Digital Ultra Flushmount Package H 56800Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813830023510), received between Dec 29, 2023 and Nov 21, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K052335); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  DISTRIBUTOR REPORTED PATIENTS GETTING SICK ON N2O. TWO PATIENTS VOMITED MID-TREATMENT ON DIFFERENT DAYS IN THIS SAME ROOM.

  Patient problems: Vomiting

  MAUDE report 23620054 ↗
• MalfunctionDec 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT PATIENTS ARE "REACTING UNUSUAL TO NITROUS".

  Patient problems: Insufficient Information

  MAUDE report 18418568 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K052335. One submission often covers many models, so check the product and lot details in each record.

• Z-0018-2013 · Apr 29, 2012 · Terminated
  Ultra PC% Cabinet Mount Package G, Model #36600, Serial # 13593, 13594, 13595, 13596, 13597, 13598, 13599, 13600, 13602, 13605, 13610, 13611, 13612, 13615, 13616, 13617, 13621, 13
• Z-0017-2013 · Apr 29, 2012 · Terminated
  Flow Meter, CM Assembly, Model #27025, Serial # 13686, 13690, 13712, 13793. Flowmeter, CM Assembly, Model#31970, Serial#13692. Product Usage: Conscious Sedation Unit Analgesia
• Z-0019-2013 · Apr 29, 2012 · Terminated
  CM Flowmeter Pkg H, Model #36700, Serial # 13749 Product Usage: Conscious Sedation Unit Analgesia Gas Machine.
• Z-0020-2013 · Apr 29, 2012 · Terminated
  Newport Portable Package, Model #50000, Serial # 13591, 13592, 13604, 13606, 13614, 13662, 13663, 13664, 13726, 13731, 13733, 13736, 13737, 13738, 13740, 13768, 13770, 13771, 1377