FDA Device · 2022
FDA Device recalls in 2022
RecallRadar indexes 2,191 FDA Device recall notices published in 2022. By classification: 168 Class I, 1,946 Class II, 77 Class III.
- NEW SKIN LIQUID BANDAGE CLEAR .3FL OZ, SKU 999417
FDA Device · Class II · 2022-08-24 · Family Dollar Stores - AT HOME MARIJUANA TEST STRIP, SKU 900752
FDA Device · Class II · 2022-08-24 · Family Dollar Stores - ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
FDA Device · Class II · 2022-08-17 · Olympus - 3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Sterile
FDA Device · Class II · 2022-08-17 · Medical Modeling - cobas e801 Immunoassay Analyzer
FDA Device · Class II · 2022-08-17 · Roche Diagnostics Operations - Cobalt Implantable Cardioverter Defibrillators: a. Cobalt VR ICD, Model Numbers: DVPB3D1, DVPB3D4
FDA Device · Class I · 2022-08-17 · Medtronic Cardiac Rhythm And Heart Failure Crhf - HAIOU Needle retractable safety syringe with needle-(1ml syringe with 25G x 1-inch needle} 200 pieces/box
FDA Device · Class II · 2022-08-17 · Guangdong Haiou Medical Apparatus - Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4
FDA Device · Class I · 2022-08-17 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Haiou Needle Retractable Safety Syringe with Needle-1ML 23G x 1 (0.6x25mm). 200pcs/Box Intended Use: Disposable sterile needle retractable…
FDA Device · Class II · 2022-08-17 · Guangdong Haiou Medical Apparatus - Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010
FDA Device · Class II · 2022-08-17 · Aesculap Implant Systems - HXBL/WETEX/Genesis Biomedical Viral Transport Container, Custom Made
FDA Device · Class I · 2022-08-17 · Haimen Shengbang Laboratory Equipment - HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59 Activated Type
FDA Device · Class I · 2022-08-17 · Haimen Shengbang Laboratory Equipment - Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Crome HF CRT-D, Model Numbers: DTPC2D4, DT…
FDA Device · Class I · 2022-08-17 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Service manuals for the CT, PET, or NM table as follows: GT1700/GT1700V/VT1700, GT2000/VT2000, GT2000x/VT2000x, High Capacity Table, Lite T…
FDA Device · Class II · 2022-08-17 · Ge Healthcare - Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt XT HF CRT-D, Model Numbers: DTPA2D…
FDA Device · Class I · 2022-08-17 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Xhibit Telemetry Receiver, Model: 96280
FDA Device · Class II · 2022-08-17 · Spacelabs Healthcare - HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59-1
FDA Device · Class I · 2022-08-17 · Haimen Shengbang Laboratory Equipment - Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.0103
FDA Device · Class II · 2022-08-17 · Corin - Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt HF CRT-D, Model Numbers: DTPB2D4,…
FDA Device · Class I · 2022-08-17 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4
FDA Device · Class I · 2022-08-17 · Medtronic Cardiac Rhythm And Heart Failure Crhf - The Cholestech LDX¿ System combines enzymatic methodology and solidphase technology to measure total cholesterol, HDL cholesterol, triglyce…
FDA Device · Class II · 2022-08-17 · Alere San Diego - Medline Sprinter OTW, Model/Catalog Number SPR2512W
FDA Device · Class II · 2022-08-10 · Medtronic - Merlin PCS 3650 programmer Model 3330 software
FDA Device · Class II · 2022-08-10 · St Jude Medical Cardiac Rhythm Management Division - Merlin 2 PCS MER37000 programmer Model MER3400 software
FDA Device · Class II · 2022-08-10 · St Jude Medical Cardiac Rhythm Management Division - UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool
FDA Device · Class II · 2022-08-10 · Neotract - NanoSight NS300
FDA Device · Class II · 2022-08-10 · Malvern Panalytical - CustMbite, Model Number CBT-SRS-UL
FDA Device · Class II · 2022-08-10 · Dental Choice Holding - Craftmatic Model 1 Base for Dual Bed Configurations
FDA Device · Class II · 2022-08-10 · Craftmatic Industries - Turbett Surgical Container, TS1500
FDA Device · Class II · 2022-08-10 · Turbett Surgical - EkoSonic Kit 106cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components
FDA Device · Class II · 2022-08-10 · Boston Scientific - Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and (lithium heparin) p…
FDA Device · Class II · 2022-08-10 · Siemens Healthcare Diagnostics - EkoSonic Kit 135cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components
