Medline recalls specific Namic Guidewires due to rescinded 510(k) regulatory clearances. Affected models include DYNJGWIRE20L and DYNJHWIRE series with specific lot numbers.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Medline is recalling specific Namic Guidewires because the regulatory clearances for these medical devices have been rescinded. This means the products may not meet safety standards and could pose risks during medical procedures.
The 510(k) regulatory clearances for these guidewires have been rescinded, meaning the devices no longer meet the required safety standards. This could lead to potential issues during medical procedures if the devices are used without proper regulatory approval.
Healthcare professionals and medical facilities that use these specific guidewires are likely affected. The risk is highest for those using the recalled models in clinical settings.
Check for model numbers starting with DYNJGWIRE or DYNJHWIRE followed by specific numbers like 20L, 105, 107, etc. Look for lot numbers listed in the recall notice, such as 34125030001 or 25DBG562.
Identify the model number and lot number on the guidewire packaging or label to determine if it is affected.
The 510(k) regulatory clearances for these guidewires have been rescinded, meaning they no longer meet the required safety standards.
Specific models including DYNJGWIRE20L, DYNJHWIRE105, DYNJHWIRE107, and others with the model numbers listed in the recall notice.
Check the model number and lot number on the product. Affected items have model numbers starting with DYNJGWIRE or DYNJHWIRE and specific lot numbers listed 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-1829-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1829-2026 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.
