Category
Medical Devices Recalls
15,654 medical devices recalls on record from CPSC, FDA, and USDA.
15,654 recalls
High RiskFDA
Olympus Corporation Of The Americas
EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years)...
Medical Devices126 affectedNov 10, 2023
High RiskFDA
Smiths Medical Asd Inc
48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R
Medical Devices31,685 affectedNov 10, 2023
High RiskFDA
Smiths Medical Asd Inc
Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R
Medical Devices31,685 affectedNov 10, 2023
High RiskFDA
Smiths Medical Asd Inc
1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL
Medical Devices31,685 affectedNov 10, 2023
High RiskFDA
Olympus Corporation Of The Americas
EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>...
Medical Devices5,232 affectedNov 10, 2023
High RiskFDA
Olympus Corporation Of The Americas
EZDilate Fixed Wire Balloon 18-19-20. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 yea...
Medical Devices8,294 affectedNov 10, 2023
High RiskFDA
Smiths Medical Asd Inc
HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP
Medical Devices31,685 affectedNov 10, 2023
High RiskFDA
Olympus Corporation Of The Americas
EZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolesc...
Medical Devices2,991 affectedNov 10, 2023
High RiskFDA
Olympus Corporation Of The Americas
EZDilate Wire Guided Balloon 11-12-13. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents...
Medical Devices3,354 affectedNov 10, 2023
High RiskFDA
Olympus Corporation Of The Americas
EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12...
Medical Devices1,796 affectedNov 10, 2023
High RiskFDA
Getinge Usa Sales Inc
Maquet PowerLED/HLED and PowerLED300 OR Light Systems, Model Numbers and Catalog Numbers EPS MB1 - ARDINT059002A, EPS MB1 - ARDINT059002C...
Medical Devices236,793 affectedNov 8, 2023
High RiskFDA
Getinge Usa Sales Inc
Maquet Blueline Series 30/80 OR Light Systems, Model Numbers and Catalog Numbers BLUE 30 - ARD569015111A, BLUE 30 - ARD569015111C, BLUE 3...
Medical Devices236,793 affectedNov 8, 2023
High RiskFDA
Getinge Usa Sales Inc
Maquet Rolite OR Light Systems, Model Numbers and Catalog Numbers ROL PWDII50SF - ARDPWT309001A, ROL PWDII50SF - ARDPWT309002A, ROL PWDII...
Medical Devices236,793 affectedNov 8, 2023
High RiskFDA
Getinge Usa Sales Inc
Maquet Lucea - Lucea10/40, Lucea50/100 OR Light Systems, Model Numbers and Catalog Numbers LCA 10 - ARD2LCA00040C, LCA 10 - ARDLCA109000C...
Medical Devices236,793 affectedNov 8, 2023
High RiskFDA
Getinge Usa Sales Inc
Maquet PowerLEDII OR Light System, Model Names and Catalog Numbers PWDII77SF - ARDPWT629100A, PWDII555DF - ARDPWT629101A, PWDII555SF - AR...
Medical Devices236,793 affectedNov 8, 2023
High RiskFDA
Getinge Usa Sales Inc
Maquet Equipment OR Light Systems, Model Numbers and Catalog Numbers BRAINLAB CAMERA - ARDEQT269000A, BRAINLAB CAMERA - ARDEQT269000C, BR...
Medical Devices236,793 affectedNov 8, 2023
High RiskFDA
Getinge Usa Sales Inc
Maquet Volista, Volista Access, Volista Access II, Volista Standop OR Light System, Model Numbers and Catalog Numbers ROL B FOR VLT400SF ...
Medical Devices236,793 affectedNov 8, 2023
High RiskFDA
Getinge Usa Sales Inc
Maquet Hanaulux HLX3000 OR Light Systems, Model Numbers and Catalog Numbers H3 BC - HM567811111C
Medical Devices236,793 affectedNov 8, 2023
High RiskFDA
Getinge Usa Sales Inc
Maquet G8 / G8E OR Light Systems, Model Numbers and Catalog Numbers G8 LC E - ARD568131211C, G8G8 DF E - ARD568121111C, G8G8FS DF - ARD56...
Medical Devices236,793 affectedNov 8, 2023
High RiskFDA
Getinge Usa Sales Inc
Maquet Axcel / Axcel + OR Light Systems, Model Numbers and Catalog Numbers AXL 5001 - ARD567501961C, AXL 5001S - ARD567505961C, AXL 5002 ...
