Hill-Rom, Inc.
Hill-Rom, Inc. holds FDA 510(k) medical device clearances, first cleared 1986, most recent 2026, with 37 FDA device recalls on record.
Top product codes for Hill-Rom, Inc.
FDA recalls by Hill-Rom, Inc.
10 most recent of 37- Z-0783-2022 — (1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead lift, (2)Traverse Rail Carrier 31025XX component to Liko overhead lift. Intended for to make safe lifting of a patient possible. Affected Devices: 3101704 TRAV RAIL CARR E-SYST STD 3102514 TR CARRIER SLIM/RAISED, LR 3101705 TRAV RAIL CARR ESYST WIDE 3102517 TR CARR. NORMAL/LOWER. LR 3102506 TR CARRIER WIDE/RAISED ML 3102519 TR CARR. LOW.LR 30MM/PAIR 3102511 TR CARRIER NORMAL, LR 3102531 TRAVERSE RL CARRIER STD/RAISED 3102512 TR CARRIER WIDE, LR 3102532 TRAVERSE RL CARRIER WD/RAISED 3102513 TR CARRIER SLIM, LR 3102562 TR CARRIER, PARALLEL/WIDE
- Z-0639-2022 — Liko Mobile Lifts: Primarily intended for use in nursing homes Liko M220, Model 2050010
- Z-0640-2022 — Liko Mobile Lifts: Primarily intended for use in nursing homes LikoM230 Model: 2050015
- Z-0402-2022 — These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9 b. Voalte Nurse Call, Part Number 4.0 *Product was rebranded from NaviCare to Voalte in 2020
- Z-2601-2021 — LikoStretch Mod 600 IC Model Number: 3156065 LikoStretch Mod 600 IC, Wide Model Number: 3156065B (obsolete since 12JUN2020) - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.
- Z-2598-2021 — FlexoStretch Model Number: 3156057 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.
- Z-2599-2021 — Stretch Leveller Model Number: 3156200 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.
- Z-2600-2021 — LikoStretch 1900 Model Number: 3156051 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.
- Z-2597-2021 — OctoStretch with Stretch Leveller - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient. Model Number: 3156056
- Z-2156-2021 — 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
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Hill-Rom, Inc.
- K260211 — Dashboard (P007000)
- K202018 — Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation
- K180079 — Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation
- K013709 — HILL-ROM PRIMAVIEW MONITOR SYSTEM
- K973705 — CONTOR TABLE SURFACE
- K981081 — BRIGHTSTAR
- K972111 — RUMORS DYNAMIC AIR THERAPY UNIT
- K971366 — INCUWARMER
- K970636 — TOTALCARE., MODULAR THERAPY SYSTEM (MTS)
- K964873 — SILKAIR LOW AIRLOSS THERAPY
- K964223 — CLINITRON RITE-HITE
- K970295 — FLEXICAIR EXLIPSE PLUS
- K970074 — STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D)
- K962942 — TOTALCARE
- K963091 — VOLLMAN PRONE POSITIONER
- K961437 — WHEELED STRETCHER
- K952447 — HILL-ROM AMBULATORY CARE PROCEDURAL STRETCHER
- K951001 — FLEXICAIR EXLIPSE
- K950756 — PULMONEX DYNAMIC AIR THERAPY UNIT
- K944580 — FLEXSYS MOBILEMATE EQUIPMENT STAND
- K945729 — DYNAMICAIRE(TM) SLEEP SURFACE, ZONEAIR(TM) SLEEP SURFACE
- K942904 — STABILET
- K924420 — MEDICAL DISPOSABLE BEDDING
- K926140 — VACUUM POWER BODY FLUID SUCTION APPARATUS
- K922808 — HILL-ROM VIA STRETCHER (P1300 - P1303)
- K922809 — GENERAL PROCEDURAL STRETCHERS (P880- P886)
- K915779 — AFFINITY BED MODEL 3600 SERIES
- K922352 — THE ADVANCE SERIES FROM HILL-ROM
- K915437 — CRITICAL CARE HOSPITAL BED (ICU/CCU)
- K914309 — THE GENESIS BED FROM HILL-ROM, MODEL 355 SERIES
- K921528 — HILL-ROM PATIENT ENVIRONMENTAL CONTROL SYSTEM
- K913945 — STABILET INFANT RADIANT WARMER MODEL 2000C
- K864172 — HILL-ROM CENTURY CC, MODELS 891 & 893 WEIGHING SYS
- K864186 — HILL-ROM CENTURY CC MODELS 892 &894 (RADIOLUCENT)
Data sourced from openFDA. This site is unofficial and independent of the FDA.