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.
- Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2
FDA Device · Class I · 2023-07-26 · Olympus - Contour¿ next GEN Blood Glucose Monitoring System
FDA Device · Class II · 2023-07-26 · Ascensia Diabetes Care Us - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST BIOPSY KIT, Model Number DYNDA1224B
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) EP PACER PACK, Model Number DYNJ67770A
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: STERILE SET FOR IMPLANT-LF, Model Number OST011F
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Impella LD intravascular micro axial blood pump, Product Number 005082
FDA Device · Class I · 2023-07-26 · Abiomed - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK PACK, Model Number DYNJ81722
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Olympus BRONCHOVIDEOSCOPE, Model Numbers BF-Q170
FDA Device · Class I · 2023-07-26 · Olympus - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) PORT PACK, Model Number DYNJ64675
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: ARTHROSCOPY PACK, Model Number DYNJ44322G
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CATH LAB PACK, Model Number DYNJ58351A
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-0045, 1000080
FDA Device · Class I · 2023-07-26 · Abiomed - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC INFANT INSERTION PACK, Model Number CVI4770A
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60
FDA Device · Class I · 2023-07-26 · Olympus - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK SUPPLIES NDL CNTR, Model Number DYNJRA1755
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) TOTAL JOINT, Model Number CDS985555S
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) UNIVERSAL INSERTION TRAY, Model Number CVI4325
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched device designed to fit…
FDA Device · Class II · 2023-07-26 · Materialise N V - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VISCERAL ANGIOGRAM PACK-LF, Model Number DYNJ04291…
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0…
FDA Device · Class I · 2023-07-26 · Datascope - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CATH LAB BASIN PACK, Model Number DYNJ69864A
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VAD/PICC IV KIT, Model Number DYNDV2200
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC PACK, Model Number DYNJ46967F
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) MHC VASCULAR HYBRID PK-LF, Model Number DYNJ53433K
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0…
FDA Device · Class I · 2023-07-26 · Datascope - RET Proximal Probe
FDA Device · Class II · 2023-07-26 · Cytocell - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRAPE PACK, Model Number 00-400305R
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
FDA Device · Class I · 2023-07-26 · Datascope - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VEIN KIT, Model Number DYNJ55841B
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) LACERATION TRAY, Model Number DYNDL1134A
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160
FDA Device · Class I · 2023-07-26 · Olympus - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CHN OR DAVINCI PROSTATE, Model Number DYNJ902540N
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CRANIOTOMY CDS-1, Model Number CDS982889I
FDA Device · Class II · 2023-07-26 · Medline Industries Northfield - Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190
FDA Device · Class I · 2023-07-26 · Olympus - Oxylog 3000 Plus emergency and transport ventilator
FDA Device · Class I · 2023-07-19 · Draeger Medical - GE Healthcare Vivid S70N, ultrasound device
FDA Device · Class II · 2023-07-19 · Ge Vingmed Ultrasound As - SIGMA Spectrum Infusion Pump, Product Code 35700BAX2
FDA Device · Class I · 2023-07-19 · Baxter Healthcare - MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) OCULOPLASTY PACK, Model Number DYNJ64572A
FDA Device · Class II · 2023-07-19 · Medline Industries Northfield - MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: TOTAL KNEE THEDA, Model Number DYNJ908683A
FDA Device · Class II · 2023-07-19 · Medline Industries Northfield - Allen Advance Chest Support with Pad
FDA Device · Class II · 2023-07-19 · Baxter Healthcare - Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027722, spinal implant
FDA Device · Class II · 2023-07-19 · Medtronic Sofamor Danek Usa - Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac)
FDA Device · Class I · 2023-07-19 · Abbott - VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only
FDA Device · Class II · 2023-07-19 · Ortho Clinical Diagnostics - MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: HYSTERO PACK, Model Number DYNJ61448A
FDA Device · Class II · 2023-07-19 · Medline Industries Northfield - MEDLINE NON-STERILE PVP SOLUTION, STERILE PACKAGING REF DYNDA2232A
FDA Device · Class II · 2023-07-19 · Medline Industries Northfield - Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, REF SPS03188, spinal implant kit
FDA Device · Class II · 2023-07-19 · Medtronic Sofamor Danek Usa - HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the HeartSine Samaritan Public Access Defibrillator…
FDA Device · Class II · 2023-07-19 · Heartsine Technologies - GE Healthcare Vivid S70, ultrasound device
FDA Device · Class II · 2023-07-19 · Ge Vingmed Ultrasound As - Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, REF 981023322, spinal implant
FDA Device · Class II · 2023-07-19 · Medtronic Sofamor Danek Usa - Power-PRO 2- A powered ambulance cot that consists of a platform, including a mattress, mounted on a wheeled, retractable X-frame that is d…
