Medline recalls convenience kits containing unapproved 10mL polycarbonate syringes due to design changes outside 510(k) clearance. Affected kits include FACE/RHINOPLAST: DYNJ80343C and PLASTIC HEAD-NECK: DYNJ86639 models.
Unapproved design changes to the products outside of the 510(k) clearance.
Medline is recalling convenience kits that include certain 10mL polycarbonate syringes because they were made with unapproved design changes. This could lead to safety issues if the syringes are used without proper regulatory approval.
The syringes were made with design changes that the FDA did not approve through the 510(k) clearance process. This means they might not work safely or could cause harm during medical procedures.
Patients and medical professionals who own or use the recalled Medline Convenience Kits with specific syringe models. Those using the syringes for facial or rhinoplasty procedures are at higher risk.
Check for the product codes DYNJ80343C (FACE/RHINOPLASTY PACK) or DYNJ86639 (PLASTIC HEAD-NECK PACK) on the syringes. The kits were sold with lot numbers 24ABO127 and 24FBM972.
Look for the product codes DYNJ80343C or DYNJ86639 on the syringes to identify affected kits.
The syringes were made with unapproved design changes outside the FDA's 510(k) clearance process.
The FACE/RHINOPLASTY PACK (DYNJ80343C) and PLASTIC HEAD-NECK PACK (DYNJ86639) models.
Check for product codes DYNJ80343C or DYNJ86639 with lot numbers 24ABO127 or 24FBM972.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1882-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1882-2026 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.
