Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
High RiskFDA
Ethicon, Inc.
PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T Product Usage: PERMA-HAND* suture is indi...
Medical Devices·840 affected·Dec 18, 2018
High RiskFDA
Olympus Corporation Of The Americas
Olympus PCF-Q180AC Video Colonoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within ...
Medical Devices·2 affected·Dec 17, 2018
High RiskFDA
Olympus Corporation Of The Americas
Olympus TJF-Q180V Duodenoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the ga...
Medical Devices·2 affected·Dec 17, 2018
High RiskFDA
Elekta, Inc.
MOSAIQ¿ Oncology Information System and Sequencer MOSAIQ is an oncology information system used to manage workflows for treatment plan...
Medical Devices·3,950 affected·Dec 13, 2018
High RiskFDA
Arrow International Inc
Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-44052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is in...
Medical Devices·963 affected·Dec 13, 2018
High RiskFDA
Ion Beam Applications S.a.
Proteus 235 Product Usage: The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device de...
Medical Devices·7 affected·Dec 12, 2018
High RiskFDA
Kimberly-clark Corporation
U by Kotex¿ Sleek¿, Regular Tampons, 3 Count
Medical Devices·68,852,076 affected·Dec 11, 2018
High RiskFDA
Kimberly-clark Corporation
U by Kotex¿ Sleek¿, Regular Tampons, 18 Count
Medical Devices·68,852,076 affected·Dec 11, 2018
High RiskFDA
Baxter Healthcare Corporation
Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in th...
Medical Devices·1,085 affected·Dec 11, 2018
High RiskFDA
Baxter Healthcare Corporation
AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the...
Medical Devices·7,688 affected·Dec 11, 2018
High RiskFDA
Kimberly-clark Corporation
U by Kotex¿ Sleek¿, Regular/Super Tampons, 34 Count Multipack
Medical Devices·68,852,076 affected·Dec 11, 2018
High RiskFDA
Signature Orthopedics Pty Limited
Genius Knee Cemented Tibial Component Product Usage: Knee replacement component
Medical Devices·10 affected·Dec 10, 2018
High RiskFDA
Leica Biosystems Imaging, Inc.
Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE.
Medical Devices·3 affected·Dec 10, 2018
High RiskFDA
Vygon U.s.a.
Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used for intravascular lines.
Medical Devices·339,800 affected·Dec 6, 2018
High RiskFDA
Vygon U.s.a.
Vyon DUALSTOP White Cap used for intravascular lines Product Code: 9888.002- Product Usage: Cap used for intravascular lines.
Medical Devices·107,700 affected·Dec 6, 2018
High RiskFDA
Sage Products Inc
Toothete Oral Care Sodium Bicarbonate Mouthpaste, Net Wt. 1/3 oz/ 9g, included in Independent Care System. The system is an oral care co...
Medical Devices·39 affected·Dec 5, 2018
Medium RiskFDA
Medela Inc
Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100
Medical Devices·665,600 affected·Dec 5, 2018
High RiskFDA
Beckman Coulter Inc.
UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that are re-configured so that the DxI system is separated from t...
Medical Devices·0 affected·Dec 5, 2018
High RiskFDA
Agfa-gevaert, N.v.
DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system u...
Medical Devices·10 affected·Dec 4, 2018
High RiskFDA
Elekta, Inc.
MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage workflows for treatment pla...
Medical Devices·551 affected·Dec 4, 2018
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
BiMobile UHMWPE Liner: ID-28mm/OD-54mm, Reference Number 184-260/04 The LINK BiMobile Dual Mobility System is indicated for patients w...
Medical Devices·31 affected·Dec 4, 2018
High RiskFDA
Philips Medical Systems Nederlands
Ingenia Elition S, Ingenia Elition X
Medical Devices·35 affected·Dec 3, 2018
High RiskFDA
Philips Medical Systems Nederlands
Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2
Medical Devices·229 affected·Nov 30, 2018
High RiskFDA
Ge Healthcare, Llc
System, Tomography Computed Emmission
Medical Devices·526 affected·Nov 30, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Siemens Biograph Horizon PET/CT System, Product Usage: The Siemens Biograph systems are combined X-Ray Computed Tomography (CT) and ...
Medical Devices·171 affected·Nov 30, 2018
High RiskFDA
Omnilife Science Inc.
