Reported Sep 15, 2021 · Terminated

Arc Endocuff Vision as follows

Olympus Corporation of the Americas

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-0610

Is this the product you have?

Arc Endocuff Vision as follows

4 of 4 products

Products covered by this recall
Model / numberProduct as published
E0420501ARV110 ENDOCUFF-V M BLUE PK8
E0420500ARV120 ENDOCUFF-V L GREEN PK8
E0420502ARV130 ENDOCUFF-V S PURPLE PK8
E0420503ARV140 ENDOCUFF-V XL ORANGE PK8 ARV110, Intended to be attached to the distal end of the endoscope to facilitate endoscopic therapy
Lot codes and dates
  • Lot numbers

    99 of 99 codes

    • 60780
    • 62151
    • 64141
    • 65464
    • 66365
    • 60862
    • 62405
    • 64263
    • 65465
    • 66367
    • 60865
    • 62407
    • 64265
    • 65466
    • 66634
    • 60867
    • 62469
    • 64268
    • 65489
    • 66636
    • 60869
    • 62471
    • 64533
    • 65490
    • 66638
    • 61168
    • 62473
    • 64535
    • 65491
    • 66640
    • 61171
    • 62781
    • 64537
    • 65496
    • 66910
    • 61176
    • 62783
    • 64674
    • 65497
    • 66912
    • 61285
    • 62787
    • 64676
    • 65498
    • 66914
    • 61578
    • 63035
    • 64678
    • 65499
    • 67021
    • 61580
    • 63037
    • 64738
    • 65521
    • 67023
    • 61582
    • 63039
    • 64831
    • 65523
    • 67025
Amount recalled
711,157 units units

Where it was sold

  • Nationwide

Why it was recalled

Packaging seal defect may allow a breach of the package sterile barrier and result in patient infection.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 10, 2023 · Data as of Sep 19, 4:55 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.