Hill-rom, Inc.

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Top device categories

• Bed, Ac-Powered Adjustable HospitalFNL16,754
• Stretcher, WheeledFPO3,295
• Table, Obstetrical, Ac-Powered (And Accessories)HDD1,017
• Bed, Air FluidizedINX551
• Bed, Flotation Therapy, PoweredIOQ219
• Mattress, Flotation Therapy, Non-PoweredIKY87
• Bariatric BedOSI50
• Stretcher, Wheeled, PoweredINK37
• Table, Obstetric (And Accessories)KNC28
• Lift, Patient, Non-Ac-PoweredFSA23

Recent recalls

• 2021-01-29TerminatedDevice Design

  Liko Multirall 200 overhead lift- overhead lift is a general-purpose lift with the intended use in healthcare, intensive care and rehabilitation. Affected devices: Liko Multirall 200 (product number 3130001) Universal SlingBar 450 R2R (product number 3156095) Universal SlingBar 350 R2R (product number 3156094) Carriage D45 with Double Hook (product number 3136100) Extension belt 300-400 mm (product number 3136226) Extension belt 400-600 mm (product number 3136227) Extension belt 600-1000 mm (product number 3136228) Extension belt 1000-1400mm (product number 3136229)

  Multirall Q-link strap lock has not been fully engaged in the S65 rail carriage hook by user, leading to the Multirall lift becoming detached from the rail system, potentially resulting in the fall of both the lift motor and the patient

• 2016-10-31TerminatedMixed-up of materials/components

  Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling installed rail systems: Multirall 200, Likorall 200, 242, 243, 250, and LikoGuard L and XL.

  Ceiling Bracket 71 was shipped with a larger center hole. A potentially hazardous situation exists that if the Ceiling Bracket 71 with a larger center hole is used for a concrete ceiling Ultra System installation with the M8 screw and the safe working load is exceeded, the system could fall.

• 2016-09-08TerminatedNonconforming Material/Component

  Affinity Four Birthing Bed Model P3700 The primary packaging is pictured below, and utilizes a metal packing brace, standard corrugated cardboard and plastic banding. When possible these beds are shipped as a quantity of two (2) together as shown with the nylon strapping. These are shipped in standard freight containers. There is no secondary packaging.

• 2016-08-09TerminatedDevice Design

  Volker 2080, 2082, S 280 and S 282 series beds with lateral release button. A/C Powered Adjustable Hospital Bed Product Usage: Volker model 2080/3010/3080 nursing beds are intended for the care of residents in rooms in nursing homes, in residential homes for the elderly and in suitable rooms in private residences. They may not, however, be used for transportation purposes. Any deviation from this use is expressly excluded from possible liability claims.

  The current construction of the side rail latch may not be able to support the full patient weight and may give way allowing the side rail to abruptly lower and the patient to fall, potentially resulting in harm. To date there has been one report of a related injury.

• 2016-06-07TerminatedLabeling design

  Liko Universal SlingBars Universal SlingBar" 350, Universal SlingBar" 350 QRH, Universal SlingBar" 350 R2R, Universal SlingBar" 450, Universal SlingBar" 450 QRH, Universal SlingBar" 450 R2R, Universal SlingBar" 600 Universal SlingBar" 600 QRH Component of Liko Lifts Product Usage: Universal SlingBar 350 It is commonly used for lifting children. Universal SlingBar 350 is available with three assembly options - fixed assembly, Quick-release Hook (QRH) or Room 2 Room (R2R). Universal SlingBar 450 Is appropriate in most cases and with most slings. Is installed on most lifts on delivery (does not apply to Viking XL). Universal SlingBar 450 is available with three assembly options - fixed assembly, Quick-release Hook (QRH) or Room 2 Room (R2R). Universal SlingBar 600 It is intended for use with the ComfortSling Plus mod 300/310 and 350/360, or with slings the intention of which is to overlap the leg supports, Universal SlingBar 600 is available with two assembly options - fixed assembly and Quick-release Hook (QRH).

  The center bolt of the sling bar, which connects the bar to the patient lift, has failed during use. If the sling bar is not used as intended the bolt may be weakened. If the bolt is weakened there is a potential risk for breakage with the result of a free fall of the patient. This hazard could cause potentially minor to catastrophic injuries to a patient.

• 2016-02-23TerminatedUnder Investigation by firm

  Hill-Rom Bariatric Power Recliner, Product Model # P9096 Hill-Roms 660 lb Powered Bariatric Recliner was created to provide an aesthetically pleasing design that will enhance the overall experience for the bariatric patient. Using spring box construction and an exceptionally smooth mechanism, the patient is able to move into a reclined position with little effort and infinite positions up to 38 degrees. An independent footrest enables patients to be in a fully seated position with their feet up for added comfort.

  The recliners were shipped without the foot rest ottoman linkage side shields, which could result in consumer injury.

• 2015-11-13TerminatedDevice Design

  Hill-Rom 100 Low Bed (GPAC) AC Powered adjustable hospital bed

  Hill-Rom is voluntarily recalling the Hill-Rom 100 Low Bed due to complaints of patient injury when exiting the beds set at the lowest position setting.

• 2015-06-19TerminatedLabeling design

  Viking M, L, and XL Mobile Lifts. Non-AC-powered patient lift.

  Complaints (including one reported death) allegedly of the lift arm drifting down suddenly. If the lift arm assembly is manually lifted, the actuator can become damaged and get stuck in the highest position. If a patient is lifted into the sling while the actuator is stuck, there is a potential risk of a free fall of the patient, resulting in minor or potentially catastrophic injuries.

• 2015-06-19TerminatedUse error

  Steriseal-Cannula Ophthalmic; Bi-Manual Irrigating/Aspirating Handpiece.

  The metal cannula attached to the handpiece can rotate and become dislodged from the plastic handpiece.

• 2014-09-01TerminatedNonconforming Material/Component

  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.

  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.