FDA Device · Class II · 2022-08-10 · Boston Scientific - Merlin.net model MN5000 Software
FDA Device · Class II · 2022-08-10 · St Jude Medical Cardiac Rhythm Management Division - PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10
FDA Device · Class II · 2022-08-10 · Aesculap Implant Systems - PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10
FDA Device · Class II · 2022-08-10 · Aesculap Implant Systems - MEDLINE MICRO-KILL GERMICIDAL BLEACH WIPES, Model numbers MSC351420AN, MSC351420ANH, MSC351420ANZ, MSC351430A, MSC351430AZ
FDA Device · Class II · 2022-08-10 · Medline Industries Northfield - SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen Test, SML LDT Kits, SML Brand F…
FDA Device · Class I · 2022-08-10 · North American Diagnostics - The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) designed to be used with the da Vinci Xi and X systems
FDA Device · Class II · 2022-08-10 · Intuitive Surgical - Legacy Base for Dual Bed Configurations
FDA Device · Class II · 2022-08-10 · Craftmatic Industries - Paragon 28, Inc
FDA Device · Class II · 2022-08-03 · Paragon 28 - Medline Custom procedural kits labeled as follows: a. GP-NEURO PACK, b. KIT NEUR FUS LUM POST, c. KIT PEDI VP SHUNT, d. KIT STC NEURO SPINE…
FDA Device · Class II · 2022-08-03 · Medline Industries Spt - REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL, A1cDL 2 x 35 mL
FDA Device · Class II · 2022-08-03 · Abbott Laboratories - REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL
FDA Device · Class II · 2022-08-03 · Abbott Laboratories - Medline Convenience kits labeled as: a. WET SKIN PREP TRAY, b. SKIN PREP TRAY W/CHG Model/Catalog Number: Model numbers: a. DYNDP1127A, b.…
FDA Device · Class II · 2022-08-03 · Medline Industries Spt - etouchus, model no
FDA Device · Class II · 2022-08-03 · Touch Us - X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000)
FDA Device · Class II · 2022-08-03 · Davol - Intraosseous needle and driver
FDA Device · Class I · 2022-08-03 · Bard Access Systems - Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures
FDA Device · Class II · 2022-08-03 · Stryker Instruments - Medline convenience kits labeled as: a. MIDDLE EAR PACK-LF, Model DYNJ0689093V, b. EENT PACK, Model Number DYNJ62927 Model/Catalog Number:…
FDA Device · Class II · 2022-08-03 · Medline Industries Spt - Revogene, Catalog no. 610210
FDA Device · Class II · 2022-08-03 · Meridian Bioscience - HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)
FDA Device · Class II · 2022-08-03 · Paragon 28 - Brand Name: Medline Product Name: convenience kits labeled as: LAP CHOLE Model/Catalog Number: DYNJ907150
FDA Device · Class II · 2022-08-03 · Medline Industries Spt - Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1
FDA Device · Class II · 2022-08-03 · Sight Diagnostics - ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000
FDA Device · Class III · 2022-08-03 · Zeiss Carl - AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US
FDA Device · Class II · 2022-08-03 · Fresenius Medical Care Holdings - nordicBrainEX, software versions 2.21 through 2.3.10
FDA Device · Class II · 2022-08-03 · Nordicneurolab As - Da Vinci X/Xi Large Clip Applier, Model 470230 Da Vinci X/Xi Medium-Large Clip Applier, Model 470327 Da Vinci X/Xi Small Clip Applier, Mode…
FDA Device · Class II · 2022-08-03 · Intuitive Surgical - Centricity PACS Software Version 7.0 SP0.0.4.7
FDA Device · Class II · 2022-08-03 · Ge Healthcare - TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal
FDA Device · Class II · 2022-08-03 · Covidien - REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL
FDA Device · Class II · 2022-08-03 · Abbott Laboratories - Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
FDA Device · Class II · 2022-08-03 · Medtronic Cardiac Rhythm And Heart Failure Crhf - CereLink ICP Monitor
FDA Device · Class I · 2022-08-03 · Integra Lifesciences - Description/Part: Simplify Disc Size 1, Ht 5/SM-5
FDA Device · Class II · 2022-08-03 · Nuvasive - Medline Convenience kits labeled as: a. MAJOR VASCULAR CDS, b. POST OP KIT, c. KIT NEURO FUS LUM POST SANSUR, d. KIT NEURO FUS LUM POST SAN…
FDA Device · Class II · 2022-08-03 · Medline Industries Spt - AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
FDA Device · Class II · 2022-08-03 · Fresenius Medical Care Holdings - Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier, Model 420327 Da Vinci S/Si Small Clip Applier, Mode…
