The Recall Desk
HighFDA (Devices)·Z-0427-2024·Announced 2023-12-13

ProCuity Hospital Beds: Missing electrical safety tests pose burn and shock risk

Stryker's ProCuity hospital beds (model 3009) lack electrical safety test values, creating a risk of tissue burns and electrical shock to patients. The beds were distributed nationwide and internationally.

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 with no reported illnesses or injuries. Although electrical burns and shocks are serious hazards, the source describes these as risks rather than documented incidents. Per the severity rubric, risk-of-harm products without reported injury score High (3).

Plain-English summary

Stryker Medical Division of Stryker Corporation is recalling ProCuity hospital beds, model 3009 (item number 3009PX-LE-400), due to missing electrical safety test values.

The beds lack required electrical safety testing documentation, presenting a risk of tissue burns or electrical shock to patients. The affected product is identified by UDI-DI (GTIN) 07613327541182.

These beds were distributed nationwide throughout the United States and Puerto Rico, as well as internationally to Australia, Canada, Chile, China, Mexico, Poland, Spain, and Switzerland.

The recalled product

Product
ProCuity bed series, model number 3009, item number: 3009PX-LE-400.
Manufacturer
Stryker Medical Division of Stryker Corporation
Hazard
  • electrical-burn
  • electrical-shock

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): 07613327541182. Serial numbers: 2105002838
  • 2105002832
  • 2202000312
  • 2202000286
  • 2202000278
  • 2202000180
  • 2106002241
  • 2106001240
  • 2107001002
  • 2203001053
  • 2203001898
  • 2112001135
  • 2211002054
  • 2105002782
  • 2210002902
  • 2210002890
  • 2210002876
  • 2210002858
  • 2210002848
  • 2111001420

Distribution

Distributed nationwide across the United States.