The Recall Desk
HighFDA (Devices)·Z-0431-2024·Announced 2023-12-13

ProCuity Bed Series Recalled for Electrical Safety Test Failures

Stryker is recalling ProCuity patient beds (model 3009) for missing electrical safety test values, which presents risk of electrical shock or tissue burn.

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 an FDA Class II recall of medical equipment presenting risk of patient harm (electrical shock and tissue burn). No illnesses or injuries have been reported, qualifying this as a risk-of-harm product where injury has not yet been reported, which corresponds to High severity per the rubric.

Plain-English summary

Stryker Medical Division of Stryker Corporation is recalling ProCuity bed series model 3009 (item 3009PX-Z-450) after discovering the beds are missing electrical safety test values.

Beds without completed electrical safety testing present a risk of electrical shock or tissue burn. The recalled units were distributed nationwide in the United States, including Puerto Rico, and internationally in Australia, Canada, Chile, China, Mexico, Poland, Spain, and Switzerland. The product can be identified by UDI-DI (GTIN) 07613327541250 and affected serial number 2110001715.

The recalled product

Product
ProCuity bed series, model number 3009, item number: 3009PX-Z-450.
Manufacturer
Stryker Medical Division of Stryker Corporation
Hazard
  • electrical-shock
  • burn-injury

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 (GTIN): 07613327541250. Serial number: 2110001715

Distribution

Distributed nationwide across the United States.