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.
- Beside panel FRU (Field Replacement Units) Kits
FDA Device · Class II · 2023-07-12 · Datex Ohmeda - TRACKMASTER, TREADMILL TMX428 220V, MODEL NUMBER 317-07927
FDA Device · Class II · 2023-07-12 · Full Vision - Giraffe OmniBed, with the following Model Numbers: 6650-0004-901, 6650-0001-901, 6650-0003-901, 6650-0002-901, 6650-0094-901, 6650-0001-990…
FDA Device · Class II · 2023-07-12 · Datex Ohmeda - TRACKMASTER, TREADMILL TMX428CP 110V, MODEL NUMBER 317-07928
FDA Device · Class II · 2023-07-12 · Full Vision - Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102
FDA Device · Class II · 2023-07-12 · Deroyal Industries - PriMatrix Ag
FDA Device · Class II · 2023-07-12 · Tei Biosciences - PriMatrix
FDA Device · Class II · 2023-07-12 · Tei Biosciences - LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5mm-Intended for primary and revision total knee r…
FDA Device · Class II · 2023-07-12 · Waldemar Link And Kg Mfg Site - LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Intended for primary and revision total knee r…
FDA Device · Class II · 2023-07-12 · Waldemar Link And Kg Mfg Site - TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE
FDA Device · Class I · 2023-07-12 · Ge Healthcare Finland Oy - Betta Link LG 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 - NexGen Precoat Stemmed Tibial Plate Size 5
FDA Device · Class II · 2023-07-12 · Zimmer - BETTA LINK SR 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 - Revize
FDA Device · Class II · 2023-07-12 · Tei Biosciences - Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGIO PACK, REF 89-10901 c) BASIN, REF 89-1924…
FDA Device · Class II · 2023-07-12 · Deroyal Industries - BD Synapsys Informatics Solution, Catalog Number 444150
FDA Device · Class II · 2023-07-12 · Becton Dickinson And - TruSignal Adult/Pediatric Sensor
FDA Device · Class I · 2023-07-12 · Ge Healthcare Finland Oy - Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219
FDA Device · Class II · 2023-07-12 · Deroyal Industries - TissueMend
FDA Device · Class II · 2023-07-12 · Tei Biosciences - Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941
FDA Device · Class II · 2023-07-12 · Deroyal Industries - SurgiMend 1.0
FDA Device · Class II · 2023-07-12 · Tei Biosciences - Aptio Automation Storage and Retrieval Module (SRM)
FDA Device · Class II · 2023-07-12 · Siemens Healthcare Diagnostics - TRACKMASTER, TREADMILL TMX428CP 220V, MODEL NUMBER 317-07929
FDA Device · Class II · 2023-07-12 · Full Vision - Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB and Troponin I), 97000HSEU, 97000HSEUJP, 97000HZ01, 97000QI…
FDA Device · Class I · 2023-07-12 · Quidel Cardiovascular - KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver
FDA Device · Class II · 2023-07-12 · Pro Dex - PriMatrix Fenestrated
FDA Device · Class II · 2023-07-12 · Tei Biosciences - OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck…
FDA Device · Class II · 2023-07-12 · Neurologica - Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504565
FDA Device · Class I · 2023-07-05 · Teleflex - Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380055
FDA Device · Class I · 2023-07-05 · Teleflex - Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504560
FDA Device · Class I · 2023-07-05 · Teleflex - RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480035
FDA Device · Class I · 2023-07-05 · Teleflex - Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181055
FDA Device · Class I · 2023-07-05 · Teleflex - Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781070
FDA Device · Class I · 2023-07-05 · Teleflex - Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506540
FDA Device · Class I · 2023-07-05 · Teleflex - Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380045
FDA Device · Class I · 2023-07-05 · Teleflex - Exactech Ergo Impactor Handle, Catalog #321-09-05
FDA Device · Class II · 2023-07-05 · Exactech - Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380030
FDA Device · Class I · 2023-07-05 · Teleflex - Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781040
FDA Device · Class I · 2023-07-05 · Teleflex - Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170090
FDA Device · Class I · 2023-07-05 · Teleflex - Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080080
FDA Device · Class I · 2023-07-05 · Teleflex - Radiation therapy software, RayStation standalone software treatment planning system
FDA Device · Class II · 2023-07-05 · Raysearch America - MEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosurgery
FDA Device · Class I · 2023-07-05 · Megadyne Medical Products - Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080060
FDA Device · Class I · 2023-07-05 · Teleflex - Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504590
FDA Device · Class I · 2023-07-05 · Teleflex - Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150020
FDA Device · Class I · 2023-07-05 · Teleflex - Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170145
FDA Device · Class I · 2023-07-05 · Teleflex - LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left
FDA Device · Class II · 2023-07-05 · Waldemar Link And Kg Mfg Site - Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780065
FDA Device · Class I · 2023-07-05 · Teleflex - Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14
FDA Device · Class II · 2023-07-05 · Hologic - Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170155
