CLASS III ONGOING Device recall · Reported 29 Oct 2025 · FDA Enforcement Report
One Step Sterile Lancet for Single Use (3 sizes) recalled
Home Health US is recalling One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 06949517008854, distributed nationwide in the US. The recall was initiated on 25 Jul 2025 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0226-2026
- FDA event ID
- 97350
- Recalling firm
- Home Health US, Sarasota, FL
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 25 Jul 2025
- FDA classified
- 21 Oct 2025
- Reported
- 29 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 25 Jul 2025 | Recall initiated by company | |
| 21 Oct 2025 | Classified by FDA | +88 days |
| 29 Oct 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to incorrect/lack of Unique Device Identifier (UDI) codes.
Product as listed by the FDA
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.
Where it was distributed
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
Nationwide ArizonaCaliforniaFloridaIllinoisNorth CarolinaNew MexicoNew YorkTennesseeTexasVirginia
Stores named: Amazon, Online Retailers
Questions about this recall
Why was it recalled?
Due to incorrect/lack of Unique Device Identifier (UDI) codes.
Which lots are affected?
UDI-DI code / Size: 06949517008861 / 30g Lot Number: 2312290802 06949517008854 / 28g Lot Number: 2406310201 06949517008847 / 23g Lot Number: 2406310201
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Insulin Pumps & Glucose Monitors recalls
All 459| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | CA |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | CA |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | CA |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Device Malfunction | CA |
| Device | CLASS I | Omnipod (Eros) Pod recalled by Insulet | Insulet | Packaging Defects | Nationwide |