Endoscope Grasper/Retriever Devices Mislabeled with Incorrect Catalog Numbers
Shent USA recalls grasper/retriever endoscopy devices that are mislabeled with incorrect catalog numbers. Units labeled as catalog #7208 may actually be #7226 and vice versa, potentially causing use of the wrong jaw size.
What this means for you
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: FDA Class II medical device recall involving mislabeled catalog numbers for endoscopy equipment. The error creates a risk of harm by potentially allowing healthcare providers to select the wrong jaw size. No illnesses or injuries have been reported, but the mislabeling presents a risk-of-harm scenario.
Plain-English summary
Shent USA, Inc. is recalling grasper/retriever devices used in gastrointestinal endoscopy procedures. Some units are mislabeled with incorrect catalog numbers: devices labeled as catalog #7208 may actually be catalog #7226, and devices labeled as #7226 may actually be #7208. Catalog #7208 is 2.4 mm x 5 mm x 230 cm, while catalog #7226 is 2.4 mm x 8 mm x 230 cm.
This mislabeling could result in healthcare providers using the wrong jaw size during procedures.
Approximately 85 units were distributed outside the United States in California, Colorado, Michigan, and Australia. The affected lot code is D20177226-19.
Healthcare facilities with these devices should verify the actual product identity against packaging. Contact Shent USA, Inc. regarding return or replacement of affected units.
The recalled product
- Product
- Grasper/Retriever, Alligator Jaw, Rat Tooth 2.4 mm x 8 mm x 230 cm Catalog Number: 7226 Intended use: single use accessory devices used through the working channel of a GI endoscope
- Manufacturer
- Shent USA, Inc.
- Category
- Medical Device — Endoscopy
- Hazard
- mislabeling
- device-size-mismatch
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)
- Lot Code: D20177226-19
Distribution
Distributed nationwide across the United States.
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