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

1076–1100 of 1396

SevereFDA (Devices)·Z-1055-2023·2023-02-15
GE Nuclear Medicine BRIVO B615 Imaging System Detector Fall Risk
GE Nuclear Medicine BRIVO B615 imaging systems may have an ineffective safety mitigation, allowing the detector to fall and cause life-threatening injury. The FDA issued a Class I recall for seven units distributed worldwide.
Product
GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8 inch DHP BJG NR, b) BRIVO 615 3/8 inch, c) BRIVO B615 3/8 inch DHP BJG NR, d) B615 with new rotor, e) BRIVO B615 3/8 inch BJG, f) BRIVO B615 3/8 inch DHP BJG NR, g) B615 with new rotor; Emissio
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1057-2023·2023-02-15
GE Nuclear Medicine Systems Recall Due to Potential Detector Fall Hazard
GE is recalling 86 Nuclear Medicine 600/800 series systems worldwide due to a potential failure in a safety mitigation. If not correctly implemented, the detector can fall and cause life-threatening injury.
Product
GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) D670 CZT Gantry 7.25mm, c) DISCOV NM/CT 870 CZT, d) Discovery NMCT 670 CZT O540+, e) NM/CT 870 CZT CYBER DEFENCE, f) NM/CT 870 CZT O540, g) NM/CT 870 CZT WSO, h) NM/CT 870 CZT, i
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1053-2023·2023-02-15
GE Nuclear Medicine 600/800 Series Systems Detector Fall Risk
GE Nuclear Medicine 600/800 series systems have a safety mitigation that may not be correctly implemented, allowing the detector to fall and cause life-threatening injury. 557 units are affected worldwide.
Product
GE Nuclear Medicine 600/800 series systems, specifically: a) 870, b) 870 DR 3/8 inch NM GANTRY WITH NEW ROTOR - MEA, c) 870 DR / Dismount, d) 870 DR / Dismount / 60HZ, e) 870 DR 3/8 inch WSO, f) 870 DR 3/8 inch NM Gantry, g) 870 DR 3/8 inch, h) 870 DR 3/8 inch CH, i) 8
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1058-2023·2023-02-15
GE Nuclear Medicine 600/800 Systems Recalled for Detector Fall Risk
GE Medical Systems is recalling 380 GE Nuclear Medicine 600/800 series diagnostic imaging systems worldwide due to potential failure in detector mitigation that could allow the detector to fall, risking life-threatening injury.
Product
GE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / Dismount, c) 850 3/8 inch NM Gantry, d) 860 / Dismount, e) 860 3/8 inch NM Gantry, f) 860 5/8 inch NM Gantry, g) 860 BJ, h) NM 830 3/8 inch BJ, i) NM/CT 850 3/8 inch BJ, j) NM/CT 850 3/8 inch ROW,
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0963-2023·2023-02-08
CADD Infusion Administration Sets Recalled for Tubing Occlusion and False Alarms
Smiths Medical is recalling CADD Administration Sets for two issues: tubing may become blocked, preventing medication delivery, and devices may show false alerts about disposable attachment status.
Product
CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302-24, 4) REF 21-7321-24, 5) REF 21-7322-24, 6) REF 21-7323-24, 7) REF 21-7324-24, 8) REF 21-7333-24, 9) REF 21-7336-24, 10) REF 21-7339-24, 11) REF 21-7343-24, 12) REF 21-7349-24,
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0964-2023·2023-02-08
CADD Infusion Administration Sets Recalled for Delivery Failure and Alarms
FDA recalls 726,878 CADD Infusion Administration Sets due to potential tubing occlusion causing delivery failure and false alarm warnings.
