Medline recalls 32 medical kits due to rescinded 510(k) regulatory clearances for control syringes, guidewires, and high-pressure tubing.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Medline is recalling 32 different angiography kits because the U.S. regulatory clearances for certain components like control syringes and guidewires have been rescinded. This means the products may not be safe for medical use without proper regulatory approval.
The 510(k) regulatory clearances for specific medical components have been rescinded by the FDA. This means the products may not meet safety standards for medical use, potentially leading to unsafe procedures if used without proper regulatory approval.
Healthcare professionals using these kits for medical procedures are likely affected. Patients receiving treatments with these kits could be at risk if the components are used without valid regulatory clearance.
Check for model numbers listed in the recall: DYNJQ0505M, DYNJT2021G, DYNJ31377B, DYNJ51279, DYNJ52447, DYNJ53369C, DYNJ53591A, DYNJ57516, DYNJ58722A, DYNJ62742, DYNJ67876, and VASC1170A. These kits were sold with specific lot numbers and UDI-DI codes.
Identify the model number on the kit to see if it matches the recalled list.
Reach out to Medline directly for assistance with the recall process.
The 510(k) regulatory clearances for certain control syringes, guidewires, and high-pressure tubing have been rescinded, meaning the products may not meet safety standards.
Check the model number and lot number on the kit against the list provided in the recall notice.
Contact Medline directly for guidance on the next steps.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1834-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1834-2026 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.
