Steris Recalls 5085 Surgical Tables Due to Hydraulic Column Damage
Steris is recalling 379 surgical tables because external impact damage to the hydraulic column can misalign shrouds and impede table movement.
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 medical device where a mechanical defect (impeded movement or false lock indication) poses a risk of harm to patients during surgery, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Steris Corporation is recalling 379 STERIS 5085 and 5085 SRT surgical tables. The recall was initiated after customer feedback and field service experience indicated that damage from external impact to the table's hydraulic column can cause the stainless steel shroud sections to become misaligned.
If the damage is severe, the up and down movement of the table may be impeded. Additionally, the table hand control may incorrectly indicate that the table floor locks are unlocked. The affected units have serial numbers ranging from 0403809001 to 0408612102.
These tables were distributed worldwide, including nationwide in the United States and in countries such as Australia, Canada, China, India, Korea, Mexico, Panama, and Thailand. The tables are used for general surgical procedures, including cardiac, vascular, endoscopic, gynecology, urology, nephrectomy, neurology, ophthalmologic, and orthopedic surgeries.
The recalled product
- Product
- STERIS 5085 and 5085 SRT Surgical Tables, Product Usage: The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation. It accommodates all general surgical procedures including but not limited to…
- Manufacturer
- Steris Corporation
- Affected units
- 379
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)
- Serial numbers from 0403809001 to 0408612102
Distribution
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