Wolf Medical recalls 3mL Luer Lock syringes (model SYR03L) due to not being cleared for use under FDA regulations. Affected lots from 2019-2023 may pose risks if used with devices requiring specific sizes.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Wolf Medical is recalling 3 mL Luer Lock syringes (model SYR03L) because they were not approved for use with medical devices. This could lead to incorrect dosing or device damage if used with equipment requiring specific syringe sizes.
The syringes were not cleared by the FDA for the intended medical use. This means they might not fit properly with certain medical devices, potentially causing incorrect dosing or device damage.
Healthcare professionals and patients using Wolf Medical 3 mL Luer Lock syringes (model SYR03L) with specific medical devices. Those using the syringes for procedures requiring precise measurements are most at risk.
Check for the model SYR03L on the syringe. Look for lot codes from 20191014, 20200204, 20200301, 20210104, 20210301, 20221015, 20230714, or 20231006.
Look for the model number SYR03L on the syringe label.
Check the lot code on the syringe, which should be one of the listed dates: 20191014, 20200204, 20200301, 20210104, 20210301, 20221015, 20230714, or 20231006.
The recall states the syringes were not cleared for use with medical devices, so they may not fit properly and could cause incorrect dosing or device damage.
The recall does not specify a remedy, so you should check the model and lot code to determine if they are affected.
Look for the model SYR03L and a lot code from the list: 20191014, 20200204, 20200301, 20210104, 20210301, 20221015, 20230714, or 20231006.
We’ve drafted a message you can send Wolf Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2102-2024 — Wolf Medical Wolf Medical Hello, I own a Wolf Medical that is covered by recall Z-2102-2024 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.
