Arc Endocuff Vision endoscopic device recalled for packaging seal defects
Olympus recalls Arc Endocuff Vision endoscopic devices for packaging seal defects that may breach sterile barriers, risking patient infection. Approximately 711,157 units nationwide are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall for a risk-of-harm medical device (sterile barrier breach with infection risk) where no illnesses or injuries have been reported, meeting the High severity criterion.
Plain-English summary
Olympus Corporation of the Americas is recalling Arc Endocuff Vision endoscopic devices due to a packaging seal defect. The Arc Endocuff Vision is an accessory designed to be attached to the distal end of an endoscope to facilitate endoscopic therapy. Approximately 711,157 units have been distributed nationwide.
The packaging seal defect may allow a breach of the package sterile barrier. If the sterile packaging is compromised, the device could become contaminated, posing a potential risk of patient infection.
Affected products include multiple device models (ARV110, ARV120, ARV130, ARV140) in various sizes. Specific lot numbers have been identified and are available in the official FDA recall notice.
Patients and healthcare providers should discontinue use of potentially affected units. Healthcare facilities should check their inventory against the affected lot numbers and contact Olympus Corporation of the Americas with any questions or to report adverse events related to this recall.
The recalled product
- Product
- Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0420501; ARV120 ENDOCUFF-V L GREEN PK8, Part Number: E0420500; ARV130 ENDOCUFF-V S PURPLE PK8, Part Number: E0420502; ARV140 ENDOCUFF-V XL ORANGE PK8 ARV110, Part Number: E0420503 Intended to be…
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 711,157
Distribution
Distributed nationwide across the United States.
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