Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 168 of 548
FDA Devices Moderate Sep 29, 2021
Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a, VA30A_SP3,VA30A_FP2 in Somatom systems: SOMAT…
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Sep 29, 2021
cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
Roche Molecular Systems, Inc.
FDA Devices Moderate Sep 29, 2021
Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630
Paragon 28, Inc.
FDA Devices Moderate Sep 29, 2021
DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only
Medtronic Perfusion Systems
FDA Devices Moderate Sep 29, 2021
Univation X System knee implant devices as follows: Catalog/Product: NO156Z AS UNIVATION XF TIBIA CEMENTED T1 RM; NO157Z AS UNIVATION XF TIBIA …
Aesculap Implant Systems LLC
FDA Devices Moderate Sep 29, 2021
Univation X System knee implant devices as follows: Catalog/Product: NL494 UNIVATION F MENISCAL COMP.T1 RM/LM 11MM; NL495 UNIVATION F MENISCAL C…
Aesculap Implant Systems LLC
FDA Devices Moderate Sep 29, 2021
Catalog A300318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device
C.R. Bard Inc
FDA Devices Moderate Sep 29, 2021
Univation X System knee implant devices as follows: Catalog/Product: NO180Z AS UNIVATION XF FEMUR CEMENTED F1 RM; NO181Z AS UNIVATION XF FEMUR …
Aesculap Implant Systems LLC
FDA Devices Moderate Sep 29, 2021
Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device
C.R. Bard Inc
FDA Devices Moderate Sep 29, 2021
Catalog A943216, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device
C.R. Bard Inc
FDA Devices Moderate Sep 29, 2021
Catalog A800361, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
C.R. Bard Inc
FDA Devices Moderate Sep 29, 2021
Catalog A800365, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
C.R. Bard Inc
FDA Devices Moderate Sep 29, 2021
10 ga ARS Decompression Needle, Part Number ZZ-0298
North American Rescue LLC.
FDA Devices Moderate Sep 29, 2021
General Manual surgical instrument
M.D.L. S.r.l.
FDA Devices Moderate Sep 29, 2021
Univation X System knee implant devices as follows: Catalog/Product: NL476 UNIVATION F MENISCAL COMP.T1 RM/LM 8MM; NL477 UNIVATION F MENISCAL COM…
Aesculap Implant Systems LLC
FDA Devices Moderate Sep 29, 2021
Catalog A300314A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device
C.R. Bard Inc
FDA Devices Moderate Sep 29, 2021
Catalog A902916, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device
C.R. Bard Inc
FDA Devices Moderate Sep 29, 2021
Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: Affiniti 30 795121 Affiniti 30 795218 Affiniti 50 795…
Philips Ultrasound Inc
FDA Devices Critical Sep 29, 2021
Ultrasound Gel labeled under the following brand names: MediChoice Ultrasound Gel, Athena Liquasonic Ultrasound Gel, Eco-Med EcoGel Ultrasound Gel, …
Mac Medical Supply Co Inc
FDA Devices Moderate Sep 22, 2021
BD Gravity Burette Set 60 DROP 1.2 MF 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV, REF: 10037031; BD Gravity Burette Set 20 DROP 1.2 Micron Filte…
CAREFUSION
FDA Devices Moderate Sep 22, 2021
Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10; Gastroscope Family # 2- Gas…
Pentax of America Inc
FDA Devices Moderate Sep 22, 2021
BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375
Leica Microsystems, Inc.
