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  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 401–420 of 1,000 recalls

Class IOngoing

Model Number S701 ALTRUA 2 SR SL Pacemaker

Boston Scientific Corporation

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

August 20, 2025 · DeviceView details →
Class IOngoing

Model Number L111, ESSENTIO DR SL MRI Pacemaker

Boston Scientific Corporation

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

August 20, 2025 · DeviceView details →
Class IOngoing

ACCOLADE SR SL (Model L300)

Boston Scientific Corporation

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

August 20, 2025 · DeviceView details →
Class IOngoing

Model Number U125, VALITUDE CRT-P EL

Boston Scientific Corporation

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

August 20, 2025 · DeviceView details →
Class IOngoing

Model Number L100, ESSENTIO SR SL Pacemaker

Boston Scientific Corporation

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

August 20, 2025 · DeviceView details →
Class IOngoing

ACCOLADE SR SL MRI (Model L310)

Boston Scientific Corporation

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

August 20, 2025 · DeviceView details →
Class IOngoing

PROPONENT DR SL (Model L201)

Boston Scientific Corporation

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

August 20, 2025 · DeviceView details →
Class IOngoing

Model Number S722, ALTRUA 2 DR EL Pacemaker

Boston Scientific Corporation

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

August 20, 2025 · DeviceView details →
Class IOngoing

ACCOLADE DR SL MRI (Model L311)

Boston Scientific Corporation

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

August 20, 2025 · DeviceView details →
Class IOngoing

Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

Max Mobility LLC

Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially resulting in minor or major injuries.

August 12, 2025 · DeviceView details →
Class IOngoing

Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

Max Mobility LLC

Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially resulting in minor or major injuries.

August 12, 2025 · DeviceView details →
Class IOngoing

Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

Max Mobility LLC

Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially resulting in minor or major injuries.

August 12, 2025 · DeviceView details →
Class IOngoing

Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B

Medline Industries, LP

Convenience kits labeled as sterile have not gone through the sterilization process.

August 8, 2025 · DeviceView details →
Class IOngoing

Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK, Model Number: DYNJ61038B

Medline Industries, LP

Convenience kits labeled as sterile have not gone through the sterilization process.

August 8, 2025 · DeviceView details →
Class IOngoing

DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110

Medtronic Perfusion Systems

The catheters may not retain their shape.

August 6, 2025 · DeviceView details →
Class IOngoing

ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device is made up of four main parts: a handle, a sheath, a needle, and a stylet. The sheath and needle are attached to the handle, and the stylet, which is removable, is located inside the needle tube.

Olympus Corporation of the Americas

Potential for undetected, deformed a-traumatic tips.

August 6, 2025 · DeviceView details →
Class IOngoing

DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115

Medtronic Perfusion Systems

The catheters may not retain their shape.

August 6, 2025 · DeviceView details →
Class IOngoing

DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113

Medtronic Perfusion Systems

The catheters may not retain their shape.

August 6, 2025 · DeviceView details →
Class IOngoing

Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump

Baxter Healthcare Corporation

Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).

August 4, 2025 · DeviceView details →
Class IOngoing

Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump

Baxter Healthcare Corporation

Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).

August 4, 2025 · DeviceView details →
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