Medline recalls convenience kits containing specific 10mL polycarbonate colored syringes due to unapproved design changes not reported to the FDA. Affected kits have model numbers SAMP0551 and UDI-DI 1019532:27268503.
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 reported to the FDA. This could mean the products were not properly cleared for safety before being sold.
The syringes have unapproved design changes that were not reported to the FDA. This means the products may not meet safety standards and could pose risks if used without proper clearance.
People who purchased the recalled convenience kits containing specific 10mL polycarbonate colored syringes are affected. Healthcare professionals using these syringes for medical purposes are most at risk.
Check for model numbers SAMP0551 on the kits. The kits also have a unique identifier UDI-DI 10195327268503 and were produced in lots 22JBG593 or 22JBJ361.
Look for model numbers SAMP0551 and unique identifier UDI-DI 10195327268503 on the kits.
The syringes have unapproved design changes not reported to the FDA, meaning they were not properly cleared for safety before being sold.
Check for model numbers SAMP0551 and unique identifier UDI-DI 10195327268503 on the kits, which were produced in lots 22JBG593 or 22JBJ361.
The recall record does not specify a remedy, so you should 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-2589-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2589-2026 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
