MEDLINE SYR 10ML L/L non-sterile syringes (model 83082) recalled because piston sizes don't match cleared devices. Affected lots include 63721010001 through 63723120006. No remedy provided in official notice.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
MEDLINE's SYR 10ML L/L non-sterile syringes (model 83082) are being recalled because their piston sizes and configurations don't match the medical devices cleared by the manufacturer. This could lead to improper use in medical settings if the syringes are used with devices they weren't designed for.
The syringes' piston sizes and configurations fall outside the range of devices cleared by the manufacturer's 510(k) approval. This mismatch could cause the syringes to malfunction when used with medical devices they weren't designed for, potentially leading to incorrect dosing or device damage.
Users of these syringes for medical purposes, particularly healthcare professionals and patients requiring injections. Those using the syringes with devices cleared for different sizes may be at risk of improper function.
Check for the model number 83082 on the syringe packaging or label. Affected lots include 63721010001 through 63723120006 as listed in the recall notice.
Look for the lot code on the syringe packaging or label to determine if it's affected (lots 63721010001 through 63723120006).
The syringes' piston sizes and configurations are outside the range of devices cleared under the manufacturer's 510(k) approval, which could lead to improper use in medical settings.
The recall notice does not specify a remedy, so there is no instruction to stop using them. However, you should check the lot number to see if your syringes are affected.
The official recall notice does not provide a remedy, so no specific action is required beyond checking the lot number to determine if your syringes are affected.
We’ve drafted a message you can send MEDLINE to request your refund or repair — edit it as you like.
Subject: Recall Z-2047-2024 — MEDLINE MEDLINE Hello, I own a MEDLINE that is covered by recall Z-2047-2024 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.