OMNI K1 Broach Handle, Product Code HS-10054
Medical Devices·7 affected·Nov 29, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
Sensis Vibe System, Model Number 11007642, with software version VD10B.
Medical Devices·1 affected·Nov 29, 2018
High RiskFDA
Icu Medical, Inc.
ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 152 cm (60") Tubing, Disposable Transducer, 03 ml...
Medical Devices·5,000 affected·Nov 27, 2018
High RiskFDA
Medtronic Perfusion Systems
SUCTION / ANTICOAGULATION ASSEMBLY (a) BTC93 (b) BTC98 Suction and Anticoagulation assemblies are indicated for use with an autotran...
Medical Devices·7,587 affected·Nov 27, 2018
High RiskFDA
Icu Medical, Inc.
ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Intraflo ...
Medical Devices·0 affected·Nov 27, 2018
High RiskFDA
Aroa Biosurgery
Endoform Dermal Template 2x2, SKU 529312 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived e...
Medical Devices·8,853 affected·Nov 27, 2018
High RiskFDA
Howmedica Osteonics Corp.
Reliance LITe Nerve Hook Bayoneted, 90, Blunt Tip, REF # 48066103 The blunt probe can be used as a conventional means of achieving ne...
Medical Devices·39 affected·Nov 26, 2018
High RiskFDA
Zimmer Biomet, Inc.
Biomet DVR Crosslock Screws- 2.7mm x 20mm, Sterile ITEM 131827120 Product Usage: The system is intended for stabilization and fixa...
Medical Devices·50 affected·Nov 20, 2018
High RiskFDA
Stryker Medical Division Of Stryker Corporation
Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000
Medical Devices·3,285 affected·Nov 20, 2018
High RiskFDA
Zimmer Biomet, Inc.
Biomet DVR Crosslock Screws- 2.7mm x18mm, Sterile ITEM 131827118 Product Usage: Usage: The system is intended for stabilization an...
Medical Devices·50 affected·Nov 20, 2018
High RiskFDA
Arthrex, Inc.
Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter including suture, with needles.) Part Nu...
Medical Devices·1,308 affected·Nov 19, 2018
CriticalFDA
Invacare Corporation
Invacare 9805 and 9805P Hydraulic Patient Lifts, Model Nos. 9805 and 9805P The intended use of a Non-AC-Powered patient lift is to lif...
Medical Devices·73,703 affected·Nov 16, 2018
High RiskFDA
Livanova Usa Inc
VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly
Medical Devices·643 affected·Nov 16, 2018
High RiskFDA
Livanova Usa Inc
Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The firm name on the label is CYBERONICS, INC., Houston, TX. Vag...
Medical Devices·745 affected·Nov 16, 2018
High RiskFDA
Howmedica Osteonics Corp.
HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE
Medical Devices·0 affected·Nov 15, 2018
High RiskFDA
Covidien Llc
Covidien Emprint Standard Percutaneous Antenna with Thermosphere Technology, CA20L2 intended for use in percutaneous, laparoscopic, and i...
Medical Devices·0 affected·Nov 15, 2018
High RiskFDA
Philips Electronics North America Corporation
Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 4535644...
Medical Devices·651 affected·Nov 15, 2018
High RiskFDA
Covidien Llc
Covidien Emprint Long Percutaneous Antenna with Thermosphere Technology, Material CA30L2 intended for use in percutaneous, laparoscopic, ...
Medical Devices·0 affected·Nov 15, 2018
High RiskFDA
Covidien Llc
Covidien Emprint Short Percutaneous Antenna with Thermosphere Technology, Material CA15L2 intended for use in percutaneous, laparoscopic,...
Medical Devices·0 affected·Nov 15, 2018
High RiskFDA
Prollenium Medical Technologies Inc.
Revanesse Versa, PN40081
Medical Devices·48,457 affected·Nov 15, 2018
High RiskFDA
Vital Scientific N.v.
V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180
Medical Devices·732 affected·Nov 15, 2018
High RiskFDA
Swissray Medical Ag
ddRCombi Plus FP, Model Number 8.2000.0070.0 (US Version), 8.2000.0060.0 (Europe Version) The ddRCombi Plus FP is a fully digital, mul...
Medical Devices·3 affected·Nov 14, 2018
High RiskFDA
In2bones Usa, Llc
NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010
Medical Devices·30 affected·Nov 14, 2018