Medline recalls 32 models of control syringes and manifold kits after 510(k) regulatory clearances were rescinded. Affected units include specific model numbers and lot numbers. Consumers should check their items against the list provided.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Medline is recalling 32 different models of control syringes and manifold kits because the FDA rescinded their regulatory clearances. This means the products may not be safe for medical use and could pose risks if used improperly.
The 510(k) regulatory clearances for these medical devices have been rescinded by the FDA. This means the devices may not meet safety standards and could cause harm if used in medical procedures without proper regulatory approval.
Healthcare professionals and medical facilities that use these syringes and kits are most at risk. The recall affects specific model numbers and lot numbers listed in the notice.
Check for model numbers: DYNJSYR10CWRB, VASCSLPOFF1, or VASC1018A. Look for lot numbers listed in the recall notice, such as 22IBH073 through 25ABG686. The products were sold with specific UDI-DI codes.
Identify if your syringes or kits match the model numbers and lot numbers listed in the recall notice.
The FDA rescinded the 510(k) regulatory clearances for these medical devices, meaning they no longer meet safety standards.
Check for model numbers DYNJSYR10CWRB, VASCSLPOFF1, or VASC1018A and lot numbers from 22IBH073 to 25ABG686 as listed in the recall notice.
The recall notice does not specify a remedy, so contact Medline directly to determine 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-1833-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1833-2026 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.
