Medline recalls convenience kits containing unapproved 10mL polycarbonate syringes due to design changes not cleared by the FDA. Products not initially reported in RES 98601. Affected kits include DR G's Breast Pack and Liposupplement packs.
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 colored syringes because they have unapproved design changes not cleared by the FDA. These products were not initially reported in RES 98601, which is a regulatory requirement. This recall affects specific kits sold with model numbers like DYNJ51124B and DYNJ0341174D.
The syringes have unapproved design changes that were not cleared by the FDA through the 510(k) process. Products were not initially reported in RES 98601, a regulatory requirement for medical devices. This could lead to non-compliance with FDA standards, though the specific risk to users is not clearly described.
Users of Medline convenience kits containing the specified syringes are affected. Healthcare professionals and individuals using these kits for medical purposes are most at risk due to potential regulatory non-compliance.
Check for convenience kits with model numbers DYNJ51124B (DR G's Breast Pack), DYNJ0341174D (Liposupplement Pack), or DYNJ66746/ DYNJ85702. Products sold with lot numbers 24ABS353, 24BBB383, or 24BBD114 are also affected.
Verify the model number and lot number on the syringe kit to confirm if it matches the affected items listed in the recall.
The syringes have unapproved design changes not cleared by the FDA through the 510(k) process and were not initially reported in RES 98601.
Affected model numbers include DYNJ51124B (DR G's Breast Pack), DYNJ0341174D (Liposupplement Pack), DYNJ66746, and DYNJ85702.
Check for model numbers DYNJ51124B, DYNJ0341174D, DYNJ66746, or DYNJ85702 with lot numbers 24ABS353, 24BBB383, or 24BBD114.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2584-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2584-2026 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.
