Myoscience iovera Smart Tip Recalled for Incorrect Expiration Date Labeling
Myoscience Inc. is recalling iovera 155 Smart Tips because the expiration dates on the outer boxes and pouches are incorrect.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is limited to incorrect expiration date labeling without reported injuries or illnesses, fitting the criteria for a Low severity score (documentation/packaging issues).
Plain-English summary
Myoscience Inc. is recalling iovera 155 Smart Tips, a cryogenic surgical device used to destroy tissue during surgical procedures. The recall involves 12 boxes of the product, specifically catalog numbers STT0412-10 and STT0412-5, with lot numbers 1504021-01 and 1505008.
The recall was initiated because the expiration dates on the outer box labels and the individual pouch labels are incorrect. The labels incorrectly indicate an expiration date of 2016-05, whereas the correct expiration date is 2015-12.
The affected products were distributed nationwide in the United States, specifically in the states of Texas, New York, Maryland, Colorado, and California. Consumers and healthcare providers should stop using the affected Smart Tips and contact Myoscience Inc. for further instructions.
The recalled product
- 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…
- Manufacturer
- Myoscience Inc
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Catalog numbers:STT0412-¿10 and STT0412-¿5
- Lot numbers : 1504021-¿01 and 1505008.
Distribution
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