Medical Devices236,793 affectedNov 8, 2023
High RiskFDA
Getinge Usa Sales Inc
Maquet Hanaulux HLX2000 OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722001C, 3001 HXS12 ...
Medical Devices236,793 affectedNov 8, 2023
High RiskFDA
Getinge Usa Sales Inc
Maquet Hanaulux 2006/ 2007, Blue 100, Blue 130/ 90, Blue Series 30/ 80, and Prismatic OR Light Systems. No Model Numbers.
Medical Devices236,793 affectedNov 8, 2023
RecallFDA
Apn Health Llc
Navik 3D v2, REF NAVIK3D, 3D Mapping System
Medical Devices1 affectedNov 7, 2023
High RiskFDA
Medtronic Xomed, Inc.
NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 8229707, 7.0MM ID; c) 8229708, 8.0MM ...
Medical Devices80,569 affectedNov 7, 2023
High RiskFDA
Sarnova Hc, Llc
Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP, 6.0mm, Item Number 351631i-A. The kit provides healthcare professional...
Medical Devices15 affectedNov 6, 2023
CriticalFDA
Nurse Assist, Llc
0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NURSE ASSIST: 3ML IV FLUSH SYRINGE/1203...
Medical Devices61,740 affectedNov 6, 2023
High RiskFDA
Wilson-cook Medical Inc.
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree
Medical Devices553 affectedNov 3, 2023
High RiskFDA
Wilson-cook Medical Inc.
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used to dilate strictures of the biliary tree
Medical Devices941 affectedNov 3, 2023
High RiskFDA
Medline Industries, Lp - Northfield
STERILE PVP SOLUTION, REF DYNDA1907
Medical Devices8,250 affectedNov 3, 2023
High RiskFDA
Medline Industries, Lp - Northfield
STERILE POVIDONE, REF DYNDA2061
Medical Devices300 affectedNov 3, 2023
High RiskFDA
Wilson-cook Medical Inc.
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; used to dilate strictures of the biliary tree
Medical Devices157 affectedNov 3, 2023
High RiskFDA
Medline Industries, Lp - Northfield
STERILE BETADINE, REF DYNDA1998
Medical Devices1,800 affectedNov 3, 2023
High RiskFDA
Wilson-cook Medical Inc.
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree
Medical Devices731 affectedNov 3, 2023
High RiskFDA
Liberty Medical Solutions, Llc
Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation
Medical Devices473 affectedNov 3, 2023
High RiskFDA
Inpeco S.a.
Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to automate Pre-Analyt...
Medical Devices1 affectedNov 3, 2023
High RiskFDA
Wilson-cook Medical Inc.
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; used to dilate strictures of the biliary tree
Medical Devices888 affectedNov 3, 2023
High RiskFDA
Wilson-cook Medical Inc.
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; used to dilate strictures of the biliary tree
Medical Devices111 affectedNov 3, 2023
High RiskFDA
Medline Industries, Lp - Northfield
STERILE PVP, REF DYNDA1649
Medical Devices700 affectedNov 3, 2023
High RiskFDA
Medline Industries, Lp - Northfield
STERILE STERILE PREP STICK, REF DYNDA1134
Medical Devices240 affectedNov 3, 2023
High RiskFDA
Atrium Medical Corporation
Atrium Oasis Drain Single W / AC, Part No. 3600-100
Medical Devices835 affectedNov 1, 2023
High RiskFDA
Change Healthcare Canada Company
Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.
Medical Devices454 affectedNov 1, 2023
CriticalFDA
B. Braun Medical, Inc.
Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 362032 15 drops/...
Medical Devices33,820,976 affectedNov 1, 2023
High RiskFDA
Medline Industries, Lp - Northfield
ADLT BLOOD CULTURE COLLECT KIT, REF DYNDH1245
Medical Devices4,850 affectedNov 1, 2023
High RiskFDA
Medline Industries, Lp - Northfield
PERIPHERAL BLOOD CULTURE DRAW, REF DYNDH1561
Medical Devices1,770 affectedNov 1, 2023
High RiskFDA
Medline Industries, Lp - Northfield
BLOOD CULTURE KIT, REF DYNDH1647B
Medical Devices1,890 affectedNov 1, 2023
High RiskFDA
Turncare, Inc
Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-59 (Fix)
Medical Devices1,081 affectedNov 1, 2023
High RiskFDA
Zeus Scientific, Inc.
ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G
Medical Devices293 affectedOct 31, 2023
High RiskFDA
Limacorporate S.p.a
PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
Medical Devices33 affectedOct 27, 2023