Safety Recalls
RSS ↗15,379 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 15,151–15,200 of 15,379
- Unclassified
Vehicle Recall · July 3, 2023
2023 KIA K5Air bags that do not deploy as intended can increase the risk of injury in a crash.
- Class II
Medical Device Recall · June 28, 2023
stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgeryThere is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice versa).
- Class II
Medical Device Recall · June 28, 2023
stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurgeryThere is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice versa).
- Class II
Medical Device Recall · June 28, 2023
The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throatThere is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-030 but package contains a 5820-107-530 device).
- Class II
Medical Device Recall · June 15, 2023
Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Number: RII1001 (Small), RII1002 (Medium), RII1003 (Large) Software Version: N/A Product Description: Nasal pillowsPackaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).
- Class II
Medical Device Recall · June 14, 2023
IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062;Devices with Option CP2 and initially programmed to software version P.01.01 were configured incorrectly at the factory. Therefore, Enhanced ECG Capabilities provided by Option CP2 were not enabled in these devices. Without Option C01 Full Arrhythmia, the device will not provide the yellow alarms for enhanced arrhythmia detection. This is a retrospectively reported recall from 6/14/23.
- Unclassified
Vehicle Recall · June 12, 2023
2023 BMW X3, 2023 BMW X4, 2023 BMW X5, 2023 BMW X6, 2023 TOYOTA SUPRATransmission oil that leaks into the control unit can lead to a seizure of the transmission gears, causing a sudden loss of drive power and increasing the risk of a crash.
- Unclassified
Vehicle Recall · June 11, 2023
2024 BUICK ENCORE GX, 2024 BUICK ENVISTA, 2024 CHEVROLET TRAXA blank instrument panel will not show critical information, such as vehicle speed and warning lights, increasing the risk of a crash.
- Class II
Medical Device Recall · June 9, 2023
Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S.
REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292Sterility of Ultrasound gel can not be guaranteed.
- Class I
Medical Device Recall · June 6, 2023
GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant warmer. Model Numbers: 1) 2082844-001-01040418; 2) 2082844-001-01046784; 3) 2082844-001-01052324; 4) 20Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during clinical use that would rapidly decrease over a week. Affected customers were notified in June 2023 to run incubators for a week to potentially off gas any residual airborne formaldehyde. The general scientific consensus is that sensory irritation of the eyes is the most sensitive endpoint with respect to exposure to airborne formaldehyde and is the adverse effect clinically experienced at the lowest concentration.
- Class I
Medical Device Recall · June 6, 2023
GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-01040417; 2) 2082844-002-01044956; 3) 2082844-002-01058424; 4) 2082844-002-01069017; 5) 2082Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during clinical use that would rapidly decrease over a week. Affected customers were notified in June 2023 to run incubators for a week to potentially off gas any residual airborne formaldehyde. The general scientific consensus is that sensory irritation of the eyes is the most sensitive endpoint with respect to exposure to airborne formaldehyde and is the adverse effect clinically experienced at the lowest concentration.
- Unclassified
Vehicle Recall · June 6, 2023
Mitsubishi Motors North America, Inc.
2023 MITSUBISHI OUTLANDER, 2023 MITSUBISHI OUTLANDER PHEVA rearview camera that does not display an image can reduce the driver's rear view, increasing the risk of a crash or injury.
- Class II
Medical Device Recall · June 6, 2023
Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00A premature failure condition was identified with the L2050R pulse oximeter SpO2 sensor that connects to the L2050G Vios chest sensor device. When a failure occurs, a Pulse Ox Sensor Off warning condition will be incorrectly displayed by the system.
- Unclassified
Vehicle Recall · June 4, 2023
2023 BMW X5A head restraint without a locking tab may not properly restrain an occupant during a crash, increasing the risk of injury.
- Unclassified
Vehicle Recall · June 4, 2023
Jaguar Land Rover North America, LLC
2023 LAND ROVER RANGE ROVER SPORTTaillights and brake lights that do not illuminate correctly can reduce vehicle visibility or cause confusion for other drivers, increasing the risk of a crash.
- Unclassified
Vehicle Recall · June 4, 2023
Jaguar Land Rover North America, LLC
2023 LAND ROVER RANGE ROVERAn improperly welded second-row left seat frame may not adequately secure occupants during sudden braking or a crash, increasing the risk of injury.