FDA Devices Moderate Sep 22, 2021
The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications, including …
Philips North America Llc
FDA Devices Moderate Sep 22, 2021
Configura Advance Chair, Model Number: CHAIR-0-SC1-030; Advance Chair, 100mm Castors, Std Backrest, Manual; Serial Numbers: 10001-SC1-20 to 10483-SC…
Accora Inc
FDA Devices Moderate Sep 22, 2021
BD Gravity IV Set 3-port Closed Manifold Back Check Valve 3 Needle-Free Y-sites, REF: CM42500E-07; BD Gravity IV Set 3-port Closed Stopock Manifold B…
CAREFUSION
FDA Devices Moderate Sep 22, 2021
Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"
Cellex
FDA Devices Moderate Sep 22, 2021
BD SE Burette Set 20 Drops 2 Injection Ports Vented/NonVented, REF: 72103E-0006
CAREFUSION
FDA Devices Moderate Sep 22, 2021
BD Alaris Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSite Port (Burette) SmartSite Y-Site, REF: 10015012; BD Alaris Pump Infu…
CAREFUSION
FDA Devices Moderate Sep 22, 2021
Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3490Li, EC-38…
Pentax of America Inc
FDA Devices Critical Sep 22, 2021
Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB
Cordis Corporation
FDA Devices Moderate Sep 22, 2021
BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES, REF: 20019E
CAREFUSION
FDA Devices Moderate Sep 22, 2021
BD SmartSite Bag Access Device, REF: 2300E-0500; BD BAG ACCESS DEVICE CHECK VALVE SmartSite VALVE, REF: 2309E
CAREFUSION
FDA Devices Critical Sep 22, 2021
AMSORB PLUS PREFILLED G-CAN 1.0L; Carbon dioxide absorbent canister; Product codes AMAB3801 and AMAB3801GE. Used in anesthesia.
Armstrong Medical Services Limited
FDA Devices Moderate Sep 22, 2021
The Azurion series (within the limits of the used Operation Room table) are intended for use to perform: "Image guidance in diagnostic, intervention…
Philips North America Llc
FDA Devices Moderate Sep 22, 2021
BD SmartSite 'Y' Extension Set 2 Needle-Free Valves, REF: 20019E7D
CAREFUSION
FDA Devices Moderate Sep 22, 2021
cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
Roche Diagnostics Operations, Inc.
FDA Devices Moderate Sep 22, 2021
McKesson Lap Sponge, X-Ray Detectable 12"x 12", 5/pack, Sterile McKesson Part # 16-2112121
Cypress Medical Products LLC
FDA Devices Moderate Sep 22, 2021
BD BURETTE GRAVITY SET 60 DROP 2 Smartsite VALVES VENTED/NONVENTED, REF: 42163E
CAREFUSION
FDA Devices Moderate Sep 22, 2021
Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human body temperature for patients having ages ranging from …
Welch Allyn Inc
FDA Devices Moderate Sep 22, 2021
Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro diagnostic use. Model number LN 03R70-01
Abbott Laboratories
FDA Devices Moderate Sep 22, 2021
Maxi Sky 1000 (Arjo) and V10 (BHM) Bariatric Ceiling Rail - Mounted Lift with measuring function
Arjohuntleigh Magog, Inc.
FDA Devices Moderate Sep 22, 2021
Medtronic HVAD Pump Implant Kits
Heartware, Inc.
FDA Devices Critical Sep 22, 2021
Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C
Cordis Corporation
FDA Devices Moderate Sep 22, 2021
Verigene EP Amplification Reagent Kit Test
Luminex Corporation
FDA Devices Critical Sep 22, 2021
Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B
Cordis Corporation
FDA Devices Critical Sep 22, 2021
Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB
Cordis Corporation
FDA Devices Moderate Sep 22, 2021
BD SmartSite, REF: 2000E CHINA; BD SmartSite Connector, REF: 2000E-04; BD SmartSite J-LOOP Extension Set One Needle Free Valve, REF: 20021E7D; BD Sma…
CAREFUSION
FDA Devices Moderate Sep 22, 2021
syngo.CT VA20A, VA30A and VA40A in: syngo.via RT Image Suite / Sim&Go SOMATOM go.Now SOMATOM go.Up SOMATOM go.All SOMATOM go.Top SOMATOM…
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Sep 22, 2021
Potassium Hydroxide 10% (KOH 10%), Cat. No. 300145 Potassium Hydroxide 10% (KOH 10%) is intended for use in the demonstration of yeast and fungal …
Gibson Bioscience
FDA Devices Moderate Sep 22, 2021
Arjo Disposable Repositioning Sling, Model AHD001
Getinge Dominican Republic SA