FDA Medical Device Recalls (openFDA)
Steris Corp: Steris Small Renaissance Eagle 3000 -- Remanufactured Gravity Models 3011 and 3021 and Prevacuum Models 3013 and 3023. Products are designed for efficient sterilization of non-porous and porous, heat and moisture-stable materials used in healthcare facilities.
- Recall number
- Z-2350-2008
- Recalling firm
- Steris Corp
- Product
- Steris Small Renaissance Eagle 3000 -- Remanufactured Gravity Models 3011 and 3021 and Prevacuum Models 3013 and 3023. Products are designed for efficient sterilization of non-porous and porous, heat and moisture-stable materials used in healthcare facilities.
- Status
- Terminated
- Initiated
- 2008-03-06
- Posted
- 2008-09-17
- Terminated
- 2010-09-28
- Reason
- The firm discovered that some Eagle 3000 units may have a door post pin missing which could cause incomplete or no engagement of the radial arms into the lock rails of the door. The sterilizer is designed with switches that prevent cycle initiation if the door is not locked. However, in the event the door switches are not properly adjusted they may falsely indicate that the door is locked even t
- Root cause
- Employee error
- Action
- On March 5, 2008, Steris issued an Urgent Product Correction. Beginning March 6, 2008 customers were notified by telephone. The firm instructed their customers to immediately discontinue using the small Renaissance Eagle 3000 steam sterilizer(s) until inspected and corrected by a service technician. Steris Service technicians were dispatched to affected customers to inspect and correct the sterilizers as appropriate. If you have any questions contact Holly Wright Lee at (404) 392-7019 or 1-800-548-4873 ext. 27019.
- Quantity
- 148 units
- Distribution
- Class II Recall - Worldwide Distribution --- USA including states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KY, LA, MD, MI, MN, MO, MT, NC, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WI, and WY, and countries of Canada and Mexico.
- Lot, serial or model codes
- Gravity Models 3011 & 3021 and Prevaccuum Models 3013 and 3023.
- 510(k) numbers
- ["K964332"]
- PMA numbers
- not on file
- Product code
- FLE
- Firm FEI
- 1527821
- Firm city
- Mentor
- Firm state
- OH
- 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