Z-0226-2026Class III

One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06949517008847 23g...

Name: Z-0226-2026 One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06949517008847 23g...
Creator: Home Health US, Incorporated
Published: 2025-07-25
License: https://open.fda.gov/license/

Home Health US, Incorporated / initiated 2025-07-25 / Open, Classified / root cause: labeling and UDI

FDA source

Home Health US, Incorporated began a recall of One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06949517008847 23g The Lancing System is intended for the hygienic... on 2025-07-25. FDA classified it as Class III and gives the reason as "Due to incorrect/lack of Unique Device Identifier (UDI) codes". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0226-2026
Classification: Class III
Status: Open, Classified
Initiated: 2025-07-25
Posted: 2025-10-21
Recalling firm: Home Health US, Incorporated
Product: 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.
Product code: QRL Multiple Use Blood Lancet For Single Patient Use Only
Reason for recall: Due to incorrect/lack of Unique Device Identifier (UDI) codes.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: On 07/25/2025, the firm indicated that they notified Amazon of the recall (mis-labeling) and Amazon has returned affected products that Amazon had in their possession.
Quantity in commerce: 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
Product codes and lots: UDI-DI code / Size: 06949517008861 / 30g Lot Number: 2312290802 06949517008854 / 28g Lot Number: 2406310201 06949517008847 / 23g Lot Number: 2406310201

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0226-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0226-2026	Class III	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-21

Product code QRL

K222472Class IILancing System, Sterile Lancet for Single Use, Lancing DeviceShandong Lianfa Medical Plastic Products Co. , Ltd. / cleared 2022-11-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)