Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2025-06-27 | Z-2331-2025 | Class II | Open, Classified | Affected product show elevated cytotoxicity values. Use of affected injection needles may present a risk of intolerance reaction or allergic reaction.Distribution: US Nationwide distribution in the states of California, Connecticut, Missouri, and Ohio. | N/A | code info di |
Regulatory clearances
None linked.
Manufacturer compliance record
None in the loaded window.
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