Henry Schein 5701766Recalls & reported problems
Henry Schein, Inc. · Low Speed Contra Angle Head · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00304040126424), received between Aug 24, 2023 and Aug 28, 2023 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Insufficient Device Problem Information2
- Misassembly by Users2
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
HEAD PART OF DEVICE FELL APART INTO PATIENT'S MOUTH DURING REMOVAL OF DECAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17639079 ↗MalfunctionAug 28, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
HEAD PART OF DEVICE FELL APART INTO PATIENT'S MOUTH DURING REMOVAL OF DECAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17639078 ↗InjuryAug 24, 2023Detachment of Device or Device Component; Misassembly by Users; Detachment of Device or Device Component; Misassembly by Users
HEAD PART OF DEVICE FELL APART INTO PATIENT'S MOUTH DURING REMOVAL OF DECAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17613385 ↗InjuryAug 24, 2023Detachment of Device or Device Component; Misassembly by Users; Detachment of Device or Device Component; Misassembly by Users
HEAD PART OF DEVICE FELL APART INTO PATIENT'S MOUTH DURING REMOVAL OF DECAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17613304 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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