Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

576–600 of 5027

SevereFDA (Devices)·Z-2085-2025·2025-07-16
FEM-FLEX II FEMII018AS cannulas may have wire protruding from body
Edwards FEM-FLEX II Femoral Arterial Cannulas, model FEMII018AS, are being recalled after complaints of a 3 mm to 4 mm section of wire exposed or protruding from the cannula body. 558 units affected.
Product
Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018AS Software Version: N/A Product Description: The Edwards FEMFLEXII Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2083-2025·2025-07-16
FEM-FLEX II femoral arterial cannulas may have wire protruding from body
Edwards FEM-FLEX II Femoral Arterial Cannulas are being recalled after complaints of a 3 mm to 4 mm section of wire exposed or protruding from the outside of the cannula body. 847 units affected.
Product
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2032-2025·2025-07-16
Hillrom LikoScale patient lift components may falsely latch and detach
Hillrom LikoScale components used with patient lift adapter kits are being recalled because the Q-link 13 may allow false latching of the quick-release hook. 9,839 units are affected.
Product
Hillrom LikoScale component, Product Code 3156232, used with the following adapter kits for patient lifts: 1) LikoScale 200 Accessory - Product Code 3156225; 2) LikoScale 350 Accessory - Product Code 3156228; 3) LikoScale 400 Accessory - Product Code 3156226.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2082-2025·2025-07-16
FEM-FLEX II FEMII016A cannulas may have wire protruding from body
Edwards FEM-FLEX II Femoral Arterial Cannulas, model FEMII016A, are being recalled after complaints of a 3 mm to 4 mm section of wire exposed or protruding from the cannula body. 6,801 units affected.
Product
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2035-2025·2025-07-09
BiPAP V30 Auto ventilators are not indicated for respiratory failure
The Philips Respironics BiPAP V30 Auto Ventilator is being recalled because the device does not indicate for use in patients with respiratory failure. 5,958 units affected.
Product
BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2037-2025·2025-07-09
BiPAP A40 ventilators are not indicated for respiratory failure patients
The BiPAP A40 Ventilator is being recalled because the device does not indicate for use in patients with respiratory failure. 6 units in the US and 67,534 outside it are affected.
Product
BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sold OUS
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2041-2025·2025-07-09
HardyCHROM CRE Culture Medium Recalled for Quality Control Failure
Hardy Diagnostics is recalling HardyCHROM CRE culture medium (Catalog No. G323) distributed across 22 US states and Puerto Rico. The product failed quality control testing due to breakthrough growth of Klebsiella pneumoniae.
Product
HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
Category
Medical Device
Distribution
22 states
SevereFDA (Devices)·Z-2014-2025·2025-07-09
Servo-n ventilators may measure patient circuit compliance inaccurately
The Servo-n Ventilator System is being recalled because patient circuit compliance may be measured inaccurately during the patient circuit test. 7,688 units affected.
Product
Servo-n Ventilator System. Model Number: 6694800.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2013-2025·2025-07-09
Servo-u ventilators may measure patient circuit compliance inaccurately
The Servo-u Ventilator System is being recalled because patient circuit compliance may be measured inaccurately during the patient circuit test. 874 units are affected.
Product
Servo-u Ventilator System. Model Number: 6688600.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2015-2025·2025-07-09
Servo-u MR Ventilator System inaccurate patient circuit compliance measurement
Servo-u MR Ventilator System (Model 6888800) may measure patient circuit compliance inaccurately due to incorrect pre-use leakage testing and incorrect active humidifier use.
Product
Servo-u MR Ventilator System. Model Number: 6888800.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2048-2025·2025-07-09
Philips Ultrasound Transducers Recalled After Over-Refurbishment
Philips Ultrasound, Inc is recalling 5,230 Philips 3D9-3v Transducer devices because they were refurbished beyond their useful life, posing a risk of device failure during medical use.
Product
Philips 3D9-3v Transducer.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2036-2025·2025-07-09
BiPAP A30 and BiPAP Hybrid A30 Ventilators Recalled by Philips
Philips Respironics is recalling BiPAP A30 and BiPAP Hybrid A30 ventilators. The devices do not have an indication for use in patients with respiratory failure.
Product
BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more than 10 kg. BiPAP Hybrid A30 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1961-2025·2025-07-02
MicroMyst Applicator recalled due to lack of sterility assurance
Integra LifeSciences Corp. is recalling the MicroMyst Applicator Box of 5 due to lack of sterility assurance. The product is used with the Integra Flow Source for controlled application of two liquids.
Product
MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow Source for the controlled application of two liquids.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2016-2025·2025-07-02
Omnipod 5 iOS App software design issue causes insulin overdose risk
Insulet Corporation is recalling the Omnipod 5 iOS App due to a software issue where decimal separators are not recognized in manual insulin entry, potentially causing insulin overdose and severe hypoglycemia.
Product
Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software Version: all Product Description: The Omnipod 5 iOS App software is available to download through the Apple app store. The Omnipod 5 App is the user interface t
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1960-2025·2025-07-02
Extended Tip Applicator 8CM medical devices recalled due to sterility concerns
Integra LifeSciences is recalling Extended Tip Applicator 8CM devices nationwide and internationally because they may contain potentially out-of-specification endotoxin levels and lack sterility assurance.
Product
Extended Tip Applicator 8CM, Box of 1.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2023-2025·2025-07-02
BD BACTEC MGIT 960 PZA Kit tuberculosis susceptibility testing recall
Becton Dickinson is recalling BD BACTEC MGIT 960 PZA Kit due to reports of intermittent false resistance results during pyrazinamide susceptibility testing of Mycobacterium tuberculosis. The issue affects units distributed worldwide.
Product
BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA).
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1958-2025·2025-07-02
Extended Tip Applicator 8CM distributed by Integra LifeSciences recalled nationwide
Integra LifeSciences is recalling Extended Tip Applicator 8CM devices due to potentially out-of-specification endotoxin levels and lack of sterility assurance. The recall affects 6,216 units distributed across the US and internationally.
Product
Extended Tip Applicator, 8CM, Box of 5.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1904-2025·2025-07-02
Broselow Pediatric Emergency Rainbow Tape recalled for incorrect dosing values
SunMed Holdings is recalling Broselow Pediatric Emergency Rainbow Tape due to incorrect values printed on the tape that could lead to improper medication dosing and defibrillation in pediatric emergency care.
Product
Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36-23446 Rev 2 Print Version The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1959-2025·2025-07-02
Extended Tip Applicator 15 CM recalled for endotoxin and sterility issues
Integra LifeSciences is recalling Extended Tip Applicators (15 CM, Box of 5) because they may contain out-of-specification levels of endotoxins and lack sterility assurance.
Product
Extended Tip Applicator, 15 CM, Box of 5.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1946-2025·2025-06-25
Dexcom One Continuous Glucose Monitoring System Receiver Speaker Defect
Dexcom, Inc. is recalling Dexcom One Continuous Glucose Monitoring System receivers due to potential defective foam or assembly errors that may cause the speaker to lose contact with internal components, resulting in missed audible alerts for dangerous blood glucose levels.
Product
Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006 (MT27409-1), STK-DO-013 (MT27409-1), STK-DO-103 (MT27409-2), STK-DO-109 (MT27409-2)
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1944-2025·2025-06-25
Dexcom G7 Glucose Receiver recalled due to defective foam or assembly error
Dexcom, Inc. is recalling Dexcom G7 Glucose Receiver units due to defective foam or assembly error that may cause the speaker to lose contact with the circuit board, preventing audible alerts for low or high blood glucose.
Product
Dexcom G7 Glucose Receiver, SKUs (part number): STK-AT-011(MT26403-0), STK-AT-012 (MT26403-0), STK-AT-013 (MT26403-0), STK-GT-001 (MT26403-1), STK-GT-008 (MT26403-5), STK-GT-013 (MT26403-1) , STK-GT-019 (MT26403-4) , STK-GT-100 (MT26403-2), STK-GT-109 (MT26403-2) , STK-GT-113 (
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1945-2025·2025-06-25
Dexcom One+ Continuous Glucose Monitoring System Receiver Speaker Defect
Dexcom, Inc. is recalling 26,291 units of the Dexcom One+ Continuous Glucose Monitoring System due to defective foam or assembly errors that may prevent audible alerts for low or high blood glucose levels, potentially leading to seizures, loss of consciousness, or death.
Product
Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013 (MT28285-1), STK-D7-014 (MT28285-1), STK-D7-103 (MT28285-2)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1902-2025·2025-06-25
Cook Beacon Tip Angiographic Catheters Recalled for Tip Separation Risk
Cook Incorporated is recalling specific lots of Beacon Tip 5.0 Fr Angiographic catheters due to the risk that the catheter tip may separate during use. The affected catheters were distributed worldwide.
Product
Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters are available in various configurations. Configurations include different shaft lengths and tip curves and some catheters are manufactured with a hydrophilic coati
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1943-2025·2025-06-25
Dexcom G6 Glucose Receiver recalled for missed audible alerts
Dexcom G6 Glucose Receiver units may have defective foam or assembly errors that disable audible alerts for dangerously low or high blood glucose, risking seizures, loss of consciousness, or death.
Product
Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001 (MT27408-1)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1963-2025·2025-06-18
Microtek Patient Drape Adapter Plug Kits Recalled for Non-Sterile Labeling
Microtek Medical is recalling Patient Drape adapter plug kits (models AP6MMN and AP8MMN) because non-sterile products were labeled as sterile. The affected adapters are used to connect drain hoses to fluid management devices.
Product
Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN UDI code: (01)10748426139986 AP8MMN Patient Drape, 8mm Adapter Plug Kit REF AP8MMN UDI code: (01)10748426139429 These adapters function as accessories for a device or drape, serving to
Category
Medical Device
Distribution
20 states

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576–600 of 5027