Stryker Orthobiologics Recalls Imbibe Bone Marrow Aspiration Needles
Stryker Orthobiologics is recalling Imbibe Bone Marrow Aspiration Needles due to a potential breach in the inner or outer packaging pouches.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a potential packaging breach, which is a quality control issue rather than a direct, reported injury or high-risk pathogen exposure.
Plain-English summary
Stryker Orthobiologics is recalling all lots of the Imbibe Bone Marrow Aspiration Needle. The recall affects specific model numbers including 2090-0027, 2090-0028, 2090-0029, 2090-0030, and 2090-0047. These needles are intended for use to aspirate bone marrow or autologous blood.
The recall is being conducted because there is the potential for a breach in the inner or outer packaging pouches of the devices. The source text does not specify the exact nature of the breach or the specific risks associated with it beyond the packaging integrity issue.
The affected products were distributed nationwide in the United States and in Canada. The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled items, nor does it state the total quantity of units recalled or the specific dates of distribution.
The recalled product
- Product
- Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle, Model Numbers: 2090-0027 Needle (bullet-tip), 11 gauge x 4 inch 2090-0028 Needle (bullet-tip), 11 gauge x 6 inch 2090-0029 Needle (bullet-tip), 8 gauge x 6 inch 2090-0047 Needle (bullet-tip), 8 gauge x 8 inch…
- Manufacturer
- Orthovita, Inc., dBA Stryker Orthobiologics.
- Hazard
- Affected units
- 89,770
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 (6)
- all lots of the Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle
- Catalog No.: 2090-0027
- 2090-0028
- 2090-0029
- 2090-0030
- 2090-0047
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Orthovita, Inc., dBA Stryker Orthobiologics. 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.
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