Severity
Low
LowClass IIIOngoing
FDA Devices recall · Reported October 29, 2025
One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06949517008847 23g The Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.
Due to incorrect/lack of Unique Device Identifier (UDI) codes.
Home Health US, Incorporated recalled One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 … — a low-severity action.
One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 … was recalled by Home Health US, Incorporated in October 29, 2025. Reason: Due to incorrect/lack of Unique Device Identifier (UDI) codes.. Check the official notice for the remedy. Verify recall #Z-0226-2026 with the FDA Devices before acting.
The recall
Home Health US, Incorporated issued this low-severity FDA Devices recall — Due to incorrect/lack of Unique Device Identifier (UDI) codes..
- Low
- severity level
- Class III
- classification
- October 29, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0226-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0226-2026) was formally reported on October 29, 2025, with the manufacturer initiating the action on July 25, 2025. It is classified under Low severity (Class III), with a current status of Ongoing. Home Health US, Incorporated is listed as the recalling firm, operating out of Sarasota, FL. Federal records list the affected scope as 4,661 lancets.
The documented reason for this recall is: Due to incorrect/lack of Unique Device Identifier (UDI) codes. Distribution data in the federal record shows the product reached: U.S.: Nation-wide distributed thru Amazon U.S. States include: AZ, CA, FL, IL, NC, NM, NY, TN, TX, and VA. O.U.S.: N/A. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.
Affected scope
4,661 lancets
Related Recalls
6
6 from same agency
Product description
One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06949517008847 23g The Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.
Reason for recall
Due to incorrect/lack of Unique Device Identifier (UDI) codes.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Ongoing |
| Recall number | Z-0226-2026 |
| Date reported | October 29, 2025 |
| Date initiated | July 25, 2025 |
| Recalling firm | Home Health US, Incorporated |
| Firm location | Sarasota, FL |
| Affected scope | 4,661 lancets |
| Distribution | U.S.: Nation-wide distributed thru Amazon U.S. States include: AZ, CA, FL, IL, NC, NM, NY, TN, TX, and VA. O.U.S.: N/A |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0226-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting — recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06949517008847 23g The Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.. Recalled by Home Health US, Incorporated. Units affected: 4,661 lancets.
Why was this product recalled? ▼
Due to incorrect/lack of Unique Device Identifier (UDI) codes.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 29, 2025. Severity: Low. Recall number: Z-0226-2026.
Where was the recalled product distributed? ▼
Distribution: U.S.: Nation-wide distributed thru Amazon U.S. States include: AZ, CA, FL, IL, NC, NM, NY, TN, TX, and VA. O.U.S.: N/A.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0226-2026) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported October 29, 2025.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.