Class IIOngoingZ-3306-2026
NOXBOX LTD recalls NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I.
Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors.
NOXBOX LTDOct 7, 2026
Recalls: Component design/selection
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–12 of 54 recalls
Class IIOngoingZ-3215-2026
Heidelberg Engineering GmbH recalls Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Mod…
Wheels may come loose when module is being pushed or pulled during movement or transportation, affecting stability of the stand. The stand may tip over as a result.…
Heidelberg Engineering…Sep 30, 2026
Class IIOngoingZ-2983-2026
Fort Defiance Industries, LLC recalls Fort Defiance Industries (FDI)
The Automated Field Steam Sterilizer's water recovery system 120V Amphenol connector may experience an intermittent loss of ground continuity, which could result in an unreliable fault current return path.
Fort Defiance Industri…TNAug 26, 2026
Class IIOngoingZ-2855-2026
THERANICA BIOELECTRONICS LTD recalls Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0
Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.
- Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
- Component design/selection
THERANICA BIOELECTRONI…Aug 12, 2026
Class IIOngoingZ-2837-2026
INTEGRATED MEDCRAFT LLC recalls Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the affe…
Devices could potentially contain an occluded or partially occluded Guedel Airway tip.
INTEGRATED MEDCRAFT LL…CTAug 12, 2026
Class IIOngoingZ-2836-2026
INTEGRATED MEDCRAFT LLC recalls FORWARD Oral Airway Kit (OPA Sizes 5
Devices could potentially contain an occluded or partially occluded Guedel Airway tip.
INTEGRATED MEDCRAFT LL…CTAug 12, 2026
Class IOngoingZ-2735-2026
ResMed Ltd. recalls Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides cont…
Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.
ResMed Ltd.Aug 5, 2026
Class IIOngoingZ-2746-2026
Tosoh Bioscience Inc recalls ST AIA-Pack Testosterone
The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA) which could cause falsely elevated or falsely low total testosterone resul…
Tosoh Bioscience IncOHJul 22, 2026
Class IOngoingZ-2463-2026
Hamilton Medical AG recalls Breathing circuit set
Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-operative test, which will result in "exhalation obstructed " alarm, which may result…
Hamilton Medical AGJul 8, 2026
Class IIOngoingZ-2552-2026
Stryker Neurovascular recalls INZONE DETACHMENT SYSTEM
Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators;…
Stryker NeurovascularCAJul 1, 2026
Class IIOngoingZ-2477-2026
GE Medical Systems, LLC recalls Giraffe OmniBed Field Replaceable Unit (FRU)
GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device.…
GE Medical Systems, LL…WIJun 24, 2026
Class IIOngoingZ-2476-2026
GE Medical Systems, LLC recalls Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1
GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device.…
GE Medical Systems, LL…WIJun 24, 2026