Recall archive
2 recalls · page 1 of 1
Reported Sep 13, 2023
Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aomori Olympus Co., Ltd.
Matched: Brand · Product · Product details — The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17:…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 17, 2021
B5-2Q BALLOON CATHETER, Model No. B5-2Q - Product Usage: Used with endoscopes to inject contrast medium or other…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aomori Olympus Co., Ltd.
Matched: Brand — Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if…
110 more products in this recall
FDA (openFDA device enforcement)
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