Medical Device Air Supply Unit Recalled for Potential Electrical Shock Hazard
Baxter Healthcare is recalling the Compella Therapy Air Supply Unit due to potential power cord damage that could expose electrical conductors and create a shock risk. The recall affects 6,022 units distributed worldwide.
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: FDA Class II medical device with a serious electrical hazard (shock risk from exposed electrical conductors), but no reported injuries, deaths, or illnesses. The hazard is theoretical but presents a credible risk of harm.
Plain-English summary
The Compella Therapy Air Supply Unit, manufactured by Baxter Healthcare Corporation, is being recalled due to potential damage to the power cord that could expose electrical conductors and create a risk of electrical shock from the mains power supply.
The device has been distributed worldwide, including across the United States and 39 other countries. A total of 6,022 units are affected by this recall.
Consumers and healthcare facilities using this device should immediately discontinue use and contact Baxter Healthcare Corporation for instructions on inspection, repair, or replacement options. The device can be identified using the UDI (Unique Device Identifier): 00887761013803.
The recalled product
- Product
- Compella Therapy Air Supply Unit
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 6,022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Baxter Healthcare 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 2 products in this recall →Related recalls
Same manufacturer · Baxter Healthcare Corporation
See all →- HighBaxter Duo-Vent Solution Set Recalled for Air Bubbles in Tubing
FDA (Devices) · 2026-08-19
- SevereBaxter Recalls Cefazolin Injection Bags Due to Particulate Matter
FDA (Drugs) · 2026-08-19
- SevereHillrom VOLARA System P.CIRCUIT KIT Medical Device Recall for Oxygen Drop Risk
FDA (Devices) · 2026-07-08
- HighBaxter Head Positioning Adapter May Loosen During Patient Positioning
FDA (Devices) · 2026-07-08
- SevereHillrom VOLARA System patient circuits recalled for nebulizer leakage risk
FDA (Devices) · 2026-07-08
Same hazard · electrical shock
See all →- HighFort Defiance Automated Field Steam Sterilizer Recalled for Electrical Grounding Defect
FDA (Devices) · 2026-08-26
- Severe
- SevereJayco Recalls 2026 Seismic Fifth Wheel Toy Haulers Due to Fire Risk
NHTSA · 2026-07-02
- HighLomi roll-on waxing kit power cords can overheat and short circuit
CPSC · 2026-06-25
- High