GMAX SYR 60ML/LL Blue syringes (model TS2260LB-M) are recalled due to being cleared for use outside approved medical device standards. This could lead to improper medical use if used without proper clearance.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
GMAX SYR 60ML/LL Blue syringes (model TS2260LB-M) are being recalled because they were not approved for the intended medical use. Using these syringes could lead to improper medical procedures if they don't meet the required safety standards.
The syringes were not cleared by the manufacturer for the intended medical use. This means they may not meet the required safety standards for medical procedures, potentially leading to improper use or complications.
Users of GMAX SYR 60ML/LL Blue syringes (model TS2260LB-M) with lot codes SL22080108, SL23020210, or SL23040209 are affected. Healthcare providers and patients using these syringes for medical procedures are at risk.
Check for the model number TS2260LB-M on the syringe. Look for lot codes SL22080108, SL23020210, or SL23040209 on the packaging or label.
Identify the lot code on the syringe packaging or label to determine if it is affected (SL22080108, SL23020210, or SL23040209).
The recall states these syringes were not cleared for the intended medical use, so they may not meet safety standards. Do not use them for medical procedures.
Check the lot code on the syringe packaging. If it matches SL22080108, SL23020210, or SL23040209, contact the manufacturer for instructions.
The syringes were not cleared by the manufacturer for the intended medical use, meaning they may not meet the required safety standards for medical procedures.
We’ve drafted a message you can send GMAX to request your refund or repair — edit it as you like.
Subject: Recall Z-2123-2024 — GMAX GMAX Hello, I own a GMAX that is covered by recall Z-2123-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