FDA Device · Class II · 2022-08-03 · Intuitive Surgical - ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: 8300-0167 (Abacus V3.1 CE), 8300-0168 (Abacus V3.1 SE), 8300-0…
FDA Device · Class I · 2022-08-03 · Baxter Healthcare - Medline convenience kits: a. VENOUS ACCESS PACK-LF, Model Number DYNJ36725B, Lot codes: 19UBB149, b. KIT LB SHUNT, Model NumberDYNJ905860A,…
FDA Device · Class II · 2022-08-03 · Medline Industries Spt - Medline Convenience kits labeled as follows: a. BEDSIDE PICC CDS, Model Number CDS984642, b. VASCULAR CDS, Model Number DYNJ902880J, c. VAS…
FDA Device · Class II · 2022-08-03 · Medline Industries Spt - Hill-Rom PRO+ MRS Surface For Versacare With X-Ray mattress, REF P3255A01
FDA Device · Class II · 2022-07-27 · Baxter Healthcare - BD Connecta Stopcock with OFF Directed Tap Without Extension Tube (500 eaches/carton) Catalog No. 394910 (US)
FDA Device · Class II · 2022-07-27 · Becton Dickinson And - Trevo Trak 21 Microcatheter, REF: 90338
FDA Device · Class II · 2022-07-27 · Stryker Neurovascular - ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
FDA Device · Class II · 2022-07-27 · Aesculap Implant Systems - Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma
FDA Device · Class II · 2022-07-27 · Randox Laboratories - BD Connecta" Plus1 360 Blue Blend Catalog No. 394911 (OUS)
FDA Device · Class II · 2022-07-27 · Becton Dickinson And - Nonsterile convenience kit: regard Item #830014016, LD00199P - C Section Mother
FDA Device · Class II · 2022-07-27 · Roi Cps - Hobbs Medical Polypectomy Snare, Catalog No. 7202
FDA Device · Class II · 2022-07-27 · Hobbs Medical - GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000
FDA Device · Class I · 2022-07-27 · Ge Healthcare - NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036 NeuRx Diaphragm Pac…
FDA Device · Class III · 2022-07-27 · Synapse Biomedical - ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
FDA Device · Class II · 2022-07-27 · Aesculap Implant Systems - BD Connecta Stopcock Without Extension Tube Catalog No. 394605 (OUS)
FDA Device · Class II · 2022-07-27 · Becton Dickinson And - LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip
FDA Device · Class II · 2022-07-27 · Lumiradx - Hill-Rom PRO+ MRS Surface For Versacare mattress, REF P3255A02
FDA Device · Class II · 2022-07-27 · Baxter Healthcare - AESCULAP S4 Cervical Cross Connector L 33-42mm, S4C CROSS CONNECTOR VARIABLE 33-42MM, product code SW116T. Used in spinal fusion surgery
FDA Device · Class II · 2022-07-27 · Aesculap Implant Systems - Nexiva with Single BD Connecta Stopcock Version (20 Ga Blue) Catalog No.383682 (OUS)
FDA Device · Class II · 2022-07-27 · Becton Dickinson And - Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology s…
FDA Device · Class II · 2022-07-27 · Siemens Medical Solutions Usa - SIGNA Premier magnetic resonance scanner, model 5748519
FDA Device · Class II · 2022-07-27 · Ge Healthcare - ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant…
FDA Device · Class II · 2022-07-27 · Aesculap Implant Systems - Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01
FDA Device · Class II · 2022-07-27 · Baxter Healthcare - Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle
FDA Device · Class II · 2022-07-27 · Roi Cps - BD Connecta 3-Way Stopcocks Catalog No. 394900 (OUS)
FDA Device · Class II · 2022-07-27 · Becton Dickinson And - ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant Part…
FDA Device · Class II · 2022-07-27 · Depuy Orthopaedics - Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scanning Label (component part num…
FDA Device · Class II · 2022-07-27 · Stryker Instruments Div - LEFT CORONAL BENDER, TEK1939
FDA Device · Class II · 2022-07-27 · Aesculap Implant Systems - YelloPort Elite Universal Seal
FDA Device · Class II · 2022-07-27 · Surgical Innovations - SX-One MicroKnife
FDA Device · Class II · 2022-07-27 · Sonex Health - Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only)
FDA Device · Class III · 2022-07-27 · Randox Laboratories - Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoietin concentrations…
FDA Device · Class III · 2022-07-27 · R And D Systems - LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
FDA Device · Class II · 2022-07-27 · Lumiradx - RIGHT CORONAL BENDER, TEK1940
FDA Device · Class II · 2022-07-27 · Aesculap Implant Systems
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