Z-1781-2013Class II

Myoscience brand iovera Smart Tip, Myoscience Cryo-Touch IV, a Cryogenic Surgical device, REF Catalog Number...

Name: Z-1781-2013 Myoscience brand iovera Smart Tip, Myoscience Cryo-Touch IV, a Cryogenic Surgical device, REF Catalog Number...
Creator: Myoscience Inc
Published: 2013-06-21
License: https://open.fda.gov/license/

Myoscience, Inc. / initiated 2013-06-21 / Terminated / root cause: labeling and UDI

FDA source

Myoscience Inc began a recall of Myoscience brand iovera Smart Tip, Myoscience Cryo-Touch IV, a Cryogenic Surgical device, REF Catalog Number: STA0311-10. Product Usage: The Myoscience... on 2013-06-21. FDA classified it as Class II and gives the reason as "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...". 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-1781-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-21
Posted: 2013-07-20
Terminated: 2014-07-15
Recalling firm: Myoscience, Inc.
Product: 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.
Product code: GXH Device, Surgical, Cryogenic
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Myoscience representatives visited both affected sites on June 14, 2013 and relabeled the product in person. Neither site had used the product and was unaffected by the relabeling. No formal communication was issued.
Quantity in commerce: 3 units
Distribution: US distribution including CA and ID.
Product codes and lots: Serial Numbers: 100100, 100101, 100103

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1781-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1781-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-19

Product code GXH

K123516Class IICryo-Touch IVMyoscience, Inc. / cleared 2013-01-10

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)