Medline recalls General Laparoscopy Kits (Model CDS930027Y) after regulatory clearances for certain components were rescinded. Affected kits may pose safety risks during medical procedures.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Medline is recalling General Laparoscopy Kits with model number CDS930027Y because regulatory clearances for some components have been rescinded. This could affect the safety of these kits during medical procedures.
Regulatory clearances for certain components like control syringes, guidewires, and high-pressure tubing have been rescinded. This means these components may not meet safety standards for medical use, potentially leading to complications during procedures.
Medical professionals using these kits are likely affected. Patients undergoing laparoscopic surgery may be at risk if the kits are used without proper regulatory clearance.
Check for model number CDS930027Y on the kit. The lot number is 25EBE671. These kits were sold with a unique device identifier (UDI-DI) of 10198459303128 each and 40198459303129 per case.
Verify the model number on the kit label to ensure it matches CDS930027Y.
Regulatory clearances for certain components like control syringes, guidewires, and high-pressure tubing have been rescinded.
The recall record does not specify a remedy, so contact Medline directly for guidance.
The rescinded regulatory clearances could mean these kits may not meet safety standards, but the exact risk is not detailed in the recall notice.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1840-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1840-2026 from Medline. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
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