- Unclassified
Vehicle Recall · June 3, 2023
Triumph Motorcycles America, Ltd.
2023 TRIUMPH BONNEVILLE T120The detachment of the LHS brake disc can reduce brake performance, increasing the risk of a crash.
- Class II
Medical Device Recall · May 31, 2023
MICRO-X Rover Mobile X-ray System, # MXU-RV35Shots were terminated by the mAs integrator; however, the 4 ms exposure time did not allow enough tolerance to achieve diagnostic exposures due to variations in hardware and how different timers are started.
- Class II
Medical Device Recall · May 30, 2023
Alinity ci-series System Control Module, REF: 03R70-01There are potential performance issues found in the Alinity ci-series System software versions 3.4.0 and lower, including: 1) SCC Reagent load error during daily maintenance; 2) Sample Laboratory Report error; 3) Customer requests mechanism to prevent user error when creating new lots of value assigned Calibrators; 4) Error in processing tests after CCCintController encountered an error with the assay information downloaded from SCC; 5) The assay editor does not correctly check sample dilution total volume limits; 6) User-Applied Labels not adhering to Reagent Bottles; 7) ICT Module did not expire after warranty was exceeded. These performance issues could lead to erroneous results for multiple analytes.
- Class II
Medical Device Recall · May 30, 2023
ACETABULAR FIXATION CUP, (xx)MM, 5 HOLE, Ti-6AI-4V ELI TiN CERAMIC W/PLASMA SPRAY, STERILEEO, Reference Numbers: 01-01-0554 01-01-0556 01-01-0558 01-01-0560 01-01-0562 01-01-0564 01-01-0566Medical device components were marketed without FDA clearance and without FDA approval
- Class II
Medical Device Recall · May 30, 2023
ACETABULAR BEARING (xx)MM I.D X (xx) O.D. UHMWPE 1020, STERILEEO, Reference Numbers: 01-02-4254 01-02-4456 01-02-4558 01-02-4760 01-02-4962 01-02-5164 01-02-5266Medical device components were marketed without FDA clearance
- Class II
Medical Device Recall · May 30, 2023
Femoral Resurfacing Cup - (xx)MM, Ti-6AI-4V ELI, TiN CERAMIC W/ PLASMA SPRAY, STERILEEO, Reference Numbers: 01-03-0042 01-03-0044 01-03-0045 01-03-0047 01-03-0049 01-03-0051 01-03-0052Medical device components were marketed without FDA clearance
- Class II
Medical Device Recall · May 24, 2023
EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnosticComplaints that specific samples produced false positive EliA GBM results. A positive signal was present when these samples were tested for coating-solution reactivity using EliA wells without antigen.
- Unclassified
- Unclassified
Vehicle Recall · May 10, 2023
2024 JAYCO PRECEPTAn obstructed emergency exit window may prevent or delay occupants from exiting in an emergency, increasing the risk of injury.
- Class II
Medical Device Recall · May 10, 2023
LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004Retroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-Stop) alarm when an administration set is loaded or coupled while the pump is executing the power-up sequence. May lead to delay in therapy. 2) Alert is not annunciated informing the clinician that the bolus cannot be delivered when the entered bolus dose exceeds the Care Profile Hard Rate Max limit and Rapid Bolus is selected. May lead to over infusion. Both issues were resolved in all fielded product in software version 5.8.0, which was installed in affected units May thru August 2023.
- Unclassified
Vehicle Recall · May 9, 2023
2023 KENWORTH T280, 2024 PETERBILT 548A disconnected hose will result in an engine stall, increasing the risk of a crash. Also, a fuel leak in the presence of an ignition source increases the risk of a fire.
- Unclassified
Vehicle Recall · May 6, 2023
2023 TIFFIN ALLEGRO BUSLoss of power to the chassis can cause an engine stall, increasing the risk of a crash.
- Unclassified
- Unclassified
Vehicle Recall · May 5, 2023
2023 AIRSTREAM ATLASWiring that overheats can increase the risk of a fire.
- Class II
Medical Device Recall · April 19, 2023
Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1During extended operation of the MX40 with the PIC iX, the DHCP (Dynamic Host Configuration Protocol) lease can expire on the MX40. If the DHCP lease expires while the device is offline, upon reconnecting with the PIC iX, a new IP address will be assigned to the MX40. The PIC iX will not recognize the new IP address after reconnecting and therefore the expecting settings sync fails.
