Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 192 of 548
FDA Devices Moderate Jan 13, 2021
Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS) UPN: M00553560 - Product Usage: The stent is intended for implantation…
Boston Scientific Corporation
FDA Devices Moderate Jan 13, 2021
AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm UPN: M00553660 - Product Usage: The stent is intended for implantation up to 60 …
Boston Scientific Corporation
FDA Devices Moderate Jan 13, 2021
Resect. Intest. Laparo-LF, Model DYNJ42667A - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal…
Medline Industries Inc
FDA Devices Moderate Jan 13, 2021
VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product Usage: intended to automate pre-analytical and post-analytical sample p…
Ortho-Clinical Diagnostics, Inc.
FDA Devices Moderate Jan 13, 2021
Eleganza 5 (AC powered adjustable bed), Item Numbers: a) 1GE512055-40, b) 1GE512055-45, c) 1GE512055-85, and d) 1GE512055-95 - Product Usage: Elegan…
Linet Spol. S.r.o.
FDA Devices Moderate Jan 13, 2021
Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 1…
DePuy Orthopaedics, Inc.
FDA Devices Moderate Jan 13, 2021
Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883713
Steris Corporation
FDA Devices Moderate Jan 13, 2021
Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per case 6 rolls/cs Model Number: 881091
Steris Corporation
FDA Devices Moderate Jan 13, 2021
Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case Model Number: 884118
Steris Corporation
FDA Devices Moderate Jan 13, 2021
Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884039
Steris Corporation
FDA Devices Moderate Jan 13, 2021
VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide cartridge) Product Code:8058232 (2)VITROS CKMB Slides (18 Slide cartri…
Ortho Clinical Diagnostics Inc
FDA Devices Moderate Jan 13, 2021
MiniCap Extended Life PD Transfer Set
Baxter Healthcare Corporation
FDA Devices Moderate Jan 13, 2021
Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883610
Steris Corporation
FDA Devices Moderate Jan 13, 2021
Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881061
Steris Corporation
FDA Devices Moderate Jan 13, 2021
Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm (OUS) UPN: M00553550 - Product Usage: The stent is intended for implantation…
Boston Scientific Corporation
FDA Devices Moderate Jan 13, 2021
Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884510
Steris Corporation
FDA Devices Moderate Jan 13, 2021
TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated system for the planning and precise delivery of radiation ther…
Accuray Incorporated
FDA Devices Moderate Jan 13, 2021
CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking anticoagulation medications such as Coumad…
Roche Diagnostics Operations, Inc.
FDA Devices Moderate Jan 13, 2021
Cardiac Pack - LF, Model DYNJ31903I - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and ne…
Medline Industries Inc
FDA Devices Moderate Jan 13, 2021
CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfar…
Roche Diagnostics Operations, Inc.
FDA Drug Low Jan 6, 2021
Neostigmine Methylsulfate PF Inj. 5 mg/5 mL, 5 mL Single Use Syringes, Hospital/Office Use Only. US Compounding 1270 Don's Lane Conway, AR 72032 (800…
US Compounding Inc
FDA Devices Moderate Jan 6, 2021
Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only, (01)00884450255803 For Angiography/angioplasty. The contents of…
Merit Medical Systems, Inc.
FDA Devices Moderate Jan 6, 2021
BD Phoenix PMIC-107: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera …
Becton Dickinson & Co.
FDA Devices Moderate Jan 6, 2021
BD Phoenix PMIC/ID-108: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the gene…
Becton Dickinson & Co.
FDA Devices Moderate Jan 6, 2021
Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard, PACEMAKER, Item 800221010, Lot # 82466. 2) Regard, BASIC, It…
ROi CPS LLC
FDA Devices Moderate Jan 6, 2021
BD Phoenix PMIC-108: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera …
Becton Dickinson & Co.
FDA Devices Moderate Jan 6, 2021
BD Phoenix" PMIC-109: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera…
Becton Dickinson & Co.