Product
CADD Administration Set, List Numbers: a) REF 21-7308-24, b) REF 21-7309-24, c) REF 21-7310-24, d) REF 21-7308-24JP, e) REF 21-7309-24JP. Computerized Ambulatory Delivery Device
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0929-2023·2023-02-08
SARS-CoV-2 Antigen Rapid Test Kits Recalled for Lack of FDA Authorization
Universal Meditech Inc. is recalling approximately 56,300 SARS-CoV-2 Antigen Rapid Test Kits distributed without FDA approval, clearance, or Emergency Use Authorization. Products were distributed nationwide in California and Texas.
Product
Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT Green and white box under the brand DiagnosUS, and, White box without brand name labeled as "SARS -COV-2 ANTIGEN DEVELOPMENT MADE IN USA ORAL SWAB TES
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0962-2023·2023-02-08
CADD Administration Set recall: medication underdelivery and false alarms
Smiths Medical is recalling 1.6 million CADD Infusion System Administration Sets due to tubing occlusion causing medication underdelivery and false alarm conditions affecting patients worldwide.
Product
CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0965-2023·2023-02-08
CADD Infusion Administration Set Recalled for Delivery Failure and False Alarms
Smiths Medical is recalling CADD Administration Sets due to tubing occlusion that can prevent medication delivery and false pump alarms. This FDA Class I recall affects 214,668 units worldwide.
Product
CADD Administration Set, List Numbers: a) REF 21-7600-24, b) REF 21-7609-24, c) REF 21-7624-24, d) REF 21-7649-24, e) REF 21-7600-24JP, f) REF 21-7609-24JP, g) REF 21-7624-24JP, h) REF 21-7649-24JP Computerized Ambulatory Delivery Device
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0966-2023·2023-02-08
CADD Administration Sets recall for delivery failure and false alarms
Smiths Medical is recalling CADD Administration Sets due to potential tubing occlusion causing medication underdelivery and false alarm errors. The FDA classified this as a Class I recall affecting nearly 48 million units worldwide.
Product
CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24, 3) REF 21-7302-24, 4) REF 21-7308-24, 5) REF 21-7309-24, 6) REF 21-7310-24, 7) REF 21-7322-24, 8) REF 21-7323-24, 9) REF 21-7324-24, 10) REF 21-7333-24, 11) REF 21-7343-24, 12) REF 21-7346-24
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0961-2023·2023-02-01
Getinge Flow-e Anesthesia System Software Defect Prevents Patient Ventilation
Getinge Flow-e Anesthesia System units with certain software versions contain a bug that can prevent pressure buildup and ventilation delivery. This may result in inadequate oxygen delivery and hypoxia in anesthesia patients.
Product
Getinge Flow-e Anesthesia System, Part No. 6887900
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0959-2023·2023-02-01
Getinge Flow-i Anesthesia Systems Recalled for Software Ventilation Defect
Getinge Flow-i Anesthesia Systems models C20, C30, and C40 are being recalled due to a software bug that can prevent proper ventilation, potentially leading to hypoxia in patients.
Product
Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0960-2023·2023-02-01
Getinge Flow-c Anesthesia System Software Bug May Prevent Ventilation
The Getinge Flow-c Anesthesia System contains a software bug that can prevent pressure buildup and ventilation delivery. Under certain conditions, oxygen delivery may decrease, which may lead to hypoventilation and hypoxia.
Product
Getinge Flow-c Anesthesia System, Part No. 6887700
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0886-2023·2023-01-25
Cardiosave IABP may shut down unexpectedly due to blood contamination
The Cardiosave Rescue Intra-Aortic Balloon Pump may shut down unexpectedly if blood enters the device through a compromised balloon catheter. Approximately 46 units have been distributed worldwide.
Product
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0926-2023·2023-01-25
Medical device controller software update addresses critical failure
Cardiac Assist is issuing a software update for LifeSPARC Controller units that may experience critical failure causing the system to freeze, crash, or lose display functionality. Affected units are identified by specific serial numbers.
