FDA Medical Device Recalls (openFDA)
Boddingtons Plastics Ltd: 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
- Recall number
- Z-1718-2020
- 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
- Status
- Terminated
- Initiated
- 2020-03-11
- Posted
- not on file
- Terminated
- 2022-08-10
- Reason
- Updated Instructions For Use- to contraindications and potential complications/adverse events of the colonoscopy procedure (without using Endocuff Vision Device)
- 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 mdr@boddingtons.co.uk or fax to 004401622833701 to enable Boddingtons to reconcile this process.
- Quantity
- 13202 Units US
- Distribution
- Nationwide Foreign:
- Lot, serial or model codes
- All batches distributed prior to 1st May 2020.
- 510(k) numbers
- K151801
- PMA numbers
- not on file
- Product code
- FED
- Firm FEI
- 3009837469
- Firm city
- Tonbridge
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 3e6df46828c1, published 2026-10-06