Blue Ortho GPS Trackers: Instructions For Use Document Language Appropriateness
Blue Ortho recalls specific GPS Tracker models (A100003, A100004, A100005, A100006) due to potential language issues in reprocessing instructions. Affected units have listed serial numbers.
Lower-risk recall
Appropriateness of the language used in the Tracker reprocessing instruction. Reason is that some Low Temperature sterilization conditions mentioned in the IFUs are approved based on rational documents.
Contact the company
What happened, in plain English
Blue Ortho is recalling GPS Trackers with specific model numbers and serial numbers because the Instructions For Use document contains language that may not be appropriate for low-temperature sterilization procedures. This recall addresses potential confusion in following sterilization guidelines, though it does not pose an immediate safety risk. Read more at govinfonow.com/recall/64312-blue-ortho-gps-trackers-instructions-for-use-document-language-appropriateness.
Source Summary by GovInfoNow · govinfonow.com/recall/64312-blue-ortho-gps-trackers-instructions-for-use-document-language-appropriateness · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0288-2021
Cite this page
“Blue Ortho GPS Trackers: Instructions For Use Document Language Appropriateness.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64312-blue-ortho-gps-trackers-instructions-for-use-document-language-appropriateness. Based on FDA recall #Z-0288-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0288-2021%22&limit=1).
Why it’s dangerous
The Instructions For Use document mentions low-temperature sterilization conditions that are approved based on rational documents, but the language used may not be clear or appropriate for certain users. This could lead to confusion when following sterilization procedures, especially in healthcare settings where precise instructions are critical.
Who’s affected
Users of Blue Ortho GPS Trackers with model numbers A100003, A100004, A100005, or A100006 and the listed serial numbers are affected. Healthcare facilities using these devices for sterilization processes are most at risk due to potential misinterpretation of instructions.
How to tell if you have this one
Check your GPS Tracker for model numbers A100003, A100004, A100005, or A100006. The specific serial numbers listed in the recall record indicate which units are affected.
- Brand
Blue Ortho- Category
Medical device
What to do — step by step
Check Product Model
Identify your GPS Tracker's model number (A100003, A100004, A100005, or A100006) to determine if it is affected.
Review Serial Numbers
Compare your Tracker's serial number against the list provided in the recall to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed in 4 states.
FDA distribution: “Domestic Distribution Only: CA, CO, SC and WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Colorado, South Carolina, Wisconsin.
Recall timeline
FDA terminated this recall 2.7 years 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.
Questions people ask
Is this a safety hazard?
This recall addresses potential confusion in instructions, not an immediate safety risk. The hazard level is low risk as it does not involve physical harm or injury.
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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-0288-2021 (September 10, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0288-2021 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.