Medline Arthroscopy Convenience Kits Recalled for Weak Packaging Seals
Medline Industries recalled 222 arthroscopy convenience kits due to potential open or weak seals on breather pouches used for sterile packaging. The compromised seals could affect the ability to maintain sterility of the surgical instruments.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of sterile surgical kits due to potential weak or open seals on protective packaging. While no illnesses or injuries have been reported and the hazard is theoretical, compromised seals on sterile medical devices used in invasive procedures constitute a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medline Industries is recalling three models of arthroscopy convenience kits, with a total of 222 units identified. The recalled products are: ARTHROSCOPIE DU GENOU-LF (Model DYNJ40229A), ARTHROSCOPY PACK-LF (Model OPK382N), and ARTHROSCOPY NEW TEGH-LF (Model DYNJ46723B).
The recall was initiated due to a potential for open or weak seals on breather pouches used to package these sterile surgical kits. Breather pouches are designed to maintain the sterility of medical devices during storage and transport. Compromised seals could affect the ability to maintain the sterilization barrier around the instruments.
These kits were distributed worldwide, including throughout the United States, Canada, Mexico, Panama, and the Virgin Islands. Healthcare facilities and medical professionals who received these products should immediately cease use of the affected lots and contact Medline Industries for return or replacement instructions. The specific lot numbers being recalled are 24JBM438 (Model DYNJ40229A), 24JBN001 (Model OPK382N), and 24JBQ891 (Model DYNJ46723B).
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
- Category
- Medical Device — Surgical Kits
- Hazard
- seal-failure
- contamination-risk
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.
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