Medline recalls convenience kits containing unapproved 10mL polycarbonate syringes due to design changes not cleared by FDA. Affected kits include ANGIO CATH COMBINED PACK DYNJ43609S and others with specific lot numbers. No remedy provided in recall notice.
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 include certain 10mL polycarbonate colored syringes because they have unapproved design changes not cleared by the FDA. This means the products were not properly reported to the FDA and could pose a risk if used without the required design approvals.
The syringes have design changes that were not approved by the FDA through the 510(k) process. Products not initially reported in RES 98601 may not meet safety standards, potentially leading to improper use or injury if the syringes are used without the required design approvals.
Healthcare professionals who use these syringes in medical settings are most at risk. Patients receiving treatments with these syringes could be affected if the products are used without proper FDA clearance.
Check for the product names listed in the recall, such as ANGIO CATH COMBINED PACK DYNJ43609S. Look for specific lot numbers like 23BMG740, 22LMI014, or 23JLA076 on the packaging.
Identify the product name and lot number on the packaging to confirm if it is affected by this 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.
The recall notice does not specify a remedy, so contact Medline directly to get guidance on next steps.
Yes, specific lot numbers like 23BMG740, 22LMI014, and 23JLA076 are listed in the recall notice.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2582-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2582-2026 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.
