Medline Arthroscopy Pack regulatory clearance rescinded
The FDA has rescinded regulatory clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing included in Medline's Arthroscopy Pack (Model DYNJ82440). Affected units should not be used.
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 involving loss of regulatory clearance for device components. No injuries, illnesses, or deaths are reported in the source text, and the hazard is regulatory/administrative in nature rather than an acute safety defect.
Plain-English summary
Medline Industries, LP is recalling the Arthroscopy Pack, Model Number DYNJ82440 (Lot Number 24BMD005). The FDA has rescinded the 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing that are components of this product.
27 units of this product were distributed nationwide in the US. Healthcare facilities and providers who received this product should discontinue use and contact Medline Industries, LP for further instructions on how to proceed.
The recalled product
- Product
- Medline Kits: 1) ARTHROSCOPY PACK, Model Number: DYNJ82440
- Manufacturer
- Medline Industries, LP
- Affected units
- 27
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 (4)
- 1) DYNJ82440
- UDI-DI: 10195327196240(each)
- 40195327196241(case)
- Lot Number: 24BMD005
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 22 recalled by Medline Industries, LP 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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