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 the agency’s own highest classification or reported deaths or serious injuries, 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

14151–14175 of 27471

SevereFDA (Devices)·Z-1142-2020·2020-02-26
Abbott NC Traveler Coronary Dilatation Catheter Recall for Balloon Deflation Issues
Abbott Vascular is recalling NC Traveler Coronary Dilatation Catheters because the balloon may fail to deflate. The device is not cleared for commercial distribution in the US.
Product
NC TRAVELER Coronary Dilatation Catheter, REF 1013157-15, Rx Only,NC Traveler RX 4.0 X 15MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1129-2020·2020-02-26
Abbott NC TREK Coronary Dilatation Catheters Recalled for Deflation Issues
Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may be difficult or unable to deflate.
Product
NC TREK Coronary Dilatation Catheter, REF 1012453-12 Rx Only, NC TREK RX 4.00 X 12MM 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…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0946-2020·2020-02-26
Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect
Philips Respironics is recalling 105 Trilogy EVO ventilators because a software defect causes inoperative power alarms. The units are distributed internationally but not in the US.
Product
Garbin EVO Ventilator, Linde - Model Number: LD2110X23B 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 appropriate…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0951-2020·2020-02-26
Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect
Philips Respironics is recalling three Trilogy EVO Ventilators in Italy because a software defect causes the loss of all power alarms.
Product
Trilogy EVO Ventilator, 02 - Italy - Model Number: IT2100X21B 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…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1333-2020·2020-02-26
Siemens Uroskop Omnia max Recalled for Collision Control Override Risk
Siemens is recalling 192 Uroskop Omnia max devices because a bypass key can override collision controls, creating a risk of collision with obstacles or persons.
Product
Uroskop Omnia max, Model No. 10762473 - Product Usage: Uroskop Omnia Max is a device intended to visualize anatomical structures by converting an Xray pattern into a visible image. The system is designed primarily for urological diagnosis and the support of urological…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1272-2020·2020-02-26
Philips HeartStart AEDs Recalled for Quality Standards Defect
Philips is recalling 96 HeartStart AEDs because their Printed Circuit Assemblies were not manufactured or repaired to quality standards.
Product
Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED, Model 861304, HSI codeRev: E.03.063
Category
Medical Device
Distribution
9 states
SevereFDA (Devices)·Z-1286-2020·2020-02-26
Recall of Polysorb Sutures Due to Potential Packaging Integrity Issues
Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that could impact sterility.
Product
Polysorb Braided Absorbable Suture 2-0 VIOLET 30" V-20, Item Code GL123 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0953-2020·2020-02-26
Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect
Philips Respironics is recalling 27 Trilogy EVO ventilators because a software defect causes the loss of all power alarms.
Product
Trilogy EVO Ventilator, 02 - EU - Model Number: EU2100X15B 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 appropriate…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1140-2020·2020-02-26
Abbott NC Traveler Coronary Dilatation Catheter Recall for Deflation Issues
Abbott Vascular is recalling NC Traveler Coronary Dilatation Catheters because they may fail to deflate. The device is not cleared for commercial distribution in the US.
Product
NC TRAVELER Coronary Dilatation Catheter, REF 1013157-08, Rx Only,NC Traveler RX 4.0 X 8MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1139-2020·2020-02-26
Abbott NC TREK Coronary Dilatation Catheters Recalled for Deflation Issues
Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may be difficult or unable to deflate.
Product
NC TREK Coronary Dilatation Catheter, REF 1012455-120 Rx Only,NC TREK RX 5.00 X 20MM 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…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1137-2020·2020-02-26
Abbott NC TREK Coronary Dilatation Catheter Recall for Deflation Issues
Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may be difficult or unable to deflate.
Product
NC TREK Coronary Dilatation Catheter, REF 1012455-12 Rx Only, NC TREK RX 5.00 X 12MM 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…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1138-2020·2020-02-26
Abbott NC TREK Coronary Dilatation Catheters Recalled for Balloon Deflation Issues
Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may be difficult or unable to deflate.
Product
