Medline recalls D&C Pack kits (Model DYNJ41254B) due to rescinded 510(k) regulatory clearances for medical devices. Affected units include specific lot numbers and UDI-DI codes.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Medline is recalling D&C Pack kits with model number DYNJ41254B because regulatory clearances for certain medical devices have been rescinded. This means the products may not meet safety standards and could pose risks during medical procedures.
The rescinded 510(k) regulatory clearances mean the devices may not meet safety standards. This could lead to improper function during medical procedures, potentially causing harm to patients or healthcare workers.
Healthcare professionals using these kits for medical procedures are most at risk. Patients receiving treatments with these kits could be affected if the devices are used without proper regulatory clearance.
Check for model number DYNJ41254B on the kit. Look for lot numbers starting with 25FBA224 and UDI-DI codes 10888277882003 or 40888277882004.
Verify the model number, lot number, and UDI-DI codes to confirm if your kit is affected.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Check for model number DYNJ41254B, lot numbers starting with 25FBA224, and UDI-DI codes 10888277882003 or 40888277882004.
The recall record does not specify a remedy, so contact Medline directly for guidance.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1848-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1848-2026 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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