Wolf Medical recalls 35mL Luer Lock syringes with model SYR35L that may not meet safety standards due to incorrect size configurations. Affected units include specific lot codes from 2019-2023.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Wolf Medical is recalling 35 mL Luer Lock syringes (model SYR35L) because they may not meet safety standards for their intended use. This could lead to improper medical procedures if used with devices cleared for different syringe sizes.
The syringes may not fit properly with medical devices cleared by the manufacturer. This could cause incorrect dosing or procedure errors if used with devices designed for different syringe sizes.
Healthcare professionals and patients using Wolf Medical 35 mL Luer Lock syringes with model SYR35L. Those using these syringes for medical procedures are most at risk.
Check for model SYR35L on the syringe. Look for lot codes: 20190517, 20191014, 20200204, 20200301, 20210301, 20210901, 20211112, 20220414, 20220614, 20221015, 20231006.
Look for model SYR35L on the syringe label.
Check if the syringe has one of the listed lot codes: 20190517, 20191014, 20200204, 20200301, 20210301, 20210901, 20211112, 20220414, 20220614, 20221015, 20231006.
The recall indicates these syringes may not meet safety standards for their intended use, so they should not be used without confirming they are not recalled.
Check the model and lot code to see if they are affected. If they match, contact Wolf Medical for instructions.
Look for model SYR35L and one of the specific lot codes listed in the recall notice.
We’ve drafted a message you can send Wolf Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2106-2024 — Wolf Medical Wolf Medical Hello, I own a Wolf Medical that is covered by recall Z-2106-2024 from Wolf Medical. 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.
