Medline recalls specific syringe models due to rescinded 510(k) regulatory clearances. Affected items include 12ml and 10ml control syringes with rotator and related accessories. Consumers should check model numbers and lot numbers for affected units.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Medline is recalling several syringe models and related accessories because the regulatory clearances that allowed them to be sold have been rescinded.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 if used.
The recall is based on the rescission of 510(k) regulatory clearances, which means the syringes were approved for use but later found to not meet safety standards. This could lead to potential safety issues if the syringes are used without proper regulatory oversight.
Healthcare professionals and medical facilities that use these syringes are most likely affected. Individuals with the specific model numbers and lot numbers listed in the recall are at risk.
Check for model numbers starting with DYNJSYR (e.g., DYNJSYR12CWR) and lot numbers from 25ABF227 to 25JDB602. The syringes are 10ml or 12ml control syringes with rotator features.
Look for model numbers starting with DYNJSYR and lot numbers from 25ABF227 to 25JDB602 on the product packaging.
The 510(k) regulatory clearances for these syringes have been rescinded, meaning they no longer meet safety standards.
Check for model numbers starting with DYNJSYR and lot numbers from 25ABF227 to 25JDB602 on the product packaging.
The recall does not specify a stop-use instruction, so you can continue using them but should check if they are affected.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1831-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1831-2026 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.
