Remel SWIN 2017 Model YSW4000: Potential for Out of Range Microbial Results
Remel recalls SWIN 2017 database Model YSW4000 due to potential for out of range microbial results. Affected units may need to be returned or disposed of.
Lower-risk recall
Potential for out of range microbial results
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What happened, in plain English
Remel is recalling its SWIN 2017 database Model YSW4000 because it may produce microbial test results outside the expected range. This could lead to inaccurate health assessments if used for medical testing. Read more at govinfonow.com/recall/69189-remel-swin-2017-model-ysw4000-potential-for-out-of-range.
Source Summary by GovInfoNow · govinfonow.com/recall/69189-remel-swin-2017-model-ysw4000-potential-for-out-of-range · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1939-2020
Cite this page
“Remel SWIN 2017 Model YSW4000: Potential for Out of Range Microbial Results.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69189-remel-swin-2017-model-ysw4000-potential-for-out-of-range. Based on FDA recall #Z-1939-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1939-2020%22&limit=1).
Why it’s dangerous
The device may produce microbial test results that fall outside the intended range. This could cause inaccurate health assessments if used for medical testing, potentially leading to incorrect health decisions.
Who’s affected
Users of the SWIN 2017 database Model YSW4000 for medical testing are likely affected. Healthcare professionals and labs using this device for microbial analysis are at the highest risk.
How to tell if you have this one
Check for the SWIN 2017 database Model YSW4000 label. This product was sold by Remel, Inc. in 2017.
- Brand
Remel- Category
Medical device
What to do — step by step
Check Product Label
Look for the SWIN 2017 database Model YSW4000 label on the device.
How this recall unfolded
Recall timeline
FDA terminated this recall 19 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-1939-2020 (January 4, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1939-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.