Medline Stanbio TDM Controls Recall: Shipped at Room Temperature
Medline recalls Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls shipped without refrigeration. Affected units may degrade test results. Contact Medline for details.
Lower-risk recall
Affected product was shipped from the warehouse at room temperature instead of the required refrigerated environment.
Contact the company
What happened, in plain English
Medline is recalling Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls that were shipped at room temperature instead of refrigerated. This could cause inaccurate test results if used. Read more at govinfonow.com/recall/61492-medline-stanbio-tdm-controls-recall-shipped-at-room-temperature.
Source Summary by GovInfoNow · govinfonow.com/recall/61492-medline-stanbio-tdm-controls-recall-shipped-at-room-temperature · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0404-2022
Cite this page
“Medline Stanbio TDM Controls Recall: Shipped at Room Temperature.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61492-medline-stanbio-tdm-controls-recall-shipped-at-room-temperature. Based on FDA recall #Z-0404-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0404-2022%22&limit=1).
Why it’s dangerous
The product was shipped at room temperature instead of refrigerated. This could cause the test strips to degrade, leading to inaccurate blood test results. The hazard does not pose a direct physical risk to users.
Who’s affected
Users of the Stanbio TDM controls who purchased them between 2016 and 2017 are likely affected. Those using the devices for medical testing are at higher risk of inaccurate results.
How to tell if you have this one
Check for model number S-O2460605 and batch numbers 161603, 165148, 156205, 158144, 169124, 171961, or 175250. The product was sold from 2016 to 2017.
- Brand
Medline- Category
Medical device
What to do — step by step
Check Product Details
Verify the model number and batch numbers listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 4 states.
FDA distribution: “US Nationwide distribution in the states of IL, OH, MS, and PA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Illinois, Mississippi, Ohio, Pennsylvania.
Recall timeline
FDA terminated this recall 13 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-0404-2022 (November 30, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0404-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.