FDA Device · Class I · 2023-07-05 · Teleflex - Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180035
FDA Device · Class I · 2023-07-05 · Teleflex - Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082100
FDA Device · Class I · 2023-07-05 · Teleflex - Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170070
FDA Device · Class I · 2023-07-05 · Teleflex - Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150025
FDA Device · Class I · 2023-07-05 · Teleflex - Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180050
FDA Device · Class I · 2023-07-05 · Teleflex - Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504550
FDA Device · Class I · 2023-07-05 · Teleflex - MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during electrosurgery
FDA Device · Class I · 2023-07-05 · Megadyne Medical Products - Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082065
FDA Device · Class I · 2023-07-05 · Teleflex - Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170120
FDA Device · Class I · 2023-07-05 · Teleflex - Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080090
FDA Device · Class I · 2023-07-05 · Teleflex - LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Right
FDA Device · Class II · 2023-07-05 · Waldemar Link And Kg Mfg Site - Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170065
FDA Device · Class I · 2023-07-05 · Teleflex - Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170055
FDA Device · Class I · 2023-07-05 · Teleflex - Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150030
FDA Device · Class I · 2023-07-05 · Teleflex - Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181060
FDA Device · Class I · 2023-07-05 · Teleflex - Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181040
FDA Device · Class I · 2023-07-05 · Teleflex - Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150040
FDA Device · Class I · 2023-07-05 · Teleflex - Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or p…
FDA Device · Class II · 2023-07-05 · Phadia Us - Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170050
FDA Device · Class I · 2023-07-05 · Teleflex - Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170085
FDA Device · Class I · 2023-07-05 · Teleflex - Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150035
FDA Device · Class I · 2023-07-05 · Teleflex - Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781080
FDA Device · Class I · 2023-07-05 · Teleflex - REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R
FDA Device · Class II · 2023-07-05 · Limacorporate S P A - Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180055
FDA Device · Class I · 2023-07-05 · Teleflex - Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780050
FDA Device · Class I · 2023-07-05 · Teleflex - Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170135
FDA Device · Class I · 2023-07-05 · Teleflex - Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 1700100
FDA Device · Class I · 2023-07-05 · Teleflex - RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480045
FDA Device · Class I · 2023-07-05 · Teleflex - RelieVR REF: RVX-2002, Rx Only
FDA Device · Class II · 2023-07-05 · Appliedvr - Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of ana…
FDA Device · Class III · 2023-07-05 · Randox Laboratories - Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780035
FDA Device · Class I · 2023-07-05 · Teleflex - Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181065
FDA Device · Class I · 2023-07-05 · Teleflex - Design Options¿ / Epidural anesthesia kit (10 count carton)
FDA Device · Class II · 2023-07-05 · B Braun Medical - Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180070
FDA Device · Class I · 2023-07-05 · Teleflex - Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504585
FDA Device · Class I · 2023-07-05 · Teleflex - Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780080
FDA Device · Class I · 2023-07-05 · Teleflex - RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480030
FDA Device · Class I · 2023-07-05 · Teleflex - Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380065
FDA Device · Class I · 2023-07-05 · Teleflex - Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780090
FDA Device · Class I · 2023-07-05 · Teleflex - Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506525
FDA Device · Class I · 2023-07-05 · Teleflex - Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080075
FDA Device · Class I · 2023-07-05 · Teleflex - MEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosurgery
FDA Device · Class I · 2023-07-05 · Megadyne Medical Products - AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118
FDA Device · Class II · 2023-07-05 · Tornier - MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during electrosurgery
FDA Device · Class I · 2023-07-05 · Megadyne Medical Products - Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150055
FDA Device · Class I · 2023-07-05 · Teleflex - RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480025
FDA Device · Class I · 2023-07-05 · Teleflex - Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082080
FDA Device · Class I · 2023-07-05 · Teleflex - NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed
FDA Device · Class II · 2023-07-05 · Baxter Healthcare - Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382055
FDA Device · Class I · 2023-07-05 · Teleflex - REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R
FDA Device · Class II · 2023-07-05 · Limacorporate S P A
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