 24752), due to a labeling error on the outer kit packaging. The outer kit label displays an incorrect expiration date—specifically, the manufacturing date was used in place of the correct expiration date.
The inner labels on all kit components display the correct expiration date. This recall affects kits distributed nationwide in New Mexico, Massachusetts, Colorado, and Ohio, as well as in Mongolia and South Korea. A total of 8 units were distributed.
There have been no reported illnesses or injuries related to this recall. However, users relying solely on the outer label for expiration information could incorrectly determine the kit's usability. Consumers who have received this product should verify the expiration date on the inner component labels before use.
If you have received this kit, contact Diversatek Healthcare for instructions or a replacement.
The recalled product
- Product
- Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
- Manufacturer
- Diversatek Healthcare
- Hazard
- mis-labeling
- expiration-date-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 00816734022863
- Lot: 24752
Distribution
Distributed nationwide across the United States.
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