Medline arthroscopy surgical kits recalled for incomplete packaging seal
Medline Industries is recalling 80 arthroscopy surgical convenience kits due to incomplete packaging seals. The affected lot numbers are 24GBI464 and 24HBO800.
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 precautionary recall for a manufacturing defect with no reported illnesses or injuries. The incomplete seal is a packaging integrity issue without confirmed consequences.
Plain-English summary
Medline Industries, LP is recalling ARTHROSCOPY Convenience kits (SKU SYNJ910004C) used in surgical procedures. The recall involves 80 units with lot numbers 24GBI464 and 24HBO800 that were distributed nationwide in Tennessee.
A packaging error resulted in an incomplete seal on the kit packaging, creating a packaging seal gap. This manufacturing defect may compromise the integrity of the product packaging.
Healthcare facilities and surgical centers that received these products should stop using affected units immediately. Contact Medline Industries for further guidance on replacement or return procedures.
The recalled product
- Product
- ARTHROSCOPY Convenience kit used for surgical procedures, SKU SYNJ910004C
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kit
- Affected units
- 80
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: 10195327246747
- Lot Numbers: 24GBI464 24HBO800
Distribution
Part of a larger recall action
This product is one of 2 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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