Product
SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001. Component of LifeSPARC System, used to pump the blood through an extracorporeal circuit.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0885-2023·2023-01-25
Cardiosave Hybrid Intra-Aortic Balloon Pump may shut down unexpectedly
The Cardiosave Hybrid Intra-Aortic Balloon Pump may shut down unexpectedly when blood enters the device through a compromised balloon catheter during use.
Product
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-36, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-08
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0773-2023·2023-01-18
RSDL Reactive Skin Decontamination Lotion Kit recalled for leaking packets
Emergent Protective Products USA Inc recalls RSDL Decontamination Lotion Kits due to complaints of leaking packets. Approximately 4,000 units were distributed to Virginia, Canada, and Switzerland.
Product
RSDL (Reactive Skin Decontamination Lotion) Kit, NSN 6505-21-912-5229. Used to remove and/or neutralize chemical warfare agents and T-2 Toxin from the skin.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-0883-2023·2023-01-18
Philips Trilogy 100 and 200 Ventilators Recalled for Foam Separation Risk
Silicone foam in some Philips Trilogy 100 and 200 ventilators may separate and block the air inlet, potentially reducing therapy delivery. This is an FDA Class I recall.
Product
Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1040005B, CA1032800B, CA1032800, KO1032800, 1032800, R1032804TP, R1032804B, R1032804TPV, 1032804B
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0882-2023·2023-01-18
Philips Trilogy 100 Ventilator Foam May Separate and Block Air Inlet
Silicone sound abatement foam in some Philips Trilogy 100 ventilators may separate and block the air inlet, potentially reducing delivered therapy volume or pressure and causing device alarms.
Product
Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 1054096B, R1054260, RSL1054260, CA1054096, R1054260B, R1054655TPV, AU1054096, AU1054096B, 1054096B, 1054097, BR1054096, LA1054096, CN1054096, KO1054096, KR1054096
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0877-2023·2023-01-18
Mahurkar Dialysis Catheters Recalled Due to Leaking Hub Defect
Covidien LP is recalling Mahurkar dialysis catheters for a potential leaking condition in the hub that may cause unanticipated fluid return during use. Over 359,000 units are affected worldwide.
Product
MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single Use, Rx Only: 13.5cm, Straight Extensions, Kit - Model No. 8888135131; 13.5 cm, Curved Extensions, Kit - Model No. 8888135132; 13.5cm, Pre-Curved, Kit - Model No. 8888135133; 13.5cm, Straight
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0908-2023·2023-01-18
Philips Fetal Spiral Electrode may break off during labor monitoring
Philips is recalling fetal spiral electrodes used for labor monitoring because the spiral tip can break off during use, requiring surgery to remove the fragment from the newborn.
Product
Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0884-2023·2023-01-18
Philips Garbin Ventilator Foam May Separate, Blocking Air Intake
Silicone foam in some Philips Garbin Ventilators may separate and block the air inlet, reducing therapy volume and causing alarms. Nine units are affected.
Product
Philips Garbin Ventilator, Model Number 1058180B
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0438-2023·2022-12-21
Arrow AC3 Optimus IABP recalled for shortened battery run-times
Arrow AC3 Optimus Intra-Aortic Balloon Pump (IABP) devices are recalled worldwide due to a potential issue with shortened battery run-times. All lot and serial numbers of model IAP-0700 are affected.
Product
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700 (IPN001112), cardiac pump
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0432-2023·2022-12-21
Arrow AutoCAT2 Intra-Aortic Balloon Pump Battery Runtime Recall
The Arrow AutoCAT2 intra-aortic balloon pump has been recalled due to potential short battery run-times. This Class I recall affects devices distributed worldwide.
Product
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329), cardiac pump
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0454-2023·2022-12-21
Intra-Aortic Balloon Pump Battery Run-Time Issue Recall
Arrow AutoCAT2WAVE intra-aortic balloon pumps are recalled due to a potential issue with short battery run-times. Fifteen units distributed worldwide are affected.
Product
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500SV (IPN000327), cardiac pump
Category
Medical Device
Distribution
0 states

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1076–1100 of 1396