FDA Devices Moderate Jan 6, 2021
Custom Procedure Kit, Cardiac Cath Pack, Product Code: K12T-10996 Rev. B, Sterile EO, Rx Only, (01)00884450515105 For Angiography/angioplasty. Th…
Merit Medical Systems, Inc.
FDA Devices Moderate Jan 6, 2021
Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3. Intended for abdominal, gynecological, pediatric and thoracic sur…
Covidien Llc
FDA Devices Moderate Jan 6, 2021
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 95001, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt syste…
Medtronic Neurosurgery
FDA Devices Moderate Jan 6, 2021
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt sy…
Medtronic Neurosurgery
FDA Devices Moderate Jan 6, 2021
Product Code: K12T-02871, Revision A, Custom Procedure Kit, Embolization Kit Sterile EO, Rx Only, (01)00884450339121 For Angiography/angioplasty. …
Merit Medical Systems, Inc.
FDA Devices Moderate Jan 6, 2021
REF 0562, Adult Elongated O2/CO2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female Luer Connectors, 7' Oxygen Supply Tubing, Rx Only, CE0482, (…
Westmed, Inc.
FDA Devices Moderate Jan 6, 2021
REF 0562K (Adult Elongated O2/CO2 Mask - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
Westmed, Inc.
FDA Devices Moderate Jan 6, 2021
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 93092, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt sys…
Medtronic Neurosurgery
FDA Devices Moderate Jan 6, 2021
Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing Systems; Multipac Anasthesia Breathing Syst…
Intersurgical Inc
FDA Devices Moderate Jan 6, 2021
Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. Intended for abdominal, gynecological, pediatric and thoracic surgical…
Covidien Llc
FDA Devices Moderate Jan 6, 2021
REF 0930 Adult Elongated CO2/O2 Mask, 7' Tubing w/ Threaded Nut, Sivel GSE, 10' GSL X .038" ID X .107" OD, Reflective Luer Connectors, Rx Only, CE048…
Westmed, Inc.
FDA Devices Moderate Jan 6, 2021
cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use
Roche Diagnostics Operations, Inc.
FDA Devices Moderate Jan 6, 2021
BD Phoenix PMIC/ID-105: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the gene…
Becton Dickinson & Co.
FDA Devices Moderate Jan 6, 2021
BD Phoenix PMIC/ID-109: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the gene…
Becton Dickinson & Co.
FDA Devices Moderate Jan 6, 2021
BD Phoenix PMIC/ID-107: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the gene…
Becton Dickinson & Co.
FDA Devices Moderate Jan 6, 2021
Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 analytical units) Chemistry Analyzer (photometric discrete), for cl…
Roche Diagnostics Operations, Inc.
FDA Devices Moderate Jan 6, 2021
BD Phoenix PMIC-110: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera …
Becton Dickinson & Co.
FDA Devices Moderate Jan 6, 2021
REF 3102-E, Elongated Oxygen Mask, Adult Oxygen Elongated Mask with 8' Tubing, Rx Only, CE0482, (01)00709078003172 - Product Usage: intended to conne…
Westmed, Inc.
CPSC Moderate Dec 31, 2020
Anticimex Recalls SMART Connect Mini Devices Due to Fire and Injury Hazards (Recall Alert)
FDA Devices Moderate Dec 30, 2020
30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger, REF: CL3011; 31" (79 cm) Appx 3.4 ml, 20 Dr…
ICU Medical, Inc.
FDA Devices Moderate Dec 30, 2020
26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z2795
ICU Medical, Inc.
FDA Devices Moderate Dec 30, 2020
IceSeed" 1.5 Cryoablation Needle
Boston Scientific Corporation
FDA Devices Moderate Dec 30, 2020
ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393 Sagamore Avenue, Mineola, NY 11501 Product Code: 345SVVO1
GA HEALTH COMPANY LIMITED