Pink Series - EF SP030USRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00851861007062), received between Jan 25, 2023 and Jan 25, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K150572); they may or may not involve this specific model.

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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 25, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT EXPERIENCES REACTION FROM METAL TO METAL IN HIS MOUTH, POSSIBLY GALVANIC SHOCK. THE PATIENT ALSO HAD SIGNIFICANT SOFT TISSUE LESIONS FROM THE SCREW/HUB PLACEMENT.

  Patient problems: Hypersensitivity/Allergic reaction; Localized Skin Lesion

  MAUDE report 16242614 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K150572. One submission often covers many models, so check the product and lot details in each record.

• Z-1947-2018 · Sep 1, 2017 · Terminated
  Respire Pink Series EF+ Oral Sleep Apnea Device.
• Z-1949-2018 · Sep 1, 2017 · Terminated
  Respire Pink+ Hard Oral Sleep Apnea Device
• Z-1948-2018 · Sep 1, 2017 · Terminated
  Respire Pink+ Hard/Soft Oral Sleep Apnea Device