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

1276–1300 of 1396

CriticalFDA (Devices)·Z-0450-2022·2022-01-26
Medtronic HawkOne Atherectomy System Recalled for Tip Detachment and Embolization Risk
Medtronic is recalling the HawkOne Directional Atherectomy System globally due to reports of tip damage that can detach and cause embolization. The device is used to remove arterial plaque in peripheral blood vessels.
Product
Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire. The HawkOne directional atherectomy system is intended for use in atherectomy of the peripheral vasculature
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0451-2022·2022-01-26
Medtronic HawkOne Directional Atherectomy Device Recalled for Tip Damage
Medtronic is recalling 28,094 units of its HawkOne directional atherectomy system due to reports of catheter tip damage and detachment that can cause blood clots in blood vessels.
Product
Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small Vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire. The HawkOne directional atherectomy system is intended for use in atherectomy of the peripheral vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0468-2022·2022-01-19
Maquet Sevoflurane vaporizer filling recalled due to potential hydrogen fluoride exposure
Getinge Usa Sales Inc recalls Vaporizer Sevoflurane components in anesthesia systems due to potential chemical degradation that may cause hydrogen fluoride exposure via inhalation or skin contact.
Product
Vaporizer Sevoflurane Maquet Filling, Part No. 6886601 Component of the following systems: Product Code(s) UPN/UDI: Flow-c Anesthesia System 6887700 07325710009765 Flow-e Anesthesia System 6887900 07325710010457 Flow-i Anesthesia System C20 6888520 07325710010617 Flow-i
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0394-2022·2021-12-29
WIRION Embolic Protection System Filter Withdrawal Difficulties
Cardiovascular Systems Inc recalls WIRION Embolic Protection System devices (6Fr) because the filter assembly may become difficult to withdraw, and the device may tear or separate, creating a risk of blood clot embolization.
Product
WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6
Category
Medical Device
Distribution
38 states
SevereFDA (Devices)·Z-0383-2022·2021-12-29
Stealthstation and Synergy Cranial surgical navigation system software synchronization error
Stealthstation and Synergy Cranial surgical navigation systems may display an incorrect biopsy needle position due to software synchronization failure. This could result in prolonged surgery, additional procedures, or tissue injury.
Product
Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy Cranial, Model: 9733763, and StealthStation Cranial, Model: 9735585
Category
Medical Device
Distribution
51 states
SevereFDA (Devices)·Z-0336-2022·2021-12-22
Cardiosave Hybrid IntraAortic Balloon Pump Recall Due to Fluid Ingress Risk
Datascope Corp. is recalling Cardiosave Hybrid IntraAortic Balloon Pumps due to the risk of fluid entering the device, which could cause system failure and hemodynamic instability.
Product
Cardiosave Hybrid IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-UC-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-UC-0800-34, 0998-00-0800-35, 0998-UC-0800-35, 0998-00-0800-36, 0998-UC-0800-36, 0998-00-0800-45,
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0337-2022·2021-12-22
FDA Class I Recall: Cardiosave Rescue Intra-Aortic Balloon Pump Fluid Ingress
Datascope is recalling Cardiosave Rescue Intra-Aortic Balloon Pump devices due to possibility of fluid ingress, which could short electronic components and cause unsafe system shutdown.
Product
Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83, 0998-00-0800-85, 0998-UC-0800-85.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0344-2022·2021-12-15
Puritan Bennett 980 Series Ventilators Recalled for Incorrect Capacitor Assembly
Covidien is recalling 278 Puritan Bennett 980 Series Ventilators worldwide due to incorrect capacitor assembly that may cause devices to become inoperable during patient use.
Product
Puritan Bennett 980 Series Ventilator, 980U3ESDIUU
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0349-2022·2021-12-15
Puritan Bennett 980 Series Ventilator recalled for assembly defect
Puritan Bennett 980 Series Ventilators are recalled due to a capacitor assembly error that may cause the device to become inoperable during use. The recall affects 278 units distributed worldwide.
Product
Puritan Bennett 980 Series Ventilator, 980X1JADIJJ
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0351-2022·2021-12-15
Puritan Bennett 980 Series Ventilator Recalled for Assembly Error Risk
Covidien is recalling 278 Puritan Bennett 980 Series Ventilators due to an assembly error in a capacitor that may cause the device to become inoperable during use. This recall affects units worldwide and in the US.
Product
Puritan Bennett 980 Series Ventilator, 980X2ESDIEC
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0335-2022·2021-12-15
OsteoMed Surgical Consoles Recalled for Electrical Safety Violations
OsteoMed OsteoPower Power Consoles and footswitches are being recalled due to non-compliance with electrical safety standard IEC 60601. The product has shocked a patient, creating a significant electrical hazard.
Product
OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Conso
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0340-2022·2021-12-15
Puritan Bennett 980 Series Ventilator Recalled for Manufacturing Defect
Covidien Llc is recalling 278 Puritan Bennett 980 Series Ventilators due to a manufacturing assembly error where a capacitor may have been installed incorrectly, potentially causing device inoperability during use.
