Biologic Therapies Recalls Bio-CORE Cannula Sets for Misbranding
Biologic Therapies, Inc. is recalling Bio-CORE Cannula (Needle) Sets because they were distributed without proper FDA clearance and classification.
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 regulatory misbranding failure (lack of clearance) rather than a physical defect causing injury, and no illnesses or injuries are reported.
Plain-English summary
Biologic Therapies, Inc. is recalling Bio-CORE Cannula (Needle) Sets, identified by catalog numbers BCORE.60, BCORE.80, and BCORE.105. The recall is due to the devices being misbranded, specifically because the company failed to properly classify the devices and obtain FDA clearance prior to their distribution.
The affected products were distributed in the United States to the states of Massachusetts, California, Washington, New Jersey, Texas, Illinois, and Florida. The source text indicates that 0 units were distributed or released, though the distribution pattern lists specific states.
Consumers and healthcare providers who have these specific catalog numbers should stop using the devices and contact Biologic Therapies, Inc. for further instructions or a return.
The recalled product
- Product
- Bio-CORE Cannula (Needle) Set
- Manufacturer
- Biologic Therapies, 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 (3)
- Catalog Numbers: Part # BCORE.60
- BCORE.80
- and BCORE.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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