The Recall Desk
HighFDA (Devices)·Z-0426-2024·Announced 2023-12-13

ProCuity Hospital Beds Missing Electrical Safety Test Data

Stryker's ProCuity bed series model 3009 lacks required electrical safety test documentation, creating a risk of tissue burns or electrical shock. The beds are distributed across North America, Europe, and other regions.

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 Class II medical device recall involving potential for serious patient harm (electrical shock and tissue burns) from missing electrical safety testing. No illnesses or injuries have been reported, making this a risk-of-harm situation that qualifies as High severity per the rubric.

Plain-English summary

Stryker Medical Division has recalled ProCuity bed series model 3009 (item number 3009PX-L-200) due to missing electrical safety test values. Patient beds in this model line lack the required test documentation for electrical safety compliance.

The missing test values present a risk of tissue burns or electrical shock to patients. Electrical safety testing is critical for medical devices that patients interact with directly, and incomplete testing data raises patient safety concerns.

The affected beds were distributed to hospitals and healthcare facilities in the United States (including Puerto Rico), Canada, Mexico, Australia, Chile, China, Poland, Spain, and Switzerland.

Healthcare facilities using ProCuity model 3009 beds should contact Stryker Medical Division directly for remediation guidance. The FDA recall notice includes specific serial numbers of affected units and further details.

The recalled product

Product
ProCuity bed series, model number 3009, item number: 3009PX-L-200
Manufacturer
Stryker Medical Division of Stryker Corporation
Category
Medical Device — Hospital Equipment
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 (14)

  • UDI-DI (GTIN): 07613327541199 Serial numbers: 2211000305
  • 2112000828
  • 2109001676
  • 2109001666
  • 2209002657
  • 2208001565
  • 2208001555
  • 2208001541
  • 2203002178
  • 2203002161
  • 2203002159
  • 2203002157
  • 2106000232
  • 2106000210

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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