Quick Facts at a Glance
- Recall Date
- July 25, 2025
- Hazard Level
- HIGH
- Brand
- Home Health US
- Category
- Health & Personal Care
- Sold At
- Amazon
- Geographic Scope
- 10 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Home Health US
- Product type
- Sterile Lancet
- Model numbers
- 06949517008861, 06949517008854, 06949517008847
- Sizes
- 30g, 28g, 23g
- Sold at
- Amazon
- Where affected
- AZ, CA, FL, IL, NC, NM, NY, TN +2 more
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
July 25, 2025
Reported by FDA DEVICE
October 29, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Due to incorrect/lack of Unique Device Identifier (UDI) codes.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Home Health US, Incorporated or your healthcare provider for instructions. Notification method: Letter
About This Product
One Step Sterile Lancet is a single-use device used to collect capillary blood for testing from fingertip and other sites. It comes in three sizes to accommodate user preference and testing needs.
Why This Is Dangerous
The hazard stems from incorrect or missing UDI codes, which can impede device identification and postmarket safety tracking.
Industry Context
This recall is not described as part of a broader pattern in the supplied data.
Real-World Impact
The immediate impact is limited to traceability concerns. Consumers should stop use and follow recall directions to avoid regulatory or patient-tracking issues.
Practical Guidance
How to identify if yours is affected
- Verify UDI codes on the device packaging if present.
- Review the recall notice for instructions.
Where to find product info
FDA recall page and the recall notice linked by the manufacturer
What timeline to expect
The recall is active as of 2025-10-29. Processing of refunds or replacements is not specified in the notice.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- Consider contacting regulatory authorities if the company is unresponsive.
How to prevent similar issues
- Verify UDI presence in future purchases.
- Purchase lancets from reputable retailers with clear recall information.
- Keep recall notices for reference.
Documentation advice
Save the recall notice, model numbers, and any correspondence. Photograph the packaging and lancets if applicable.
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Product Details
Model numbers and sizes: - 06949517008861 — 30g, Lot Number: 2312290802 - 06949517008854 — 28g, Lot Number: 2406310201 - 06949517008847 — 23g, Lot Number: 2406310201 Where sold: U.S. nationwide via Amazon When sold: Unknown Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Sizes: 30g, 28g, 23g
- Distribution: U.S. nationwide via Amazon
- States affected: AZ, CA, FL, IL, NC, NM, NY, TN, TX, VA
- Recall date: 2025-07-25; Report date: 2025-10-29
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Safety Guide
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