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

1326–1350 of 1396

SevereFDA (Devices)·Z-2518-2021·2021-10-06
FDA Recalls Ultrasound Gels for Bacterial Contamination Risk
Omnisound Gel and EcoGel 200 ultrasound gels distributed nationwide from January 2018 to August 2021 may contain bacterial contamination. The FDA issued a Class I recall; health care providers should immediately stop using these products.
Product
Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in ultrasound procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2577-2021·2021-10-06
Reperfusion Catheter Recalled Due to Risk of Distal End Fracture
Imperative Care ZOOM 71 Reperfusion Catheters are recalled due to potential for distal end fracture and detachment. This FDA Class I recall affects units distributed nationwide.
Product
Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm), STERILE.EO, Rx Only, UDI: (01) 00812212030191. For neurovascular procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2583-2021·2021-10-06
Ultrasound Gels and Lotions Recalled Due to Bacterial Contamination Risk
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical may contain bacterial contamination. The FDA issued a Class I recall on August 18, 2021.
Product
EcoLotion Transmission Lotion, used in ultrasound procedures. Item/Description: NC70481/Eco Lotion 5 liters, NC70482/Eco Lotion with Aloe 5 liters, NC70482C/Eco Lotion with Aloe 5 liters (4); Myossage Lotion, 1 Gallon, Item: NC31208
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2587-2021·2021-10-06
GENOSYL DS vasodilator console recalled for reversed gas lines defect
Vero Biotech recalled 3 GENOSYL DS consoles for a manufacturing defect that reverses gas inlet and outlet lines, causing delivery of toxic nitrogen dioxide instead of therapeutic nitric oxide.
Product
GENOSYL DS (Delivery System) console, for use as a vasodilator.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2499-2021·2021-10-06
DeRoyal Procedure Packs with NORMOFLO Warming Sets Recalled for Aluminum Leaching
DeRoyal procedure packs containing Smiths Medical NORMOFLO warming systems are recalled due to potential aluminum ion leaching into warming fluids. The FDA classified this Class I recall affecting 2880 units distributed in Florida and South Carolina.
Product
DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2480-2021·2021-09-29
Ultrasound Gels and Lotions Recalled Due to Bacterial Contamination
Eco-Med Pharmaceutical, Inc. is recalling ultrasound gels and lotions that may contain bacterial contamination. Products were distributed nationally and internationally.
Product
EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiPurpose Gel (CLEAR), and EcoLotion Transmission Lotion 1) 100, 200 gel Intended for use in acoustic coupling of ultrasound transducer to tissue 2) Lotion Ecolotion transmission and massage lotion is in
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2469-2021·2021-09-29
Multiple Ultrasound Gel Products Recalled for Potential Bacterial Contamination
Ultrasound gels sold under multiple brand names have been recalled due to potential bacterial contamination. Approximately 100,114 units distributed nationwide between August 2018 and August 2021 are affected.
Product
Ultrasound Gel labeled under the following brand names: MediChoice Ultrasound Gel, Athena Liquasonic Ultrasound Gel, Eco-Med EcoGel Ultrasound Gel, MAC Medical Supply Ultrasound Gel, Eco-Med EcoGel 200 Blue High Velocity Ultrasound Gel, Eco-Med EcoGel 200 Multi-Purpose Ultrasoun
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2428-2021·2021-09-22
Angiographic Catheter Recall: Cordis SUPER TORQUE Entrapment and Dislodgement Risk
Cordis is recalling its SUPER TORQUE MB Angiographic Catheter worldwide because it may become entrapped between endovascular devices and the vessel wall. This entrapment can cause marker band movement or dislodgement.
Product
Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2430-2021·2021-09-22
Cordis SUPER TORQUE Angiographic Catheter Recalled for Entrapment Risk
Cordis is recalling the SUPER TORQUE MB angiographic catheter (18,730 units) due to risk of entrapment between endovascular devices and vessel wall, which can cause marker band movement or dislodgement. Units were distributed worldwide.
Product
Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2433-2021·2021-09-22
AMSORB PLUS Anesthesia Canisters Recalled for Gas Flow Obstruction Risk
Armstrong Medical Services Limited is recalling AMSORB PLUS PREFILLED anesthesia canisters due to risk of high resistance to gas flow that could prevent adequate ventilation. Not all defective units will be detected by standard pre-use testing.
Product
AMSORB PLUS PREFILLED G-CAN 1.0L; Carbon dioxide absorbent canister; Product codes AMAB3801 and AMAB3801GE. Used in anesthesia.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2432-2021·2021-09-22
Cordis SUPER TORQUE MB Angiographic Catheter Recalled for Device Entrapment Risk
Cordis Corporation recalls SUPER TORQUE MB angiographic catheters worldwide due to risk of entrapment between endovascular devices and vessel wall, potentially causing marker band dislodgement.
Product
Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2429-2021·2021-09-22
Cordis Angiographic Catheter Recall Due to Potential Marker Band Dislodgement
Cordis is recalling approximately 1,610 SUPER TORQUE PIG PIGTAIL SPECIAL angiographic catheters worldwide because the device can become entrapped between endovascular devices and the vessel wall, potentially causing marker band movement or dislodgement.
