CLASS II Device recall · Reported 27 Nov 2019 · FDA Enforcement Report
Starburst Talon Semi-Flex Electrosurgical Device recalled
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling Starburst Talon Semi-Flex Electrosurgical Device, distributed in Louisiana, Massachusetts, Oregon, Virginia, Washington. The recall was initiated on 2 Oct 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0411-2020
- FDA event ID
- 84072
- Recalling firm
- Angiodynamics Inc. (Navilyst Medical Inc.), Glens Falls, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Oct 2019
- FDA classified
- 15 Nov 2019
- Reported
- 27 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Labeling Errors
- Device type
- Surgical Instruments
Timeline
| 2 Oct 2019 | Recall initiated by company | |
| 15 Nov 2019 | Classified by FDA | +44 days |
| 27 Nov 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The devices are not labelled correctly. End users impacted by this issue may experience a procedural delay.
Product as listed by the FDA
Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 incorrectly labelled as Starburst MRI Semi-Flex Electrosurgical Device, Part Number H7877001026151
Where it was distributed
The products were distributed to the following US states: LA, MA, OR, VA, and WA.
Questions about this recall
Why was it recalled?
The devices are not labelled correctly. End users impacted by this issue may experience a procedural delay.
Which lots are affected?
Lot 5476032
Where was it sold?
The products were distributed to the following US states: LA, MA, OR, VA, and WA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Angiodynamics Inc. (Navilyst Medical Inc.)
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Other Surgical Instruments recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Other | Nationwide |