FDA Medical Device Recalls (openFDA)
Diversatek Healthcare: Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
- Recall number
- Z-2324-2025
- Recalling firm
- Diversatek Healthcare
- Product
- Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
- Status
- Open, Classified
- Initiated
- 2025-06-04
- Posted
- 2025-08-14
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Error in labeling
- Action
- On 6/4/2025, field safety notices were emailed to GI Lab / Endoscopy Unit Managers who were asked to do the following: Check your inventory for devices with the part and lot numbers listed below. 2. Discard any affected product. 3. Complete and return the attached MEDICAL DEVICE RECALL RETURN RESPONSE form via email to clahr@diversatek.com If you have questions about this issue, please contact your Sales Representative or the firm at 1-800-558-6408
- Quantity
- 8
- Distribution
- Worldwide - US Nationwide distribution in the states of NM, MA, CO, OH and the countries of Mongolia, South Korea.
- Lot, serial or model codes
- UDI-DI: 00816734022863, Lot: 24752
- 510(k) numbers
- ["K190208"]
- PMA numbers
- not on file
- Product code
- FFX
- Firm FEI
- 2023374
- Firm city
- Highlands Ranch
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28