The Recall Desk
HighFDA (Devices)·Z-0432-2024·Announced 2023-12-13

ProCuity Patient Beds Recalled for Missing Electrical Safety Tests

Stryker's ProCuity bed series (model 3009) is being recalled due to missing electrical safety test documentation. The beds present a potential risk of electrical shock or tissue burn.

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 medical device recall involving missing electrical safety test documentation. Although the hazard presents a theoretical risk of electrical shock or tissue burn, no illnesses or injuries have been reported, qualifying it as a high-risk product where harm has not yet occurred.

Plain-English summary

Stryker Corporation is recalling the ProCuity bed series model 3009 (item number 3009PX-ZM-450). The recalled beds lack required electrical safety test values necessary to verify their electrical safety performance.

Patient beds missing electrical safety test documentation present a potential risk of electrical shock or tissue burn to patients and medical personnel. The missing test values indicate incomplete electrical safety verification before distribution.

The recall affects ProCuity beds with serial numbers 2208002548 and 2212001984, which were distributed nationwide across the United States and internationally to Puerto Rico, Australia, Canada, Chile, China, Mexico, Poland, Spain, and Switzerland.

Healthcare facilities and providers using these beds should contact Stryker Medical Division of Stryker Corporation for instructions regarding the recall and necessary remediation.

The recalled product

Product
ProCuity bed series, model number 3009, item number: 3009PX-ZM-450.
Manufacturer
Stryker Medical Division of Stryker Corporation
Hazard
  • electrical-shock
  • burn-injury

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): 07613327541274 . Serial numbers: 2208002548 & 2212001984

Distribution

Distributed nationwide across the United States.