The Recall Desk
LowFDA (Devices)·Z-2201-2015·Announced 2015-07-29

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.

What this means for you

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 Th
Manufacturer
Myoscience Inc

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

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Same manufacturer · Myoscience Inc

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