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All Product Recalls

49,195 recalls from FDA (high severity)

Source:AllCPSCFDAUSDASeverity:AllCriticalHighMedium
High RiskFDA
Baxter Healthcare Corporation
Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a...
Medical Devices·4,065 affected·Apr 17, 2020
High RiskFDA
Biomet, Inc.
Knee Products: 154335 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D3 154336 Oxford Partial Knee System,...
Medical Implants·76 affected·Apr 17, 2020
High RiskFDA
Alcon Research Llc
Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE LENS, w/UltraSert DELIVERY SYSTEM, UV w/BLUE LIG...
Medical Devices·84 affected·Apr 17, 2020
High RiskFDA
Biomet, Inc.
Knee Products: 184762 Knees Vanguard Knee System, Series-A Standard Patella, 28 MM; 184764 Knees Vanguard Knee System, Series-A Stand...
Medical Implants·91 affected·Apr 17, 2020
High RiskFDA
Biomet, Inc.
Knee Products: TMJPM-1510 Microfixation Custom Made Device, Left PM-TMJ Model (01)00841036226534(17)220111(10)735550 Product Usage: ...
Medical Implants·1 affected·Apr 17, 2020
High RiskFDA
Biomet, Inc.
Knee Products: 189260 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM 189720 Vanguard Knee System, CR Mono Lock Tibi...
Medical Implants·11 affected·Apr 17, 2020
High RiskFDA
Biomet, Inc.
Knee Products: US154709 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B8 US154722 Knees Vangua...
Medical Implants·105 affected·Apr 17, 2020
High RiskFDA
Biomet, Inc.
Knee Products: 150414 Orthopedic Salvage System (OSS) Tibial Bearing, 20 MM Standard - Product Usage: Knee prosthesis
Medical Implants·12 affected·Apr 17, 2020
High RiskFDA
Biomet, Inc.
Knee Products: 155308 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM 155326 Knees AGC Knee System PS Molded Tibial Com...
Medical Implants·54 affected·Apr 17, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-10308194
Medical Devices·20 affected·Apr 17, 2020
High RiskFDA
Biomet, Inc.
Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366 Comprehensive Reverse Shoulder Humeral Bearing, ArCo...
Medical Devices·122 affected·Apr 17, 2020
High RiskFDA
Biomet, Inc.
Knee Products: 183622 Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67 MM 183620 Vanguard Knee System PS Tibial Bearing, 10 MM X 6...
Medical Devices·46 affected·Apr 17, 2020
High RiskFDA
Baxter Healthcare Corporation
Gambro Cartridge Blood Set Prime Line - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Sys...
Medical Devices·2,361,885 affected·Apr 17, 2020
High RiskFDA
Biomet, Inc.
Knee Products: 189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM 189422 Vanguard Knee System, PS Mono Lock Tibial...
Medical Devices·107 affected·Apr 17, 2020
High RiskFDA
Biomet, Inc.
Hip Products Item Number: 1) 110010462 RingLoc Hip System, Acetabular Bi-Polar Cup, 28 MM X 51 MM 2) 11-165218 RingLoc Bi-Polar Hip S...
Medical Devices·58 affected·Apr 17, 2020
High RiskFDA
Biomet, Inc.
Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regenerex Series-A Patella 3 Peg, 37 MM Product Usage: Knee prost...
Medical Implants·15 affected·Apr 17, 2020
High RiskFDA
Baxter Healthcare Corporation
Gambro Cartridge Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatmen...
Medical Devices·53,895 affected·Apr 17, 2020
High RiskFDA
Howmedica Osteonics Corp.
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Right, Sterile, Catalog # 504-02-54C-R, UDI (01)07613327012415(17)
Medical Devices·4,895 affected·Apr 16, 2020
High RiskFDA
Howmedica Osteonics Corp.
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 left, Sterile, Catalog # 504-02-64E-L, UDI (01)07613327012484(17)
Medical Devices·0 affected·Apr 16, 2020
High RiskFDA
Howmedica Osteonics Corp.
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Right, Sterile, Catalog # 504-02-56D-R, UDI (01)07613327012347(17)
Medical Devices·4,895 affected·Apr 16, 2020
High RiskFDA
Howmedica Osteonics Corp.
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Left, Sterile, Catalog # 504-02-54C-L, UDI (01)07613327012354(17)
Medical Devices·4,895 affected·Apr 16, 2020
High RiskFDA
Howmedica Osteonics Corp.
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 right, Sterile, Catalog # 504-02-60D-R, UDI (01)07613327012408(17)
Medical Devices·4,895 affected·Apr 16, 2020
High RiskFDA
Howmedica Osteonics Corp.
