October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP);
Hazard: The potential for devices to experience inflation and/or deflation performance issues or difficulties.
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls TENACIO Pump without InhibiZone; UPN: 72404420;
Hazard: The potential for devices to experience inflation and/or deflation performance issues or difficulties.
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls TENACIO Pump with InhibiZone; UPN: 72404429;
Hazard: The potential for devices to experience inflation and/or deflation performance issues or difficulties.
October 22, 2025Medical DevicesFDA
Medline Industries, LP recalls Medline Adult Anesthesia Set, REF DYNJ39985G
Hazard: Specific items and lots of Medline Kits may contain Clearlink IV Sets which Baxter recalled due to customer reports of leaking.
October 22, 2025Medical DevicesFDA
Iantrek Inc. recalls C-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120. Product Description: The C-Rex UNO Microi
Hazard: Potential for compromised integrity of the sterile packaging.
October 22, 2025Medical DevicesFDA
Iantrek Inc. recalls Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The CycloPen Microinter
Hazard: Potential for compromised integrity of the sterile packaging.
October 22, 2025Medical DevicesFDA
Ferno-Washington Inc recalls FERNO POWER X2 POWERED AMBULANCE COT, Model/Catalog Number: 0015816; FOR USE IN GROUND TRANSPORTATION AMBULANCES.
Hazard: The fastening post hardware could loosen allowing the fastening post to detach from the cot
October 22, 2025Medical DevicesFDA
Insulet Corporation recalls The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify
Hazard: The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard. This causes the single digit number to duplicate. This could result in errors in manual entry of digits - examples: bolus entry, I:C ratio, bolus calculator, prior to starting the bolus insulin delivery. Therefore, this may result in over delivery of insulin which may cause hypoglycemia.
October 22, 2025Medical DevicesFDA
Contego Medical LLC recalls Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP
Hazard: Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter that may not open or may not fully open during sheath retraction and operation of the filter knob. The stent is used with a primary distal embolic protection device.
October 22, 2025Medical DevicesFDA
Abbott recalls TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter
Hazard: Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
October 22, 2025Medical DevicesFDA
Abbott recalls TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter
Hazard: Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
October 22, 2025Medical DevicesFDA
Abbott recalls TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF; cardiac catheter
Hazard: Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
October 22, 2025Medical DevicesFDA
Abbott recalls TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter
Hazard: Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
October 22, 2025Medical DevicesFDA
Abbott recalls TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter
Hazard: Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
October 22, 2025Medical DevicesFDA
MICROVENTION INC. recalls Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED551
Hazard: Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attachment pattern, which may lead the device to be incompletely open or not properly apposed to the vessel wall, which may necessitate device recapture and withdrawal of the delivery system and microcatheter together. Insufficient apposition could lead to long-term health consequences.
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls Model Number U228, VISIONIST CRT-P EL MRI
Hazard: 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).
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls Model Number U226, VISIONIST CRT-P EL
Hazard: 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).
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls Model Number U225 VISIONIST CRT-P EL
Hazard: 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).
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls Model Number U128, VALITUDE CRT-P EL MRI
Hazard: 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).
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls Model Number U125, VALITUDE CRT-P EL
Hazard: 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).
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls Model Number S722, ALTRUA 2 DR EL Pacemaker
Hazard: 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).
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls Model Number S702, ALTRUA 2 DR SL Pacemaker
Hazard: 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).
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls Model Number S701 ALTRUA 2 SR SL Pacemaker
Hazard: 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).
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls Model Number L131, ESSENTIO DR EL MRI Pacemaker
Hazard: 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).
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls Model Number L121 ESSENTIO DR EL Pacemaker
Hazard: 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).
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls Model Number L111, ESSENTIO DR SL MRI Pacemaker
Hazard: 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).
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls Model Number L110, ESSENTIO SR SL MRI Pacemaker
Hazard: 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).
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls Model Number L101, ESSENTIO DR SL Pacemaker
Hazard: 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).
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls Model Number L100, ESSENTIO SR SL Pacemaker
Hazard: 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).
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls Model Number L231, PROPONENT DR EL MRI Pacemaker
Hazard: 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).