Z-0478-2014Class II

AMSCO Evolution steam sterilizer Transfer Carriage

Name: Z-0478-2014 AMSCO Evolution steam sterilizer Transfer Carriage
Creator: Steris Corporation
Published: 2013-10-18
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2013-10-18 / Terminated / root cause: design

FDA source

Steris Corporation began a recall of AMSCO Evolution steam sterilizer Transfer Carriage. Product Usage: Mobile, wheeled transportation unit utilized to carry, load, & unload the Loading Car into... on 2013-10-18. FDA classified it as Class II and gives the reason as "The firm discovered that unlatching can occur when overloaded transfer carriages are pulled or maneuvered incorrectly or with excessive force". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0478-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-18
Posted: 2013-12-11
Terminated: 2014-05-13
Recalling firm: STERIS Corporation
Product: AMSCO Evolution steam sterilizer Transfer Carriage. Product Usage: Mobile, wheeled transportation unit utilized to carry, load, & unload the Loading Car into and out of steam sterilizer units.
Product code: FLE Sterilizer, Steam
Reason for recall: The firm discovered that unlatching can occur when overloaded transfer carriages are pulled or maneuvered incorrectly or with excessive force.
Root cause tag: design
FDA root cause: Device Design
Action: Steris sent an Urgent Voluntary Field Correction Notice letter dated October 18, 2013 to their customers. The letter identified the affected product, problem, and actions to be taken. The letter informed customers that a Steris Service Representative will contact affected facility to arrange for Steris to upgrade the Transfer Carriage(s). For questions contact Steris Field Service Dispatch at 1-800-333-8828.
Quantity in commerce: 936 units
Distribution: Worldwide Distribution - USA Nationwide in the states of: AL, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MI, MO, MT, NE, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY and the District of Columbia including the countries of: Brazil, Canada, Chile, Guam, Mexico, Saudi Arabia, United Arab Emirates & Venezuela.
Product codes and lots: Serial Number Range: 030061103 - 0535531220

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0478-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0478-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-18	2013-12-10

Product code FLE

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)