The Recall Desk
HighFDA (Devices)·Z-0479-2023·Announced 2022-12-21

Medical cot may experience unintended motion due to cable damage

Stryker's Power-PRO 2 surgical cot may lower unexpectedly due to damaged cables, risking soft tissue injuries to patients. The recall affects 465 units distributed in the US and internationally.

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 recall involves a mechanical failure (damaged cables) that creates a real risk of soft tissue injury to patients, though no injuries have been reported. This fits the 'risk-of-harm product where injury has not yet been reported' criterion for a High severity rating.

Plain-English summary

Stryker Medical Division of Stryker Corporation has recalled the Power-PRO 2 surgical cot, Model No. 6507. The device may experience unintended motion due to damaged cables.

Damaged cables in affected units can cause the cot to lower faster than intended. This creates a risk of soft tissue injury to patients, such as scrapes or bruising.

The recall affects 465 units, including 403 in the United States and 62 units distributed internationally to Australia, Canada, the Netherlands, and the United Kingdom. The FDA has classified this as a Class II medical device recall.

The recalled product

Product
Power-PRO 2, Model No. 6507, Item No. 650705550001 (US); 650700000000 (International)
Manufacturer
Stryker Medical Division of Stryker Corporation
Hazard
  • mechanical-failure
  • soft-tissue-injury
  • unintended-motion

Distribution

Distributed nationwide across the United States.