Medline recalls convenience kits containing select 10mL polycarbonate colored syringes with unapproved design changes outside 510(k) clearance. Affected kits include specific SKUs and lots listed in the recall notice.
Unapproved design changes to the products outside of the 510(k) clearance.
Medline is recalling convenience kits that contain certain 10mL polycarbonate colored syringes due to unapproved design changes not cleared by the FDA. These changes could pose risks if the syringes are used in medical procedures without proper regulatory approval.
The syringes have unapproved design changes that were not cleared by the FDA through the 510(k) process. This means they might not meet safety standards for medical use, potentially leading to issues during procedures.
Healthcare professionals using Medline Convenience Kits with specific syringe SKUs and lots listed in the recall notice are most at risk. Patients using these kits for medical procedures may also be affected.
Check for Medline Convenience Kits with specific SKUs like DYNJ87052, DYNJ83976, or DYNJ80700. Look for the lot numbers listed in the recall notice, such as 24FLA345 or 24FLA915.
Identify your Medline Convenience Kit by SKU codes like DYNJ87052 or lot numbers such as 24FLA345.
The recall is due to unapproved design changes to the syringes that were not cleared by the FDA through the 510(k) process.
Check the SKU codes and lot numbers listed in the recall notice, such as DYNJ87052 or lot 24FLA345.
The recall notice 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-1883-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1883-2026 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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