The Recall Desk
HighFDA (Devices)·Z-2216-2021·Announced 2021-08-18

Hospital Bed Model 3005 Recalled for Distribution to Home Residents

Stryker's S3 MedSurg hospital bed was distributed to home residents instead of healthcare facilities. The devices are designed for professional operation, and untrained home users may not understand safety instructions.

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: Hospital beds are risk-of-harm medical devices requiring professional training to operate safely. Distributing them to untrained home users creates genuine risk of patient injury, even though no incidents have yet been reported.

Plain-English summary

Stryker Medical Corporation is recalling four units of the S3 MedSurg Bed Model 3005 because they were shipped to residential customers instead of healthcare facilities. These devices are designed to support and transport patients in hospital and critical care environments.

The product labeling correctly identifies the intended use environment as a healthcare facility. However, residential customers who received these devices may not be aware of or understand the instructions, which are written for healthcare professionals.

The four units were distributed to the United States and eight other countries: Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, and Thailand. The affected serial numbers are: 120916611, 121016000, 130115957, and 130815166.

The recalled product

Product
S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number: 3005, Part # 3005S3EX
Manufacturer
Stryker Medical Division of Stryker Corporation
Hazard
  • improper-use-environment
  • lack-of-operator-training

Distribution

Distributed nationwide across the United States.