Medline recalls specific angio catheter kits due to rescinded 510(k) regulatory clearances for control syringes, guidewires, and high-pressure tubing. Affected kits may pose safety risks.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Medline is recalling angio catheter packs with model DYNJ245: 1) ANGIO CATH PACK-MARY IMMACULAT. The recall is due to regulatory clearances for certain medical components being rescinded, which could affect safety.
The rescinded 510(k) regulatory clearances mean the medical devices in these kits no longer meet safety standards. This could lead to potential safety issues during medical procedures.
Healthcare professionals using these kits for medical procedures are most at risk. Patients receiving treatments with these kits may also be affected.
Check for model number DYNJ24517D on the kit packaging. The lot number 25CBA224 is also associated with this recall.
Verify the model number DYNJ24517D and lot number 25CBA224 on the kit packaging.
The 510(k) regulatory clearances for certain control syringes, guidewires, and high-pressure tubing have been rescinded.
The recall record does not specify a remedy or action steps.
The recall indicates rescinded regulatory clearances, but the specific injury risk is not detailed in the record.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1832-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1832-2026 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.
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