Z-0196-2015Class II

The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower...

Name: Z-0196-2015 The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower...
Creator: Steris Corporation
Published: 2014-10-10
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2014-10-10 / Terminated / root cause: design

FDA source

Steris Corporation began a recall of The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation on 2014-10-10. FDA classified it as Class II and gives the reason as "The 5085 and 5085SRT stainless steel column shrouds may become damaged as a result of misalignment during extreme table articulation, excessive side force on the table column, or pressure on the base of the table...". 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-0196-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-10
Posted: 2014-11-07
Terminated: 2015-06-26
Recalling firm: STERIS Corporation
Product: The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation.
Product code: GDC Table, Operating-Room, Electrical
Reason for recall: The 5085 and 5085SRT stainless steel column shrouds may become damaged as a result of misalignment during extreme table articulation, excessive side force on the table column, or pressure on the base of the table. Severe damage to the shrouds may prevent the user from raising or lowering the surgical table.
Root cause tag: design
FDA root cause: Device Design
Action: STERIS will mail Consignee Notification Letters to the affected Consignees via FedEx with tracking numbers for delivery confirmation. The Consignee Notification mailing will initiate the week of October 13, 2014.
Quantity in commerce: 999
Distribution: US distribution: AL, AZ, AR, CA, CO, CN, DC, FL, GA, HI, ID, IL, IN, IA, KN, KY, LA, ME, MD, MI, MN, MS, MO, NB, NV, NY, NC, ND, OH, OK, OR, PN, RI, SC, SD, TN, TX, VA, WV, WI. Foriegn: Austrialia, Brazil, Canada, China, Ecuador, India, Korea, Mexico, Pnama, and Thailand.
Product codes and lots: 5085 and 5085SRT

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0196-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0196-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-19	2014-11-07

Product code GDC

K090136Class ISteris Cmax Xlt Surgical TableSTERIS Corporation / cleared 2009-03-20

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)