Rapicide PA High-Level Disinfectant ML020117Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00724995245962), received between Jul 9, 2026 and Sep 10, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K082988); 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.

Recalls naming this device

1. Sep 21, 2026Open, Classified

   If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted during opening, which could result in user exposure if required personal protective equipment (PPE) is not properly used. Such exposure may result in injury to the user or others in close proximity.

   Z-0156-2027 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50721691 ↗
• MalfunctionAug 28, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50498790 ↗
• InjuryAug 13, 2026Device Handling Problem

  The user facility reported while an employee was utilizing a Rapicide PA Test Strip test after a cycle, the collection container was dropped subsequently causing Rapicide PA High-Level Disinfectant to splash into the employee¿s eye. The employee flushed their eyes with water and sought treatment at the facility¿s Emergency Department.

  Patient problems: Eye Irritation

  MAUDE report 50238207 ↗
• InjuryJul 31, 2026Leak/Splash

  The user facility reported that an employee came into contact with Rapicide PA High-level Disinfectant and sustained a burn. It is unknown whether medical treatment was sought or administered.

  Patient problems: Burn(s)

  MAUDE report 50098269 ↗
• MalfunctionJul 16, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25846920 ↗
• MalfunctionJul 9, 2026Leak/Splash

  Patient problems: Upper Respiratory Tract Irritation

  MAUDE report 25770997 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082988. One submission often covers many models, so check the product and lot details in each record.

• Z-0154-2027 · Sep 21, 2026 · Open, Classified
  RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115
• Z-0155-2027 · Sep 21, 2026 · Open, Classified
  RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116
• Z-0617-2024 · Nov 13, 2023 · Open, Classified
  Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru Automated Endoscope Reprocessors Model # Model Description 2-8-001 HU ZERO CHANNEL NO LT 2-8-01