Stryker Instruments Div. of Stryker Corporation Stryker brand Consolidated Operating Room Equipment (CORE) System Powered Instrument Driver, REF 5400-50; Model 5400-050-000. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Stryker brand Consolidated Operating Room Equipment (CORE) System Powered Instrument Driver, REF 5400-50; Model 5400-050-000.
Brand
Stryker Instruments Div. of Stryker Corporation
Lot Codes / Batch Numbers
All units manufactured July 22, 2005 through July 25, 2005.
Products Sold
All units manufactured July 22, 2005 through July 25, 2005.
Stryker Instruments Div. of Stryker Corporation is recalling Stryker brand Consolidated Operating Room Equipment (CORE) System Powered Instrument Driver, REF 540 due to Potential electrical shock hazard, in that the potential exists for the patient to be exposed to an earth-referenced electrical current.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential electrical shock hazard, in that the potential exists for the patient to be exposed to an earth-referenced electrical current.
Recommended Action
Per FDA guidance
U.S. customer was notified via recall letter dated August 5, 2005 and international affiliates were notified via email. U.S. account was requested to return the product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
VA
Page updated: Jan 10, 2026