FDA Medical Device Recalls (openFDA)
Steris Corporation: OT1000 Series Orthopedic Surgical Tables
- Recall number
- Z-2248-2016
- Recalling firm
- Steris Corporation
- Product
- OT1000 Series Orthopedic Surgical Tables
- Status
- Terminated
- Initiated
- 2016-05-23
- Posted
- not on file
- Terminated
- 2016-08-22
- Reason
- STERIS has identified that the pivot pin assembly located on the table top may become loose preventing the table from articulating properly.
- Root cause
- Other
- Action
- Recall Notification Letters to the affected Consignees was sent on May 23, 2016 via FedEx with tracking numbers for delivery confirmation. STERIS Field Service Technicians will visit each domestic Customer location to perform the inspection and reinstallation of the pivot pin assemblies. For international direct accounts who have further distributed the surgical table, Steris asked to identify the Customers, and to notify them of this product field correction, and that not to operate the tables until the inspection has been done of the pivot pin assembly on all affected tables.
- Quantity
- 148
- Distribution
- AL;AK, AZ; AR; CA; CO; CT; DC; FL; GA; IL; IN; IA; NY; NJ; NC; OH; OK; OR; PA; PR; SC; TX; UT and VA. Foreign accounts: Canada; France; Korea; Panama; Qatar and Thailand.
- Lot, serial or model codes
- OT1000, OT1100, and OT1200 Orthopedic Surgical Table
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JEA
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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