Medline Sterile Convenience Kits Recalled for Open Breather Pouches
Medline Industries is recalling three models of sterile convenience kits used for arthroscopy procedures due to potential open or weak seals on the breather pouches used for packaging.
What this means for you
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: FDA Class II recall with a potential product defect (open/weak seals on packaging). No illnesses or injuries have been reported, and the hazard is theoretical packaging compromise rather than a direct clinical risk.
Plain-English summary
Medline Industries, LP (Northfield) is recalling three models of sterile convenience kits due to a potential for open or weak seals on purchased breather pouches used for packaging these kits. The affected products are: ARTHROSCOPIE DU GENOU-LF (Model DYNJ40229A), ARTHROSCOPY PACK-LF (Model OPK382N), and ARTHROSCOPY NEW TEGH-LF (Model DYNJ46723B). A total of 222 units have been distributed.
These kits have been distributed worldwide, including throughout the United States and to Canada, Mexico, Panama, and the Virgin Islands. Affected lot numbers are 24JBM438 (DYNJ40229A), 24JBN001 (OPK382N), and 24JBQ891 (DYNJ46723B).
Consumers and healthcare facilities in possession of these kits should discontinue use and contact Medline Industries for further instructions. Facilities should verify whether they received affected lots using the UDI-DI and lot numbers provided.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) ARTHROSCOPIE DU GENOU-LF, Model Number: DYNJ40229A; 2) ARTHROSCOPY PACK-LF, Model Number: OPK382N; 3) ARTHROSCOPY NEW TEGH-LF, Model Number: DYNJ46723B
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 222
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 (12)
- 1) DYNJ40229A
- UDI-DI: 10889942670482(each)
- 40889942670483(case)
- Lot Number: 24JBM438
- 2) OPK382N
- UDI-DI: 10889942686704(each)
- 40889942686705(case)
- Lot Number: 24JBN001
- 3) DYNJ46723B
- UDI-DI: 10889942747405(each)
- 40889942747406(case)
- Lot Number: 24JBQ891
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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