Affinity 4 Birthing Bed Recalled for Faulty Actuator Signal Wires
Baxter Healthcare is recalling Affinity 4 Birthing Beds due to improper crimps on actuator signal wires that could prevent the bed or foot section from lowering. The defect affects 164 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: This is an FDA Class II recall of a medical device used in a clinical setting where a functional defect (inability to lower the bed) could result in patient harm. Although no illnesses or injuries are reported in the source text, the potential for harm and the loss of a critical device function in obstetric care justifies a High severity rating.
Plain-English summary
Baxter Healthcare Corporation is recalling Affinity 4 Birthing Beds with product codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435, P3700E100436, P3700E100437, P3700E100438, P3700E100439, P3700E100441, P3700E100442, P3700E100443, P3700E100444, P3700E100445, P3700E100446, P3700E100448, P3700E100449, P3700E100450, P3700E100453, P3700E100455, P3700E100456, P3700E100457, P3700E100459, P3700E100463, P3700E100468, P3700E100472, P3700E100476, and P3700E100477. The recall was issued because of a potential for improper crimps on the signal wires of the actuators.
These faulty crimps could result in a loss of ability to lower the bed or the foot section of the bed, compromising the intended functionality of the device.
The affected units total 164 devices and have been distributed worldwide to the United States and the countries of Bahrain, Canada, Chile, France, Kuwait, Netherlands, Norway, and the United Arab Emirates. A complete list of affected serial numbers is available from the FDA. Facilities using these beds should contact Baxter Healthcare Corporation for guidance on correction or return of the affected units.
The recalled product
- Product
- Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435, P3700E100436, P3700E100437, P3700E100438, P3700E100439, P3700E100441, P3700E100442, P3700E100443, P3700E100444, P3700E100445, P3700E100446, P3700E100448, P3700E100449, P37
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- actuator-wire-defect
- device-malfunction
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 (20)
- UDI-DI: 00887761000896
- 1) P3700E100429
- Serial Number: A008AA9216
- 2) P3700E100429
- Serial Number: A008AA9217
- 3) P3700E100429
- Serial Number: A009AA9218
- 4) P3700E100429
- Serial Number: A009AA9219
- 5) P3700E100429
- Serial Number: A009AA9220
- 6) P3700E100429
- Serial Number: A031AA9361
- 7) P3700E100429
- Serial Number: A031AA9362
- 8) P3700E100429
- Serial Number: A042AA9428
- 9) P3700E100429
- Serial Number: Z352AA9154
- 10) P3700E100429
Distribution
Distributed nationwide across the United States.
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