MEDLINE recalls SYR 20ML/L WHITE HEP FLUSH syringes (model 91862) due to incorrect device clearance. These non-sterile syringes without needles may not be safe for intended use.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
MEDLINE is recalling SYR 20ML/L WHITE HEP FLUSH syringes (model 91862) because they were cleared for use without matching the actual device specifications. This could lead to unsafe medical use if used without proper clearance.
The syringes were cleared for use under a specific medical device approval but have sizes and configurations outside that approval. This mismatch could lead to improper medical use if the syringes are used without the correct device specifications.
Healthcare professionals and patients using these syringes for medical purposes may be affected. Those using the syringes for injections without proper clearance are at risk.
Check for the model number 91862 on the syringe packaging. These non-sterile syringes without needles are for single use and were sold with lot code 63722030001.
Look for model number 91862 and lot code 63722030001 on the syringe packaging.
The recall indicates these syringes may not be safe for intended medical use due to incorrect device clearance. They should not be used without checking the recall.
The recall does not specify a remedy, so contact MEDLINE directly for guidance on handling the syringes.
The syringes were cleared for use under a specific medical device approval but have sizes and configurations outside that approval.
We’ve drafted a message you can send MEDLINE to request your refund or repair — edit it as you like.
Subject: Recall Z-2126-2024 — MEDLINE MEDLINE Hello, I own a MEDLINE that is covered by recall Z-2126-2024 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.
