Medline recalls convenience kits containing unapproved 10mL polycarbonate syringes due to FDA design changes not reported in initial clearance. Affected kits include model DYNJ85723.
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Medline is recalling convenience kits that contain certain 10mL polycarbonate syringes because they have unapproved design changes not reported to the FDA. This could lead to safety issues if the syringes are used without proper regulatory approval.
The syringes have design changes that were not approved by the FDA through the 510(k) process. This means they were not initially reported in the required regulatory clearance, which could lead to safety risks if used without proper oversight.
Healthcare professionals and facilities using Medline convenience kits with the specific model DYNJ85723 are most at risk. The recall affects products sold with the UDI-DI 10195327538491 lot number.
Check for the model number DYNJ85723 on the convenience kit. Products with the UDI-DI 10195327538491 and lot number 24ABO130 are affected.
Look for the model number DYNJ85723 and UDI-DI 10195327538491 on the convenience kit.
The syringes have unapproved design changes not reported to the FDA in the initial clearance process.
The official recall notice does not specify a remedy or action steps for affected products.
The recall indicates potential safety issues due to unapproved design changes, but specific risks are not detailed in the notice.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2588-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2588-2026 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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