iovera 155 Smart Tip — Class II medical device recall Z-2201-2015
Terminated recall by Myoscience Inc, reported 2015-07-29, distributed nationwide. The expiration date on the outer box label and the pouch label for the iovera Smart Tip product is incorrect.
| Recall number | Z-2201-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Myoscience Inc, Fremont, CA, United States |
| Recall initiated | 2015-07-01 |
| Classified | 2015-07-22 |
| Reported by FDA | 2015-07-29 |
| Terminated | 2015-09-08 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| Lot numbers | 1505008 |
| Model numbers | STT0412-10, STT0412-5 |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2201-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.