# FDA recall Z-1816-2025

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2025-05-06.

## Product

Affinity 4 Birthing Bed, 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

## Reason for recall

There is a potential for improper crimps on the signal wires of the actuators which could result in a loss of ability to lower the bed or the foot section of the bed.

## Distribution

Worldwide distribution - US Nationwide and the countries of BAHRAIN, Canada, Chile, FRANCE, KUWAIT, NETHERLANDS, NORWAY, UNITED ARAB EMIRATES.

## Key facts

- **Recall number:** Z-1816-2025
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-06
- **Report date:** 2025-06-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deerfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1816-2025

## Citation

> AI Analytics. FDA recall Z-1816-2025. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-1816-2025. Source: US FDA. Licensed CC0.

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