Product
Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2402-2021·2021-09-15
Pipeline Flex Embolization Device Recalled for Potential Push Wire Fracture Risk
Micro Therapeutics recalls Pipeline Flex Embolization Devices for potential push wire fractures in the delivery system during use. Device fractures in the Hypotube may result in malfunction during vascular procedures.
Product
Pipeline Flex Embolization Device
Category
Medical Device
Distribution
48 states
CriticalFDA (Devices)·Z-2392-2021·2021-09-15
Eco-Med ultrasound gels and lotions recalled for bacterial contamination
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. are being recalled due to potential bacterial contamination. The FDA issued a Class I recall on August 18, 2021, advising health care providers to stop using all affected products.
Product
LiquaSonic Ultrasound Gel 5L, Model No. 001222
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2377-2021·2021-09-15
NORMOFLO Irrigation Warming Sets Recalled for Aluminum Leaching Risk
Smiths Medical is recalling NORMOFLO Irrigation Warming sets (Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700) due to potential aluminum leaching when used at lower flow rates with certain solutions and blood products. No illnesses have been reported.
Product
NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2376-2021·2021-09-15
NORMOFLO Irrigation Fluid Warmer Recalled for Risk of Aluminum Leaching
Smiths Medical recalls NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129 (913 units) due to potential harmful aluminum leaching when used at lower flow rates with certain solutions and blood products.
Product
NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2403-2021·2021-09-15
EV3 Pipeline Flex Embolization Device Recalled for Push Wire Fracture Risk
Micro Therapeutics Inc. is recalling 16,169 EV3 Pipeline Flex Embolization Devices due to potential push wire fractures in the delivery system during use.
Product
EV3 Pipeline Flex Embolization Device with Flex Shield Technology
Category
Medical Device
Distribution
48 states
SevereFDA (Devices)·Z-2391-2021·2021-09-15
FDA Recalls Ultrasound Gel for Risk of Bacterial Contamination
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. are being recalled due to the risk of bacterial contamination. Healthcare providers and consumers should stop using affected products.
Product
LiquaSonic Ultrasound Gel 250mL, Model No. 001205
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-2285-2021·2021-09-01
Monoject Sodium Chloride Flush Syringes Recalled for Air Embolism Risk
Cardinal Health recalls 267 million Monoject 0.9% Sodium Chloride Flush Syringes due to a plunger defect that may reintroduce air into the syringe, posing a risk of air embolism during IV administration.
Product
Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code 8881570123 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2284-2021·2021-09-01
Monoject flush syringe recall: plunger may reintroduce air into IV lines
Cardinal Health Monoject flush syringes may have a defect allowing the plunger to draw back and reintroduce air into the syringe. The FDA issued a Class I recall for over 267 million units distributed nationwide.
Product
Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8881570121 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2286-2021·2021-09-01
Sodium Chloride Flush Syringe Recalled Due to Plunger Malfunction Risk
Cardinal Health is recalling Monoject 0.9% Sodium Chloride Flush Syringes because the plunger may draw back after use and reintroduce air into the syringe.
Product
Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2244-2021·2021-08-25
Argyle UVC Insertion Tray Recalled for Safety Scalpel Locking Defect
Cardinal Health's Argyle UVC Insertion Tray, used for neonatal umbilical catheter insertion, lacks proper instructions for the included Safety Scalpel N11. Once locked, clinicians cannot unlock it, potentially delaying critical treatment.
Product
Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to insert an Umbilical Venous Catheter (UVC) into the umbilical artery or vein of neonate. Product Code: 43201
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2188-2021·2021-08-18
FDA Recalls HeartWare HVAD Pump Implant Kit for Neurological Events and Mortality
Medtronic is recalling the HeartWare HVAD Pump Implant Kit due to higher rates of neurological adverse events and mortality compared to other heart pump devices. The pump may also delay or fail to restart.
Product
HeartWare HVAD Pump Implant Kit, REF 1103
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2194-2021·2021-08-18
HeartWare HVAD Heart Pump Recalled for Neurological Events and Mortality
Medtronic is recalling the HeartWare HVAD heart pump implant due to higher rates of neurological adverse events and mortality compared to other devices. The internal pump may also delay or fail to restart.
Product
HeartWare HVAD Implant Kit, REF 1104JP
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2191-2021·2021-08-18
HeartWare HVAD Pump Implant Kit Recalled for Increased Mortality and Device Failure
Medtronic is recalling 163 HeartWare HVAD Pump Implant Kits distributed worldwide due to higher rates of neurological adverse events, mortality, and pump malfunction compared to other cardiac assist devices.
Product
HeartWare HVAD Pump Implant Kit, REF 1153
Category
Medical Device
Distribution
Distributed nationwide

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