CLASS II Device recall · Reported 31 Jul 2013 · FDA Enforcement Report
iovera Smart Tip, Myoscience Cryo-Touch IV recalled
Myoscience is recalling Myoscience iovera Smart Tip, Myoscience Cryo-Touch IV, a Cryogenic Surgical device, distributed in California, Idaho. The recall was initiated on 21 Jun 2013 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-1781-2013
- FDA event ID
- 65542
- Recalling firm
- Myoscience, Redwood City, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Jun 2013
- FDA classified
- 19 Jul 2013
- Reported
- 31 Jul 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Visit
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 21 Jun 2013 | Recall initiated by company | |
| 19 Jul 2013 | Classified by FDA | +28 days |
| 31 Jul 2013 | 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 outer box label of the product was labeled with a down revision label which did not include the US labeling requirements, specifically the symbol descriptors and also the "Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician." This product was previously labeled for EU distribution only.
Product as listed by the FDA
Myoscience brand iovera Smart Tip, Myoscience Cryo-Touch IV, a Cryogenic Surgical device, REF Catalog Number: STA0311-10. Product Usage: The Myoscience Cryo-Touch IV (a.k.a. iovera) is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. The Cryo-Touch IV (a.k.a. iovera) is not indicated for treatment of central nervous system tissue.
Where it was distributed
US distribution including CA and ID.
Questions about this recall
Is iovera Smart Tip, Myoscience Cryo-Touch IV, a Cryogenic Surgical device recalled?
Yes. Myoscience recalled iovera Smart Tip, Myoscience Cryo-Touch IV, a Cryogenic Surgical device on 21 Jun 2013. The recall is Class II and its status is Terminated. Recall number Z-1781-2013.
Why was it recalled?
The outer box label of the product was labeled with a down revision label which did not include the US labeling requirements, specifically the symbol descriptors and also the "Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician." This product was previously labeled for EU distribution only.
Which lots are affected?
Serial Numbers: 100100, 100101, 100103
Where was it sold?
US distribution including CA and ID.
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 21 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 Myoscience
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | iovera 155 Smart Tip recalled by Myoscience | Myoscience | Labeling Errors | Nationwide |
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