Affinity Four Birthing Bed-used as a birthing bed for women of child… — Class II medical device recall Z-2156-2021
Terminated recall by Hill-Rom, Inc., reported 2021-08-04, distributed nationwide. Latch mechanism on the Lift-Off foot section of the Affinity Four Birthing Bed is damaged, it could potentiall
| Recall number | Z-2156-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hill-Rom, Inc., Batesville, IN, United States |
| Recall initiated | 2021-05-28 |
| Classified | 2021-07-28 |
| Reported by FDA | 2021-08-04 |
| Terminated | 2024-06-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CH, CL, CN, DE, DK, ES, FI, FR, GB, IE, IL, IT, JO, KW, NL, NO, NZ, PT, SA, SE, SG, TW |
| Quantity | 1,096 beds |
| Serial numbers | H126AA5629, H338AA4821, H346AA4882, H347AA4900, H348AA4902, H352AA4924, I004AA4998, I009AA5035, I009AA5036, I009AA5037, I009AA5038, I010AA5039, I010AA5040, I018AA5106, I022AA5129, I024AA5148, I024AA5150, I024AA5152, I025AA5154, I031AA5200, I031AA5201, I031AA5202, I032AA5204, I032AA5212, I033AA5214 and 475 more |
| Model numbers | P3700B, P3700C, P3700D, P3700E |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2156-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.