Myoscience Inc: Medical Device Recall in 2015 - (Recall #: Z-2201-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: July 1, 2015

Date Posted: July 29, 2015

Recall Number: Z-2201-2015

Event ID: 71650

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.

Status: Terminated

Product Quantity: 12 boxes - 3 boxes of 10 count and 9 boxes of 5 count.

Code Information:

Catalog numbers:STT0412-¿10 and STT0412-¿5; Lot numbers : 1504021-¿01 and 1505008.

Distribution Pattern:

US Nationwide Distribution in the states of TX, NY, MD, CO and CA.

Voluntary or Mandated:

Voluntary: Firm initiated