CLASS II Device recall · Reported 22 Apr 2020 · FDA Enforcement Report
Endocuff Vision recalled by Boddingtons Plastics
Boddingtons Plastics is recalling Endocuff Vision, distributed nationwide in the US. The recall was initiated on 11 Mar 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1718-2020
- FDA event ID
- 85214
- Recalling firm
- Boddingtons Plastics, Tonbridge
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Mar 2020
- FDA classified
- 16 Apr 2020
- Reported
- 22 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 11 Mar 2020 | Recall initiated by company | |
| 16 Apr 2020 | Classified by FDA | +36 days |
| 22 Apr 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Updated Instructions For Use- to contraindications and potential complications/adverse events of the colonoscopy procedure (without using Endocuff Vision Device)
Product as listed by the FDA
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
Where it was distributed
Nationwide Foreign:
Questions about this recall
Is Endocuff Vision recalled?
Yes. Boddingtons Plastics recalled Endocuff Vision on 11 Mar 2020. The recall is Class II and its status is Terminated. Recall number Z-1718-2020.
Why was it recalled?
Updated Instructions For Use- to contraindications and potential complications/adverse events of the colonoscopy procedure (without using Endocuff Vision Device)
Which lots are affected?
All batches distributed prior to 1st May 2020.
Where was it sold?
Nationwide Foreign:
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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