Olympus Corporation of the Americas Single Use 3-Lumen Sphincterotome V recall — FDA Z-1271-2026
Devices which did not undergo thermoforming could deform and lose performance.
Complete FDA and NHTSA recall records dated in February 2026.
These records include useful source details for the selected month.
Devices which did not undergo thermoforming could deform and lose performance.
A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it became…
Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to…
Devices which did not undergo thermoforming could deform and lose performance.
Devices which did not undergo thermoforming could deform and lose performance.
Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which…
Undeclared Quinine
Product may contain foreign material (metal fragments).
Product contains salt and is mislabeled
potential Clostridium botulinum contamination
potential Clostridium botulinum contamination
potential Clostridium botulinum contamination
Product contains salt and is mislabeled
Product contains undeclared milk and egg
Recall is due to a misprint on the label that incorrectly identifies the total caffeine content on the can. The item contains 300mg of caffeine, instead of 150mg as provided on the can.
Product contains salt and is mislabeled
potential Clostridium botulinum contamination
Undeclared Quinine
The firm initiated a voluntary recall after NSF testing showed that labeled ingredient quantities did not align with analytical test results, manganese level was below label quantity.
Undeclared allergens (milk, soy, and peanut)
potential Clostridium botulinum contamination
Undeclared Quinine
Undeclared Quinine
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.