FDA Device · Class II · 2023-07-19 · Stryker Medical Division - GE Healthcare Vivid S60, ultrasound device
FDA Device · Class II · 2023-07-19 · Ge Vingmed Ultrasound As - Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025525, spinal implant
FDA Device · Class II · 2023-07-19 · Medtronic Sofamor Danek Usa - The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
FDA Device · Class I · 2023-07-19 · Baxter Healthcare - Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027725, spinal implant
FDA Device · Class II · 2023-07-19 · Medtronic Sofamor Danek Usa - MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: OISC HAND BEAR, Model Number DYNJ902348L
FDA Device · Class II · 2023-07-19 · Medline Industries Northfield - GE Healthcare Vivid S60N, ultrasound device
FDA Device · Class II · 2023-07-19 · Ge Vingmed Ultrasound As - MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) TOTAL JOINT, Model Number CDS985555S
FDA Device · Class II · 2023-07-19 · Medline Industries Northfield - MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: EAR CDS, Model Number CDS980089O
FDA Device · Class II · 2023-07-19 · Medline Industries Northfield - REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile
FDA Device · Class II · 2023-07-19 · Osteomed - REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile
FDA Device · Class II · 2023-07-19 · Osteomed - COULTER DxH Diluent, REF 628017
FDA Device · Class II · 2023-07-19 · Beckman Coulter - Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981023325, spinal implant
FDA Device · Class II · 2023-07-19 · Medtronic Sofamor Danek Usa - Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025522, spinal implant
FDA Device · Class II · 2023-07-19 · Medtronic Sofamor Danek Usa - Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
FDA Device · Class II · 2023-07-19 · Abiomed - SurgiMend MP
FDA Device · Class II · 2023-07-12 · Tei Biosciences - TRACKMASTER, TREADMILL GE T2100-ST2 220V CHINA, MODEL NUMBER 317-07927GE CHINA
FDA Device · Class II · 2023-07-12 · Full Vision - PriMatrix Meshed
FDA Device · Class II · 2023-07-12 · Tei Biosciences - TRACKMASTER, TREADMILL GE T2100-ST2 220V, MODEL NUMBER 317-07927GE
FDA Device · Class II · 2023-07-12 · Full Vision - TruSignal Sensitive Skin Sensor, REF TS-SE-3
FDA Device · Class I · 2023-07-12 · Ge Healthcare Finland Oy - Pilling LOWSLEY PROSTATIC TRACTOR STR, REF 243201
FDA Device · Class II · 2023-07-12 · Teleflex - BETTA LINK SR REUSABLE FISHMOUTH GUIDE-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon dis…
FDA Device · Class II · 2023-07-12 · T A G Medical Products - TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE
FDA Device · Class I · 2023-07-12 · Ge Healthcare Finland Oy - Revize-X
FDA Device · Class II · 2023-07-12 · Tei Biosciences - Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile
FDA Device · Class II · 2023-07-12 · Wright Medical Technology - PriMatrix Ag Fenestrated
FDA Device · Class II · 2023-07-12 · Tei Biosciences - SurgiMend 4.0
FDA Device · Class II · 2023-07-12 · Tei Biosciences - NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and oropharyngeal swabs i…
FDA Device · Class III · 2023-07-12 · Neumodx Molecular - Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 2074920-001-XXXXXX, c. M1050205, d. M1135822, e. M1145475, f. M11454…
FDA Device · Class II · 2023-07-12 · Datex Ohmeda - TruSignal Wrap Sensor, REF TS-W-D
FDA Device · Class I · 2023-07-12 · Ge Healthcare Finland Oy - SurgiMend
FDA Device · Class II · 2023-07-12 · Tei Biosciences - BETTA LINK SR REUSABLE PRONGED GUIDE- Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disr…
FDA Device · Class II · 2023-07-12 · T A G Medical Products - TRACKMASTER, TREADMILL GE T2100-ST1 110VV, MODEL NUMBER 317-07926GE
FDA Device · Class II · 2023-07-12 · Full Vision - Betta Link LG Reusable ProngED Guide - Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon dis…
FDA Device · Class II · 2023-07-12 · T A G Medical Products - TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H
FDA Device · Class I · 2023-07-12 · Ge Healthcare Finland Oy - TruSignal Ear Sensor, REF TS-E-D
FDA Device · Class I · 2023-07-12 · Ge Healthcare Finland Oy - SurgiMend PRS Meshed
FDA Device · Class II · 2023-07-12 · Tei Biosciences - Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014
FDA Device · Class II · 2023-07-12 · Deroyal Industries - Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use
FDA Device · Class II · 2023-07-12 · Philips Respironics - BETTA LINK LG KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disrupt…
FDA Device · Class II · 2023-07-12 · T A G Medical Products - Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A
FDA Device · Class II · 2023-07-12 · Teleflex - TRACKMASTER, TREADMILL TMX428 110V, MODEL NUMBER 317-07926
FDA Device · Class II · 2023-07-12 · Full Vision - PriMatrix Ag Meshed
FDA Device · Class II · 2023-07-12 · Tei Biosciences - TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N
FDA Device · Class I · 2023-07-12 · Ge Healthcare Finland Oy - SurgiMend 2.0
FDA Device · Class II · 2023-07-12 · Tei Biosciences - SurgiMend PRS
FDA Device · Class II · 2023-07-12 · Tei Biosciences - TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs
FDA Device · Class I · 2023-07-12 · Ge Healthcare Finland Oy - da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12
FDA Device · Class II · 2023-07-12 · Intuitive Surgical - Pilling LOWSLEY PROSTATIC TRACTOR CVD, REF 243200
FDA Device · Class II · 2023-07-12 · Teleflex - BD Pyxis CII Safe, Software: V7, REF: 107-96, 107-97, 107-97-201
FDA Device · Class II · 2023-07-12 · Carefusion 303 - SurgiMend 3.0
FDA Device · Class II · 2023-07-12 · Tei Biosciences
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