The STERIS 4085 General Surgical Table Product Usage: is an electro-hydraulically operated su...

FDA Device Recall #Z-2026-2014 — Class II — June 27, 2014

Recall Summary

Recall Number Z-2026-2014
Classification Class II — Moderate risk
Date Initiated June 27, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Steris Corporation
Location Mentor, OH
Product Type Devices
Quantity 3689

Product Description

The STERIS 4085 General Surgical Table Product Usage: is an electro-hydraulically operated surgical table designed to support all general surgical procedures.

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.

Distribution Pattern

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.

Lot / Code Information

All Model Numbers

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.