Medline surgical convenience kits recalled for non-conforming cannula components
Medline is recalling 165 surgical convenience kits because the cannula components do not meet ISO 80369-7 dimensional requirements and may leak or break during use.
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 involves cannula components that do not conform to ISO 80369-7 dimensional requirements and may leak or break during use. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Medline Industries, LP is recalling 165 surgical convenience kits labeled as OPEN HEART, Product Number/SKU DYNJ902898D. The affected kits were distributed nationwide in the United States.
The recall is due to cannula components that do not conform to ISO 80369-7 dimensional requirements. These non-conforming components may contribute to leaking or breaking during use. The affected lots are 23GBD734 and 23EBQ512, with UDI/DI 10195327369743 (each) and 40195327369744 (case).
The source text does not report any illnesses, injuries, or deaths associated with this recall. Users should stop using the affected kits and contact Medline Industries, LP for further instructions.
The recalled product
- Product
- Medline surgical convenience kits labeled as: OPEN HEART, Medline Product Number/SKU DYNJ902898D
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Affected units
- 165
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 (2)
- UDI/DI 10195327369743 (each) 40195327369744 (case). Lot Numbers: 23GBD734
- 23EBQ512
Distribution
Distributed nationwide across the United States.
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