FDA Device · 2023
FDA Device recalls in 2023
RecallRadar indexes 2,477 FDA Device recall notices published in 2023. By classification: 495 Class I, 1,959 Class II, 23 Class III.
- STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values
FDA Device · Class II · 2023-12-13 · Stanbio Laboratory - ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011
FDA Device · Class II · 2023-12-13 · Elekta - EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.1. Phakic Toric Intraocular lens
FDA Device · Class II · 2023-12-13 · Staar Surgical - ProCuity bed series, model number 3009, item number: 3009PX-L-200
FDA Device · Class II · 2023-12-13 · Stryker Medical Division - ELEKTA LIMITED Versa HD, REF XRT 2121, 2131
FDA Device · Class II · 2023-12-13 · Elekta - ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541
FDA Device · Class II · 2023-12-13 · Elekta - DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO surgical EMPOWR KNEE",…
FDA Device · Class II · 2023-12-13 · Encore Medical - EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens
FDA Device · Class II · 2023-12-13 · Staar Surgical - EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens
FDA Device · Class II · 2023-12-13 · Staar Surgical - 1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN
FDA Device · Class II · 2023-12-13 · Heartware - Remington MEDICAL Drainage Bag, REF 600-D
FDA Device · Class II · 2023-12-13 · Remington Medical - Integra Cranial Access Kit- For access to the subarachnoid space or the lateral ventricles of the brain
FDA Device · Class II · 2023-12-13 · Integra Lifesciences - QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3-E, Order Number G22765
FDA Device · Class II · 2023-12-13 · Wilson Cook Medical - Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain
FDA Device · Class II · 2023-12-13 · Integra Lifesciences - ProCuity bed series, model number 3009, item number: 3009PX-ZM-450
FDA Device · Class II · 2023-12-13 · Stryker Medical Division - Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or Hysterosonography procedures…
FDA Device · Class II · 2023-12-13 · Coopersurgical - Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation
FDA Device · Class II · 2023-12-13 · Liberty Medical Solutions - Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain
FDA Device · Class II · 2023-12-13 · Integra Lifesciences - EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens
FDA Device · Class II · 2023-12-13 · Staar Surgical - NovoTHOR Gen 2.5 XL whole body red light therapy bed, model S2184
FDA Device · Class II · 2023-12-13 · Thor Photomedicine - ProCurity bed series, model number 3009, item number: 3009PX-ZMX-600
FDA Device · Class II · 2023-12-13 · Stryker Medical Division - PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP
FDA Device · Class II · 2023-12-13 · Heartware - Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Lum…
FDA Device · Class II · 2023-12-13 · Luminex - ProCuity bed series, model number 3009, item number: 3009PX-LEX-400
FDA Device · Class II · 2023-12-13 · Stryker Medical Division - Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1
FDA Device · Class II · 2023-12-13 · Abiomed - VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only
FDA Device · Class II · 2023-12-13 · Ortho Clinical Diagnostics - vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
FDA Device · Class II · 2023-12-13 · Vyaire Medical - vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
FDA Device · Class II · 2023-12-13 · Vyaire Medical - QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766
FDA Device · Class II · 2023-12-13 · Wilson Cook Medical - Combo Kit Consists OF 10-110/INS-4500/INS-7040- For access to the subarachnoid space or the lateral ventricles of the brain
FDA Device · Class II · 2023-12-13 · Integra Lifesciences - ProCurity bed series, model number 3009, item number: 3009PX-ZX-450
FDA Device · Class II · 2023-12-13 · Stryker Medical Division - ProCuity bed series, model number 3009, item number: 300900000000
FDA Device · Class II · 2023-12-13 · Stryker Medical Division - BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI) FilmArray…
FDA Device · Class II · 2023-12-13 · Biofire Diagnostics - Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ventricles of the bra…
FDA Device · Class II · 2023-12-13 · Integra Lifesciences - ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511
FDA Device · Class II · 2023-12-13 · Elekta - Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain
FDA Device · Class II · 2023-12-13 · Integra Lifesciences - HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
FDA Device · Class II · 2023-12-13 · Heartware - NovoTHOR Gen 2.5 Regular whole body red light therapy bed, model S2183
FDA Device · Class II · 2023-12-13 · Thor Photomedicine - Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w
FDA Device · Class II · 2023-12-13 · Auris Health - EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens
FDA Device · Class II · 2023-12-13 · Staar Surgical - QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656
FDA Device · Class II · 2023-12-13 · Wilson Cook Medical - ELEKTA AXESSE, REF XRT 2181, XRT 27891
FDA Device · Class II · 2023-12-13 · Elekta - CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205
FDA Device · Class I · 2023-12-13 · Maquet Medical Systems Usa - EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocular lens
FDA Device · Class II · 2023-12-13 · Staar Surgical - CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For administering contrast media during Hysterosalpingography or…
FDA Device · Class II · 2023-12-13 · Coopersurgical - PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
FDA Device · Class II · 2023-12-13 · Heartware - Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION
FDA Device · Class II · 2023-12-13 · Atrium Medical - Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w
FDA Device · Class II · 2023-12-13 · Auris Health - ProCuity bed series, model number 3009, item number: 3009PX-LEX-450
