The Recall Desk
HighFDA (Devices)·Z-0436-2024·Announced 2023-12-13

Stryker ProCurity Hospital Beds Recalled for Missing Electrical Safety Tests

Stryker is recalling ProCurity patient beds (model 3009) due to missing electrical safety test documentation. Affected beds pose a risk of electrical shock or tissue burns. Facilities should verify their bed serial numbers and contact Stryker.

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 Class II medical device recall involves a risk of electrical shock and tissue burns, which are serious potential harms in a patient care setting. However, the source text does not report any illnesses or injuries, and the hazard stems from missing test documentation rather than an observed device failure. This fits the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Stryker Medical Division of Stryker Corporation is recalling ProCurity patient beds, model number 3009 (item number 3009PX-ZX-450) because the beds are missing test values for electrical safety tests. These test values are required to verify that the beds meet electrical safety standards.

Without proper electrical safety testing documentation, the beds present a risk of electrical shock or tissue burns to patients and staff who use or service the equipment. The missing test values prevent verification that the electrical components are safe for use.

The affected beds have been distributed nationwide in the United States, including Puerto Rico, as well as internationally to Australia, Canada, Chile, China, Mexico, Poland, Spain, and Switzerland. Healthcare facilities using ProCurity beds should check their equipment serial numbers against the list of recalled units: 2105004433, 2105004422, 2110001418, 2110001260, 2110000511, and 2110000496.

Facilities with affected beds should contact Stryker Medical Division immediately to arrange for corrective action, which may include completion of required electrical safety testing or device replacement.

The recalled product

Product
ProCurity bed series, model number 3009, item number: 3009PX-ZX-450.
Manufacturer
Stryker Medical Division of Stryker Corporation
Category
Medical Device — Hospital 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 (6)

  • UDI-DI (GTIN): 07613327541366. Serial numbers: 2105004433
  • 2105004422
  • 2110001418
  • 2110001260
  • 2110000511
  • & 2110000496

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 →

Related recalls

Same manufacturer · Stryker Medical Division of Stryker Corporation

See all →

Same hazard · electrical shock

See all →