The Recall Desk
HighFDA (Devices)·Z-1248-2022·Announced 2022-06-15

Getinge CM320-2 Surgical Instrument Washer Disinfector Recalled for Incomplete Installation Verification

Getinge recalls its CM320-2 washer disinfector due to unverified or incomplete installation, which could cause skin burns, electric shock, smoke inhalation, or crush injuries. Four units were distributed across seven US states.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Classified by FDA as Class II, this recall represents a risk-of-harm product where no injuries or illnesses have been reported, meeting the rubric criterion for High severity. The potential hazards—skin burns, electrical shock, crush injuries—are significant but theoretical pending proper installation verification.

Plain-English summary

The Getinge CM320-2 CHAMBER WU Series Washer Disinfector is a multi-chamber device used in healthcare settings to wash, disinfect, and dry surgical instruments. The FDA has recalled four units (serial numbers W50034570, WAA070170, WAA070618, and WAA081312) because verification of proper installation was not documented or may be incomplete.

Incomplete installation documentation creates potential for serious user harm. The hazard can result in skin burns, smoke inhalation, electrical shock, crush or pinch injuries, or slip and fall hazards. These installation issues may also delay patient procedures and increase infection risk if surgical instruments are not properly processed.

The affected units were distributed nationwide to healthcare facilities in Maryland, Minnesota, North Dakota, Nebraska, New York, Pennsylvania, and Virginia. Facilities operating these devices should verify installation documentation is complete and contact Getinge Usa Sales Inc for guidance.

The recalled product

Product
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
Manufacturer
Getinge Usa Sales Inc
Category
Medical Device — Sterilization Equipment
Hazard
  • skin-burns
  • smoke-inhalation
  • electric-shock
  • crush-pinch-injury
  • slip-fall-injury
  • infection-risk
  • installation-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

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

Distribution

Distributed nationwide across the United States.

Related recalls

Same category