Medline General Laparoscopy Kit regulatory clearance rescinded
The FDA has rescinded the 510(k) regulatory clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing components in Medline's General Laparoscopy Kit (Model CDS930027Y). 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 regulatory clearance rescission without reported adverse events or hospitalizations. The source text provides no evidence of illness, injury, or harm, making it a precautionary regulatory action that meets the threshold for Moderate severity.
Plain-English summary
Medline Industries, LP has issued a recall of its General Laparoscopy Kit (Model Number CDS930027Y, Lot Number 25EBE671) following the FDA's rescission of 510(k) regulatory clearances. The clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing components within this kit have been withdrawn.
The recall affects 75 units that were distributed nationwide in the United States. Healthcare facilities and providers that have received this kit should discontinue use of the affected components and follow Medline's recall instructions for return or disposal.
Consumers or healthcare organizations with questions about this recall should contact Medline Industries, LP directly for guidance on replacement or return procedures.
The recalled product
- Product
- Medline Kits: 1) GENERAL LAPAROSCOPY, Model Number: CDS930027Y
- Manufacturer
- Medline Industries, LP
- Affected units
- 75
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) CDS930027Y
- UDI-DI: 10198459303128(each)
- 40198459303129(case)
- Lot Number: 25EBE671
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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