Product
Puritan Bennett 980 Series Ventilator, 980S1ENDICU
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0347-2022·2021-12-15
Puritan Bennett 980 Series Ventilator Recalled for Manufacturing Assembly Defect
Covidien LLC is recalling 278 units of the Puritan Bennett 980 Series Ventilator due to a manufacturing defect that may cause the device to become inoperable during clinical use.
Product
Puritan Bennett 980 Series Ventilator, 980X1ENDIUU
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0346-2022·2021-12-15
Puritan Bennett 980 Series Ventilator Recalled for Capacitor Assembly Defect
Covidien is recalling 278 Puritan Bennett 980 Series Ventilators (Model 980X1ENDIPC) due to incorrect capacitor assembly that may cause the device to malfunction during use.
Product
Puritan Bennett 980 Series Ventilator, 980X1ENDIPC
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0338-2022·2021-12-15
Puritan Bennett 980 Series Ventilator recalled for capacitor assembly error
The Puritan Bennett 980 Series Ventilator is being recalled because a capacitor may be assembled incorrectly, which could cause the ventilator to stop working during use.
Product
Puritan Bennett 980 Series Ventilator, 980A1ENNISB
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0350-2022·2021-12-15
Puritan Bennett 980 Series Ventilator Recall Due to Assembly Defect
Covidien is recalling 278 Puritan Bennett 980 Series Ventilators worldwide due to an assembly error where a capacitor was incorrectly installed, potentially causing the device to become inoperable during use.
Product
Puritan Bennett 980 Series Ventilator, 980X1PLDIPC
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0341-2022·2021-12-15
Puritan Bennett 980 Series Ventilator Recall Due to Manufacturing Defect
Covidien is recalling 278 Puritan Bennett 980 Series Ventilators due to a manufacturing error where a capacitor was assembled incorrectly, which may cause the device to become inoperable during use.
Product
Puritan Bennett 980 Series Ventilator, 980S3ENDICU
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0348-2022·2021-12-15
Puritan Bennett 980 Ventilator recalled for capacitor assembly defect
The Puritan Bennett 980 Series Ventilator may become inoperable due to a manufacturing defect in the internal capacitor assembly. A total of 278 units worldwide have been affected.
Product
Puritan Bennett 980 Series Ventilator, 980X1ENNISB
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0342-2022·2021-12-15
Puritan Bennett 980 Ventilator Recalled for Capacitor Assembly Error
Puritan Bennett 980 Series Ventilators are recalled due to an assembly error in a capacitor that may cause the device to become inoperable during use. The recall affects 278 units.
Product
Puritan Bennett 980 Series Ventilator, 980U1ENASAA
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0353-2022·2021-12-15
Puritan Bennett 980 Series Ventilator Recall Due to Assembly Error
Covidien LLC is recalling 278 Puritan Bennett 980 Series Ventilators due to a capacitor assembly error that may cause the device to become inoperable during use. Affected devices were distributed worldwide with specific serial numbers targeted.
Product
Puritan Bennett 980 Series Ventilator, 980X3JADIJJ
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0339-2022·2021-12-15
Puritan Bennett 980 Series Ventilator Recalled for Assembly Defect
Covidien is recalling Puritan Bennett 980 Series Ventilators due to an assembly error in a capacitor. The defect may cause the ventilator to become inoperable during use.
Product
Puritan Bennett 980 Series Ventilator, 980A3ENNISB
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0343-2022·2021-12-15
Puritan Bennett 980 Ventilator Recalled for Capacitor Assembly Error
Covidien is recalling the Puritan Bennett 980 Series Ventilator due to incorrect capacitor assembly that may cause the device to become inoperable during patient use.
Product
Puritan Bennett 980 Series Ventilator, 980U1ESDIUC
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0352-2022·2021-12-15
Puritan Bennett 980 Series Ventilator Recall - Capacitor Assembly Error
Covidien is recalling 278 Puritan Bennett 980 Series ventilators (model 980X3ENDIUU) due to a capacitor assembly error that may cause the device to become inoperable during patient use.
Product
Puritan Bennett 980 Series Ventilator, 980X3ENDIUU
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0232-2022·2021-11-24
Arrow-Trerotola Percutaneous Thrombolytic Device Catheter Lumen Detachment Recall
Arrow International is recalling Arrow-Trerotola Percutaneous Thrombolytic Device catheters because the inner lumen can detach from the device basket, causing embolization requiring additional intervention and delaying dialysis therapy. Approximately 1,245 units are affected worldwide.
Product
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-HFWC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-veno
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0234-2022·2021-11-24
Arrow-Trerotola Percutaneous Thrombolytic Device: Inner Lumen Detachment Risk
Arrow International is recalling 1918 units of the Arrow-Trerotola Percutaneous Thrombolytic Device due to inner lumen detachment that can cause embolization, requiring emergency retrieval and delaying treatment.
Product
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-WC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous
Category
Medical Device
Distribution
Distributed nationwide

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1276–1300 of 1396