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
- Affected units
- 1
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.
Part of a larger recall action
This product is one of 19 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 19 products in this recall →Related recalls
Same manufacturer · Stryker Medical Division of Stryker Corporation
See all →- ModerateStryker Cub pediatric cribs sold in USA missing two warning labels
FDA (Devices) · 2026-03-25
- ModerateBariatric hospital beds recalled because they are not tested with certain mattresses
FDA (Devices) · 2025-12-17
- ModerateHospital mattresses recalled because they are not tested with certain beds
FDA (Devices) · 2025-12-17
- HighProCurity patient beds recalled for electrical safety testing defects
FDA (Devices) · 2023-12-13
- HighProCuity Hospital Patient Beds Recalled for Missing Electrical Safety Testing
FDA (Devices) · 2023-12-13
Same hazard · improper use environment
See all →- High
- HighHospital Bed Model 3005 Recalled for Distribution to Home Residents
FDA (Devices) · 2021-08-18