Agency classClass IIOur severity:High FDA (Devices)·Z-0424-2024·Announced 2023-12-13

ProCuity Patient Beds Missing Electrical Safety Tests: Burn and Shock Risk

Stryker ProCuity patient beds lack required electrical safety test values, posing risk of tissue burn or electrical shock to patients and healthcare workers.

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 for a risk-of-harm product (electrical shock and tissue burn hazard). No illnesses or injuries are reported in the source text, so the recall meets the High severity criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Stryker Corporation is recalling certain ProCuity patient beds (model 3009) due to missing electrical safety test values. These test values are required to ensure the beds meet electrical safety standards.

The missing test documentation presents a risk of electrical shock or tissue burn to patients and healthcare workers who may contact the bed during operation or maintenance.

The affected beds were distributed nationwide in the United States and to healthcare facilities in Puerto Rico, Australia, Canada, Chile, China, Mexico, Poland, Spain, and Switzerland. Specific serial numbers have been identified for the affected units.

Healthcare facilities and users should verify their device serial numbers against the FDA recall notice and contact Stryker for guidance on inspection, testing, or replacement procedures.

The recalled product

Product: ProCuity bed series, model number 3009, item number: 300900000000,
Manufacturer: Stryker Medical Division of Stryker Corporation
Category: Medical Device — Patient Beds / Hospital Equipment
Hazard: electrical-shock
tissue-burn

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): 07613327512656. Serial numbers: 2207000698
2207000676
2207000619
2206001100
2206001090
2206001089
2206001086
2206001084
2208001745
2208001734
2208001725
2208001724
2208000397
2208000394
2208000032
2209002157
2209002158
2209002165
2210000711
2210000721

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 →

Same manufacturer · Stryker Medical Division of Stryker Corporation

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Same hazard · electrical shock