Z-2026-2014Class II

The STERIS 4085 General Surgical Table

Name: Z-2026-2014 The STERIS 4085 General Surgical Table
Creator: Steris Corporation
Published: 2014-06-27
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2014-06-27 / Terminated / root cause: design

FDA source

Steris Corporation began a recall of The STERIS 4085 General Surgical Table Product Usage: is an electro-hydraulically operated surgical table designed to support all general surgical procedures on 2014-06-27. FDA classified it as Class II and gives the reason as "STERIS engineering analysis has determined the D1 pressure switch in the hydraulic column manifold does not adequately detect pressure level. If one or more of the table floor lock feet become unlocked due to the loss...". 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-2026-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-27
Posted: 2014-07-09
Terminated: 2015-09-16
Recalling firm: STERIS Corporation
Product: The STERIS 4085 General Surgical Table Product Usage: is an electro-hydraulically operated surgical table designed to support all general surgical procedures.
Product code: FQO Table, Operating-Room, Ac-Powered
Reason for recall: STERIS engineering analysis has determined the D1 pressure switch in the hydraulic column manifold does not adequately detect pressure level. If one or more of the table floor lock feet become unlocked due to the loss of hydraulic pressure, there is a potential for the table hand control to incorrectly indicate that the floor lock feet are locked.
Root cause tag: design
FDA root cause: Device Design
Action: STERIS sent an Urgent Voluntary Field Correction Noticel letter dated June 27, 2014 to affected Customers.via FedEx with tracking numbers for delivery confirmation. The letter identified the description of the product, description of the problem and the actions to be taken. For questions contact Steris Field Service Dispatch at 1-800-333-8828.
Quantity in commerce: 3689
Distribution: Worldwide Distribution - US (nationwide in the states of AL, AK, AZ, AR, CA,CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY in the countries of Canada, India, Vietnam, China, India, Korea, Mexico, costa Rica, Brazil, Taiwan, Australia, New Zealand, El Salvador, Indonesia, Hong Kong, Singapore, Nepal.
Product codes and lots: All Model Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2026-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2026-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-16	2014-07-09

Product code FQO

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)