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© 2026Civic Data · Data sourced from OpenFDA, updated weekly · Not affiliated with the U.S. Food and Drug Administration · Always verify against official FDA sources before acting

  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 81–100 of 1,000 recalls

Class ITerminated

Puritan Bennett 980 Series Ventilator, 980U1ESDIUC

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →
Class ITerminated

Puritan Bennett 980 Series Ventilator, 980U1ENASAA

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →
Class ITerminated

Puritan Bennett 980 Series Ventilator, 980X3ENDIUU

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →
Class ITerminated

Puritan Bennett 980 Series Ventilator, 980X1ENNISB

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →
Class ITerminated

Puritan Bennett 980 Series Ventilator, 980S3ENDICU

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →
Class ITerminated

Puritan Bennett 980 Series Ventilator, 980A3ENNISB

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →
Class ITerminated

Puritan Bennett 980 Series Ventilator, 980X1ENDIPC

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →
Class ITerminated

Puritan Bennett 980 Series Ventilator, 980S1ENDICU

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →
Class ITerminated

Puritan Bennett 980 Series Ventilator, 980X1ENDIUU

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →
Class ITerminated

Puritan Bennett 980 Series Ventilator, 980A1ENNISB

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →
Class ITerminated

Puritan Bennett 980 Series Ventilator, 980X1JADIJJ

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →
Class ITerminated

Puritan Bennett 980 Series Ventilator,980X1ENAIQC

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →
Class ITerminated

Puritan Bennett 980 Series Ventilator, 980U3ESDIUU

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →
Class ITerminated

Puritan Bennett 980 Series Ventilator, 980X3JADIJJ

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →
Class ITerminated

Puritan Bennett 980 Series Ventilator, 980X1PLDIPC

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →
Class ITerminated

IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063); and IPL Coupling Gel or EcoGel 200, 0.25 L (AX1009012) manufactured by Eco-Med Pharmaceutical

Lumenis, Inc.

Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.

October 14, 2021 · DeviceView details →
Class ITerminated

Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-W The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venousfistulae and synthetic dialysis grafts

Arrow International Inc

7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy.

September 20, 2021 · DeviceView details →
Class ITerminated

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-venousfistulae and synthetic dialysis grafts

Arrow International Inc

7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy.

September 20, 2021 · DeviceView details →
Class ITerminated

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-venousfistulae and synthetic dialysis grafts

Arrow International Inc

7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy.

September 20, 2021 · DeviceView details →
Class ITerminated

Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-12709-WC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venousfistulae and synthetic dialysis grafts

Arrow International Inc

7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy.

September 20, 2021 · DeviceView details →
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