Safety Recall Directory
Browse and filter the latest official safety alerts globally.
FDA DevicesBrand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/A
Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/A
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
FDA DevicesHappiest Baby, Inc Pre-loved SNOO Smart Sleeper Model:S1000
Happiest Baby, Inc Pre-loved SNOO Smart Sleeper Model:S1000
This recall is retroactively being reported. Refurbished bassinets failed to meet quality standards prior to distribution.
FDA Devicesmunevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelchair Head Control System
munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelchair Head Control System
A software issue may cause the wheelchair's driving mechanism to fall out of calibration. When this occurs, the device may experience unexpected steering drift or imprecise control while driving the wheelchair. The wheelchair may veer from its intended path, which may cause in low-speed collision, tipping, or injuries to user or bystanders.
NHTSAMack Trucks, Inc. - Marker Lights May Fail to Illuminate/FMVSS 108
Mack Trucks, Inc. - Marker Lights May Fail to Illuminate/FMVSS 108
Marker lights that fail to illuminate can reduce visibility, increasing the risk of a crash.
NHTSAVolvo Trucks North America - Marker Lights May Fail to Illuminate/FMVSS 108
Volvo Trucks North America - Marker Lights May Fail to Illuminate/FMVSS 108
Marker lights that fail to illuminate can reduce visibility, increasing the risk of a crash.
FDA DevicesHalyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. HEART CATH, SELF REGIONAL SELF131-05
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. HEART CATH, SELF REGIONAL SELF131-05
Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.
FDA DevicesRadial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5; Outer Box UPN: M00513363; Inner Box UPN: M00513360.
Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5; Outer Box UPN: M00513363; Inner Box UPN: M00513360.
Potential for breach in sterile barrier of device packaging.
FDA DevicesPhilips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System.
Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System.
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
FDA DevicesBrand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4mm, 6mm, right Model/Catalog Number: 9323-5335, 9323-5337, 9323-5339 and 9323-5336, 9323-5338, 9323-5340 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No
Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4mm, 6mm, right Model/Catalog Number: 9323-5335, 9323-5337, 9323-5339 and 9323-5336, 9323-5338, 9323-5340 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
FDA FoodClover Hill Dairy LLP, Soft Cuajada (vacuum sealed), sold in 14oz- and 2.5 lb clam shells, and 5-lb bags. Unknown information: labeling, or total quantity of product distributed. Keep refrigerated.
Clover Hill Dairy LLP, Soft Cuajada (vacuum sealed), sold in 14oz- and 2.5 lb clam shells, and 5-lb bags. Unknown information: labeling, or total quantity of product distributed. Keep refrigerated.
Product contaminated with Listeria monocytogenes.
FDA Food"***Hondashi 0.25oz***" seasoning packed in silver plastic/metallic pouch, pouches packed in brown paperboard cartons (600 packets/carton), Carton label reads in part as "***Hondashi 0.25oz*600bags/ctn, Ingredients: salt, sodium glutamate, bonito, cornstarch, maltodextrin, water, flavored sodium nucleotide, glucose, soybean protein powder Allergen: Soybean, 1025 Ave S, Ste 150, Grand Prairie, TX 75050***"
"***Hondashi 0.25oz***" seasoning packed in silver plastic/metallic pouch, pouches packed in brown paperboard cartons (600 packets/carton), Carton label reads in part as "***Hondashi 0.25oz*600bags/ctn, Ingredients: salt, sodium glutamate, bonito, cornstarch, maltodextrin, water, flavored sodium nucleotide, glucose, soybean protein powder Allergen: Soybean, 1025 Ave S, Ste 150, Grand Prairie, TX 75050***"
Allergen missing from contains statement: fish
FDA DevicesBrand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2 Product Description: The DASH¿ Rapid PCR Instrument (DASH Instrument) is an automated, fluorescence-based, reverse-transcription polymerase chain reaction (RT-PCR) instrument that extracts specimens and performs nucleic acid amplified tests (NAAT) in DASH test cartridges for the qualitative detection of infectious diseases. The DASH Instrument is intended for use in conjunction with DASH Rapid PCR System tests to aid in the diagnosis of infectious diseases. Component: No.
Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2 Product Description: The DASH¿ Rapid PCR Instrument (DASH Instrument) is an automated, fluorescence-based, reverse-transcription polymerase chain reaction (RT-PCR) instrument that extracts specimens and performs nucleic acid amplified tests (NAAT) in DASH test cartridges for the qualitative detection of infectious diseases. The DASH Instrument is intended for use in conjunction with DASH Rapid PCR System tests to aid in the diagnosis of infectious diseases. Component: No.
Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).
NHTSABMW of North America, LLC - Incorrectly Attached Steering Spindle
BMW of North America, LLC - Incorrectly Attached Steering Spindle
An incorrectly attached steering spindle can lead to a loss of steering control, increasing the risk of a crash.
FDA DevicesAtellica CH Urine Albumin REF: 11537225, in vitro diagnostic
Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results; Increased rate of reaction cuvette QC failures and Delayed results due to QC failures.
FDA Devices5-PLASMA Bivalirudin Control, Model Number 5D-44905
5-PLASMA Bivalirudin Control, Model Number 5D-44905
Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.
FDA DevicesHalyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. SAMMC ANGIOGRAPHY SAMM066-15
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. SAMMC ANGIOGRAPHY SAMM066-15
Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.
FDA DevicesNeuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0630-140-2, NG-0640-140-2, NG-0730-140-2, NG-0740-140-2, NG-NV-6-30, NG-NV-6-40, NG-NV-7-30, NG-NV-7-40
Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0630-140-2, NG-0640-140-2, NG-0730-140-2, NG-0740-140-2, NG-NV-6-30, NG-NV-6-40, NG-NV-7-30, NG-NV-7-40
Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter, that due to a wire-to-filter-bond issue, may fail to open following sheath retraction; and if this condition were to occur during a procedure, the result may be loss of intended integrated embolic protection.
NHTSABMW of North America, LLC - Loss of Rear Wheel Power from Driveshaft Damage
BMW of North America, LLC - Loss of Rear Wheel Power from Driveshaft Damage
An unexpected loss of drive power can increase the risk of a crash. In addition, a damaged driveshaft can result in a vehicle rollaway if the parking brake is not applied, increasing the risk of a crash or injury.
FDA DevicesBrand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Model/Catalog Number: 9323-5310 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No, N/A
Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Model/Catalog Number: 9323-5310 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No, N/A
Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
FDA FoodClover Hill Dairy LLP, Smoked Cheddar Cheese Varieties (Cheddar, White Cheddar). Sold in 1/2-lb and 1-lb units. Unknown information: packaging, labeling, or total quantity of product distributed. Keep refrigerated.
Clover Hill Dairy LLP, Smoked Cheddar Cheese Varieties (Cheddar, White Cheddar). Sold in 1/2-lb and 1-lb units. Unknown information: packaging, labeling, or total quantity of product distributed. Keep refrigerated.
Product contaminated with Listeria monocytogenes.
FDA FoodBig Way Hot Pot "Hot Pot Miso Paste"; 1kg (35.3oz) unit package. Product is packaged in generic bulk packaging.
Big Way Hot Pot "Hot Pot Miso Paste"; 1kg (35.3oz) unit package. Product is packaged in generic bulk packaging.
Undeclared milk from lactose.
FDA FoodFLOUNDER SASHIMI WITH SAUCE; Keep Frozen; Net WT: 300g; UPC: 8 809342 366186
FLOUNDER SASHIMI WITH SAUCE; Keep Frozen; Net WT: 300g; UPC: 8 809342 366186
Foreign Manufacturer label contains Undeclared allergen ingredients Wheat, Soy, Sesame, Yellow #5 and Blue #1 in Frozen Flounder Products.
FDA FoodClover Hill Dairy LLP, Smoked Pepper Cheese Varieties (Jalapeno Cheddar), sold in 1/2-lb and 1-lb units. Unknown information: packaging, labeling, or total quantity of product distributed. Keep refrigerated.
Clover Hill Dairy LLP, Smoked Pepper Cheese Varieties (Jalapeno Cheddar), sold in 1/2-lb and 1-lb units. Unknown information: packaging, labeling, or total quantity of product distributed. Keep refrigerated.
Product contaminated with Listeria monocytogenes.
FDA DevicesFlow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i C20 6888520 Flow-i C30 6888530 Flow-i C40 6888540 Flow-c 6887700 Flow-e 6887900
Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i C20 6888520 Flow-i C30 6888530 Flow-i C40 6888540 Flow-c 6887700 Flow-e 6887900
Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failure to deliver the anesthetic agent may result in the patient receiving insufficient anesthesia and may lead to intraoperative awareness.