FDA Medical Device Recalls (openFDA)
Cenorin, LLC: HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer.
- Recall number
- Z-1995-2014
- Recalling firm
- Cenorin, LLC
- Product
- HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer.
- Status
- Terminated
- Initiated
- 2013-01-24
- Posted
- 2014-07-06
- Terminated
- 2015-02-10
- Reason
- The temperature sensor/control system in the HLD Systems Model 610 may provide a false temperature reading. This caused the water to remain at ambient temperature throughout the pasteurization cycle rather than using hot water.
- Root cause
- Device Design
- Action
- Cenorin sent a Notification letter dated December 18, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter stated: Cenorin has developed an upgrade to mitigate this issue as well as provide additional process control and system monitoring benefits. Cenorin included a Return Response form with the recall letter to be completed and return. For questions contact HLD Systems Sales Representative for questions.
- Quantity
- 25 HLD systems
- Distribution
- Worldwide Distribution - US (nationwide): CA, DE, FL, MA, MI, NY, PA, TX, UT, WA, and WI and the countries of Uruguay and Taiwan.
- Lot, serial or model codes
- 610601, 610603, 610703, 610704, 610705, 610707, 610708, 610802, 610803, 610804, 610901, 610903, 610904, 610905, 611001, 611002, 611004, 611101, 611102, 611103, 611201, 611202, 611203, 610902L, 611204.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LDS
- Firm FEI
- 3004153171
- Firm city
- Kent
- Firm state
- WA
- 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