Steris 4085 General Surgical Table Recalled for Pressure Switch Defect
Steris Corporation is recalling 3,689 STERIS 4085 General Surgical Tables because a defective pressure switch may cause the hand control to incorrectly indicate that floor lock feet are locked.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where injury has not yet been reported, which corresponds to a High severity score of 3 according to the rubric.
Plain-English summary
Steris Corporation is recalling 3,689 units of the STERIS 4085 General Surgical Table. This electro-hydraulically operated surgical table is designed to support all general surgical procedures. The recall covers all model numbers and includes units distributed worldwide, including across the United States and in various international markets.
The recall was initiated after Steris engineering analysis determined that the D1 pressure switch in the hydraulic column manifold does not adequately detect pressure levels. 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.
This defect poses a risk of harm to patients and medical staff if the table is used while the floor lock feet are not securely engaged. The source text does not report any specific injuries or illnesses associated with this defect. Users of these surgical tables should contact Steris Corporation for instructions on how to resolve the issue.
The recalled product
- Product
- The STERIS 4085 General Surgical Table Product Usage: is an electro-hydraulically operated surgical table designed to support all general surgical procedures.
- Manufacturer
- Steris Corporation
- Category
- Medical Device — Surgical Table
- Affected units
- 3,689
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Model Numbers
Distribution
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