Myoscience iovera Smart Tip Recalled for Missing US Labeling Requirements
Myoscience Inc is recalling three iovera Smart Tip units because their labels lacked required US regulatory text and symbols.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as a labeling error (missing regulatory text and symbols) rather than a functional defect or contamination, aligning with the rubric for minor labeling errors.
Plain-English summary
Myoscience Inc is recalling three units of the Myoscience brand iovera Smart Tip, also known as the Myoscience Cryo-Touch IV. The affected devices are cryogenic surgical instruments used to destroy tissue during surgical procedures by applying freezing cold. The specific units involved have serial numbers 100100, 100101, and 100103, and were distributed in the United States, including California and Idaho.
The recall was initiated because the outer box labels for these products were marked with a down revision label that did not include specific US labeling requirements. Specifically, the labels were missing symbol descriptors and the mandatory statement: "Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician." The source text notes that this product was previously labeled for EU distribution only.
Healthcare providers and facilities that may have received these specific serial numbers should contact Myoscience Inc for further instructions. Consumers should not use the device if they possess one of the affected serial numbers.
The recalled product
- Product
- Myoscience brand iovera Smart Tip, Myoscience Cryo-Touch IV, a Cryogenic Surgical device, REF Catalog Number: STA0311-10. Product Usage: The Myoscience Cryo-Touch IV (a.k.a. iovera) is used to destroy tissue during surgical procedures by applying freezing cold. It can also…
- Manufacturer
- Myoscience Inc
- Hazard
- Affected units
- 3
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 (3)
- Serial Numbers: 100100
- 100101
- 100103
Distribution
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