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

376–400 of 582

CriticalFDA (Devices)·Z-0947-2020·2020-02-26
Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Alarm Defect
Philips Respironics is recalling 15 Trilogy EVO Ventilators because a software defect causes the loss of all power alarms.
Product
Trilogy EVO Ventilator, Great Britain - Model Number: GB2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropri
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-1136-2020·2020-02-26
Abbott NC TREK Coronary Dilatation Catheters Recalled for Deflation Issues
Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may fail to deflate. The recall covers 39,687 units distributed worldwide.
Product
NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK RX 5.00 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myoc
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-1115-2020·2020-02-19
Teleflex Medical Recalls Hudson RCI Comfort Flo Humidification Systems
Teleflex Medical is recalling 95,696 Hudson RCI Comfort Flo Humidification Systems due to a potential risk of water flooding the column and entering the patient circuit during high-flow oxygen therapy.
Product
HUDSON RCI COMFORT FLO Humidification System With Remote Temperature Port, REF 2414, humidifier nebulizer kit
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1114-2020·2020-02-19
Teleflex Medical Recalls Hudson RCI Comfort Flo Humidification Systems
Teleflex Medical is recalling 127,293 Hudson RCI Comfort Flo Humidification Systems nationwide due to a potential risk of water flooding the column and entering the circuit during high-flow oxygen therapy.
Product
HUDSON RCI COMFORT FLO Humidification System, REF 2410, humidifier nebulizer kit
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0022-2020·2020-01-01
Galemed Babi.Plus Pressure Relief Manifold Recalled for Low Venting Pressure
Galemed is recalling Babi.Plus 12.5 cm H2O Pressure Relief Manifolds because they may vent gas below standard pressure. The recall covers 14,964 units distributed in North Carolina and Nevada.
Product
Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802
Category
Medical Device
Distribution
2 states
CriticalFDA (Devices)·Z-0588-2020·2019-12-18
Cook CrossCath Support Catheter Recalled for Manufacturing Error
Cook Inc. is recalling six CrossCath Support Catheters due to a manufacturing error that may cause radiopaque marker bands to be too loose or too tight.
Product
CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 For diagnostic and interventional vascular procedures.
Category
Medical Device
Distribution
20 states
CriticalFDA (Devices)·Z-0541-2020·2019-12-11
GE Healthcare Recalls Giraffe Infant Warmers Due to Latching Defect
GE Healthcare is recalling Giraffe infant warmers because bedside panels and portholes may appear closed without being latched, posing a risk of patient falls.
Product
Giraffe Incubator infant warmer
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-0203-2020·2019-11-06
Ethicon Echelon Flex Powered Plus Stapler Recalled for Anvil Defect
Ethicon Endo-Surgery Inc is recalling 2,112 Echelon Flex Powered Plus ENDOPATH 60mm Staplers worldwide due to out-of-specification anvil components that may compromise staple line integrity.
Product
ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code PSEE60A
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2601-2019·2019-10-09
Medtronic Recalls 10 Sherpa NX Active Guiding Catheters for Material Loss
Medtronic Vascular is recalling 10 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.
Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F, PK1, 47CM, 070", REF SA6PK1W. for cardiovascular use
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-2589-2019·2019-10-09
Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 22 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.
Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL4.0, 110CM, 070", REF SA6JL40A. for cardiovascular use
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-2691-2019·2019-10-09
Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 23 units of Sherpa NX Active Guiding Catheters because of a potential loss of primary segment material that could expose underlying stainless-steel braid wires.
Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP1.5, .070", REF SA6CHAMP15. for cardiovascular use
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-2715-2019·2019-10-09
Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 57 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.
Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F JR6.0, .070", REF SA6JR60. for cardiovascular use
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-2618-2019·2019-10-09
Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 15,603 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.
Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.0, .070", REF SA6JR40. for cardiovascular use
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-2564-2019·2019-10-09
Medtronic Recalls SHERPA NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 538 units of SHERPA NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.
Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F, 3DRC 100CM .070", REF SA63DRC. for cardiovascular use
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-2729-2019·2019-10-09
Medtronic Sherpa NX Active Guiding Catheter Recalled for Material Loss
Medtronic Vascular is recalling 3 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.
Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC4.0 SH, .070", REF SA6MAC40SH. for cardiovascular use
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-2627-2019·2019-10-09
Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 167 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.
Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD LEFT, .070", REF SA6ERADL. for cardiovascular use
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-2717-2019·2019-10-09
Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 40 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.
Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F AL1.5 SH, .070", REF SA6AL15SH. for cardiovascular use
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-2626-2019·2019-10-09
Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 614 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.
Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.5 SH, .070", REF SA6EBU35SH. for cardiovascular use
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-2565-2019·2019-10-09
Medtronic Recalls Sherpa NX Active Guiding Catheters
Medtronic Vascular is recalling 12 units of the SHERPA NX Active Guiding Catheter due to a potential for extensive loss of primary segment material, which exposes underlying stainless-steel braid wires.
Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL1.0 110CM .070", REF SA6AL10A. for cardiovascular use
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-2594-2019·2019-10-09
Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 39 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.
Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F, JR4.0, 55CM, 070", REF SA6JR40K. for cardiovascular use
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-2630-2019·2019-10-09
Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 90 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.
Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.5, .070", REF SA6JR45. for cardiovascular use
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-2660-2019·2019-10-09
Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 409 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.
Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F 3DRIGHT, .070", REF SA63DRIGHT. for cardiovascular use
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-2646-2019·2019-10-09
Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 492 units of Sherpa NX Active Guiding Catheters because primary segment material may be lost, exposing underlying stainless-steel braid wires.
Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F MB1, .070", REF SA6MB1. for cardiovascular use
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-2603-2019·2019-10-09
Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 55 units of Sherpa NX Active Guiding Catheters due to a potential loss of primary segment material that could expose underlying stainless-steel braid wires.
Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F, RBU3.5 SH, 100CM, 070", REF SA6RBU35SH. for cardiovascular use
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-2670-2019·2019-10-09
Medtronic Recalls Sherpa NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 615 units of Sherpa NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.
Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.0, .070", REF SA6JR405. for cardiovascular use
Category
Medical Device
Distribution
0 states

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