Biologic Therapies Recalls Bio-PLASTY Cannulas for Misbranding
Biologic Therapies, Inc. is recalling 58 Bio-PLASTY Cannulas 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 or reported injury, fitting the criteria for moderate severity involving labeling or regulatory errors.
Plain-English summary
Biologic Therapies, Inc. is recalling 58 units of Bio-PLASTY Cannulas (Needles). The affected products include catalog numbers BPC.45, BPC.60, BPC.80, and BPC.105. These devices were distributed in the United States to the states of Massachusetts, California, Washington, New Jersey, Texas, Illinois, and Florida.
The recall was initiated because the devices are misbranded. Specifically, the manufacturer failed to properly classify the devices and obtain FDA clearance prior to their distribution. This is a regulatory compliance issue rather than a report of physical defects or patient injuries.
Consumers and healthcare providers who possess these specific catalog numbers should stop using the devices and contact Biologic Therapies, Inc. for instructions on return or disposal.
The recalled product
- Product
- Bio-PLASTY Cannula (Needle)
- Manufacturer
- Biologic Therapies, Inc
- Affected units
- 58
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 (4)
- Catalog Numbers: Part # BPC.45
- BPC.60
- BPC.80
- and BPC.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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