Batesville, IN, United States
Hill-Rom, Inc. recalls
10 recalls recorded since 2018, most recently on 14 January 2022. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls10
Ongoing (FDA)2
Terminated or completed8
Class I (FDA)1
Terminated Class II Medical devices
- Recall started
- 14 January 2022
- Terminated
- 7 November 2024
- Reason
- Traverse rail carriage delivered with non-conforming screws are too short to ensure appropriate installation. There is potential that the screws are unable to secure the traverse rail appropriately and could loosen over time causing the rail system to fall, potentially causing injury to caregivers and/or patients
- Distribution
- Worldwide distribution - US Nationwide and the countries of AT, CA, CZ, DE, DK, ES, FI, FR, GB, HK, IE, IL, IT, JP, NL, NO, NZ, RU, SE, SG, SK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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. Affecte
Ongoing Class II Medical devices
- Recall started
- 23 December 2021
- Reason
- Missing bushing on Liko M220 and M230 causing wear and potential for patient falling
- Distribution
- Worldwide distribution - US Nationwide and the countries of Austria, Austria, Bahrain, Canada, Switzerland, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, Italy, Norway, Saudi Arabia, Sweden, Slovenia, Taiwan (Province of China), South Africa, Oman.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0640-2022, Z-0639-2022
- Liko Mobile Lifts: Primarily intended for use in nursing homes LikoM230 Model: 2050015
- Liko Mobile Lifts: Primarily intended for use in nursing homes Liko M220, Model 2050010
Terminated Class II Medical devices
- Recall started
- 14 October 2021
- Terminated
- 16 August 2024
- Reason
- An unrecoverable error may occur where a component will fail to complete the reboot cycle, become non-functional and must be replaced.
- Distribution
- Worldwide distribution - US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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
Ongoing Class II Medical devices
- Recall started
- 11 August 2021
- Reason
- Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is lost the patient can slide backwards and potentially may fall out of the Oct lift sheet back onto the surface it is being lifted from.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, DE, IL, ME, MI, MO, MS, NJ, OH, PA, VA, WA and the countries of Argentina, Australia, Austria, Bolivia, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Great Britain, G
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2601-2021, Z-2600-2021, Z-2599-2021, Z-2598-2021, Z-2597-2021
- 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 gravi
- 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.
- 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.
- FlexoStretch Model Number: 3156057 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.
- 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
Terminated Class II Medical devices
- Recall started
- 28 May 2021
- Terminated
- 6 June 2024
- Reason
- 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.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL, CA, IA, MS, NC, NY, OH, PA, TX, VA and the countries of Australia, Austria, Azerbaijan, Belgium, Chile, China, Denmark, Finland, France, Germany, Ireland, Israel, Italy, Jordan, Kuwait, Netherlands, New Zealand, Norway, Portug
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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 mark
Terminated Class I Medical devices
- Recall started
- 18 December 2020
- Terminated
- 26 September 2023
- Reason
- 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
- Distribution
- Worldwide distribution: US (Nationwide) and countries of::AT, AU, BR, CA, CH, CZ, DE, DK, ES, FI, FR, GB, GR, IE, IL, IS, IT, JP, LV, NL, NO, NZ, SE & SK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0925-2021
- 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) Universa
Terminated Class II Medical devices
- Recall started
- 30 June 2020
- Terminated
- 20 October 2022
- Reason
- Affected beds may have screws installed that do not meet material tensile strength requirements. Failure of this screw could result in serious patient or user injury.
- Distribution
- Worldwide distribution - US nationwide distribution including in the states of AR, AZ, CA, DE, IN, KY, MD, ME, MI, MO, NC, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, WV and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2737-2020, Z-2738-2020
- Progressa Bed, Catalog No. P7500 - Product Usage: intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medic
- Centrella Smart+ Bed, Catalog No. P7900 - Product Usage: intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use wher
Terminated Class II Medical devices
- Recall started
- 30 April 2020
- Terminated
- 23 January 2024
- Reason
- The Bed Exit System may fail to send a remote alert through the nurse call system if a remote alert was previously sent and cancelled at the in-room nurse call wall unit.
- Distribution
- Domestic distribution nationwide. Foreign distribution to Canada and Australia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2246-2020
- Centrella Smart+ Bed, Catalog Number P7900
Terminated Class II Medical devices
- Recall started
- 14 February 2020
- Terminated
- 11 February 2021
- Reason
- There is a software issue which may result in failure to monitor or control patient's bed exit mechanism.
- Distribution
- Colorado, Georgia, Indiana, Louisiana, North Carolina, Nevada, Oregon, South Carolina, Tennessee, Virginia, Washington.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1554-2020
- NaviCare Patient Safety Software Versions 3.5.400-3.9.300. The NaviCare Patient Safety (Patient Safety) Software is compatible with the following beds: 1. VersaCare Revision A-J with upgrade kit Revision K
Terminated Class II Medical devices
- Recall started
- 12 January 2018
- Terminated
- 26 June 2020
- Reason
- A component used within the braking system may break resulting in one or more brake pedals on the bed staying in brake or not being engaged which could result in unwanted bed movement and possible patient or user injury.
- Distribution
- Worldwide distribution. US nationwide, Canada, Chile, Colombia, Costa Rica, France, Hong Kong, Israel, Jamaica, Japan, Jordan, Malaysia, Mexico, Oman, Panama, Russian Federation, Saudi Arabia, Singapore, Spain, Taiwan, UAE, and UK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1319-2018
- Progressa Bed - AC-powered adjustable hospital bed
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.