Medline recalls ENT and LH kits with specific model numbers due to rescinded 510(k) regulatory clearances for medical devices. Affected kits include ENT PACK (DYNJ59030B) and others. No remedy specified in recall notice.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Medline is recalling ENT and LH medical kits with specific model numbers because the regulatory clearances for certain medical devices have been rescinded. This means the products may not meet safety standards and could pose risks during medical procedures.
The recall is triggered by the rescission of 510(k) regulatory clearances for specific medical devices. This means the devices may not have been properly tested for safety and effectiveness before being approved for use, potentially leading to complications during medical procedures.
Healthcare professionals using these kits for ENT (ear, nose, throat) procedures or other medical applications are most at risk. Patients receiving care with these kits could be affected if the devices are used without proper regulatory clearance.
Check for model numbers: DYNJ59030B (ENT PACK), DYNJ908586C (ENT), and VASC1081C (LH 3 PORT W/O WASTEBAG). The kits were sold with specific lot numbers and UDI-DI codes listed in the recall notice.
Identify the model number on the kit to see if it matches DYNJ59030B, DYNJ908586C, or VASC1081C.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded, meaning the devices may not meet safety standards.
The recall notice does not specify a remedy, so contact Medline directly for guidance on next steps.
Yes, the recall includes specific lot numbers such as 24KBL574, 24IBJ666, and others listed in the product details.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1839-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1839-2026 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.
