Class II — Shent USA, Inc.
| Recalling firm | SHENT USA, INC. |
|---|---|
| Registered facility | TeleMed Systems (the firm's only registered facility) |
| Classification | Class II |
| Status | Completed |
| 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). |
| Product | Grasper/Retriever, Alligator Jaw 2.4 mm x 5 mm x 230 cm Catalog Number: 7208 Intended use: single use accessory devices used through the working channel of a GI endoscope |
| Quantity | 47 units (20 US; 27 OUS) |
| Distribution | US Nationwide Distribution - CA, CO, MI Foreign: Australia |
| Initiated | 2021-01-12 |
| Classified | 2021-08-06 |
| Recall number | Z-2229-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Shent USA, Inc. (Z-2229-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88136/
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