FDA recalls Sol-M Syringe Tip Caps (blue/red models) due to being substantially different from cleared 510(k)s. Affected units sold in Canada with specific model numbers and lot numbers.
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-M Medical Inc. recalls blue and red syringe tip caps that were found by the FDA to be substantially different from their cleared medical devices. This means the caps may not work as intended for medical use, potentially causing safety issues.
The FDA determined the recalled syringe tip caps differ significantly from the intended medical use as cleared by the FDA. This could mean the caps don't function properly during medical procedures, but the risk is not described as causing serious injury.
Healthcare professionals and patients using syringe tip caps in Canada. Those with the specific model numbers and lot numbers listed are most at risk.
Check for blue or red syringe tip caps with model numbers STCB01 (blue), STCB02 (red), or 110101150020 (red). These were sold in Canada with specific lot numbers listed in the recall.
Identify the model number and lot number on the syringe tip cap to see if it matches the recalled items listed in the notice.
The FDA found the recalled syringe caps to be substantially different from the cleared medical devices, so they may not function as intended. Use only the non-recalled products.
The recalled products were sold in Canada with specific model numbers and lot numbers listed in the recall notice.
Check the model number and lot number on the syringe cap. Blue caps with model STCB01 (lot numbers 4201063, 4209005, etc.) and red caps with model STCB02 or 110101150020 are affected.
We’ve drafted a message you can send Sol-M to request your refund or repair — edit it as you like.
Subject: Recall Z-3079-2024 — Sol-M Sol-M Hello, I own a Sol-M that is covered by recall Z-3079-2024 from Sol-M. 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.
