The Recall Desk
HighFDA (Devices)·Z-2229-2021·Announced 2021-08-18

Shent USA Grasper/Retriever Endoscopic Instruments Recalled for Mislabeling

Shent USA is recalling Grasper/Retriever endoscopic instruments (lot 020377208) due to mislabeling. Products bearing one catalog number may contain different devices with different jaw specifications, potentially resulting in wrong instrument selection.

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 recall of mislabeled endoscopic instruments where products bearing one catalog number may contain devices with different functional specifications. While no injuries have been reported, the potential for selecting the incorrect instrument during invasive GI procedures constitutes a risk-of-harm scenario.

Plain-English summary

Shent USA, Inc. is recalling Grasper/Retriever instruments with alligator jaws in catalog numbers #7208 (2.4 mm x 5 mm x 230 cm) and #7226 (2.4 mm x 8 mm x 230 cm). These are single-use endoscopic accessory devices used through the working channel of gastrointestinal endoscopes.

The recall was issued due to mislabeling in lot code 020377208. Packages labeled as catalog #7208 may actually contain #7226 devices (with 8 mm jaw specification), and packages labeled as #7226 may actually contain #7208 devices (with 5 mm jaw specification). This mismatch between the label and actual device specifications could lead to clinicians selecting the wrong instrument for their intended procedure.

A total of 47 units were affected: 20 units distributed in the United States (California, Colorado, Michigan) and 27 units distributed internationally (Australia). Clinicians and healthcare facilities should verify their inventory of these instruments against the actual device specifications and contact Shent USA regarding replacement or additional guidance. This recall was classified as FDA Class II.

The recalled product

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
Manufacturer
Shent USA, Inc.
Category
Medical Device — Endoscopic Instruments
Hazard
  • mislabeling
  • device-specification-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: 020377208

Distribution

Distributed nationwide across the United States.

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