Steris Corp Steris C1160 Universal Flexible Processing Tray, for use with STERIS SYSTEM 1 Processor, used for sterilization of flexible endoscopes. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Steris C1160 Universal Flexible Processing Tray, for use with STERIS SYSTEM 1 Processor, used for sterilization of flexible endoscopes.
Brand
Steris Corp
Lot Codes / Batch Numbers
All codes
Products Sold
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Steris Corp is recalling Steris C1160 Universal Flexible Processing Tray, for use with STERIS SYSTEM 1 Processor, used for st due to Failure to effectively sterilize: Under certain conditions, the design/operation of the C1160 Tray may compromise the ability of the SYSTEM 1 process. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failure to effectively sterilize: Under certain conditions, the design/operation of the C1160 Tray may compromise the ability of the SYSTEM 1 processor to correctly assess the state of the high pressure pump during the Sterile Cycle. The L6 sensor fails to alarm when the high pressure pump is not working properly.
Recommended Action
Per FDA guidance
Steris sent an Urgent Safety Alert/Recall letter dated 2/8/2008, to all customers. The letter stated that any device sterilized in the C1160 Tray should not be used clinically prior to a completion of a successful diagnostic cycle. Until further notice, you must run a diagnostic cycle after each sterile cycle involving a C1160 tray or alternately you must discontinue use of these trays. Steris service technicians will schedule visits to correct the problem.
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
PR
Page updated: Jan 10, 2026