Medline GYN Laparoscopy Pack regulatory clearance rescinded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regulatory clearances for certain components—including Control Syringes, Guidewires, and High-Pressure Tubing—have been rescinded.
What this means for you
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clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing contained in this kit have been rescinded.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
- Hazard
- regulatory-clearance-rescission
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.
Related recalls
Same category
- HighMedtronic DLP Retrograde Cannula 15FR Model 94665 Sterile Barrier
FDA (Devices) · 2026-05-27
- ModerateOneLIF Interbody Cage Inserter Attachment Failure Recall
FDA (Devices) · 2026-05-27
- ModerateMedtronic DLP Retrograde Cannula Model 94965 Sterile Barrier Breach
FDA (Devices) · 2026-05-27
- HighTangent Single Use Digital Catheter Recalled for Distal Shaft Fractures
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27