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MicronJet
NANOPASS TECHNOLOGIES LTD · Model 800X3 · UDI-DI 17290015928271
FMI
Prescription
1
510(k) clearances
40,761
Adverse events (72 deaths)
311
Recalls
450
Facilities
Description
A female luer connector equipped with a chip having 3 microneedles; each microneedle is 0.8 mm (800 micron) in length (height). This device can be mounted on any standard syringe (luer slip or luer lock connection)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-30 | Bard Access Systems, Inc. | After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases, users may exp |
| 2025-06-05 | Waismed Ltd. | Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion. |
| 2025-06-05 | Waismed Ltd. | Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion. |
| 2024-11-19 | Greiner Bio-One GmbH | The VACUETTE SAFELINK Holder with male luer lock may leak blood due to the protective rubber sleeve bunching up and not retracting when using the device. |
| 2024-06-18 | Embecta Corp. | BD Nano 2nd Gen Pen Needle was shipped close to or after the labeled expiration date of February 29, 2024. Using a device past its expiry sterility and integrity of the device cann |
| 2024-02-05 | Retractable Technologies, Inc. | The needle cannula of a retractable needle may detach from the needle holder in the patient. |
| 2023-08-22 | Apellis Pharmaceuticals, Inc. | 19-gauge x 1" inch filter needles showed appearances of a small fraction of non-preferred characteristics. A causal relationship has not been established between the structural var |
| 2023-07-26 | embecta Medical II LLC | Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices. |
| 2023-07-26 | embecta Medical II LLC | Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices. |
| 2022-06-20 | Bard Access Systems, Inc. | BD Intraosseous Needle Kits may exhibit: 1) Increased force required to remove the stylet from intraosseous needle during placement may cause removal of the entire needle assembly |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.