Birthing Bed May Fail to Lower Due to Signal Wire Crimps
Affinity 4 Birthing Beds may have improper signal wire crimps that could prevent lowering the bed or foot section. 164 units have been recalled 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: Rated High (3) per the rubric criterion 'risk-of-harm products where injury has not yet been reported.' The identified defect could impair critical function (lowering bed during labor), but no hospitalizations or injuries are documented. FDA Class II designation indicates potential for adverse health consequence.
Plain-English summary
The Affinity 4 Birthing Bed, manufactured by Baxter Healthcare Corporation, is being recalled due to potential improper crimps on signal wires in the bed's actuators. This defect has been identified on 164 units.
The improper crimps could result in the inability to lower the bed or its foot section. These are critical functions used during labor and delivery.
The recalled units have been distributed worldwide, including throughout the United States and to Bahrain, Canada, Chile, France, Kuwait, Netherlands, Norway, and the United Arab Emirates.
Healthcare facilities using Affinity 4 Birthing Beds should check their product codes and serial numbers against FDA recall notice Z-1816-2025. Those with affected units should contact Baxter Healthcare Corporation for repair or replacement guidance.
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
- improper-crimp
- control-failure
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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