GMAX SYR 10ML/LS syringes (model TS2210S-M) without needles are recalled due to piston size mismatch with cleared devices. Non-sterile syringes were sold with specific lot codes.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
GMAX SYR 10ML/LS syringes (model TS2210S-M) without needles are being recalled because their piston sizes don't match the medical devices they were cleared for. This mismatch could lead to improper use in medical settings.
The syringes have piston sizes and configurations that don't match the medical devices cleared by the manufacturer. This mismatch could cause improper use or ineffective medical procedures if used with devices intended for different specifications.
Users of these non-sterile syringes for medical purposes are affected. Healthcare professionals and patients using the recalled model may be at risk.
Check for the model number TS2210S-M on the syringe. Look for lot codes: SL21030105, SL21040104, SL21070104, SL21090105, SL21110104, SL21110304, SL21120104, SL22030105, SL22070106, SL22100205, SL22120203, SL23020204, SL23080305, SL23100405, SL23120405.
Identify the model number on the syringe, which should be TS2210S-M for recalled units.
Check for specific lot codes listed in the recall notice to confirm if the syringe is affected.
The recall states that the syringes have piston sizes outside the cleared range, so they may not be safe for medical use. The manufacturer recommends checking the model and lot codes.
The recall does not specify a remedy, so you should check the model and lot codes to determine if your syringes are affected. If they match, contact the manufacturer for guidance.
The hazard description indicates a potential mismatch with cleared devices, which could lead to improper use. However, the exact risk level is not specified in the recall notice.
We’ve drafted a message you can send GMAX to request your refund or repair — edit it as you like.
Subject: Recall Z-2117-2024 — GMAX GMAX Hello, I own a GMAX that is covered by recall Z-2117-2024 from GMAX. 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.
