Pink Series - Hard SP000USRecalls & reported problems
Respire Medical Holdings LLC · Respire Pink Series (Herbst) - Hard · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00851861007086), received between May 1, 2019 and May 1, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Corroded” (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 18, 2026.
Most reported problems
Device problems
- Corroded1
- Crack1
- Fracture1
Patient problems
- Burn(s)1
- Ulceration1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 1, 2019Corroded; Crack; Fracture; Corroded; Crack; Fracture
ON 4/24/2019 RESPIRE MEDICAL RECEIVED A REPAIR FOR CASE (B)(4). THE DENTIST'S OFFICE STATED THAT THE PATIENT HAS A BURN ON LEFT CHEEK, AND THAT THEY BELIEVE THAT THE CHIP LEAKED AND MIXED WITH SALIVA. THE PATIENT REPORTED THIS TO THE DENTIST OFFICE ON (B)(6) 2019.
Patient problems: Burn(s); Ulceration
MAUDE report 8571028 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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