US Endoscopy Recalls Talon Grasping Devices Due to Detached Wire Component
US Endoscopy Group Inc is recalling 1,695 Talon Grasping Devices because a wire component on the distal grasping assembly became detached.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, placing it in the 'High' category for risk-of-harm products where injury has not yet been reported.
Plain-English summary
US Endoscopy Group Inc is recalling 1,695 units of the Talon Grasping Device, 160 cm, Model #00711175. This medical device is used for the retrieval of foreign bodies, tissue specimens, stones, or calculi during endoscopic procedures of the gastrointestinal tract.
The recall was initiated because a wire component on the distal grasping assembly of the device became detached. The affected units were distributed to 41 U.S. states and the District of Columbia, as well as to Argentina, Australia, Belgium, Canada, Estonia, France, Mexico, New Zealand, Saudi Arabia, and Sweden.
Healthcare providers and consumers should stop using the affected devices immediately. The specific lot numbers involved are 1407418, 1407419, 1408069, 1408070, 1408739, 1408740, 1408741, 1408742, 1410178, 1410179, 1410478, 1410480, 1410990, 1411518, 1423937, and 1423938.
The recalled product
- Product
- Talon Grasping Device, 160 cm, US endoscopy. Used for retrieval of foreign bodies, tissue specimens, stones or calculi in endoscopic procedures of the gastrointestinal tract.
- Manufacturer
- US Endoscopy Group Inc
- Category
- Medical Device — Endoscopy
- Hazard
- Affected units
- 1,695
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 (17)
- Model #00711175
- Lot #'s: 1407418
- 1407419
- 1408069
- 1408070
- 1408739
- 1408740
- 1408741
- 1408742
- 1410178
- 1410179
- 1410478
- 1410480
- 1410990
- 1411518
- 1423937
- and 1423938.
Distribution
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