77 results
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Sources: EU EUDAMED, US FDA
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Classification: Class I
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Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric IOL; now to include AcrySof IQ Toric models SN6AT6, SN6AT7, SN6AT8, and SN6AT9. Intended for primary implantation in the capsular bag of the eye for visual correction.
FDA Enforcement
Class I
·Terminated·Alcon Research, Ltd.·December 2, 2015
CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #: 8065754007. For ophthalmic use.
FDA Enforcement
Class I
·Terminated·Alcon Research, LTD.·October 31, 2018
Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician
FDA Enforcement
Class I
·Terminated·Spacelabs Healthcare, Ltd.·November 29, 2017
CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754010. For ophthalmic use.
FDA Enforcement
Class I
·Terminated·Alcon Research, LTD.·October 31, 2018
CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754001. For ophthalmic use.
FDA Enforcement
Class I
·Terminated·Alcon Research, LTD.·October 31, 2018
Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Model #: 99999. This system includes a ventilator. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician.
FDA Enforcement
Class I
·Terminated·Spacelabs Healthcare, Ltd.·August 22, 2018
CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF CATALOG #: 8065754003 For ophthalmic use.
FDA Enforcement
Class I
·Terminated·Alcon Research, LTD.·October 31, 2018
Quantum Pump Console
FDA Enforcement
Class I
·Terminated·Spectrum Medical Ltd.·September 4, 2019
Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)
FDA Enforcement
Class I
·Ongoing·EITAN MEDICAL LTD·October 25, 2023
SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
FDA Enforcement
Class I
·Ongoing·Glycar SA Pty., Ltd.·December 3, 2025
BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac 1), 040-02-0120U (Mac 2), 040-02-0130U (Mac 3), 040-02-0131U (Mac 3 Strong Curve) 040-02-0140U (Mac 4), 040-02-0400U (Miller 00), 040-02-0410U (Miller 1), 040-02-0420U (Miller 2), 040-02-0430U (Miller 3),
FDA Enforcement
Class I
·Ongoing·Flexicare Medical (Dongguan) Ltd.·August 13, 2025
BritePro Solo Single-Use Fiber Optic Handle and Blade Refs: 040-331U (Mac 1), 040-332U (Mac 2), 040-333U (Mac 3), 040-335U (Mac 3.5) 040-334U (Mac 4), 040-341U (Miller 1), 040-342U (Miller 2), 040-343U (Miller 3), 040-344U (Miller 4), 040-361U (Phillips 1), 040-362U (Phillips 2)
FDA Enforcement
Class I
·Ongoing·Flexicare Medical (Dongguan) Ltd.·August 13, 2025
BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309U
FDA Enforcement
Class I
·Ongoing·Flexicare Medical (Dongguan) Ltd.·August 13, 2025
BritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and 040-310U
FDA Enforcement
Class I
·Ongoing·Flexicare Medical (Dongguan) Ltd.·August 13, 2025
Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0000U
FDA Enforcement
Class I
·Ongoing·Flexicare Medical (Dongguan) Ltd.·August 13, 2025
SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
FDA Enforcement
Class I
·Ongoing·Glycar SA Pty., Ltd.·December 3, 2025
BritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415U
FDA Enforcement
Class I
·Ongoing·Flexicare Medical (Dongguan) Ltd.·August 13, 2025
Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.
FDA Enforcement
Class I
·Terminated·Fisher & Paykel Healthcare, Ltd.·January 9, 2013
CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the BleaseFocus Anesthesia Workstation with the following part numbers: 12200900; 12200901; 12200902; 12200903; 14200100, and service kits part number 050-0659-00 and 050-0901-00. BleaseFocus Anesthesia Workstation: The Blease Frontline Plus Range, Anesthesia Machines are intended for use in the hospital environment and locations not requiring portability. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of a mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. This device is intended for use only by a suitably qualified physician. BleaseSirius Anesthesia Workstation: The Spacelabs BleaseSirius Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician.
FDA Enforcement
Class I
·Terminated·Del Mar Reynolds Medical, Ltd.·November 27, 2013
Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS I/II Absorber contained in Service Kits Part Number 12200902, 050-0659-00 and 050-0901-00 and any workstation installed with the CAS I/II Absorber. Anesthesia workstation for use in the hospital environment and locations not requiring portability.
FDA Enforcement
Class I
·Terminated·Del Mar Reynolds Medical, Ltd.·March 27, 2013