Z-2229-2021Class II

Grasper/Retriever, Alligator Jaw 2.4 mm x 5 mm x 230 cm Catalog Number: 7208

Name: Z-2229-2021 Grasper/Retriever, Alligator Jaw 2.4 mm x 5 mm x 230 cm Catalog Number: 7208
Creator: Shent USA, Inc.
Published: 2021-01-12
License: https://open.fda.gov/license/

TeleMed Systems / initiated 2021-01-12 / Completed / root cause: packaging

FDA source

Shent USA, Inc. began a recall of 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... on 2021-01-12. FDA classified it as Class II and gives the reason as "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 of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2229-2021
Classification: Class II
Status: Completed
Initiated: 2021-01-12
Posted: 2021-08-06
Recalling firm: TeleMed Systems
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
Product code: OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered
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).
Root cause tag: packaging
FDA 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: [email protected]. 508-723-6609; [email protected] 978-567-9033
Quantity in commerce: 47 units (20 US; 27 OUS)
Distribution: US Nationwide Distribution - CA, CO, MI Foreign: Australia
Product codes and lots: Lot Code: 020377208

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2229-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2229-2021	Class II	Completed	Voluntary: Firm initiated	2021-08-18	2021-08-06
Z-2230-2021	Class II	Completed	Voluntary: Firm initiated	2021-08-18	2021-08-06

Product code OCZ

K974300Class IITelemed Systems Retrieval BasketTelemed Systems, Inc. / cleared 1997-12-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)