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 right, Sterile, Catalog # 504-02-62E-R, UDI (01)07613327012439(17)
Medical Devices·4,895 affected·Apr 16, 2020
High RiskFDA
Howmedica Osteonics Corp.
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 Left, Sterile, Catalog # 504-02-60D-L, UDI (01)07613327012422(17)
Medical Devices·4,895 affected·Apr 16, 2020
High RiskFDA
Howmedica Osteonics Corp.
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Left, Sterile, Catalog # 504-02-56D-L, UDI (01)07613327012361(17)
Medical Devices·4,895 affected·Apr 16, 2020
High RiskFDA
Becton Dickinson & Company
BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 50382903065535
Medical Devices·16,099,310 affected·Apr 16, 2020
High RiskFDA
Howmedica Osteonics Corp.
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 left, Sterile, Catalog # 504-02-62E-L, UDI (01)07613327012453(17)
Medical Devices·4,895 affected·Apr 16, 2020
High RiskFDA
Howmedica Osteonics Corp.
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 right, Sterile, Catalog # 504-02-64E-R, UDI (01)07613327012460(17)
Medical Devices·4,895 affected·Apr 16, 2020
High RiskFDA
Howmedica Osteonics Corp.
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Left, Sterile, Catalog # 504-02-58D-L, UDI (01)07613327012385(17)
Medical Devices·4,895 affected·Apr 16, 2020
High RiskFDA
Absorb Health Llc
Absorb Health Advanced Joint Relief Joint Health; 510mg; 90 CAPSULES; Manufactured for: Absorb Health, 106 Countryside St NW, Supply, NC ...
Food·70 affected·Apr 15, 2020
High RiskFDA
Amneal Pharmaceuticals Of New York, Llc
Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Distributed by: Gemini Laboratories, LLC Bridgewater, NJ 08807...
Oral Drugs·11,258 affected·Apr 15, 2020
High RiskFDA
H J Harkins Company Inc Dba Pharma Pac
Acetaminophen and Codeine Phosphate 300/30 mg tablet, packaged in: a) 10-count bottle (NDC 52959-0003-10), b) 12-count bottle (NDC 52959-...
Oral Drugs·9,000 affected·Apr 15, 2020
High RiskFDA
Lupin Pharmaceuticals Inc.
Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland 21202 United State...
Oral Drugs·4,518 affected·Apr 15, 2020
High RiskFDA
B & B Pharmaceuticals, Inc.
Estradiol, USP (Non-Micronized) (Hemihydrate), packaged in: a) 500 grams (NDC 63275-9900-8), b) 100 grams (NDC 63275-9900-5), c) 25 grams...
Drugs·3,825 affected·Apr 14, 2020
High RiskFDA
Becton Dickinson & Co.
BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212525 - Product Usage: Gram Stain Ki...
Diagnostic Devices·10,568 affected·Apr 14, 2020
High RiskFDA
Becton Dickinson & Co.
BD BBLTM Gram Crystal Violet 3.8L-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212526 - Product Usage: Gram Stain Kit...
Diagnostic Devices·236 affected·Apr 14, 2020
High RiskFDA
Philips North America, Llc
Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for use in the hospital by qualified medical person...
Cardiac Devices·94,034 affected·Apr 13, 2020
High RiskFDA
American Contract Systems
Sterile Custom Packs to be used in surgical procedures.
Surgical Devices·2,868 affected·Apr 13, 2020
High RiskFDA
American Contract Systems
Sterile Custom Packs to be used in surgical procedures.
Surgical Devices·2,868 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90109, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
American Contract Systems
Sterile Custom Packs to be used in surgical procedures.
Surgical Devices·2,868 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90123, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
Ivoclar Vivadent Ag
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab Start.Kit LT - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxi...
Medical Devices·6 affected·Apr 13, 2020
High RiskFDA
Ivoclar Vivadent Ag
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A2 C17/5 - ceramic for dental use,intended for IPS e.max ZirCAD presintered yttrium oxide...
Medical Devices·332 affected·Apr 13, 2020
High RiskFDA
Ivoclar Vivadent Ag
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A3 C17/5 - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxid...
Medical Devices·639 affected·Apr 13, 2020
High RiskFDA
American Contract Systems
Sterile Custom Packs to be used in surgical procedures.
Surgical Devices·2 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90181, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020
High RiskFDA
K2m, Inc
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90151, UDI # 1088885...
Medical Implants·0 affected·Apr 13, 2020