The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0434-2024·Announced 2023-12-13

ProCurity patient beds recalled for electrical safety testing defects

Stryker is recalling ProCurity bed series (model 3009) due to missing electrical safety test values that could pose risk of electrical shock or tissue burn. Affected units were distributed nationwide and internationally.

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: FDA Class II recall involving electrical safety hazards presenting risk of tissue burn and electrical shock. No injuries or hospitalizations have been reported, satisfying the rubric criterion for Score 3: risk-of-harm product where injury has not yet been reported.

Plain-English summary

Stryker Medical Division is recalling ProCurity bed series model 3009 (item number 3009PX-ZMX-450) due to missing electrical safety test values that present a risk of electrical shock or tissue burn.

The recalled beds lack documented electrical safety test results. This deficiency means the beds may not meet required electrical safety standards, creating potential hazards to patients and clinical staff who may come into contact with the bed during operation or maintenance.

The affected beds were distributed nationwide across the United States, including Puerto Rico, and to international markets including Australia, Canada, Chile, China, Mexico, Poland, Spain, and Switzerland. The recalled units are identified by UDI-DI (GTIN) 07613327541304 and serial numbers including 2212000205.

Stryker recommends that healthcare facilities cease use of affected beds and contact the company for instructions on repair, replacement, or return. Patients and healthcare providers should report any incidents or injuries related to these beds to Stryker and the FDA.

The recalled product

Product
ProCurity bed series, model number 3009, item number: 3009PX-ZMX-450.
Manufacturer
Stryker Medical Division of Stryker Corporation
Category
Medical Device — Hospital Equipment
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 (1)

  • UDI-DI (GTIN): 07613327541304 . Serial number: 2212000205

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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