The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0428-2024·Announced 2023-12-13

ProCuity Patient Beds Recalled Missing Electrical Safety Test Values

Stryker is recalling ProCuity patient beds (model 3009) for missing required electrical safety test documentation, creating a risk of electrical shock or tissue burn.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 FDA recall of a patient-care medical device with real risk of electrical shock or tissue burn. Although no injuries have been reported, the hazard is not theoretical—the product failed to complete required electrical safety testing. This meets the High severity criterion of risk-of-harm products where injury has not yet been reported.

Plain-English summary

Stryker Medical Division of Stryker Corporation is recalling ProCuity patient beds, model number 3009 (item number 3009PX-LE-450). These beds are missing required electrical safety test values, which creates a potential risk of electrical shock or tissue burn to patients.

The recall affects units distributed nationwide throughout the United States, including Puerto Rico, as well as internationally in Australia, Canada, Chile, China, Mexico, Poland, Spain, and Switzerland. Affected units can be identified by specific serial numbers provided in the recall notice.

Facilities using these beds should contact Stryker Medical Division immediately to verify whether their unit is affected and obtain guidance on remediation or replacement.

The recalled product

Product
ProCuity bed series, model number 3009, item number: 3009PX-LE-450.
Manufacturer
Stryker Medical Division of Stryker Corporation
Category
Medical Device — Patient 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 (15)

  • UDI-DI (GTIN): 07613327541175. Serial numbers: 2109000993
  • 2208000147
  • 2209000850
  • 2211002051
  • 2202000910
  • 2209000408
  • 2205000619
  • 2205000615
  • 2205000612
  • 2205000587
  • 2205000746
  • 2205000745
  • 2205000739
  • 2109000135
  • 2109000124

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 →

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