Z-0049-04

Channel Neuroendoscope, Standard Resolution, 21.6 cm. Catalog No. 2232-001

Name: Z-0049-04 Channel Neuroendoscope, Standard Resolution, 21.6 cm. Catalog No. 2232-001
Creator: Medtronic Neurosurgery
Published: 2003-09-15
License: https://open.fda.gov/license/

Medtronic Neurosurgery / initiated 2003-09-15 / Terminated / root cause: labeling and UDI

FDA source

Medtronic Neurosurgery began a recall of Channel Neuroendoscope, Standard Resolution, 21.6 cm. Catalog No. 2232-001 on 2003-09-15. The reason FDA records is "Size mix-up. 13 cm product may be labeled as 21.6 mm and visaversa". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0049-04
Status: Terminated
Initiated: 2003-09-15
Posted: 2004-07-20
Terminated: 2003-10-21
Recalling firm: Medtronic Neurosurgery
Product: Channel Neuroendoscope, Standard Resolution, 21.6 cm. Catalog No. 2232-001
Product code: GWG Endoscope, Neurological
Reason for recall: Size mix-up. 13 cm product may be labeled as 21.6 mm and visaversa.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Firm sales representatives will contact customers and hand deliver the recall notice.
Quantity in commerce: 10
Distribution: TN, CO, GA and Japan
Product codes and lots: A20284

Product code GWG

K945633Class IINeuro Channel Endoscope Model 2232Clarus Medical Systems, Inc. / cleared 1995-09-19

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)