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FDA Medical Device Recalls (openFDA)

Steris Corporation: 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, cardiac and vascular, endoscopic, gynecology, urology, nephrectomy, neurology, ophthalmologic, orthopedics and other procedures requiring intraoperative fluoroscopic C-arm imaging and also supports laparoscopic surgical technique for the largest surgical patients. The 5085SRT table is a variation of the 5085 table that enables patient transport on hard level surfaces within the surgical suite (from pre-operative areas to the operating room and again from the operating room to post operative recovery).

Recall number
Z-2426-2012
Recalling firm
Steris Corporation
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, cardiac and vascular, endoscopic, gynecology, urology, nephrectomy, neurology, ophthalmologic, orthopedics and other procedures requiring intraoperative fluoroscopic C-arm imaging and also supports laparoscopic surgical technique for the largest surgical patients. The 5085SRT table is a variation of the 5085 table that enables patient transport on hard level surfaces within the surgical suite (from pre-operative areas to the operating room and again from the operating room to post operative recovery).
Status
Terminated
Initiated
2012-04-06
Posted
2012-09-20
Terminated
2013-09-04
Reason
STERIS has learned from Customer feedback and field service experience that damage from external impact to the table hydraulic column can cause the stainless steel shroud sections covering the table hydraulic column to become misaligned; if the damage is severe, the up/down movement of the table may be impeded. In addition, the table hand control may indicate that the table floor locks are unlock
Root cause
Device Design
Action
Steris sent an Urgent Voluntary Field Correction Notice dated April 6, 2012 to all affected customer. The letter identified the affected product, description of the problem and actions to be taken. Customers were informed that a STERIS Service Representative will contact affected facility to arrange for the replacement of the stainless steel shroud covering the hydraulic column and relocation of the floor lock pressure switches on their 5085 and/or 5085SRT table(s). For further information or if you have questions regarding the visit to your facility, contact STERIS Field Service Dispatch at 1-800-333-8828. If you have questions regarding this matter, call the Director of Marketing Tables and Case Goods at 440-392-7148 or STERIS Customer Service at 1-800-548-4873.
Quantity
379 tables
Distribution
Worldwide Distribution - US Nationwide including the states of: AL, AR, CA, CO, CT, FL, HI, ID, IL, IN, IA, KY, LA, MA, MD, ME, MI, MN, MO, MS, NV, NYH, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WI & WV and countries of: Australia, Canada, China, India, Korea, Mexico, Panama and Thailand.
Lot, serial or model codes
Serial numbers from 0403809001 to 0408612102
510(k) numbers
["K090136"]
PMA numbers
not on file
Product code
GDC
Firm FEI
1527821
Firm city
Mentor
Firm state
OH
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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