Class IIOngoingZ-0139-2026
Boston Scientific Corporation recalls TENACIO Pump without InhibiZone
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Boston Scientific Corp…MAOct 22, 2025
2025 device recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 829–840 of 2,908 recalls
Class IIOngoingZ-0138-2026
Boston Scientific Corporation recalls TENACIO Pump with InhibiZone
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Boston Scientific Corp…MAOct 22, 2025
Class IIOngoingZ-0137-2026
Medline Industries, LP recalls Medline Adult Anesthesia Set
Specific items and lots of Medline Kits may contain Clearlink IV Sets which Baxter recalled due to customer reports of leaking.
Medline Industries, LPILOct 22, 2025
Class IIOngoingZ-0135-2026
Iantrek Inc. recalls C-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120. Product…
Potential for compromised integrity of the sterile packaging.
Iantrek Inc.RIOct 22, 2025
Class IIOngoingZ-0134-2026
Iantrek Inc. recalls Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Des…
Potential for compromised integrity of the sterile packaging.
Iantrek Inc.RIOct 22, 2025
Class IIOngoingZ-0133-2026
Ferno-Washington Inc recalls FERNO POWER X2 POWERED AMBULANCE COT
The fastening post hardware could loosen allowing the fastening post to detach from the cot
Ferno-Washington IncOHOct 22, 2025
Class IIOngoingZ-0132-2026
Insulet Corporation recalls The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on…
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 singl…
Insulet CorporationMAOct 22, 2025
Class IIOngoingZ-0131-2026
Contego Medical LLC recalls Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Em…
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.…
Contego Medical LLCNCOct 22, 2025
Class IOngoingZ-0113-2026
Abbott recalls TactiFlex Sensor Enabled Ablation Catheter
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
AbbottMNOct 22, 2025
Class IOngoingZ-0112-2026
Abbott recalls TactiFlex Sensor Enabled Ablation Catheter
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
AbbottMNOct 22, 2025
Class IOngoingZ-0111-2026
Abbott recalls TactiFlex Sensor Enabled Ablation Catheter
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
AbbottMNOct 22, 2025
Class IOngoingZ-0110-2026
Abbott recalls TactiFlex Sensor Enabled Ablation Catheter
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
AbbottMNOct 22, 2025