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

14126–14150 of 27471

HighFDA (Devices)·Z-1405-2020·2020-03-04
MicroVention HydroSoft Embolization Coils Recalled for Missing Implant Coils
MicroVention is recalling 847 HydroSoft embolization coils because the implant coil may be missing from the packaging. The devices were distributed to 43 countries outside the United States.
Product
MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, HydroSoft 3D, Sterile, Rx, REF numbers 100102HFRM-V, 100152HFRM-V, 100153HFRM-V, 100154HFRM-V, 100202HFRM-V, 100206HFRM-V, 100208HFRM-V, 100254HFRM-V, 100256HFRM-V, 100308HFRM-V…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1343-2020·2020-03-04
Hologic Selenia Dimensions Mammography System Recalled for C-Arm Defects
Hologic is recalling 72 Selenia Dimensions Mammography Systems because the C-arm may seize or drop during repairs and cleaning.
Product
Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636,
Category
Medical Device
Distribution
21 states
HighFDA (Devices)·Z-1356-2020·2020-03-04
Zimmer Sterile Disposable Tourniquet Cuff Recalled for Bladder Leak
Zimmer Surgical Inc is recalling 58 units of sterile tourniquet cuffs because a leak between bladders may cause both to inflate or deflate simultaneously.
Product
Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, Dual Port, Dual Bladder, Item No. 60708015200, UDI (01)00889024377547 (17)230812(10)27968701 The product is a tourniquet - Product Usage: Tourniquets are intended to be used by qualified medical…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1351-2020·2020-03-04
St Jude Ellipse ICD Recall for Wireless Communication Loss
St Jude Medical is recalling 256 Ellipse ICDs because past updates may cause loss of wireless communication, preventing remote patient monitoring.
Product
Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD2411-36C (05414734507585), CD1277-36 (05414734506045), CD1377-36C (05414734507622), CD2277-36Q (05414734505932), CD2377-36QC (05414734507523), with Merlin Patient Care System with…
Category
Medical Device
Distribution
19 states
HighFDA (Devices)·Z-1374-2020·2020-03-04
Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Fit Issues
Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they may cause incorrect rotation and margin misalignment.
Product
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 6MM(H) Reference Number: IEHA446
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1347-2020·2020-03-04
Zimmer Biomet Recalls THP Hip Plating System Due to Fracture Risk
Zimmer Biomet is recalling 1,662 units of the THP Hip Plating System after internal testing detected a potential increase in fracture rate and packaging discoloration.
Product
THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 14-451090 14-451095 14-451100 14-451105 14-451110 14-451115 14-451120 14-451125 14-451130 . The product is a metallic bone fixation system.
Category
Medical Device
Distribution
20 states
HighFDA (Devices)·Z-1395-2020·2020-03-04
MicroVention Platinum Coil System Recalled for Missing Implant Coil
MicroVention, Inc. is recalling 780 units of Microplex 10 Platinum Coil Systems because the implant coil may be missing from the device.
Product
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Soft, Sterile, Rx, REF numbers 100206HCSR-S-V, 100208HC-S-V, 100208HCSR-S-V, 100306HCSR-S-V, 100308HCSR-S-V, 100310HC-S-V, 100310HCSR-S-V, 100410HC-S-V, 100410HCSR-S-V…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1401-2020·2020-03-04
MicroVention Platinum Coil System Recalled for Missing Implant Coil
MicroVention is recalling 19 units of the Microplex 18 Platinum Coil System because the implant coil may be missing from the device.
Product
MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Complex 18, Sterile, Rx, REF numbers 180512CC-V, 180820CC-V, 181026CC-V, 181434CC-V, and 182050CC-V. Product Usage: The MCS is also intended for vascular occlusion of blood vessels within…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1352-2020·2020-03-04
Breas Medical Recalls Vivo Ventilator Protective Covers Due to Obstruction Risk
Breas Medical is recalling 629 Vivo ventilator protective covers because the design may obstruct the exhalation valve control pressure tube.
Product
Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an accessory (i.e. protective cover) for the Vivo 50 and Vivo 65 ventilators - Product Usage: The protective cover is intended for additional protection of the Vivo 50, Vivo 55, Vivo 60 and Vivo 65…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1400-2020·2020-03-04
MicroVention Platinum Coil System Recalled for Missing Implant Coil
MicroVention is recalling Microplex 10 Platinum Coil Systems because the implant coil may be missing from the device.
Product
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Complex 10, Sterile, Rx, REF numbers 100204CC-V, 100307CC-V, 100410CC-V, 100512CC-V, 100615CC-V, 100718CC-V, 100820CC-V, 100924CC-V, and 101026CC-V. Product Usage: The MCS is also intended…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1370-2020·2020-03-04
Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Errors
Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data.
Product
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 4MM(H) Reference Number: IEHA354
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1378-2020·2020-03-04
Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Errors
Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data during scanning.
Product
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA463
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1397-2020·2020-03-04
MicroVention Platinum Coil System Recall for Missing Implant Coils
MicroVention is recalling 169 units of Microplex 18 Platinum Coil Systems because the implant coil may be missing from the device.
Product
MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Helical 18 Soft, Sterile, Rx, REF numbers 180204HC-S-V, 180208HC-S-V, 180308HC-S-V, 180410HC-S-V, and 180512HC-S-V. Product Usage: The MCS is also intended for vascular occlusion of blood…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1396-2020·2020-03-04
MicroVention Platinum Coil System Recalled for Missing Implant Coil
MicroVention is recalling 9 units of Microplex 18 Platinum Coil Systems because the implant coil may be missing from the packaging.
Product
MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Helical 18 Regular, Sterile, Rx, REF numbers 180520HC-R-V and 181230HC-R-V. Product Usage: The MCS is also intended for vascular occlusion of blood vessels within the neurovascular system…
Category
Medical Device
Distribution
1 state
CriticalFDA (Devices)·Z-1135-2020·2020-02-26
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 1012454-20 Rx Only, NC TREK RX 4.50 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
CriticalFDA (Devices)·Z-0942-2020·2020-02-26
Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Alarm Defect
Philips Respironics is recalling 21 Trilogy EVO Ventilators because a software defect causes the loss of all power alarms.
Product
Trilogy EVO Ventilator, International, Model Number IN2110X15B 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
CriticalFDA (Devices)·Z-0952-2020·2020-02-26
Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect
Philips Respironics is recalling specific Trilogy EVO ventilators because a software defect causes power alarms to fail, potentially leaving patients without critical alerts.
Product
Trilogy EVO Ventilator, 02 - Iberia - Model Number: ES2100X15B 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
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…
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-0950-2020·2020-02-26
Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect
Philips Respironics is recalling 21 Trilogy EVO Ventilators because a software defect causes the loss of all power alarms.
Product
Trilogy EVO Ventilator, 02 - International - Model Number: IN2100X15B 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
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…
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-1133-2020·2020-02-26
Abbott NC TREK Coronary Dilatation Catheter Recall for Balloon Deflation Issues
Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may fail to deflate. The recall covers 39,687 units distributed worldwide.
Product
NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 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-1278-2020·2020-02-26
FDA Recalls Polysorb Sutures Due to Packaging Integrity Issues
The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that could compromise sterility.
Product
Polysorb Braided Absorbable Suture 1 30 VIOLET GS-22, Item Code CL885 - 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-1130-2020·2020-02-26
Abbott NC TREK Coronary Dilatation Catheter Recall for Deflation Issues
Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may fail to deflate. The recall covers 39,687 units distributed worldwide.
Product
NC TREK Coronary Dilatation Catheter, REF 1012453-15 Rx Only, NC TREK RX 4.00 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-1134-2020·2020-02-26
Abbott Vascular Recalls NC TREK Coronary Dilatation Catheters
Abbott Vascular is recalling NC TREK RX Coronary Dilatation Catheters because the balloon may have difficulty or inability to deflate.
Product
NC TREK Coronary Dilatation Catheter, REF 1012454-15 Rx Only, NC TREK RX 4.50 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-0944-2020·2020-02-26
Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Alarm Defect
Philips Respironics is recalling 31 Trilogy EVO Ventilators due to a software defect that causes the loss of all power alarms.
Product
Trilogy EVO Ventilator, Germany - Model Number: DE2110X13B 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

How to read this listing

Filters

14126–14150 of 27471