Steris 5085 Surgical Tables Recalled for Damaged Column Shrouds
Steris is recalling 5085 and 5085SRT surgical tables because column shrouds may become damaged, potentially preventing the table from raising or lowering.
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 (surgical table) where injury has not yet been reported, fitting the High severity criteria for functional defects in medical devices.
Plain-English summary
Steris Corporation is recalling 999 units of the 5085 and 5085SRT general surgical tables. These stainless steel tables are designed for high patient weight capacity, extended width capability, and lower minimal table top elevation. The recall covers units distributed across numerous US states and several foreign countries, including Australia, Brazil, Canada, China, Ecuador, India, Korea, Mexico, Panama, and Thailand.
The recall is due to a defect where the stainless steel column shrouds may become damaged. This damage can result from misalignment during extreme table articulation, excessive side force on the table column, or pressure on the base of the table. If the shrouds become severely damaged, the user may be unable to raise or lower the surgical table.
Healthcare facilities and users of these surgical tables should stop using the affected units and contact Steris Corporation for further instructions on the recall process.
The recalled product
- Product
- The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation.
- Manufacturer
- Steris Corporation
- Category
- Medical Device — Surgical Tables
- Affected units
- 999
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)
- 5085 and 5085SRT
Distribution
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