Wolf Medical recalls 20mL Luer Lock syringes with model SYR20L due to incorrect size clearance. These syringes may not be compatible with medical devices, posing potential risks during use.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Wolf Medical is recalling 20mL Luer Lock syringes (model SYR20L) because they are not within the approved size range for medical devices. This could lead to improper use or device incompatibility, which may affect treatment safety.
The syringes are designed for a different size range than what the medical device approval allows. This mismatch could cause improper device compatibility during medical procedures, potentially leading to treatment errors.
Users of Wolf Medical 20mL Luer Lock syringes (model SYR20L) with lot codes from 20200204 to 20231006 are affected. Healthcare professionals and patients using these syringes for medical procedures are at risk.
Check for the model number SYR20L on the syringe packaging. Look for lot codes from 20200204 through 20231006 on the syringe or label.
Verify the model number on the syringe is SYR20L.
Check the lot code on the syringe to see if it matches the listed dates (20200204 to 20231006).
The recall indicates these syringes may not be compatible with medical devices due to incorrect size clearance. They should be checked for the model and lot codes before use.
Check the model number and lot codes. If they match the recalled items, contact Wolf Medical for guidance on next steps.
The recall states the syringes are outside the approved size range, which could lead to improper device compatibility during medical procedures.
We’ve drafted a message you can send Wolf Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2105-2024 — Wolf Medical Wolf Medical Hello, I own a Wolf Medical that is covered by recall Z-2105-2024 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.