FDA Recalls Endocuff Vision Colonoscopy Device Due to Labeling Update
Boddingtons Plastics Ltd is recalling Endocuff Vision models ARV 110, 120, 130, and 140 to update instructions regarding contraindications and potential complications.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text indicates the action is to update documentation regarding contraindications and potential complications, which aligns with the rubric for minor labeling errors or documentation issues.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Endocuff Vision device, manufactured by Boddingtons Plastics Ltd. The affected models are ARV 110, 120, 130, and 140. This device is attached to the distal end of a colonoscope to help maintain and maximize the viewable mucosa during endoscopic therapy by manipulating colonic folds.
The recall is initiated to update the Instructions For Use. Specifically, the updated documentation addresses contraindications and potential complications or adverse events associated with the colonoscopy procedure itself, independent of the use of the Endocuff Vision device.
Approximately 13,202 units were distributed nationwide and to foreign locations. The recall covers all batches distributed prior to May 1, 2020. Healthcare facilities and users should review the updated instructions and follow the recalling firm's guidance regarding the device.
The recalled product
- 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
- Manufacturer
- Boddingtons Plastics Ltd
- Category
- Medical Device — Endoscopy
- Affected units
- 13,202
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All batches distributed prior to 1st May 2020.
Distribution
Distributed nationwide across the United States.
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