Z-0576-2007

AccuGuide Injection Needles (Surface electrodes) The AccuGuide EMG Injection Needle, product 8263210...

Name: Z-0576-2007 AccuGuide Injection Needles (Surface electrodes) The AccuGuide EMG Injection Needle, product 8263210...
Creator: Medtronic Xomed, Inc.
Published: 2007-01-22
License: https://open.fda.gov/license/

Medtronic Xomed, Inc. / initiated 2007-01-22 / Terminated / root cause: labeling and UDI

FDA source

Medtronic Xomed, Inc. began a recall of AccuGuide Injection Needles (Surface electrodes) The AccuGuide EMG Injection Needle, product 8263210, contains 5 individually packaged and sterilized injection... on 2007-01-22. The reason FDA records is "A labeling discrepancy was internally identified for the surface electrode component of REF 8263210 AccuGuide EMG Injection Needle, 30G X 25MM. The outside box label correctly indicates 'Content: 5 sterile Injection...". 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-0576-2007
Status: Terminated
Initiated: 2007-01-22
Posted: 2007-03-07
Terminated: 2012-07-07
Recalling firm: Medtronic Xomed, Inc.
Product: AccuGuide Injection Needles (Surface electrodes) The AccuGuide EMG Injection Needle, product 8263210, contains 5 individually packaged and sterilized injection needles and 10 nonsterile surface electrodes that are packaged 2 per non-breathable pouch, but are not sterilized.
Product code: GZX Instrument, Microsurgical
Reason for recall: A labeling discrepancy was internally identified for the surface electrode component of REF 8263210 AccuGuide EMG Injection Needle, 30G X 25MM. The outside box label correctly indicates 'Content: 5 sterile Injection Needles and 10 non-sterile Surface electrodes'; however, the pouches for the 10 surface electrodes inside the box are incorrectly labeled as 'sterile'.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Each consignee contacted via telephone 01/22/2007, and then sent a follow-up fax letter 02/02/2007, which explained the issue, and the options for dispositioning any product that they still had in stock. Since firm has determined that the risk of keeping and using these devices is negligible to no risk, as they are intended to be and typically used in a non-sterile manner, the firm is offering the consignees the option to keep their devices or have them replaced.
Quantity in commerce: 48 boxes
Distribution: Nationwide
Product codes and lots: Lot Numbers: 45648300, 46526000, 46709500, 48166300

Product code GZX

K990793Class IIAccuguide Muscle Injection MonitorMedtronic Xomed / cleared 1999-10-22

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)