FDA Device Recall Z-0016-2026: Getinge Disinfection Ab Ljungadalsgatan

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0016-2026.

Recall Res Number

Z-0016-2026

Recalling Firm / Manufacturer

Getinge Disinfection Ab Ljungadalsgatan

FEI Number

3000231474

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2025-08-29

Date Posted

2025-10-01

Date Terminated

N/A

Product Code

MEC

Event Number

97535

Product Quantity

902 units

Product Description Getinge 88-Series Washer- Disinfector. Model Number: 88-5.

Reason for Recall 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.

Action Details Getinge notified consignees on about 08/29/2025 via letter. Consignees were instructed that Getinge service technicians will be proactively reaching out to ensure affected devices are calibrated appropriately. In the meantime, Getinge has developed a verification procedure to ensure that the circulation pressure in standby mode is correctly calibrated to 0.0 kPa. If the value deviates, recalibration by a qualified technician is required. The verification of the circulation pressure shall be performed by the operator or Getinge technician. If the value deviates from 0.0 kPa out of allowed tolerances (1 kPa), stop using the device immediately and work with your Getinge service technician to arrange recalibration. Consignees were also instructed to ensure all caregivers and users of the affected product are made aware of the recall and to complete and return the provided response form. ***UPDATE 10/16/2025: Firm notified FDA of an expansion to include additional OUS units and one additional complaint. ***UPDATE 03/02/2026: Firm notified FDA of an expansion to include additional OUS units and one additional complaint.

Distribution Pattern Worldwide - US Nationwide distribution in the states of Colorado, Massachusetts, New Mexico, New Hampshire and the countries of Algeria, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Austria, Hong Kong, Hungary, India, Iraq, Ireland, Israel, Italy, Japan, Kenya, Korea, Republic of, Kuwait, Lithuania, Mexico, Netherlands, Norway, New Zealand, Poland, Qatar, Romania, Saudi Arabia, Singapore, Spain, Sweden, Thailand, Turkey, United Arab Emirates, United Kingdom.

Code Information / Serial Numbers Model Number: 88-5. UDI-DI Numbers: 07340153700109, 07340153700116. Software Version: GD 14080 Rev A. All Lot Numbers with electrical heating.

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Heuer International (A division of GST Corporation Limited) Registration: 3005273623 View Registration
STEELCO S.P.A. Registration: 3005544459 View Registration
SUNSET HEALTHCARE SOLUTIONS, Inc. Registration: 3006446479 View Registration
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MIELE & CIE. KG Registration: 3010208143 View Registration
BELLUS MEDICAL, LLC Registration: 3010392991 View Registration
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Sunset Healthcare Solutions Central Warehouse Registration: 3010834934 View Registration
SHENZHEN DENCO MEDICAL CO., LTD. Registration: 3011554142 View Registration
REHABILITATION EQUIPMENT ASSOCIATES, INC Registration: 3012006473 View Registration
DONGGUAN I-BELIEVE ELECTRONIC APPLIANCE CO., LTD. Registration: 3012776156 View Registration
You First Services, Inc. Registration: 3014268952 View Registration
SHENZHEN ROGIN MEDICAL CO., LTD Registration: 3015136927 View Registration
DONGGUAN YINGFENG METAL & PLASTIC PRODUCTS CO., LTD Registration: 3015977541 View Registration
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SUMER ULUSLARARASI SAN. VE TIC. A.S. Registration: 3017847344 View Registration
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ENDONEST MEDICAL SYSTEMS LLP Registration: 3030516433 View Registration
GUANGDONG ERACLEAN TECHNOLOGY CO.,LTD Registration: 3030536467 View Registration
AD SUPPLY GROUP LIMITED Registration: 3030733800 View Registration
GETINGE AB Registration: 3031563141 View Registration
ELEDRICITY Registration: 3042250638 View Registration
RESTEC SOLUTIONS, LLC Registration: 3043861826 View Registration
ALBERT BROWNE LTD. Registration: 8021896 View Registration
SCICAN LTD. Registration: 8043629 View Registration
GETINGE DISINFECTION AB Registration: 9616031 View Registration
MEDISAFE UK LTD. Registration: 9617134 View Registration
BAUMER S.A. Registration: 9680101 View Registration
STERIS Canada ULC Registration: 9680353 View Registration

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Medical Device Recall: Z-0016-2026

Recall Parameters & Description

Related Establishments / Registrations

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