CLASS II Device recall · Reported 18 Aug 2021 · FDA Enforcement Report

Grasper/Retriever, Alligator Jaw recalled by Shent USA

Shent USA is recalling Grasper/Retriever, Alligator Jaw, distributed nationwide in the US. The recall was initiated on 12 Jan 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Code: 020377208

Quantity recalled47 units (20 US; 27 OUS)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2229-2021
FDA event ID: 88136
Recalling firm: Shent USA, Hudson, MA
Classification: Class II
Status: Completed
Recall initiated: 12 Jan 2021
FDA classified: 6 Aug 2021
Reported: 18 Aug 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Surgical Instruments

Timeline

12 Jan 2021	Recall initiated by company
6 Aug 2021	Classified by FDA	+206 days
18 Aug 2021	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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 as listed by the FDA

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

Where it was distributed

US Nationwide Distribution - CA, CO, MI Foreign: Australia

Nationwide California Colorado Michigan

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot Code: 020377208

Where was it sold?

US Nationwide Distribution - CA, CO, MI Foreign: Australia

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 88136

This product is part of a recall event; the main page for the event is Grasper/Retriever, Alligator Jaw, Rat Tooth recalled by Shent USA.

Reported	Class	Recall	Company	Reason	Where
18 Aug 2021	CLASS II	Grasper/Retriever, Alligator Jaw, Rat Tooth recalled by Shent USA	Shent USA	Labeling Errors	Nationwide

More recalls from Shent USA

All 2

Reported	Class	Recall	Company	Reason	Where
18 Aug 2021Device	CLASS II	Grasper/Retriever, Alligator Jaw, Rat Tooth recalled by Shent USA	Shent USA	Labeling Errors	Nationwide

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