Sol-Millennium Medical Inc. recalls syringes with fixed needles (SOL-M, SOL-CARE, MEDLINE, MONOJECT, HENRY SCHEIN) due to FDA finding they are substantially different from cleared 510(k)s with major changes to intended use. Check model numbers and lot numbers for affected items.
Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
Sol-Millennium Medical Inc. is recalling syringes with fixed needles and safety needles that were found by the FDA to be substantially different from the current cleared 510(k) devices. This recall affects specific syringe models and lot numbers across multiple brands.
The FDA determined that the recalled syringes differ substantially from the cleared 510(k) devices, indicating a major change or modification to the intended use. This could lead to improper function or safety issues during medical procedures.
Users of syringes with fixed needles or safety needles from Sol-Millennium Medical Inc. that match the listed model numbers and lot numbers are affected. Healthcare professionals and patients using these syringes for medical injections are most at risk.
Check for syringes labeled with SOL-M, SOL-CARE, MEDLINE, MONOJECT, or HENRY SCHEIN brands. Look for specific model numbers and lot numbers listed in the recall notice. The product names include syringes with fixed needles or safety needles.
Identify your syringe model number and lot number to confirm if it's affected by this recall.
The FDA found that these syringes are substantially different from the cleared 510(k) devices with a major change or modification to the intended use.
Check the model number and lot number against the list provided in the recall notice. Affected syringes include SOL-M, SOL-CARE, MEDLINE, MONOJECT, and HENRY SCHEIN brands with specific model numbers and lot numbers.
The recall does not specify a remedy, so contact Sol-Millennium Medical Inc. for guidance on next steps.
We’ve drafted a message you can send Sol-Millennium to request your refund or repair — edit it as you like.
Subject: Recall Z-3074-2024 — Sol-Millennium Sol-Millennium Hello, I own a Sol-Millennium that is covered by recall Z-3074-2024 from Sol-Millennium. 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.