- Unclassified
Vehicle Recall · April 12, 2023
2023 INFINITI QX60, 2024 INFINITI QX60Incorrectly adjusted headlights can reduce visibility, increasing the risk of a crash.
- Unclassified
Vehicle Recall · April 10, 2023
2023 HARLEY-DAVIDSON FLHXSEA brake fluid leak can reduce braking ability and increase the risk of a crash.
- Unclassified
Vehicle Recall · April 8, 2023
2024 SUBARU IMPREZA, 2024 SUBARU CROSSTREKA short circuit may cause a loss of drive power, increasing the risk of a crash.
- Unclassified
Vehicle Recall · April 8, 2023
2024 HYUNDAI TUCSONA label that incorrectly states spare tire pressure when there is no spare tire on-board may cause confusion during an emergency tire replacement, increasing the risk of a crash or injury.
- Unclassified
Vehicle Recall · April 8, 2023
2023 GENESIS GV60A seat belt that fails to fasten or extend properly may not adequately restrain an occupant in a crash, increasing the risk of injury.
- Unclassified
Vehicle Recall · April 6, 2023
2023 VOLVO VNLAn air bag that does not deploy, increases the risk of an injury.
- Unclassified
Vehicle Recall · April 5, 2023
2023 PJ TRAILERS LD, 2024 PJ TRAILERS LDA coupler that separates can allow the trailer to disconnect from the tow vehicle, increasing the risk of a crash.
- Unclassified
Vehicle Recall · April 5, 2023
Jaguar Land Rover North America, LLC
2023 LAND ROVER RANGE ROVER, 2023 LAND ROVER RANGE ROVER SPORTIn the event of a crash, unsecured objects from within the armrest compartment may strike the vehicle occupants, increasing their risk of injury.
- Unclassified
Vehicle Recall · April 5, 2023
2023 ENTEGRA VISION XL, 2024 ENTEGRA VISION, 2024 JAYCO PRECEPTA damaged wheel can result in a loss of tire pressure. A damaged brake line can cause a brake fluid leak and reduce brake performance. Either condition increases the risk of a crash.
- Class II
Medical Device Recall · April 5, 2023
BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352Due to an automated dispensing cabinet software issue, when a medication single order contains more than one component and at least one is unavailable for a multi-item or combination order, the order may display as grayed out; alternate location tooltip will display "Server connection failed," not listing other area devices where unavailable item(s) may be found, which may lead to delayed therapy.
- Unclassified
Vehicle Recall · April 5, 2023
2023 ENTEGRA EXPANSE, 2023 ENTEGRA ETHOS, 2024 ENTEGRA ETHOSA gas leak in the presence of an ignition source may increase the risk of fire.
- Unclassified
Vehicle Recall · April 5, 2023
2023 INTERNATIONAL MVA sudden loss of drive power can increase the risk of a crash.
- Unclassified
Vehicle Recall · April 4, 2023
Daimler Trucks North America, LLC
2023 FREIGHTLINER CASCADIA, 2023 FREIGHTLINER 114SD, 2023 WESTERN STAR 47XA detached steering arm can result in a sudden loss of steering control, increasing the risk of a crash.
- Class I
Medical Device Recall · March 28, 2023
Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result in less than optimal therapy.
- Class II
Medical Device Recall · March 14, 2023
Advanced Research Medical, LLC
ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4; treatment of degenerative disc diseasePotential shearing of the disposable blade may occur and be contained within the of Flexible Curette Shaft Assembly during surgery.
- Class II
Medical Device Recall · March 13, 2023
Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers: a) 51-000013-00, b) 51-000008-00The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.
- Unclassified
Vehicle Recall · March 11, 2023
2024 FOREST RIVER STEALTHA melted wire may cause a short circuit, increasing the risk of a fire.
- Unclassified
Vehicle Recall · March 8, 2023
2024 CHEVROLET SILVERADO 3500, 2024 CHEVROLET SILVERADO 2500, 2024 GMC SIERRA 3500, 2024 GMC SIERRA 2500A steering arm that disconnects may result in a total loss of steering control, increasing the risk of a crash.
- Unclassified
Vehicle Recall · March 8, 2023
2023 HIGHLAND RIDGE TT RANGE LITE AIRThe lack of a secondary escape exit can prevent or delay occupants from exiting, increasing their risk of injury during an emergency.