Medline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components
Medline is recalling 620 surgical convenience kits because the cannula components do not meet ISO 80369-7 dimensional requirements, which may cause leaking or breaking 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 is classified as Class II because the non-conforming cannula components may cause leaking or breaking during use, which may cause temporary or medically reversible adverse health consequences. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Medline Industries, LP is recalling 620 surgical convenience kits distributed nationwide. The affected products include EAR, CAROTID PACK, FEM CAROTID PACK, and CAROTID CDS-LF kits, identified by specific Medline product numbers and lot numbers.
The recall was initiated because the kits contain 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 source text does not report any illnesses, injuries, or deaths associated with the use of these products. Healthcare facilities and consumers should stop using the affected kits and contact Medline for further instructions.
The recalled product
- Product
- Medline surgical convenience kits labeled as: 1) EAR, Medline product number/SKU DYNJ909020B; 2) EAR, Medline product number/SKU DYNJ909020A; 3) CAROTID PACK, Medline product number/SKU DYNJ42922C; 4) EAR, Medline product number/SKU DYNJ909020; 5) FEM CAROTID PACK…
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Affected units
- 620
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 (20)
- Medline product number/SKU DYNJ909020B
- UDI/DI 10198459159213 (each) 40198459159214 (case)
- Lot number 26AMF311
- Lot number 25JMD500
- Lot number 25DMJ849
- Lot number 25CMD823
- Lot number 25BMG250
- Lot number 24LMG633
- Medline product number/SKU DYNJ909020A
- UDI/DI 10195327665760 (each) 40195327665761 (case)
- Lot number 24KMB736
- Lot number 24JMD634
- Lot number 24IMD605
- Medline product number/SKU DYNJ42922C
- UDI/DI 10193489335019 (each) 40193489335010 (case)
- Lot number 24HBT243
- Lot number 24HBD143
- Lot number 24GMG103
- Lot number 24DMI379
- Lot number 24CBJ928
Distribution
Distributed nationwide across the United States.
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