Z-0051-2014Class II

Synergetics 25 gauge Soft Tip Cannula, packaged in 6 units per box. Catalog number: 30.08.25. Single-use 25...

Name: Z-0051-2014 Synergetics 25 gauge Soft Tip Cannula, packaged in 6 units per box. Catalog number: 30.08.25. Single-use 25...
Creator: Synergetics Inc
Published: 2013-07-30
License: https://open.fda.gov/license/

Synergetics Inc / initiated 2013-07-30 / Terminated / root cause: labeling and UDI

FDA source

Synergetics Inc began a recall of Synergetics 25 gauge Soft Tip Cannula, packaged in 6 units per box. Catalog number: 30.08.25. Single-use 25 gauge cannula used in vitreoretinal surgery on 2013-07-30. FDA classified it as Class II and gives the reason as "One lot of 25 gauge Soft-Tip Disposable Cannulas are co-mingled with 23 gauge cannulas; the product is labeled as 25 gauge cannulas". 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-0051-2014
Classification: Class II
Status: Terminated
Initiated: 2013-07-30
Posted: 2013-10-22
Terminated: 2014-04-07
Recalling firm: Synergetics Inc
Product: Synergetics 25 gauge Soft Tip Cannula, packaged in 6 units per box. Catalog number: 30.08.25. Single-use 25 gauge cannula used in vitreoretinal surgery.
Product code: HMX Cannula, Ophthalmic
Reason for recall: One lot of 25 gauge Soft-Tip Disposable Cannulas are co-mingled with 23 gauge cannulas; the product is labeled as 25 gauge cannulas.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: The firm sent recall notification letters to their consignees on 7/30/13.
Quantity in commerce: 48/6-cannula boxes
Distribution: Nationwide Distribution-USA including the states of MO, CO, KY, TN, NC, PA, IL CA, NY, IN, MI, LA, NJ and OH.
Product codes and lots: Lot number: M222240

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0051-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0051-2014	Class II	Terminated	Voluntary: Firm initiated	2013-10-30	2013-10-22

Product code HMX

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)