FDA Device recall Z-1078-2022

Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW

FDA Device
Class II
ongoing
Published 2022-05-25

On 2022-05-25 the FDA classified a Class II recall of Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW by Getinge Usa Sales, citing inadequate documentation verifying whether device installation has been executed in accordance with the manufacturer's requirements. This can lead to installation failure modes an….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1078-2022
Classification	Class II
Status	ongoing
Initiated	2022-04-01
Published	2022-05-25
Last updated	2026-09-13 11:56 UTC
Company	Getinge Usa Sales
Distribution	AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, PA, PR, SC, SD, TX, VA, WA, WV

Product

Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW.

Reason

Inadequate documentation verifying whether device installation has been executed in accordance with the manufacturer's requirements. This can lead to installation failure modes and hazardous situations.

Identifiers

code_info	UDI Codes: [07340153710023, 07340153710047, 07340153710054, 07340153710061, 9122EW 07340153710030, 07340153710078.]… UDI Codes: [07340153710023, 07340153710047, 07340153710054, 07340153710061, 9122EW 07340153710030, 07340153710078.] Serial Numbers: WAA088008, WAA088276, WAA089054, WAA089188, WAA089511, WAA091312, WAA092134, WAA097871, WAA098978, WAA087395, WAA087675, WAA087676, WAA088563, WAA088677, WAA088684, WAA088798, WAA088973, WAA090326, WAA090827, WAA090829, WAA091562, WAA092656, WAA092905, WAA093809, WAA094122, WAA094447, WAA095653, WAA095654, WAA095655, WAA096084, WAA096723, WAA096820, WAA099698, WAA100249, WAA100596, WAA100828, WAA102416, WAA102300, WAA102301, WAA086373, WAA088830, WAA089854, WAA089735, WAA089736, WAA090141, WAA090273, WAA090274, WAA091427, WAA093786, WAA094342, WAA095013, WAA095014, WAA096724, WAA098589, WAA099164, WAA098725, WAA100514, WAA100695, WAA100704, WAA100832, WAA101375, WAA100834, WAA101893, WAA076270, WAA085559, WAA086376, WAA086914, WAA086915, WAA088007, WAA088273, WAA088464, WAA088465, WAA087754, WAA088678, WAA088685, WAA088871, WAA088998, WAA089258, WAA0893

code_info

UDI Codes: [07340153710023, 07340153710047, 07340153710054, 07340153710061, 9122EW 07340153710030, 07340153710078.]…

UDI Codes: [07340153710023, 07340153710047, 07340153710054, 07340153710061, 9122EW 07340153710030, 07340153710078.] Serial Numbers: WAA088008, WAA088276, WAA089054, WAA089188, WAA089511, WAA091312, WAA092134, WAA097871, WAA098978, WAA087395, WAA087675, WAA087676, WAA088563, WAA088677, WAA088684, WAA088798, WAA088973, WAA090326, WAA090827, WAA090829, WAA091562, WAA092656, WAA092905, WAA093809, WAA094122, WAA094447, WAA095653, WAA095654, WAA095655, WAA096084, WAA096723, WAA096820, WAA099698, WAA100249, WAA100596, WAA100828, WAA102416, WAA102300, WAA102301, WAA086373, WAA088830, WAA089854, WAA089735, WAA089736, WAA090141, WAA090273, WAA090274, WAA091427, WAA093786, WAA094342, WAA095013, WAA095014, WAA096724, WAA098589, WAA099164, WAA098725, WAA100514, WAA100695, WAA100704, WAA100832, WAA101375, WAA100834, WAA101893, WAA076270, WAA085559, WAA086376, WAA086914, WAA086915, WAA088007, WAA088273, WAA088464, WAA088465, WAA087754, WAA088678, WAA088685, WAA088871, WAA088998, WAA089258, WAA0893

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1078-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.