MEDLINE recalls SYR 20ML L/L GREEN syringes (model 91836) that may not meet FDA device clearance standards. These non-sterile syringes without needles were sold with specific lot codes and require checking for safety.
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/L GREEN syringes (model 91836) because they may not meet FDA device clearance standards. This could mean the syringes are unsafe for medical use, potentially causing harm if used incorrectly.
The syringes may not meet the FDA's device clearance standards because their sizes and configurations are outside the approved range. This could lead to improper medical use, such as incorrect dosing or injury if the syringes malfunction during procedures.
Users of these syringes for medical purposes are affected. Healthcare professionals and patients using the recalled model may be at risk if the syringes are used improperly.
Check for the model number 91836 on the syringe packaging. The lot codes listed (e.g., 63721070001, 63721080001) indicate specific batches that were sold. These non-sterile syringes without needles are for single use only.
Look for the model number 91836 on the syringe packaging or label.
Confirm the lot code matches the listed codes (e.g., 63721070001, 63721080001) to identify affected units.
The recall indicates these syringes may not meet FDA device clearance standards, so they are not safe for medical use. MEDLINE recommends checking the model and lot codes to confirm if they are affected.
If you have the model 91836 syringes with the listed lot codes, stop using them and contact MEDLINE for further instructions.
Check the model number on the syringe packaging and compare it to 91836. Also, verify the lot code against the listed codes (e.g., 63721070001, 63721080001).
We’ve drafted a message you can send MEDLINE to request your refund or repair — edit it as you like.
Subject: Recall Z-2068-2024 — MEDLINE MEDLINE Hello, I own a MEDLINE that is covered by recall Z-2068-2024 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.
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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.