One +Step LF-TL-28-IRecalls & reported problems
Shandong Lianfa Medical Plastic Products CO.,LTD · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Jul 25, 2025Class IIIOpen, Classified
Due to incorrect/lack of Unique Device Identifier (UDI) codes.
Z-0226-2026 · Root cause: Error in labeling · Recall details · FDA record ↗
Other Multiple Use Blood Lancet For Single Patient Use Only devices
- Accu-Chek Fastclix 05864666160Roche Diabetes Care GmbH · Multiple Use Blood Lancet For Single Patient Use Only70 reports
- One +Step LF-TL-23-IShandong Lianfa Medical Plastic Products CO.,LTD · Multiple Use Blood Lancet For Single Patient Use Only1 recall0 reports
- One +Step LF-TL-30-IIShandong Lianfa Medical Plastic Products CO.,LTD · Multiple Use Blood Lancet For Single Patient Use Only1 recall0 reports
- Accu-Chek Coaguchek Softclix 07313462001Roche Diabetes Care GmbH · Multiple Use Blood Lancet For Single Patient Use Only46 reports
- Accu-Chek Fastclix 07523211001Roche Diabetes Care GmbH · Multiple Use Blood Lancet For Single Patient Use Only44 reports
- Accu-Chek Coaguchek Softclix 08120242001Roche Diabetes Care GmbH · Multiple Use Blood Lancet For Single Patient Use Only11 reports
- Accu-Chek Fastclix 05360145001Roche Diabetes Care GmbH · Multiple Use Blood Lancet For Single Patient Use Only7 reports
- MICROLET® 6586 / 6586WAscensia Diabetes Care US Inc. · Multiple Use Blood Lancet For Single Patient Use Only3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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