The Recall Desk
HighFDA (Devices)·Z-0425-2024·Announced 2023-12-13

ProCuity Patient Beds Recalled for Missing Electrical Safety Tests

Stryker Medical is recalling ProCuity bed series model 3009 due to missing electrical safety test values. The beds pose a risk of electrical shock or tissue burn to patients.

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 is a Class II FDA recall involving a risk-of-harm condition (electrical shock and tissue burn) in a medical device with no reported illnesses or injuries. Risk-of-harm products where injury has not yet been reported typically rate as High (3).

Plain-English summary

Stryker Medical Division of Stryker Corporation is recalling the ProCuity bed series, model number 3009 (item number 3009PX-L-100). The beds are missing test values for electrical safety tests, which creates a potential risk of electrical shock or tissue burn to patients.

The affected beds have UDI-DI (GTIN) 07613327541168 with serial numbers 2111000766 and 2107000368. The recall affects beds distributed nationwide in the United States, including Puerto Rico, as well as internationally in Australia, Canada, Chile, China, Mexico, Poland, Spain, and Switzerland.

Patients and healthcare facilities currently using these beds should stop using them immediately and contact Stryker Medical for instructions on replacement or repair. Healthcare providers should verify the serial numbers of their beds against the provided numbers to determine if their equipment is affected.

The recalled product

Product
ProCuity bed series, model number 3009, item number: 3009PX-L-100.
Manufacturer
Stryker Medical Division of Stryker Corporation
Category
Medical Device — 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 (1)

  • UDI-DI (GTIN): 07613327541168. Serial numbers: 2111000766 & 2107000368

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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