NC TREK Coronary Dilatation Catheter, REF 1012455-15 Rx Only,NC TREK RX 5.00 X 15MM 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…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0945-2020·2020-02-26
Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect
Philips Respironics is recalling 48 Trilogy EVO ventilators due to a software defect that causes inoperative power alarms. The units were distributed in 15 countries outside the US.
Product
Trilogy EVO Ventilator, EU - Model Number: EU2110X15B 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 appropriate…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1128-2020·2020-02-26
Abbott NC TREK Coronary Dilatation Catheters Recalled for Deflation Issues
Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may be difficult or unable to deflate.
Product
NC TREK Coronary Dilatation Catheter, REF 1012453-08 Rx Only, NC TREK RX 4.00 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…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1290-2020·2020-02-26
Polysorb Braided Absorbable Suture Recalled for Packaging Integrity Issues
Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture due to potential packaging integrity issues that may impact the humidity or sterility barrier.
Product
Polysorb Braided Absorbable Suture 3/0 30" UNDYED V-20, Item Code GLS322 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1144-2020·2020-02-26
Abbott NC Traveler Coronary Dilatation Catheter Recalled for Deflation Issues
Abbott Vascular is recalling NC Traveler Coronary Dilatation Catheters because they may fail to deflate. The device is not cleared for commercial distribution in the US.
Product
NC TRAVELER Coronary Dilatation Catheter, REF 1013158-12, Rx Only,NC Traveler RX 4.5 X 12MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1131-2020·2020-02-26
Abbott NC TREK Coronary Dilatation Catheter Recall for Balloon Deflation Issues
Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may be difficult or unable to deflate.
Product
NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.00 X 20MM 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…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1264-2020·2020-02-26
Recall of Covidien Endo GIA Ultra Universal Staplers Due to Sterility Risk
COVIDIEN LLC is recalling 2,180 units of Endo GIA Ultra Universal Staplers because the sterile barrier may be compromised, increasing the risk of infection.
Product
Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1269-2020·2020-02-26
Teleflex Recalls Pilling Aortic Punch Due to Packaging Compromise
Teleflex Medical Inc. is recalling 1,764 Pilling Aortic Punch devices because packaging defects may compromise sterility.
Product
Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1314-2020·2020-02-26
Nobel Biocare Dense Bone Drill Recall Due to Sterility Concerns
Nobel Biocare is recalling Dense Bone Drills because a packaging sealing issue may compromise sterility during shelf life.
Product
Dense Bone Drill NP 3.5x16 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1235-2020·2020-02-26
Cardinal Health Recalls Presource Procedure Packs with Potential Sterility Issues
Cardinal Health is recalling Presource Procedure Packs containing AAMI Level 3 surgical gowns because they may not be sterile due to improper environmental conditions during manufacturing.
Product
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1315-2020·2020-02-26
Nobel Biocare Dense Bone Drills Recalled for Sterility Concerns
Nobel Biocare is recalling Dense Bone Drills because a packaging defect may compromise sterility during shelf life.
Product
Dense Bone Drill WP 5x13 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1332-2020·2020-02-26
Siemens Luminos Agile Max X-ray System Recalled for Collision Risk
Siemens is recalling 475 Luminos Agile Max X-ray systems because a bypass key can override collision controls, creating a risk of collision with obstacles or persons.
Product
Luminos Agile Max, Model No. 10762472 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0949-2020·2020-02-26
Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Alarm Defect
Philips Respironics is recalling five Trilogy EVO Ventilators because a software defect causes the loss of all power alarms.
Product
Trilogy EVO Ventilator, France - Model Number: FR2110X14B 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 appropriate…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1319-2020·2020-02-26
Nobel Biocare Recalls Implant Retrieval Instruments Due to Sterility Concerns
Nobel Biocare is recalling 423 implant retrieval instruments because a packaging defect may compromise sterility during shelf life.
Product
Implant Retrieval Instrument CC NP & Ext Hex WP 22 mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection.
Category
Medical Device
Distribution
Distributed nationwide

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14151–14175 of 27471