FDA Device · 2021
FDA Device recalls in 2021
RecallRadar indexes 2,303 FDA Device recall notices published in 2021. By classification: 179 Class I, 2,098 Class II, 26 Class III.
- Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 109536 - Product Usage: intended for single use in a hemod…
FDA Device · Class II · 2021-02-24 · Baxter Healthcare - 13C-Spirulina Gastric Emptying Breath Test (GEBT) - Product Usage: intended for use in the measurement of the rate of gastric emptying of s…
FDA Device · Class II · 2021-02-24 · Cairn Diagnostics - Gambro Cartridge Single Needle Conversion Kit, product code 101290 - Product Usage: intended for single use in a hemodialysis treatment usi…
FDA Device · Class II · 2021-02-24 · Baxter Healthcare - Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the following CFNs: 22011 L- SHUNT 22011 L INTL ONLY ULTRA SM LOW 2…
FDA Device · Class II · 2021-02-24 · Medtronic Neurosurgery - Getinge CM320 Series Washer Disinfector - Product Usage: A multi chamber washer disinfector intended for washing, disinfecting and drying o…
FDA Device · Class II · 2021-02-24 · Getinge Group Logistics America - Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114434 - Product Usage: intended for single use…
FDA Device · Class II · 2021-02-24 · Baxter Healthcare - LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 Antigen (Ag) Test Str…
FDA Device · Class II · 2021-02-24 · Lumiradx - System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES
FDA Device · Class II · 2021-02-24 · Ge Healthcare - Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 106289 - Product Usage: intended for single use in a hemod…
FDA Device · Class II · 2021-02-24 · Baxter Healthcare - Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts
FDA Device · Class II · 2021-02-24 · Medtronic Neurosurgery - System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex Edition
FDA Device · Class II · 2021-02-24 · Ge Healthcare - Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood convenience kit
FDA Device · Class I · 2021-02-24 · Combat Medical Systems - Valkyrie LTOWB Collection (P/N 80-820, NSN 6515016862423)
FDA Device · Class I · 2021-02-24 · Combat Medical Systems - IOLMaster 700
FDA Device · Class II · 2021-02-24 · Carl Zeiss Meditec Ag - Gambro Cartridge Blood Set Prime Line, product code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the P…
FDA Device · Class II · 2021-02-24 · Baxter Healthcare - Valkyrie LTOWB Administration (P/N 80-821 NSN 6515016862401)
FDA Device · Class I · 2021-02-24 · Combat Medical Systems - Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994)
FDA Device · Class I · 2021-02-24 · Combat Medical Systems - SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive patient monitoring of ca…
FDA Device · Class II · 2021-02-24 · Sentec Ag - B5-2C BALLOON CATHETER 11MM DIA 2.0
FDA Device · Class II · 2021-02-17 · Aomori Olympus - B-V233P-A 3-LUMEN EXTRACTION BALLOON V, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - PBD-203-0710 BILIARY STENT, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - NEEDLEMASTER 5MMx 25G LOWER, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - 154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular administration set is a single use, sterile…
FDA Device · Class II · 2021-02-17 · Icu Medical - Bemer-Set/ Pro-Set for the following models: REF. 410201 (BEMER Pro-Set), REF. 420201 (B.BOX Professional), REF. 420100 (B.BOX CLASSIC), RE…
FDA Device · Class II · 2021-02-17 · Bemer Int Ag - Lab Coats SMS Large Blue, SKU 2202LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier p…
FDA Device · Class II · 2021-02-17 · Cardinal Health 200 - Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19S, 1/19 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curve…
FDA Device · Class II · 2021-02-17 · Argon Medical Devices - Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the determination of th…
FDA Device · Class II · 2021-02-17 · Helena Laboratories - INJECTOR FORCEMAX LOWER 23G 5MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - Kendall Spill Kit, 6 Per Case, NonsterileI, BB6016K
FDA Device · Class II · 2021-02-17 · Cardinal Health 200 - NEEDLEMASTER 4MMx 23G LOWER, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - NEEDLEMASTER 3MMx 23G LOWER, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - SD-400U-10 SNAREMASTER PLUS Hot/Cold 10m, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - B7-2C BALLOON CATHETER 13mm dia 2.8
FDA Device · Class II · 2021-02-17 · Aomori Olympus - Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extracorporeal Shock Wave Lithotrip…
FDA Device · Class II · 2021-02-17 · Cook - NEEDLEMASTER 4MMx 26G UPPER, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - INJECTOR FORCEMAX UP 2MM CH 25G 6MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of IgG antibodies directed to dsDNA in human serum and…
FDA Device · Class II · 2021-02-17 · Phadia Us - MAJ-244 SINGLE USE 30MM REPLACEMENT BASKET, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - INJECTOR FORCEMAX LOWER 23G 3MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - Gown Kendall Blue RG, SKU CT5000 Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier prote…
FDA Device · Class II · 2021-02-17 · Cardinal Health 200 - NA-201SX-4022-ASPIRATION NEEDLE VIZISHOT 22G, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - SD-240U-25 ELECTROSURGICAL SNARE, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18C, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curve…
