Affinity Four Birthing Bed P3700 Product Usage: The Affinity — Class II medical device recall Z-2082-2012
Terminated recall by Hill-Rom, Inc., reported 2012-08-01, distributed nationwide. During review of our last braking system via that field corrective action, the system still did not meet our e
| Recall number | Z-2082-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hill-Rom, Inc., Batesville, IN, United States |
| Recall initiated | 2012-04-02 |
| Classified | 2012-07-26 |
| Reported by FDA | 2012-08-01 |
| Terminated | 2015-07-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, AW, BE, BG, BH, BM, BR, BS, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, EG, ES, FI, FR, GB, GR, GY, HK, HR, HU, ID, IE, IL, IN, IQ, IT, JO, JP, KE, KR, KW, KY, LB, MX, MY, NG, NL, NO, NZ, OM, PH, PK, PL, PT, QA, RO, RS, SA, SE, SG, SI, SK, TH, TR, TT, TW, VE, VN, ZA |
| Quantity | 12,726 devices |
| Serial numbers | H331AA4785 |
Product
Affinity Four Birthing Bed P3700 Product Usage: The Affinity, Four Birthing Bed 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. They are not intended for use as general hospital beds.
Reason for recall
During review of our last braking system via that field corrective action, the system still did not meet our expectations, which is to eliminate the hazards of patient falling. Bed movement immediately prior to, or during the birthing process may still create distractions and delays, resulting in patient or caregiver falls, or contribute to a deviation in a procedure, (e.g. IV insertion, epidural
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-2082-2012. 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.