Biologic Therapies Recalls Bio-MAC Cannula Sets for Regulatory Misbranding
Biologic Therapies, Inc. is recalling 2,797 Bio-MAC Cannula (Needle) Sets because the devices were distributed without proper FDA clearance.
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 and involves a regulatory compliance failure (misbranding) rather than a direct physical hazard or reported injury, fitting the criteria for a moderate severity score.
Plain-English summary
Biologic Therapies, Inc. is recalling 2,797 units of Bio-MAC Cannula (Needle) Sets. The affected products include catalog numbers BMAC.25, BMAC.45, BMAC.60, BMAC.80, and BMAC.105. The recall was initiated because the devices were misbranded due to a failure to properly classify and obtain FDA clearance prior to distribution.
The recalled products were distributed in the United States in the states of Massachusetts, California, Washington, New Jersey, Texas, Illinois, and Florida. The source text does not report any illnesses or injuries associated with the use of these devices.
Consumers who possess these specific Bio-MAC Cannula (Needle) Sets should stop using them and contact Biologic Therapies, Inc. for further instructions on the recall.
The recalled product
- Product
- Bio-MAC Cannula (Needle) Set
- Manufacturer
- Biologic Therapies, Inc
- Hazard
- Affected units
- 2,797
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 (5)
- Catalog Numbers: Part # BMAC.25
- BMAC.45
- BMAC.60
- BMAC.80
- and BMAC.105
Distribution
Part of a larger recall action
This product is one of 3 recalled by Biologic Therapies, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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