The Recall Desk
HighFDA (Devices)·Z-0430-2024·Announced 2023-12-13

ProCuity Hospital Patient Beds Recalled for Missing Electrical Safety Testing

Stryker is recalling ProCuity bed series model 3009 because they are missing electrical safety test values, presenting a risk of tissue burn or electrical shock to patients.

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: This is a risk-of-harm product involving electrical safety hazards (electrical shock and tissue burn). The source text does not report any injuries or illnesses, keeping the score at the maximum of 3 per the rubric.

Plain-English summary

Stryker Medical Division of Stryker Corporation is recalling ProCuity bed series, model number 3009 (item number 3009PX-LEX-450), because the devices are missing test values for electrical safety tests. This missing testing presents a risk of tissue burn or electrical shock to patients.

The affected beds were distributed nationwide in the United States, Puerto Rico, and internationally in Australia, Canada, Chile, China, Mexico, Poland, Spain, and Switzerland.

Healthcare facilities and patients using these beds should contact Stryker Medical Division immediately for guidance on remediation. The recall affects units with specific serial numbers identified by the manufacturer.

The recalled product

Product
ProCuity bed series, model number 3009, item number: 3009PX-LEX-450.
Manufacturer
Stryker Medical Division of Stryker Corporation
Category
Medical Device — Hospital Beds
Hazard

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 (20)

  • UDI-DI (GTIN): 07613327541236. Serial numbers: 2207000806
  • 2101001244
  • 2206000635
  • 2206000628
  • 2206000626
  • 2206000483
  • 2206000479
  • 2206000412
  • 2206000405
  • 2206000401
  • 2206000177
  • 2205000560
  • 2107001062
  • 2107001046
  • 2205000843
  • 2205000841
  • 2205000840
  • 2205000836
  • 2205000832
  • 2208000197

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 13 recalled by Stryker Medical Division of Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 13 products in this recall →

Related recalls

Same manufacturer · Stryker Medical Division of Stryker Corporation

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Same hazard · electrical shock

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