FDA Device · Class II · 2021-02-17 · Argon Medical Devices - INJECTOR FORCEMAX UP 2MM CH 23G 3MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - KD-620UR ELECTROSURGICAL SNARE, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - B7-2LA BALLOON CATHETER 13MM DIA 3.2, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - SD-230U-20 ELECTROSURGICAL SNARE, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - Lab Coats SMS Large White, SKU 2302LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier…
FDA Device · Class II · 2021-02-17 · Cardinal Health 200 - Gown Kendall Blue L, SKU CT5100, CT5101 Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrie…
FDA Device · Class II · 2021-02-17 · Cardinal Health 200 - GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) System - Product Usage: Intended for use by a qualified/traine…
FDA Device · Class II · 2021-02-17 · Ge Healthcare - NEEDLEMASTER 4MMx 26G LOWER, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - INJECTOR FORCEMAX UP 2.8MMCH 25G 4MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - PBD-203-0704 BILIARY STENT, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - WAHL 4212 HEATED MASSAGER, SKU F800000004212 - Product Usage: intended to relieve minor muscle aches and pains
FDA Device · Class II · 2021-02-17 · Wahl Clipper - K-201 GUIDE SHEATH KIT 2.0MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - Arjo Flat Dynamic Positioning System (DPS) - Product Usage: used in conjunction with passive clip slings is designed for resident transfer…
FDA Device · Class II · 2021-02-17 · Arjohuntleigh Magog - BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213
FDA Device · Class II · 2021-02-17 · Becton Dickinson And - K-204 GUIDE SHEATH Kit 2.6MM, model no K-204 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory…
FDA Device · Class II · 2021-02-17 · Aomori Olympus - ChemoPlus" Chemo Prep & Admin Kit, CT4025
FDA Device · Class II · 2021-02-17 · Cardinal Health 200 - INJECTOR FORCEMAX LOWER 23G 4MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - B7-2Q BALLOON CATHETER 13MM DIA 3.2, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - INJECTOR FORCEMAX LOWER 25G 6MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - 9180 Electrolyte Analyzer - Product Usage: intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and lith…
FDA Device · Class II · 2021-02-17 · Roche Diagnostics Operations - INJECTOR FORCEMAX LOWER 25G 5MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - B5-2Q BALLOON CATHETER, Model No. B5-2Q - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bil…
FDA Device · Class II · 2021-02-17 · Aomori Olympus - SD-400U-15 SNAREMASTER PLUS Hot/Cold 15m, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - INJECTOR FORCEMAX UP 2.8MMCH 23G 6MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - NA-411D-1521 ASPIRATION NEEDLE, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - NA-200H-8022 22G EZSHOT ASPIRATION NEEDLE, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - K-202 GUIDE SHEATH Kit 2.0MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - K-201 GUIDE SHEATH Kit 2.0MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Needle-free IV Connector, Neutral Fluid Displacement, 5.7 " (14 cm…
FDA Device · Class II · 2021-02-17 · Baxter Healthcare - NEEDLEMASTER 4MMx 25G UPPER, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - 60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Product Usage: The intravascular administration set is a single use…
FDA Device · Class II · 2021-02-17 · Icu Medical - Lab Coats SMS Medium White, SKU 2301LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier…
FDA Device · Class II · 2021-02-17 · Cardinal Health 200 - NEEDLEMASTER 6MMx 23G UPPER, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - INJECTOR FORCEMAX LOWER 23G 6MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - NA-401D-1321 ASPIRATION NEEDLE, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - NEEDLEMASTER 4MMx 25G LOWER, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - SD-240U-10 ELECTROSURGICAL SNARE, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - INJECTOR FORCEMAX LOWER 23G 3MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - INJECTOR FORCEMAX UP 2.8MMCH 21G 6MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - NEEDLEMASTER 4MMx 21G UPPER, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - K-202 GUIDE SHEATH KIT 2.0MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - INJECTOR FORCEMAX LOWER 25G 5MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - Gown Isolation W/Ties Xl Blue, SKU 2201PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barr…
FDA Device · Class II · 2021-02-17 · Cardinal Health 200 - ChemoPlus Drug Spill Kit-INSTI, SKU DP5016K
FDA Device · Class II · 2021-02-17 · Cardinal Health 200 - K-203 GUIDE SHEATH Kit 2.6MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - NEEDLEMASTER 6MMx 25G LOWER, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - NA-201SX-4022-B ASPIRATION NEEDLE ViziShot 22G, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - NEEDLEMASTER 5MMx 25G UPPER, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - NA-201SX-4021 ASPIRATION NEEDLE VIZISHOT 21G, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - NEEDLEMASTER 6MMx 25G UPPER, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - INJECTOR FORCEMAX UP 2.8MMCH 23G 5MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - Gown Kendall Blue XXL, SKU CT5102 Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier prot…
FDA Device · Class II · 2021-02-17 · Cardinal Health 200 - KD-655L ELECTROSURGICAL SNARE, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - KD-612L ELECTROSURGICAL KNIFE, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - INJECTOR FORCEMAX UP 2.8MMCH 21G 6MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus
Other years
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