DORO® Adaptor 3002-00Recalls & reported problems
Black Forest Medical GmbH · DORO® Swivel Adaptor · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04250435500569), received between May 9, 2025 and May 9, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Component Missing” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Component Missing2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 9, 2025Component Missing; Component Missing
CUSTOMER INFORMED US ON APRIL 14 THAT ONE OF OUR PRODUCTS COULD NOT BE USED IN A PROCEDURE BECAUSE A COMPONENT HAD COME LOOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21994594 ↗InjuryMay 9, 2025Component Missing; Component Missing
CUSTOMER INFORMED US ON APRIL 14 THAT ONE OF OUR PRODUCTS COULD NOT BE USED IN A PROCEDURE BECAUSE A COMPONENT HAD COME LOOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21994593 ↗
Other Headrest, Neurosurgical devices
- NA Head SupportSteris Corporation · HEADREST, NEUROSURGICAL1 recall5 reports
- NA Head SupportSteris Corporation · HEADREST, NEUROSURGICAL1 recall1 report
- MAYFIELD® A1012Integra Lifesciences Corporation · HEADREST, NEUROSURGICAL6 reports
- MAYFIELD® A1051Integra Lifesciences Corporation · HEADREST, NEUROSURGICAL5 reports
- DORO® Base Unit 3001-00Black Forest Medical GmbH · Headrest, Neurosurgical3 reports
- MAYFIELD® A1112Integra Lifesciences Corporation · HEADREST, NEUROSURGICAL1 report
- MAYFIELD® A1011Integra Lifesciences Corporation · HEADREST, NEUROSURGICAL1 report
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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