The Recall Desk
HighFDA (Devices)·Z-0429-2024·Announced 2023-12-13

Stryker ProCuity hospital beds lack electrical safety tests, presenting shock and burn risks

Stryker ProCuity beds (model 3009) are missing electrical safety test values, presenting risks of electrical shock and tissue burns. FDA Class II recall.

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: FDA Class II recall for a risk-of-harm medical device involving electrical hazard where no illnesses or injuries have yet been reported. The missing electrical safety test values present a serious potential hazard to patient safety.

Plain-English summary

Stryker Medical Division of Stryker Corporation is recalling ProCuity patient beds, model 3009 (item number 3009PX-LEX-400). The recalled units are identified by UDI-DI (GTIN) 07613327541229 and specific serial numbers listed in the recall notice.

The beds are missing test values for electrical safety tests. This creates a potential risk of electrical shock or tissue burns to patients. The missing safety test documentation indicates the beds may not have been properly validated for electrical safety standards.

The recall affects units distributed nationwide in the United States, including Puerto Rico, as well as internationally in Australia, Canada, Chile, China, Mexico, Poland, Spain, and Switzerland. Affected serial numbers are detailed in the FDA recall notice.

Patients and healthcare facilities should stop using affected units and contact the manufacturer with their unit's serial number to verify whether their bed is included in the recall and obtain replacement information.

The recalled product

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

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): 07613327541229. Serial numbers: 2203001674
  • 2203001673
  • 2203001662
  • 2203001328
  • 2112001472
  • 2201001284
  • 2201001262
  • 2201001258
  • 2210002490
  • 2210002246
  • 2203001157
  • 2210000264
  • 2108002021
  • 2207000782
  • 2207000778
  • 2208000442
  • 2107000549
  • 2103001807
  • 2107000349
  • 2206000057

Distribution

Distributed nationwide across the United States.