Medline GYN Laparoscopy Pack regulatory clearance rescinded
Medline Industries has recalled the GYN Laparoscopy Pack (Model DYNJ41257F, Lot 25GBL423) because its regulatory clearances for certain components—including Control Syringes, Guidewires, and High-Pressure Tubing—have been rescinded.
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. No illnesses, injuries, or deaths are reported in the source text. The recall is based on a loss of regulatory clearance rather than a demonstrated safety hazard, making it a precautionary action.
Plain-English summary
Medline Industries, LP is recalling the GYN Laparoscopy Pack, Model Number DYNJ41257F (Lot Number 25GBL423). The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing contained in this kit have been rescinded.
Six units of this product were distributed nationwide in the United States. The UDI-DI numbers for the product are 10193489708523 (each) and 40193489708524 (case).
Patients and healthcare providers who have this product should contact Medline Industries, LP for further instructions regarding the recalled kit and its components.
The recalled product
- Product
- Medline Kits: 1) GYN LAPAROSCOPY PACK, Model Number: DYNJ41257F
- Manufacturer
- Medline Industries, LP
- Affected units
- 6
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) DYNJ41257F
- UDI-DI: 10193489708523(each)
- 40193489708524(case)
- Lot Number: 25GBL423
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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