Z-0603-2016Class II

AMSCO Warming Cabinet. Manufactured by: STERIS Corporation To raise the temperature of blankets, linens and...

Name: Z-0603-2016 AMSCO Warming Cabinet. Manufactured by: STERIS Corporation To raise the temperature of blankets, linens and...
Creator: Steris Corporation
Published: 2015-11-20
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2015-11-20 / Terminated

FDA source

Steris Corporation began a recall of AMSCO Warming Cabinet. Manufactured by: STERIS Corporation To raise the temperature of blankets, linens and sterile surgical IV/irrigation solutions to an... on 2015-11-20. FDA classified it as Class II and gives the reason as "The firm discovered that information printed on the quick reference magnet is incorrect; specifically, Fahrenheit to Celsius temperature conversions and the default Warming Cabinet temperature". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0603-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-20
Posted: 2016-01-06
Terminated: 2016-10-27
Recalling firm: STERIS Corporation
Product: AMSCO Warming Cabinet. Manufactured by: STERIS Corporation To raise the temperature of blankets, linens and sterile surgical IV/irrigation solutions to an acceptable level for various surgical, obstetrical, emergency, critical care and other healthcare applications.
Product code: LGZ Warmer, Thermal, Infusion Fluid
Reason for recall: The firm discovered that information printed on the quick reference magnet is incorrect; specifically, Fahrenheit to Celsius temperature conversions and the default Warming Cabinet temperature.
FDA root cause: Process change control
Action: The firm, Steris, sent an "URGENT VOLUNTARY FIELD CORRECTION NOTICE" letter dated 12/14/2015 to its customers. The letter described the product, problem and actions to be taken. The firm included an updated quick reference magnet for each affected unit with the letter. The customers were instructed to replace your existing magnet with the enclosed magnet. If you have questions regarding this matter, please contact Product Manager, at 440-392-7705 or STERIS Customer Service at 1-800-548-4873.
Quantity in commerce: 2,319 units
Distribution: Worldwide Distribution: US (nationwide) and countries of: Australia, Austria, Bahrain, Canada, China, Colombia, Costa Rica, France, Hong Kong, India, Indonesia, Israel, Kuwait, Lebanon, Mexico, Panama, Peru, Republic of Korea, Russian Federation, Saudi Arabia, Singapore, Spain, Taiwan, Thailand, Turkey, Uganda, United Arab Emirates, Viet Nam & Virgin Islands.
Product codes and lots: Serial #'s: 0428014026 - 0432115014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0603-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0603-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-06

Product code LGZ

K111870Class IIAmsco Warming CabinetSTERIS Corporation / cleared 2011-07-29

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)