FDA Device · Class II · 2023-12-13 · Stryker Medical Division - ProCurity bed series, model number 3009, item number: 3009PX-ZMX-450
FDA Device · Class II · 2023-12-13 · Stryker Medical Division - EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens
FDA Device · Class II · 2023-12-13 · Staar Surgical - RANDOX Total Bilirubin
FDA Device · Class II · 2023-12-13 · Randox Laboratories - Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1
FDA Device · Class II · 2023-12-13 · Abiomed - HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205
FDA Device · Class II · 2023-12-13 · Heartware - STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101
FDA Device · Class II · 2023-12-13 · Heartware - EVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocular lens
FDA Device · Class II · 2023-12-13 · Staar Surgical - PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103
FDA Device · Class II · 2023-12-13 · Heartware - ProCuity bed series, model number 3009, item number: 3009PX-LE-400
FDA Device · Class II · 2023-12-13 · Stryker Medical Division - Freedom Boom models series: F110, F120, F130, F320, F330, F350, F410, and F420 with built in 42A Lightweight Spring Arm part numbers 42A-43…
FDA Device · Class II · 2023-12-13 · Ihb Operations B V - EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. Phakic Toric Intraocular lens
FDA Device · Class II · 2023-12-13 · Staar Surgical - Integra Cranial Access Kit -For access to the subarachnoid space or the lateral ventricles of the brain
FDA Device · Class II · 2023-12-13 · Integra Lifesciences - Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain
FDA Device · Class II · 2023-12-13 · Integra Lifesciences - ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511
FDA Device · Class II · 2023-12-13 · Elekta - ProCuity bed series, model number 3009, item number: 3009PX-LE-450
FDA Device · Class II · 2023-12-13 · Stryker Medical Division - G041 POD, THOR NOVO GEN 2.0 XL whole body red light therapy bed, model S1177
FDA Device · Class II · 2023-12-13 · Thor Photomedicine - ProCuity bed series, model number 3009, item number: 3009PX-Z-450
FDA Device · Class II · 2023-12-13 · Stryker Medical Division - EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens
FDA Device · Class II · 2023-12-13 · Staar Surgical - Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY
FDA Device · Class II · 2023-12-13 · Atrium Medical - QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657
FDA Device · Class II · 2023-12-13 · Wilson Cook Medical - Stay Safe Cap
FDA Device · Class II · 2023-12-13 · Fresenius Medical Care Holdings - Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site
FDA Device · Class I · 2023-12-13 · B Braun Medical - CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A
FDA Device · Class II · 2023-12-13 · Cardioquip - PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU
FDA Device · Class II · 2023-12-13 · Heartware - Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain
FDA Device · Class II · 2023-12-13 · Integra Lifesciences - QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655
FDA Device · Class II · 2023-12-13 · Wilson Cook Medical - NovoTHOR Gen 2.0 whole body red light therapy bed, model S1176
FDA Device · Class II · 2023-12-13 · Thor Photomedicine - SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S
FDA Device · Class II · 2023-12-06 · Path - PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
FDA Device · Class II · 2023-12-06 · Aizu Olympus - RAPIDPOINT 500 Blood Gas System
FDA Device · Class II · 2023-12-06 · Siemens Healthcare Diagnostics - SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098
FDA Device · Class II · 2023-12-06 · Path - PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
FDA Device · Class II · 2023-12-06 · Aizu Olympus - TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm) PXAVMP3: x3 (3cc)/VAMP PXVK0364:(3cc)/VAMP 96in (241c…
FDA Device · Class II · 2023-12-06 · Edwards Lifesciences - SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2
FDA Device · Class II · 2023-12-06 · Path - AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP
FDA Device · Class II · 2023-12-06 · Path - Lugol s Iodine Solution 500ML, Part Number 624-71
FDA Device · Class II · 2023-12-06 · Emd Millipore - CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
FDA Device · Class II · 2023-12-06 · Aizu Olympus - Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
FDA Device · Class II · 2023-12-06 · Intuitive Surgical - with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator device, Vivo 45LS. inten…
FDA Device · Class II · 2023-12-06 · Breas Medical - FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only
FDA Device · Class II · 2023-12-06 · Edwards Lifesciences - ICM LNQ22 LINQ II, Model LNQ22
FDA Device · Class II · 2023-12-06 · Medtronic - GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
FDA Device · Class II · 2023-12-06 · Aizu Olympus - Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only
FDA Device · Class II · 2023-12-06 · Edwards Lifesciences - GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
FDA Device · Class II · 2023-12-06 · Aizu Olympus - TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60in (150cm), PX272: 3 cc/72in (180cm), PX284: 3 cc/84 in (210 c…
FDA Device · Class II · 2023-12-06 · Edwards Lifesciences - RAPIDPOINT 500e Blood Gas System
FDA Device · Class II · 2023-12-06 · Siemens Healthcare Diagnostics - BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533
FDA Device · Class II · 2023-12-06 · Becton Dickinson Infusion Therapy Systems - Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in intravascular pressure moni…
FDA Device · Class II · 2023-12-06 · Edwards Lifesciences - Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090
FDA Device · Class II · 2023-12-06 · Abbott Molecular - FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx only
FDA Device · Class II · 2023-12-06 · Edwards Lifesciences - Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum and sigmoid colon)
FDA Device · Class II · 2023-11-29 · Aizu Olympus
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