Z-1006-03

EBI VueCath Endoscopic Spinal System

Name: Z-1006-03 EBI VueCath Endoscopic Spinal System
Creator: Ebi, L.p.
Published: 2003-06-17
License: https://open.fda.gov/license/

Ebi, LLC / initiated 2003-06-17 / Terminated / root cause: labeling and UDI

FDA source

EBI, L.P. began a recall of EBI VueCath Endoscopic Spinal System on 2003-06-17. The reason FDA records is "Non sterile device is labeled sterile". 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-1006-03
Status: Terminated
Initiated: 2003-06-17
Posted: 2003-07-15
Terminated: 2003-12-31
Recalling firm: Ebi, LLC
Product: EBI VueCath Endoscopic Spinal System
Product code: GWG Endoscope, Neurological
Reason for recall: Non sterile device is labeled sterile.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: The firm notified their customers via a field correction letter dated June 17, 2003. Instructions given are to sterilize the unit prior to use. A EBI field representative will be visiting to replace the boxes.
Quantity in commerce: 39
Distribution: Hospitals, clinics, and doctors nationwide.
Product codes and lots: Catalog Number: S002 Lot/Serial Nos: F10021, F10017, F10012, F10018, F10025, F10019, F10020, F10014, F10023, F10022, F10001, F10000, F10024, F10007, F10008, F00005, F10003, F10016, F10015, F10002, F10027.

Product code GWG

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)