FDA Medical Device Recalls (openFDA)
Steris Corporation: Steris Amsco Sonic Energy Cleaner, Part Nos.: P080000005, B018905020, B018905JBJ, and B018905JBJSS
- Recall number
- Z-1407-06
- Recalling firm
- Steris Corporation
- Product
- Steris Amsco Sonic Energy Cleaner, Part Nos.: P080000005, B018905020, B018905JBJ, and B018905JBJSS
- Status
- Terminated
- Initiated
- 2006-06-22
- Posted
- 2006-08-25
- Terminated
- 2007-01-08
- Reason
- Smoke, sparking and fire hazard-Units manufactured between November 2000 and January 2005 are susceptible to water damage at the lid switch cable wiring harness, which may result in smoking, sparking, and fire.
- Root cause
- Other
- Action
- The firm sent out a certified letter to all affected consignees alerting them to problems with the device on 6/22/06.
- Quantity
- 322 units
- Distribution
- Worldwide USA and countries of Japan, Canada, Hong Kong, Korea, Lebanon, Qatar, Poland, Russia, Saudi Arabia, Singapore, Taiwan, Germany, Northern Mariana Islands, and Malaysia.
- Lot, serial or model codes
- All units bearing serial numbers 0432000018 to 0403105051.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FLG
- Firm FEI
- 1043572
- Firm city
- Montgomery
- Firm state
- AL
- 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