The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0433-2024·Announced 2023-12-13

ProCuity Hospital Bed Model 3009 Lacks Required Electrical Safety Tests

Stryker Medical is recalling ProCuity hospital beds with missing electrical safety test documentation, creating risk of electrical shock or tissue burns.

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 an FDA Class II recall involving missing electrical safety test documentation on patient beds. Although no illnesses or injuries have been reported, the identified risks of electrical shock and tissue burns classify this as a high-severity risk-of-harm product per the rubric.

Plain-English summary

Stryker Medical Division is recalling its ProCuity hospital bed model 3009 because the beds lack required electrical safety test documentation. This creates a potential risk of electrical shock or tissue burns.

The recall affects beds distributed across the United States, Puerto Rico, and multiple countries including Australia, Canada, Chile, China, Mexico, Poland, Spain, and Switzerland. Specific serial numbers have been identified as being involved in the recall.

Facilities and healthcare providers using these beds should verify their unit's serial number against the recall list and contact Stryker Medical Division for further guidance.

The recalled product

Product
ProCuity bed series, model number 3009, item number: 3009PX-ZM-600.
Manufacturer
Stryker Medical Division of Stryker Corporation
Category
Medical Device — Hospital 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 (8)

  • UDI-DI (GTIN): 07613327541311. Serial numbers: 2201000173
  • 2110001895
  • 2203001506
  • 2110000413
  • 2110000411
  • 2208002037
  • 2208002030
  • 2208002019& 2212000691

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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