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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90146

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 13, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Getinge Usa Sales Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, etc. Model: CM320 WU

Z-1248-2022
Recall number
Z-1248-2022
Initiated
April 13, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Getinge Usa Sales Inc
Quantity
4 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a crush or pinch injury or slip and fall injury. May lead to a patient procedural delay and/or infection

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a crush or pinch injury or slip and fall injury. May lead to a patient procedural delay and/or infection

Code information

UDI-DI: 07340153700185 Serial Numbers: W50034570 WAA070170 WAA070618 WAA081312

Distribution pattern

US Nationwide distribution in the states of MD, MN, ND, NE, NY, PA, VA.

device · product 2 of 2

Getinge CM320 WUWD Series Washer Disinfector-For use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, Model: CM320 WUWD

Z-1249-2022
Recall number
Z-1249-2022
Initiated
April 13, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Getinge Usa Sales Inc
Quantity
11 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a crush or pinch injury or slip and fall injury. May lead to a patient procedural delay and/or infection

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a crush or pinch injury or slip and fall injury. May lead to a patient procedural delay and/or infection

Code information

UDI-DI: 07340153700192 Serial Numbers: W50026718 W50029991 WAA081312 W50039234 WAA062340 WAA062341 WAA070619 WAA085063 WAA089556 WAA093936 WAA094247

Distribution pattern

US Nationwide distribution in the states of MD, MN, ND, NE, NY, PA, VA.