# FDA recall Z-2156-2021

> **Hill-Rom, Inc.** · Class II · device recall initiated 2021-05-28.

## Product

Affinity Four Birthing Bed-used as a birthing bed for women of child bearing age in an LDR (Labor, Delivery, Recovery) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor and Delivery market  Model Numbers: P3700B, P3700C, P3700D, & P3700E

## Reason for recall

Latch mechanism on the Lift-Off foot section of the Affinity Four Birthing Bed is damaged, it could potentially cause the installed foot section to be improperly engaged onto the bed, could result in injury to the user due to a fall.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of AL, CA, IA, MS, NC, NY, OH, PA, TX, VA and the countries of Australia, Austria, Azerbaijan, Belgium, Chile,  China, Denmark, Finland, France, Germany, Ireland, Israel, Italy, Jordan, Kuwait, Netherlands, New Zealand, Norway, Portugal, Saudi Arabia, Singapore, Spain, Sweden,   Switzerland, Taiwan, United Arab Emirates, United Kingdom.

## Key facts

- **Recall number:** Z-2156-2021
- **Recalling firm:** Hill-Rom, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-05-28
- **Report date:** 2021-08-04
- **Termination date:** 2024-06-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Batesville, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2156-2021

## Citation

> AI Analytics. FDA recall Z-2156-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2156-2021. Source: US FDA. Licensed CC0.

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