FDA Medical Device Recalls (openFDA)
Hidrex GmbH: Hidrex USA DP450
- Recall number
- Z-1236-2017
- Recalling firm
- Hidrex GmbH
- Product
- Hidrex USA DP450
- Status
- Terminated
- Initiated
- 2017-01-30
- Posted
- 2017-02-22
- Terminated
- 2017-08-04
- Reason
- The device was reclassified from a class III device to a class II device and there are new documentation requirements.
- Root cause
- Error in labeling
- Action
- Distributor sent recall notification letter to affected dealers and end users on 2/10/17. Notification letter will include a copy of the addendum to the user manual. The device is not instructed to be returned.
- Quantity
- 64 units
- Distribution
- Nationwide throughout the US
- Lot, serial or model codes
- SN# 16-3.7091 to 16-3.7134, 17-3.7001 to 17-3.7020
- 510(k) numbers
- ["K133033"]
- PMA numbers
- not on file
- Product code
- EGJ
- Firm FEI
- 3008642982
- Firm city
- Heiligenhaus
- Firm state
- not on file
- Firm country
- Germany
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