Z-1718-2020Class II

Endocuff Vision: models ARV 110, 120, 130, 140

Name: Z-1718-2020 Endocuff Vision: models ARV 110, 120, 130, 140
Creator: Boddingtons Plastics Ltd
Published: 2020-03-11
License: https://open.fda.gov/license/

Boddingtons Plastics, Ltd. / initiated 2020-03-11 / Terminated / root cause: labeling and UDI

FDA source

Boddingtons Plastics Ltd began a recall of Endocuff Vision: models ARV 110, 120, 130, 140 Intended Use: ENDOCUFF VISION is a device attached to the distal end of a colonoscope, designed to maintain and... on 2020-03-11. FDA classified it as Class II and gives the reason as "Updated Instructions For Use- to contraindications and potential complications/adverse events of the colonoscopy procedure (without using Endocuff Vision Device)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1718-2020
Classification: Class II
Status: Terminated
Initiated: 2020-03-11
Posted: 2020-04-16
Terminated: 2022-08-10
Recalling firm: Boddingtons Plastics, Ltd.
Product: Endocuff Vision: models ARV 110, 120, 130, 140 Intended Use: ENDOCUFF VISION is a device attached to the distal end of a colonoscope, designed to maintain and maximize the viewable mucosa during endocosopic therapy by manipulating colonic folds
Product code: FED Endoscopic Access Overtube, Gastroenterology-Urology
Reason for recall: Updated Instructions For Use- to contraindications and potential complications/adverse events of the colonoscopy procedure (without using Endocuff Vision Device)
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Boddingtons issued Medical Device Correction Notice dated 3/13/20 to the Distributor stating reason for correction and take the following actions: It is not necessary to return any Endocuff Vision you have in stock, as this recall affects the IFU and not the device. It can continue to be used, provided users are aware of the updated information in the IFU. Healthcare letters dated 3/2/620 was distributed There is no requirement to replace existing stock. New stock with the updated IFU will become available in May 2020. Ensure relevant staff members are informed of this recall, including locums, biomedical engineers, operating theatre staff and relevant clinicians who may decide to monitor for adverse events, as applicable. If you have supplied or transferred any potentially affected product to another facility or organisation, let that facility know of the recall immediately by providing a copy of this letter. Please complete the attached acknowledgement form immediately even if you do not have any affected stock and return it to [email protected] or fax to 004401622833701 to enable Boddingtons to reconcile this process.
Quantity in commerce: 13202 Units US
Distribution: Nationwide Foreign:
Product codes and lots: All batches distributed prior to 1st May 2020.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1718-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1718-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-22	2020-04-16

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)