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.
- Carefusion V. Mueller GERALD BIPOLAR FORCEPS 1.0MM WIDE TIP OVERALL LENGTH 7" (17.8CM) , REF F-1110
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulated
FDA Device · Class II · 2022-12-14 · Integrity Implants - CAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System Unit
FDA Device · Class I · 2022-12-14 · Caire - Carefusion V. Mueller"GERALD BIPOLAR FORCEPS INSULATED, 1.0MM TIP OVERALL LENGTH 7" (180MM), REF F-1112
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - Carefusion V. Mueller CUSHING BAYONET BIPOLAR FORCEPS, 0.7MM TIP, INSULATED IRRIGATING OVERALL LENGTH 7-1/2" (190MM), REF F-1300
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - Carefusion V. Mueller SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIPS, IRRIGATING OVERALL LENGTH 7-3/4" (19.7CM), REF F-1304
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - FULL VISION INC. TRACKMASTER, TREADMILL GE T2100-ST1 110V, Model #317-07926GE
FDA Device · Class II · 2022-12-14 · Full Vision - Philips MR 7700 System, Model Number 782120
FDA Device · Class II · 2022-12-14 · Philips North America - CareFusion V. Mueller Neuro/Spine TITANUIM BIPOLAR FORCEPS STRAIGHT, 0.25MM TIP OVERALL LENGTH 6" (150MM) , REF F-5128
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 0.5MM TIP, ANGLED-UP FINE OVERALL LENGTH 8-3/4" (225MM), REF F-5127
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)
FDA Device · Class II · 2022-12-14 · Getinge Usa Sales - CareFusion V. Mueller TITANIUM BAYONET INSULATED IRRIGATING BIPOLAR FORCEPS 1.0MM TIP, STR, MED, INSULATED OVERALL LENGTH 8-3/4" (225MM), R…
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST
FDA Device · Class I · 2022-12-14 · Remel - CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS, 0.7MM TIP OVERALL LENGTH 9-1/2" (240MM) , REF F-5008
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 14 Fr/Ch (4.7 mm) Product Code: 3410 Intended for urinary drainage from…
FDA Device · Class II · 2022-12-14 · Cardinal Health - CareFusion V. Mueller euro/Spine TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH 8-1/2" (215MM), REF F-5006
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - Carefusion V. Mueller SCOVILLE-GREENWOOD BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED, 1.5MM TIP OVERALL LENGTH 7-3/4" (195MM), REF F-1305
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - Carefusion V. Mueller ADSON BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 4-3/4" (120MM), REF F-3010
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS, 1.0MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5069
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated
FDA Device · Class II · 2022-12-14 · Integrity Implants - Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044
FDA Device · Class II · 2022-12-14 · Intersect Ent - FULL VISION INC. TRACKMASTER,TREADMILL TMX428 220V, Model #317-07927
FDA Device · Class II · 2022-12-14 · Full Vision - Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST
FDA Device · Class I · 2022-12-14 · Remel - Carefusion V. Mueller" HARDY-STYLE BAYONET BIPOLAR FORCEPS, 0.5MM TIP, INSULATED OVERALL LENGTH 8-1/2" (215MM) , REF F-1035
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - Philips Upgrade to MR 7700 System, Model Number 782130
FDA Device · Class II · 2022-12-14 · Philips North America - Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD AST
FDA Device · Class I · 2022-12-14 · Remel - Carefusion V. Mueller CUSHING BIPOLAR FORCEPS 1.5MM TIP, INSULATED OVERALL LENGTH 7" (180MM), REF F-2002
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - CareFusion V. Mueller SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH 7-3/4" (195MM) , REF F-1002
FDA Device · Class II · 2022-12-14 · Carefusion 2200 - Busse JOINT INJECTION TRAY -Intended as a nerve block REF No. 8561 R1
FDA Device · Class II · 2022-12-07 · Busse Hospital Disposables - Busse SPINE INJECTION TRAY-Intended as a nerve block REF No. 8563R1
FDA Device · Class II · 2022-12-07 · Busse Hospital Disposables - CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200
