Support Surface Device Distributed to Home Patients Without Healthcare Professional Instructions
An Isolibrium Support Surface intended for healthcare facilities was distributed to home customers. While the labeling is correct, home users may not understand instructions intended for healthcare professionals.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II device with no reported hospitalizations, injuries, or adverse events. The issue is distribution to home users who may not understand professional instructions—consistent with a precautionary recall lacking reported harm.
Plain-English summary
Stryker Medical Division has recalled the Isolibrium Support Surface, Model 2972, due to distribution to residential customers. This medical device was designed and labeled for use in healthcare facilities where trained professionals supervise patient care.
The product's labeling correctly identifies its intended use environment. However, the device was distributed to home users who may not be aware of or fully understand instructions that were designed for healthcare professionals. Without proper training, home users may not use the device correctly.
The recalled device has serial number 219009000417 and UDI 07613327278453. It was distributed worldwide, including throughout the United States and to Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, and Thailand.
Consumers who have received this device should contact Stryker Medical Division for guidance on proper use or return of the device. Healthcare facilities should verify that their Isolibrium Support Surfaces are being used only by trained personnel.
The recalled product
- Product
- Isolibrium Support Surface - support surface assists in the prevention and treatment of all pressure injury stages (including stages 1, 2, 3, 4, Unstageable and Deep Tissue Pressure Injury, Model Number: 2972, Part # 2972000000
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Hazard
- improper-use-environment
- inadequate-user-instructions
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)
- Serial Numbers: 219009000417 UDI: 07613327278453
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27