Hill-Rom Affinity Four Birthing Bed Recall for Latch Mechanism Defect
Hill-Rom is recalling 13,000 Affinity Four Birthing Beds because the attachment latch mechanism can bend, potentially causing the foot section to fail and resulting in user injury from a fall.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves a risk-of-harm product (fall injury) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Hill-Rom, Inc. is recalling 13,000 units of the Affinity Four Birthing Bed, models P3700B, P3700C, P3700D, and P3700E. These beds are intended for use in acute care Labor and Delivery settings for women of childbearing age. The recall covers units distributed worldwide, including the United States and numerous international locations.
The recall is due to a defect in the attachment latch mechanism, which can become bent depending on user handling. If the latch mechanism bends, it may lead to improper engagement of the foot section. This failure could result in injury to the user due to a fall.
The source text does not specify specific actions for consumers or healthcare facilities beyond the recall notice itself. No illnesses or injuries have been reported in the provided text.
The recalled product
- Product
- Affinity¿ Four Birthing Bed, Product Usage: Product is intended to be used as birthing beds 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.
- Manufacturer
- Hill-Rom, Inc.
- Category
- Medical Device — Hospital Bed
- Affected units
- 13,000
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 (3)
- Model #'s: P3700B
- P3700C
- P3700D and P3700E
Distribution
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