FDA Medical Device Recalls (openFDA)
Shent USA, Inc.: 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
- Recall number
- Z-2230-2021
- Recalling firm
- Shent USA, Inc.
- 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
- Status
- Completed
- Initiated
- 2021-01-12
- Posted
- not on file
- Terminated
- not on file
- Reason
- Mislabeled: Devices labeled as catalog #7208 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 230 cm) may actually be catalog #7226 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 8 mm x 230 cm) and Devices labeled as catalog #7226, (Grasper/Retriever, Alligator Jaw, Rat Tooth, 2.4 mm x 8 mm x 230 cm) may actually be catalog #7208, Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 230 cm).
- Root cause
- Packaging process control
- Action
- Telemed issued Urgent Medical Device Recall letter on 1/12/21. Letter states reason for recall, health risk and action to take: Please respond to this recall notification (email response is acceptable) to let us know whether or not you have any of the recalled product in your inventory. If you are in possession of any recalled devices, please provide the quantity, catalog number and lot number. All affected devices must be returned to TeleMed; upon receiving your response to this notification, TeleMed Customer Service will provide you with an RGA number for product return. If you have any questions regarding this medical device recall, please contact: prakash@telemedsystems.com. 508-723-6609; Customerservice@telemedsystems.com 978-567-9033
- Quantity
- 85 units OUS
- Distribution
- US Nationwide Distribution - CA, CO, MI Foreign: Australia
- Lot, serial or model codes
- Lot Code: D20177226-19
- 510(k) numbers
- ["K974300"]
- PMA numbers
- not on file
- Product code
- OCZ
- Firm FEI
- 1222168
- Firm city
- Hudson
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28