FDA Medical Device Recalls (openFDA)
Synergetics Inc: 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.
- Recall number
- Z-0051-2014
- 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.
- Status
- Terminated
- Initiated
- 2013-07-30
- Posted
- 2013-10-22
- Terminated
- 2014-04-07
- Reason
- 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
- Labeling Change Control
- Action
- The firm sent recall notification letters to their consignees on 7/30/13.
- Quantity
- 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.
- Lot, serial or model codes
- Lot number: M222240
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HMX
- Firm FEI
- 1000119053
- Firm city
- O Fallon
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28