Medline Sterile Convenience Kits Recalled for Defective Breather Pouches
Medline Industries is recalling select sterile convenience kits due to the potential for open or weak seals on breather pouches used in packaging. Affected units were distributed nationwide and internationally.
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: This is an FDA Class II recall of a medical device with a packaging/seal defect. The source text does not report any illnesses, injuries, or confirmed product failures—only a potential hazard. The defect is related to packaging integrity rather than a direct patient safety failure, meeting the criteria for a Moderate severity score.
Plain-English summary
Medline Industries, LP is recalling select sterile convenience kits because of a potential for open or weak seals on purchased breather pouches used for packaging these kits. A total of 14,760 units have been recalled.
The affected kits were distributed worldwide, including in the US nationwide and internationally to Canada, Mexico, Panama, and the Virgin Islands. The recall involves 121 different product codes with corresponding lot numbers spanning from January through December 2024.
Consumers and healthcare facilities who have received these kits should contact Medline Industries, LP for further instructions on how to proceed. Specific guidance on inspection, return, or replacement of affected units should be obtained directly from the manufacturer.
The recalled product
- Product
- Refer to RES
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 14,760
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)
- 1) DYNJ84990
- UDI-DI: 10195327444068(each)
- 40195327444069(case)
- Lot Number: 24IBE926
- 2) DYNJ45711B
- UDI-DI: 10193489856149(each)
- 40193489856140(case)
- Lot Number: 24IBE981
- 3) DYNJ45266B
- UDI-DI: 10193489852417(each)
- 40193489852418(case)
- Lot Number: 24IBF031
- 4) DYNJ80737B
- UDI-DI: 10198459050855(each)
- 40198459050856(case)
- Lot Number: 24IBF165
- 5) DYNJ67785A
- UDI-DI: 10193489945638(each)
- 40193489945639(case)
- Lot Number: 24IBG441
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 34 recalled by MEDLINE INDUSTRIES, LP - Northfield 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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