Z-2423-2021Class II

Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0420501; ARV120 ENDOCUFF-V L...

Name: Z-2423-2021 Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0420501; ARV120 ENDOCUFF-V L...
Creator: Olympus Corporation of the Americas
Published: 2021-08-03
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2021-08-03 / Terminated / root cause: manufacturing process

FDA source

Olympus Corporation of the Americas began a recall of 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... on 2021-08-03. FDA classified it as Class II and gives the reason as "Packaging seal defect may allow a breach of the package sterile barrier and result in patient infection". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2423-2021
Classification: Class II
Status: Terminated
Initiated: 2021-08-03
Posted: 2021-09-03
Terminated: 2023-01-10
Recalling firm: OLYMPUS Corporation of the Americas
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 attached to the distal end of the endoscope to facilitate endoscopic therapy
Product code: FED Endoscopic Access Overtube, Gastroenterology-Urology
Reason for recall: Packaging seal defect may allow a breach of the package sterile barrier and result in patient infection.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Olympus Own Label Distributor US issued letter 8/3/21 via UPS Ground, letter states reason for recall, health risk and action to take: Olympus requires you to take the following immediate action: 1. Carefully read the content of this Field Safety Notice. 2. Below are examples of a gap in the seal between the lid and the plastic package 3. As per the instructions for use, do not use if packaging is damaged. If you observe this packaging anomaly or any other damage to the packaging, immediately cease any further use of any affected product you have, remove it from your inventory and quarantine it until it is shipped back to us. 4. Call your Olympus customer service representative at 1-888-524-7266 option 1. Olympus will issue a Return Material Authorization to return any affected product at no charge to you. Olympus will issue a credit or replacement to your facility for your affected product. 5. Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number Recall-0399 and provide your contact information as indicated in the portal. 6. If you have further distributed this product, identify your customers, forward them this Field Safety Notice, and appropriately document your notification process. Please do not hesitate to contact me directly at 484-896-5688 or at email [email protected] for any additional information concerning this matter
Quantity in commerce: 711,157 units units
Distribution: Nationwide
Product codes and lots: Lot numbers: 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 61662 63310 64844 65525 69148 61664 63314 65173 65527 69150 62007 63316 65340 66017 69260 62009 63582 65342 66019 69554 62011 63584 65344 66021 69556 62013 63586 65390 66023 69774 62146 64132 65391 66361 69776 62149 64134 65392 66363

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2423-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2423-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-15	2021-09-03

Product code FED

K151801Class IIArc Endocuff VisionBoddingtons Plastics, Ltd. / cleared 2015-08-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)