Medline recalls specific control syringes and rotating syringes due to rescinded 510(k) regulatory clearances. Affected models include DNSC89369 and DYNJSYR10C with various lot numbers.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Medline is recalling certain control syringes and rotating syringes because the regulatory clearances that allowed them to be sold have been rescinded. This means the products may not meet safety standards and could pose risks during medical use.
The recall is due to the rescission of 510(k) regulatory clearances, which means the syringes were no longer approved for sale by the FDA. This could lead to potential safety issues during medical procedures if the syringes are used without proper regulatory oversight.
Healthcare professionals and medical facilities that use these syringes are most at risk. The specific models and lot numbers listed in the recall affect a large number of units.
Check for model numbers DNSC89369 (rotating syringe) or DYNJSYR10C (10ml control syringe) with lot numbers listed in the recall details. The specific lot numbers range from 21BBM369 to 25JDB828.
Identify the model number and lot number on the syringe packaging to confirm if it is affected by this recall.
The 510(k) regulatory clearances for these syringes have been rescinded, meaning they no longer meet FDA safety standards.
Check the model number and lot number against the list provided in the recall to determine if they are affected. If affected, contact Medline for further instructions.
The recall indicates that the syringes were no longer approved for sale, but the specific safety risks are not detailed in the official notice.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1843-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1843-2026 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.
