Z-2201-2015Class II

iovera 155 Smart Tip; Catalog numbers:STT0412-10 and STT0412-5 (10 and 5 count respectively) iovera Smart...

Name: Z-2201-2015 iovera 155 Smart Tip; Catalog numbers:STT0412-10 and STT0412-5 (10 and 5 count respectively) iovera Smart...
Creator: Myoscience Inc
Published: 2015-07-01
License: https://open.fda.gov/license/

Myoscience, Inc. / initiated 2015-07-01 / Terminated / root cause: labeling and UDI

FDA source

Myoscience Inc began a recall of iovera 155 Smart Tip; Catalog numbers:STT0412-10 and STT0412-5 (10 and 5 count respectively) iovera Smart Tips are individually packaged in Tyvek PET pouches... on 2015-07-01. FDA classified it as Class II and gives the reason as "The expiration date on the outer box label and the pouch label for the iovera Smart Tip product is incorrect. Instead of indicating the correct expiration or 2015-12. the labels were incorrectly labeled 2016-05". 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-2201-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-01
Posted: 2015-07-22
Terminated: 2015-09-08
Recalling firm: Myoscience, Inc.
Product: iovera 155 Smart Tip; Catalog numbers:STT0412-10 and STT0412-5 (10 and 5 count respectively) iovera Smart Tips are individually packaged in Tyvek PET pouches, which are then packaged into 5 or 10 pack boxes and shipper boxes. Product Usage: Cyrogenic Surgical Device The myoscience iovera device 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 iovera device is not indicated for treatment of central nervous system tissue
Product code: GXH Device, Surgical, Cryogenic
Reason for recall: The expiration date on the outer box label and the pouch label for the iovera Smart Tip product is incorrect. Instead of indicating the correct expiration or 2015-12. the labels were incorrectly labeled 2016-05.
Root cause tag: labeling and UDI
FDA root cause: Incorrect or no expiration date
Action: Myoscience sent an Urgent Medical Device Correction letters dated July 1, 2015 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers are requested to quarantine any affected product at their site. Myoscience will make arrangements to either correct the incorrect expiation date label or remove the product and replace it with correctly labeled product immediately. Question or concerns may be directed to Customers Service at 510-933-1500.
Quantity in commerce: 12 boxes - 3 boxes of 10 count and 9 boxes of 5 count.
Distribution: US Nationwide Distribution in the states of TX, NY, MD, CO and CA.
Product codes and lots: Catalog numbers:STT0412-¿10 and STT0412-¿5; Lot numbers : 1504021-¿01 and 1505008.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2201-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2201-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-22

Product code GXH

K142866Class IIMyoscience iovera systemMyoscience, Inc. / cleared 2015-01-21

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)