GETINGE 88-SERIESRecalls & reported problems across all models

We found 2 models of GETINGE 88-SERIES by Getinge Disinfection AB in the FDA's device registry (GUDID). Together they are named in 6 adverse event reports in the FDA's MAUDE database, received between Sep 19, 2017 and Sep 23, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fire” (3 reports).

3 FDA recall records name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

GETINGE 88-SERIES recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Aug 29, 2025Open, Classified

   Potential for device to overheat during operation if the circulation pressure calibration was not performed or had been performed incorrectly, and the low-pressure alarm is not triggered.

   Z-0016-2026 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

2. Feb 10, 2020Terminated

   Potential leakage that may occur due to ruptured spot welds in the chamber, could generate a situation for the user such as risk for slipping or infection from contaminated water

   Z-1475-2020 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗

3. Mar 2, 2018Terminated

   There is potential for a cart with disinfected goods to unload without the trolley being docked. Disinfected goods could end up falling to the floor causing risk to nearby users and damage to goods and equipment.

   Z-1380-2018 · Root cause: Software design · names 2 of these models · Recall details · FDA record ↗

Most reported GETINGE 88-SERIES problems

GETINGE 88-SERIES models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• GETINGE 88-SERIES 88-5

  Disinfector, Medical Devices
  3 recalls6 reports
• GETINGE 88-SERIES 88-5

  Disinfector, Medical Devices
  3 recalls0 reports

Recent GETINGE 88-SERIES adverse event reports

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

• MalfunctionSep 23, 2024Fire; Fire

  ON SEPTEMBER 19TH, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH THE 88-SERIES WASHER DISINFECTOR WITH THE MODEL NAME: 88-5. AS IT WAS STATED, THE WASHER DISINFECTOR CAUGHT ON FIRE AFTER ALL EMPLOYEES HAD GONE HOME. SO FAR, WE HAVE NOT BEEN INFORMED ABOUT ANY SERIOUS INJURY AS A CONSEQUENCE OF REPORTED ISSUE, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AND BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20276739 ↗
• MalfunctionOct 31, 2023Fire; Fire

  ON (B)(6) 2023 GETINGE BECAME AWARE OF AN ISSUE WITH THE 88-SERIES WASHER DISINFECTOR WITH THE MODEL NAME:88-5. AS IT WAS STATED, THE WASHER CAUGHT FIRE DURING CYCLE. IT WAS CONFIRMED THAT A FIRE ALARM STARTED AND THE FLOOR LEVEL WAS EVACUATED. SO FAR, WE HAVE NOT BEEN INFORMED ABOUT ANY SERIOUS INJURY AS A CONSEQUENCE OF REPORTED ISSUE, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AND BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18037297 ↗
• MalfunctionMar 13, 2020Inadequate User Interface; Device Handling Problem; Inadequate User Interface; Device Handling Problem

  MANUFACTURER REFERENCE NUMBER (B)(4).

  Patient problems: Hematoma

  MAUDE report 9829114 ↗
• MalfunctionOct 16, 2019Fire; Overheating of Device; Fire; Overheating of Device

  MANUFACTURER REFERENCE NUMBER (B)(4).

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9198503 ↗
• MalfunctionAug 27, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON 2ND OF AUGUST 2018 GETINGE BECAME AWARE OF AN SITUATION WHERE AN ARM OF OPERATOR WAS CAUGHT BETWEEN WASHER DISINFECTOR AND THE CART TRANSFERRED INTO THE WASHER BY THE FREE STANDING LOADER. AFTER THE INCIDENT OCCURRENCE, THE PERSON WENT TO THE EMERGENCY DEPARTMENT WHERE, AFTER THE ASSESSMENT, IT HAS BEEN CONFIRMED THAT THE ARM WAS NOT BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7817431 ↗
• MalfunctionSep 19, 2017Overheating of Device; Overheating of Device

  MANUFACTURER'S REFERENCE NUMBER TW: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 6875167 ↗

Other Getinge Disinfection AB products

• GETINGE CM320-SERIES6 models · 5 reports · 3 recalls
• Getinge Aquadis 562 models · 13 reports · 2 recalls
• GETINGE 46-SERIES3 models · 4 reports · 2 recalls
• GETINGE 86-SERIES5 models · 39 reports · 1 recall
• GETINGE 9100-SERIES6 models · 17 reports · 1 recall