US Endoscopy Raptor Grasping Device Recalled for Potential Jaw Failure
US Endoscopy Group Inc is recalling 1,153 Raptor grasping devices because the jaws may become stuck open if excessive force is applied while the catheter is coiled.
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 hazard involves a risk-of-harm product where the device may fail during a procedure, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
US Endoscopy Group Inc is recalling 1,153 units of the disposable Raptor grasping device, model #00711177. This endoscopic retrieval device is intended to retrieve foreign bodies or resected tissue specimens during procedures in the upper and lower gastrointestinal or biliary tracts.
The recall is due to a defect where the jaws may become inoperable and stuck in the open condition. This can occur if the outer catheter is coiled or contorted outside of the endoscope and patient, and excessive force is applied to the handle.
The affected devices were distributed nationwide in the United States and to numerous international countries. Specific serial numbers involved in the recall are 52979, 52981, 52982, 53643, 53644, 53891, 53892, and 54238. Healthcare providers should stop using these devices and contact the manufacturer for instructions.
The recalled product
- Product
- Endoscopic retrieval device. The disposable Raptor grasping device in intended to retrieve foreign bodies or resected tissue specimens in endoscopic procedures of the upper and lower gastrointestinal tract or biliary tract.
- Manufacturer
- US Endoscopy Group Inc
- Affected units
- 1,153
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 (9)
- Model #00711177
- S/N: 52979
- 52981
- 52982
- 53643
- 53644
- 53891
- 53892
- 54238
Distribution
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