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Browse Device Recalls

35 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 35 FDA device recalls.

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DateProductReasonClassFirm
Jan 14, 2022 (1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead l... Traverse rail carriage delivered with non-conforming screws are too short to ensure appropriate i... Class II Hill-Rom, Inc.
Dec 23, 2021 Liko Mobile Lifts: Primarily intended for use in nursing homes Liko M220, Mo... Missing bushing on Liko M220 and M230 causing wear and potential for patient falling Class II Hill-Rom, Inc.
Dec 23, 2021 Liko Mobile Lifts: Primarily intended for use in nursing homes LikoM230 Mode... Missing bushing on Liko M220 and M230 causing wear and potential for patient falling Class II Hill-Rom, Inc.
Aug 11, 2021 OctoStretch with Stretch Leveller - The combination of this products allows t... Stretch Leveller has the potential to lose the function of maintaining a patient in the horizonta... Class II Hill-Rom, Inc.
Aug 11, 2021 FlexoStretch Model Number: 3156057 - The combination of this products allows ... Stretch Leveller has the potential to lose the function of maintaining a patient in the horizonta... Class II Hill-Rom, Inc.
Aug 11, 2021 Stretch Leveller Model Number: 3156200 - The combination of this products all... Stretch Leveller has the potential to lose the function of maintaining a patient in the horizonta... Class II Hill-Rom, Inc.
Aug 11, 2021 LikoStretch 1900 Model Number: 3156051 - The combination of this products all... Stretch Leveller has the potential to lose the function of maintaining a patient in the horizonta... Class II Hill-Rom, Inc.
Aug 11, 2021 LikoStretch Mod 600 IC Model Number: 3156065 LikoStretch Mod 600 IC, Wide Mo... Stretch Leveller has the potential to lose the function of maintaining a patient in the horizonta... Class II Hill-Rom, Inc.
May 28, 2021 Affinity Four Birthing Bed-used as a birthing bed for women of child bearing ... Latch mechanism on the Lift-Off foot section of the Affinity Four Birthing Bed is damaged, it cou... Class II Hill-Rom, Inc.
Dec 18, 2020 Liko Multirall 200 overhead lift- overhead lift is a general-purpose lift wi... Multirall Q-link strap lock has not been fully engaged in the S65 rail carriage hook by user, lea... Class I Hill-Rom, Inc.
Jun 30, 2020 Centrella Smart+ Bed, Catalog No. P7900 - Product Usage: intended to be used ... Affected beds may have screws installed that do not meet material tensile strength requirements. ... Class II Hill-Rom, Inc.
Jun 30, 2020 Progressa Bed, Catalog No. P7500 - Product Usage: intended to be used to trea... Affected beds may have screws installed that do not meet material tensile strength requirements. ... Class II Hill-Rom, Inc.
Apr 30, 2020 Centrella Smart+ Bed, Catalog Number P7900 The Bed Exit System may fail to send a remote alert through the nurse call system if a remote ale... Class II Hill-Rom, Inc.
Jan 12, 2018 Progressa Bed - AC-powered adjustable hospital bed A component used within the braking system may break resulting in one or more brake pedals on the... Class II Hill-Rom, Inc.
Feb 23, 2017 TotalCare Bed Systems, Model Numbers P1900, PR1900, and U1900 with 3-Level Pa... The bed exit alarm may not function properly if the alarm has been armed for a period longer than... Class II Hill-Rom, Inc.
Aug 9, 2016 Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling in... Ceiling Bracket 71 was shipped with a larger center hole. A potentially hazardous situation exi... Class II Hill-Rom, Inc.
Jul 15, 2016 Affinity Four Birthing Bed Model P3700 The primary packaging is pictured... Class II Hill-Rom, Inc.
Jun 14, 2016 Volker 2080, 2082, S 280 and S 282 series beds with lateral release button. ... The current construction of the side rail latch may not be able to support the full patient weigh... Class II Hill-Rom, Inc.
Mar 8, 2016 Liko Universal SlingBars Universal SlingBar" 350, Universal SlingBar" 35... The center bolt of the sling bar, which connects the bar to the patient lift, has failed during u... Class II Hill-Rom, Inc.
Jan 20, 2016 Hill-Rom Bariatric Power Recliner, Product Model # P9096 Hill-Roms 660 lb P... The recliners were shipped without the foot rest ottoman linkage side shields, which could result... Class II Hill-Rom, Inc.
Oct 7, 2015 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 wh... Class II Hill-Rom, Inc.
Mar 20, 2015 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 t... Class II Hill-Rom, Inc.
Mar 2, 2015 Steriseal-Cannula Ophthalmic; Bi-Manual Irrigating/Aspirating Handpiece. The metal cannula attached to the handpiece can rotate and become dislodged from the plastic hand... Class II Hill-Rom, Inc.
Jun 26, 2014 Affinity¿ Four Birthing Bed, Product Usage: Product is intended to be us... The attachment latch mechanism can become bent depending on user handling. Latch mechanism bendi... Class II Hill-Rom, Inc.
May 30, 2013 TotalCare Bed used with AccuMax Quantum VPC mattress AccuMax Quantum Complet... When the bed is put into the chair egress position, the magnets on the mattress may not hold the... Class II Hill-Rom, Inc.
Apr 30, 2013 SlingBar Wide 670. Designed to meet the needs for lifting humans. Retrospective review found 4 sling bars that may present a potential for impalement if a patient,... Class II Hill-Rom, Inc.
Apr 30, 2013 SlingBar 360. Designed to meet the needs for lifting humans. Retrospective review found 4 sling bars that may present a potential for impalement if a patient,... Class II Hill-Rom, Inc.
Apr 30, 2013 SlingBar Standard. Designed to meet the needs for lifting humans. Retrospective review found 4 sling bars that may present a potential for impalement if a patient,... Class II Hill-Rom, Inc.
Apr 30, 2013 SlingBar 350. Designed to meet the needs for lifting humans. Retrospective review found 4 sling bars that may present a potential for impalement if a patient,... Class II Hill-Rom, Inc.
Apr 15, 2013 Hill-Rom 1000 Bed, Product No. P1160. The Hill-Rom 1000 Bed is intended for... Complaints have been reported for brakes disengaging when the bed is subjected to a hard jolt or ... Class II Hill-Rom, Inc.
Feb 26, 2013 TotalCare SpO2RT2 bed. Product Usage: Bed, flotation therapy, powered ... In certain situations a software problem with the TotalCare SpO2RT¿ 2 bed may occur that can lead... Class II Hill-Rom, Inc.
Dec 6, 2012 Liko Standard Slingbar 450. The Standard Slingbar 450 is a versatile sling... Liko/Hill-Rom has received reports from facilities which indicate that serious injuries have been... Class II Hill-Rom, Inc.
Oct 31, 2012 Liko Overhead Rail System, Ceiling Mounted Rail Systems for all Liko Stationa... Liko/Hill-Rom to date has received two reports from facilities alleging that the overhead rail sy... Class II Hill-Rom, Inc.
Jun 18, 2012 Advanta 2 Bed. The Advanta 2 Bed is intended for low to moderate acuity pa... During an evaluation of Advanta 2 siderail samples returned from the field it was found that the ... Class II Hill-Rom, Inc.
Apr 2, 2012 Affinity Four Birthing Bed P3700 Product Usage: The Affinity, Four Birth... During review of our last braking system via that field corrective action, the system still did n... Class II Hill-Rom, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.