CLASS II Device recall · Reported 10 Sep 2014 · FDA Enforcement Report

Affinity¿ Four Birthing Bed recalled by Hill-Rom

Hill-Rom is recalling Affinity¿ Four Birthing Bed, distributed nationwide in the US. The recall was initiated on 26 Jun 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel #'s: P3700B, P3700C, P3700D and P3700E

Quantity recalled13,000 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2562-2014
FDA event ID: 68650
Recalling firm: Hill-Rom, Batesville, IN
Classification: Class II
Status: Terminated
Recall initiated: 26 Jun 2014
FDA classified: 1 Sep 2014
Reported: 10 Sep 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

26 Jun 2014	Recall initiated by company
1 Sep 2014	Classified by FDA	+67 days
10 Sep 2014	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The attachment latch mechanism can become bent depending on user handling. Latch mechanism bending could lead to improper engagement of the foot section and this could result in injury to the user due to a fall.

Product as listed by the FDA

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.

Where it was distributed

Worldwide Distribution - US Nationwide and the following countries: Argentina , Aruba, Australia, Austria, Bahamas, Bahrain, Belgium, Belize, Bermuda, Brazil, Brunei, Bulgaria, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Equatorial Guinea, Finland, France, Germany, Greece, Guam, Guyana, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Lebanon, Libya, Malaysia, Mauritius, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turks and Caicos Islands, United Arab Emirates, United Kingdom, US Virgin Islands, Venezuela and Vietnam.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

Model #'s: P3700B, P3700C, P3700D and P3700E

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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