Sol-Millennium Medical Inc. recalls syringes with low dead space that differ from FDA-cleared models. Affected products include specific models and lot numbers sold in Canada and the US. Stop using immediately to avoid potential safety risks.
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 labeled as having low dead space because they were found to be substantially different from the FDA-cleared versions. This could pose a safety risk if used improperly. Affected products include specific models and lot numbers sold in Canada and the US.
The syringes were found by the FDA to be substantially different from the current cleared 510(k)s, meaning they may not function as intended. This could lead to improper dosing or other safety issues if used without the correct specifications.
People who own or use the recalled syringes, especially those in medical settings or for self-injections, are at risk. The recall affects specific models and lot numbers sold in Canada and the US.
Check for syringes labeled with low dead space, including models like SOL-M 1ml Slip Tip Syringe w/o needle (Model No. 180011LDS), SOL-CARE 1ml Luer Lock Syringe w/Safety Needle (Model No. 12558LDS), and others listed in the recall notice. Products sold in Canada are also affected.
Discard any recalled syringes to avoid potential safety risks.
No, the FDA found these syringes to be substantially different from the cleared models, so they are not safe to use as intended.
Affected models include SOL-M 1ml Slip Tip Syringe w/o needle (Model No. 180011LDS), SOL-M 1ml Luer Lock Syringe w/Exch Needle 23G*1", and others with specific lot numbers listed in the recall notice.
Lot numbers are provided for each model in the recall notice, such as 1102070 for Model No. 180011LDS.
We’ve drafted a message you can send Sol-Millennium to request your refund or repair — edit it as you like.
Subject: Recall Z-3078-2024 — Sol-Millennium Sol-Millennium Hello, I own a Sol-Millennium that is covered by recall Z-3078-2024 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.