FDA Device · Class II · 2022-12-07 · Gs Biomark - CMV IgM EIA, in vitro diagnostic
FDA Device · Class II · 2022-12-07 · Bio Rad Laboratories - CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782
FDA Device · Class II · 2022-12-07 · Cytocell - CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy
FDA Device · Class II · 2022-12-07 · Cytocell - GREER M. FAENI, 0.25 mL 20 MG/ML, Item: K6, Analyte Specific Reagent, HYPERSENSITIVITY PNEUMONITIS test system, gel diffusion kit for demon…
FDA Device · Class II · 2022-12-07 · Greer Laboratories - MobiCT-32 AIRO Mobile CT Scanner, Cat
FDA Device · Class II · 2022-12-07 · Mobius Imaging - Accelerate PhenoTest BC kit REF 10101018
FDA Device · Class II · 2022-12-07 · Accelerate Diagnostics - GREER DIA - KIT ANTIGEN M. FAENI, 2.0mL 20 MG/ML, Analyte Specific Reagent, Item: K62, HYPERSENSITIVITY PNEUMONITIS test system, gel diffus…
FDA Device · Class II · 2022-12-07 · Greer Laboratories - Alcon Custom Pak Surgical Procedure Pack
FDA Device · Class II · 2022-12-07 · Alcon Research - A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin A1c Assay, REF 45052, part number 05-01-0…
FDA Device · Class III · 2022-12-07 · Primus - Accelerate PhenoTest BC kit REF 10102018
FDA Device · Class II · 2022-12-07 · Accelerate Diagnostics - Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis
FDA Device · Class III · 2022-12-07 · Primus - Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734
FDA Device · Class II · 2022-12-07 · Owens And Minor Distribution - INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Gray 4-Ro…
FDA Device · Class II · 2022-12-07 · Intuitive Surgical - 3M Steri-Drape, Small Drape with Adhesive Aperture, REF 1020NS, general surgery drape
FDA Device · Class II · 2022-11-30 · 3m Healthcare Business - ¿regard SHOULDER PK, GS00125U, Item Number 880120021
FDA Device · Class II · 2022-11-30 · Roi Cps - regard TOTAL JOINT, OR00446F, Item Number 880291
FDA Device · Class II · 2022-11-30 · Roi Cps - Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO
FDA Device · Class II · 2022-11-30 · Southmedic - ¿regard EYE TRAY, EY00099AE, Item Number 880099031
FDA Device · Class II · 2022-11-30 · Roi Cps - Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP)…
FDA Device · Class II · 2022-11-30 · Smiths Medical Asd - VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS) - 785nm Product Number: 175-0012
FDA Device · Class II · 2022-11-30 · Visionsense - Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Blue Electric Heating Pad, MB-001
FDA Device · Class I · 2022-11-30 · Whele - regard FOOT PACK - MERCY SPRINGFIELD , OR00123Z, Item Number 880118026
FDA Device · Class II · 2022-11-30 · Roi Cps - regard SPINE PACK,NU00395J, Item Number 800241010
FDA Device · Class II · 2022-11-30 · Roi Cps - regard PEDIATRIC UROLOGY, GS00467J, Item Number 880306010
FDA Device · Class II · 2022-11-30 · Roi Cps - regard ACDF, NU00698H, Item Number 800246008
FDA Device · Class II · 2022-11-30 · Roi Cps - InControl Insulin Syringes, Short Needle, 29 Gauge, 1CC
FDA Device · Class II · 2022-11-30 · Allison Medical - regard TOTAL HIP ARTHROPLASTY A&B, OR00032W, Item Number 880028023
FDA Device · Class II · 2022-11-30 · Roi Cps - 3M Steri-Drape, Small Drape with Incise Film, REF 1021, general surgery drape
FDA Device · Class II · 2022-11-30 · 3m Healthcare Business - eSuction Small Cavity, Model ET2005
FDA Device · Class II · 2022-11-30 · Endo Therapeutics - regard MAJOR CRANI, NU00921E, Item Number 800716005
FDA Device · Class II · 2022-11-30 · Roi Cps - regard ACDF, NU00698I, Item Number 800246009
FDA Device · Class II · 2022-11-30 · Roi Cps - 3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030, general surgery drape
FDA Device · Class II · 2022-11-30 · 3m Healthcare Business - regard CERVICAL PACK, NU00303H, Item Number 800058008
FDA Device · Class II · 2022-11-30 · Roi Cps - regard NEURO TRAY, NU00160R, Item Number 880158018
FDA Device · Class II · 2022-11-30 · Roi Cps - regard VITRECTOMY PK, EY00938C, Item Number 800733003
