GMAX SYR 60ML/LS syringes (model TS2260S-M) without needles are recalled due to incorrect medical device clearance. These non-sterile syringes may not be safe for medical use as they don't meet regulatory standards.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
GMAX SYR 60ML/LS syringes (model TS2260S-M) without needles are being recalled because they were not cleared for medical use. Using these syringes could lead to incorrect medical procedures if they don't meet regulatory standards.
These syringes were not cleared by the manufacturer for medical use. They may not function correctly or meet safety standards, which could lead to incorrect medical procedures.
Users of these syringes for medical purposes are affected. Healthcare providers and patients using non-sterile syringes for injections may be at risk.
Check for the model number TS2260S-M on the syringe. These non-sterile syringes without needles were sold with lot codes including SL21030109, SL21070111, and others.
Look for the model number TS2260S-M on the syringe to confirm it is part of the recall.
No, these syringes were not cleared for medical use and may not function correctly.
Lot codes SL21030109, SL21070111, SL21090111, SL21110111, SL21120110, SL22030111, SL22080107, SL22100213, SL23080312, and SL23100411 are affected.
The recall record does not specify a return process or remedy.
We’ve drafted a message you can send GMAX to request your refund or repair — edit it as you like.
Subject: Recall Z-2120-2024 — GMAX GMAX Hello, I own a GMAX that is covered by recall Z-2120-2024 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.
