BoneScalpel MXB-TRecalls & reported problems
Misonix, Inc. · Irrigation Tubeset · Class U
All models of BoneScalpel (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841626101258), received between Jun 25, 2021 and Jun 25, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
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 16, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 25, 2021Fluid/Blood Leak; Fluid/Blood Leak
ON MAY 26, 2021, MISONIX RECEIVED MEDWATCH REPORT NUMBER (B)(4) FILED BY (B)(6) MEDICAL CENTER OF A NON-CONFORMING IRRIGATION TUBESET (MXB-T). (B)(6) OF (B)(6) MEDICAL CENTER, (B)(6), REPORTED THE TUBING LEAKED WHEN SPIKED DURING A PROCEDURE ON (B)(6) 2021. THE IRRIGATION TUBESET WAS NOT USED ON THE PATIENT AND REPLACED WITH A NEW ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12071333 ↗
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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 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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