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
BF-1TQ180: EVIS EXERA II Bronchovideoscope
Medical Devices·242 affected·Mar 8, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes containing Levels 1-6, 1 x 4 mL each, REF 2450-604, Medline catal...
Medical Devices·10 affected·Mar 8, 2022
High RiskFDA
Simplivia Healthcare Ltd.
OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143
Medical Devices·293,520 affected·Mar 8, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,
Medical Devices·31 affected·Mar 7, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SO...
Medical Devices·547 affected·Mar 7, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Number 11061620. Running on servers with syngo.via VB60 softwa...
Medical Devices·1 affected·Mar 7, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number 10496180. Running on servers with syngo.via VB60 software af...
Medical Devices·1 affected·Mar 7, 2022
High RiskFDA
Abbott Molecular, Inc.
Alinity m HBV AMP Kit (US and CE)
Medical Devices·4,966 affected·Mar 4, 2022
High RiskFDA
Whpm Inc.
First SIGN SARS-CoV-2 Antigen Test
Medical Devices·535,755 affected·Mar 4, 2022
High RiskFDA
Draegar Medical Systems, Inc.
Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry ...
Medical Devices·1,950 affected·Mar 4, 2022
High RiskFDA
Ge Healthcare, Llc
GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery MR750w 3.0T, Disc...
Medical Devices·18,411 affected·Mar 4, 2022
High RiskFDA
Deroyal Industries Inc
DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the p...
Medical Devices·780 affected·Mar 3, 2022
High RiskFDA
Intuitive Surgical, Inc.
VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422
Medical Devices·140,519 affected·Mar 3, 2022
High RiskFDA
Deroyal Industries Inc
DeRoyal ST Neonatal Dressing Change Kit, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for prepa...
Medical Devices·400 affected·Mar 3, 2022
High RiskFDA
Boston Scientific Corporation
EXALT Model D Single- Use Duodenoscope (Box 2) UPN: M00542421 Intended Use: sterile, single-use, flexible video duodenoscope intend...
Medical Devices·6,946 affected·Mar 3, 2022
High RiskFDA
Intuitive Surgical, Inc.
DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440
Medical Devices·7,995 affected·Mar 3, 2022
High RiskFDA
Boston Scientific Corporation
EXALT Model D Single- Use Duodenoscope (Box 1) UPN: M00542420 Intended Use: sterile, single-use, flexible video duodenoscope intend...
Medical Devices·1,486 affected·Mar 3, 2022
High RiskFDA
Edwards Lifesciences, Llc
FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA.
Medical Devices·402 affected·Mar 1, 2022
High RiskFDA
Edwards Lifesciences, Llc
FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10
Medical Devices·8,389 affected·Mar 1, 2022
High RiskFDA
Malvern Panalytical Ltd
NanoSight LM10 fitted with LM12 module. A laboratory instrument for determination of particle characteristics (e.g. size).
Medical Devices·111 affected·Feb 28, 2022
High RiskFDA
Medtronic Neuromodulation
MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1) T...
Medical Devices·1,005 affected·Feb 28, 2022
High RiskFDA
Integra Lifesciences Corp.
Integra Universal Flexible Arm part number REF 1362275
Medical Devices·54 affected·Feb 28, 2022
High RiskFDA
Microbiologics Inc
Mycoplasma genitalium Control Panel (Inactivated Pellet)
Medical Devices·80 affected·Feb 25, 2022
High RiskFDA
Celltrion Usa Inc
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Medical Devices·1,228,200 affected·Feb 25, 2022
High RiskFDA
Stradis Medical, Llc Dba Stradis Healthcare
Surgicare Neuro Pack - Neurological Kit
Medical Devices·176 affected·Feb 25, 2022
High RiskFDA
Qiagen Sciences Llc
therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)
Medical Devices·435 affected·Feb 25, 2022
High RiskFDA
Baxter Healthcare Corporation
MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C4483, R5C4484
Medical Devices·498 affected·Feb 25, 2022
High RiskFDA
Brainlab Ag
ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 I...
Medical Devices·205 affected·Feb 25, 2022
High RiskFDA
Boston Scientific Corporation
SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily position the anterior rectal wall away from the prostat...
Medical Devices·61,852 affected·Feb 24, 2022
High RiskFDA
Boston Scientific Corporation
SpaceOAR Vue System, UPN SV-1010 and SV-2101. Used to temporarily position the anterior rectal wall away from the prostate during radiot...
Medical Devices·23,368 affected·Feb 24, 2022
RecallFDA
Roi Cps Llc
Regard Custom Procedure Kits containing BD Luer Lok Access Devices
Medical Devices·1,750 affected·Feb 24, 2022
High RiskFDA
International Science & Technology, Lp, Dba Diamatrix Ltd.
Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Sterile R, Multi-Use 2.2mm Double Bevel Slit, Angled 6 units, ...
Medical Devices·90 affected·Feb 24, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee floor MN, Model Number 10094142
Medical Devices·24 affected·Feb 23, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q ceiling, Model Number 10848281
Medical Devices·418 affected·Feb 23, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q zeego, Model Number 10848283
Medical Devices·38 affected·Feb 23, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q.zen floor, Model Number 10848353
Medical Devices·33 affected·Feb 23, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee biplane, Model Number 10094141
Medical Devices·373 affected·Feb 23, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee multi-purpose, Model Number 10094139
Medical Devices·277 affected·Feb 23, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee biplane MN, Model Number 10094143
Medical Devices·7 affected·Feb 23, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q floor, Model Number 10848280
Medical Devices·80 affected·Feb 23, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee ceiling, Model Number 10094137
Medical Devices·709 affected·Feb 23, 2022
High RiskFDA
Busse Hospital Disposables, Inc.
3.2MM Pellet Insertion Tray Catalog Number: B9743
Medical Devices·150 affected·Feb 22, 2022
High RiskFDA
Busse Hospital Disposables, Inc.
Female SS 3.5MM Pellet Insertion Tray Catalog Number: B1568
Medical Devices·100 affected·Feb 22, 2022
High RiskFDA
Busse Hospital Disposables, Inc.
Nerve Block Tray Catalog Number: 8415
Medical Devices·420 affected·Feb 22, 2022
High RiskFDA
Busse Hospital Disposables, Inc.
Single Shot Epidural Tray Catalog Number: 8417
Medical Devices·400 affected·Feb 22, 2022
High RiskFDA
Busse Hospital Disposables, Inc.
SS 4.5MM DIAMOND TIP TROCAR WITH MEDIUM GLOVES Catalog Number: B1560
Medical Devices·30 affected·Feb 22, 2022
High RiskFDA
Busse Hospital Disposables, Inc.
SS 4.5MM Pellet Insertion Tray Catalog Number:B8128R1
Medical Devices·50 affected·Feb 22, 2022
High RiskFDA
Busse Hospital Disposables, Inc.
Pain Tray Catalog Number: 9883
Medical Devices·421 affected·Feb 22, 2022