Z-2350-2008

Steris Small Renaissance Eagle 3000 -- Remanufactured Gravity Models 3011 and 3021 and Prevacuum Models 3013...

Name: Z-2350-2008 Steris Small Renaissance Eagle 3000 -- Remanufactured Gravity Models 3011 and 3021 and Prevacuum Models 3013...
Creator: Steris Corp
Published: 2008-03-06
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2008-03-06 / Terminated / root cause: manufacturing process

FDA source

Steris Corp began a recall of Steris Small Renaissance Eagle 3000 -- Remanufactured Gravity Models 3011 and 3021 and Prevacuum Models 3013 and 3023. Products are designed for efficient... on 2008-03-06. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2350-2008
Status: Terminated
Initiated: 2008-03-06
Posted: 2008-09-17
Terminated: 2010-09-28
Recalling firm: STERIS Corporation
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.
Product code: FLE Sterilizer, Steam
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: Gravity Models 3011 & 3021 and Prevaccuum Models 3013 and 3023.

Product code FLE

K964332Class IIEagle Century Steam SterilizerAmsco Intl., Inc. / cleared 1998-06-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)