FDA Device · Class II · 2022-11-30 · Roi Cps - 3M Steri-Drape, Small Drape with Incise Film, REF 1021NS, general surgery drape
FDA Device · Class II · 2022-11-30 · 3m Healthcare Business - regard SHOULDER ARTHROSCOPY, OR01103A, Item Number 880471001
FDA Device · Class II · 2022-11-30 · Roi Cps - 3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030NS, general surgery drape
FDA Device · Class II · 2022-11-30 · 3m Healthcare Business - regard FOOT PACK, OR00123Y, Item Number 880118
FDA Device · Class II · 2022-11-30 · Roi Cps - Unity Total Knee System
FDA Device · Class II · 2022-11-30 · Corin - regard MAJOR EAR, ET00326J, Item Number 800070010
FDA Device · Class II · 2022-11-30 · Roi Cps - B. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214, Central Venous (cardiac) Catheter Tray (REF number corrected 11/23/2022)
FDA Device · Class II · 2022-11-30 · Medical Action Industries 306 - regard MINOR NEURO, NU00140AD, Item Number 880135030
FDA Device · Class II · 2022-11-30 · Roi Cps - VS3 Iridium Visionsense Infrared (IR) Fluorescence Light Integrator (Beam Combiner) Product Number: 161-0001
FDA Device · Class II · 2022-11-30 · Visionsense - 3M Steri-Drape, Small Towel Drape, REF 1000NSD, general surgery drape
FDA Device · Class II · 2022-11-30 · 3m Healthcare Business - regard SHOULDER PACK, GS00125V, Item Number 880120022
FDA Device · Class II · 2022-11-30 · Roi Cps - regard SPINE PACK , NU00193N, Item Number 880179014
FDA Device · Class II · 2022-11-30 · Roi Cps - 3M Steri-Drape, Small Drape with Adhesive Aperture, REF 1020, general surgery drape
FDA Device · Class II · 2022-11-30 · 3m Healthcare Business - PAJUNK Continuous Epidural Tray, Tuohy Epidural Needle 17G x 4" with EpiLong Soft Catheter, Closed Tip, 19G, Model #TAL101, sterile, each t…
FDA Device · Class II · 2022-11-30 · Pajunk Medical Systems L P - regard VITRECTOMY PACK, EY00266H, Item Number 800028008
FDA Device · Class II · 2022-11-30 · Roi Cps - regard CATARACT, EY00450L, Item Number 880295012
FDA Device · Class II · 2022-11-30 · Roi Cps - regard HIP ARTHROSCOPY, OR01092B, Item Number 880462002
FDA Device · Class II · 2022-11-30 · Roi Cps - regard CATARACT, EY00450K, Item Number 880295011
FDA Device · Class II · 2022-11-30 · Roi Cps - regard DAVINCI PACK, GS00137W, Item Number 880132023
FDA Device · Class II · 2022-11-30 · Roi Cps - regard SPINE , NU00974F, Item Number 800769006
FDA Device · Class II · 2022-11-30 · Roi Cps - regard MINOR DAVINCI PACK, GS00349M, Item Number 880251013
FDA Device · Class II · 2022-11-30 · Roi Cps - regard RETINAL PACK, EY00935C, Item Number 800730003
FDA Device · Class II · 2022-11-30 · Roi Cps - regard SPINE, OR01100A, Item Number 880468001
FDA Device · Class II · 2022-11-30 · Roi Cps - regard HAND PACK, OR00594K, Item Number 800243011
FDA Device · Class II · 2022-11-30 · Roi Cps - regard KYPHOPLASTY, OR01101, Item Number 880469
FDA Device · Class II · 2022-11-30 · Roi Cps - regard LAMINECTOMY, NU01140, Item Number 900940
FDA Device · Class II · 2022-11-30 · Roi Cps - 3M Steri-Drape, Medium Drape with Incise Film and Pouch, REF 1061, general surgery drape
FDA Device · Class II · 2022-11-30 · 3m Healthcare Business - 3M Steri-Drape, Urological Drape, REF 1071, general surgery (urology) drape
FDA Device · Class II · 2022-11-30 · 3m Healthcare Business - ¿regard CV¿PART¿¿1¿BUNDLE¿- MERCY¿ST¿ANTHONY , CV01005H, Item Number 830099008
FDA Device · Class II · 2022-11-30 · Roi Cps - BASIN SET, MEBS42K, general surgical kit
FDA Device · Class II · 2022-11-30 · American Contract Systems - regard LATERAL SHOULDER, OR01044C, Item Number 880435003
FDA Device · Class II · 2022-11-30 · Roi Cps - ¿regard SHOULDER ARTHROSCOPY, OR00049Q, Item Number 880044017
FDA Device · Class II · 2022-11-30 · Roi Cps - Mighty Bliss Electric Heating Pad, Extra-Large (20 x 24 ) Blue Electric Heating Pad, MB-002
FDA Device · Class I · 2022-11-30 · Whele - VS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-IR) Product Number: 174-0012
FDA Device · Class II · 2022-11-30 · Visionsense
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