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15,654 recalls
High RiskFDA
Biomet, Inc.
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 70 MM Item Number: 11-301331
Medical Devices·0 affected·Jun 2, 2021
High RiskFDA
Biomet, Inc.
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 60 MM Item Number: 11-301311
Medical Devices·22 affected·Jun 2, 2021
High RiskFDA
Biomet, Inc.
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size B, 60 MM Item Number: 11-301312
Medical Devices·33 affected·Jun 2, 2021
High RiskFDA
Biomet, Inc.
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 70 MM Item Number: 11-301335
Medical Devices·0 affected·Jun 2, 2021
High RiskFDA
Biomet, Inc.
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 50 MM Item Number: 11-301310
Medical Devices·81 affected·Jun 2, 2021
High RiskFDA
Biomet, Inc.
Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 80 MM Item Number: 11-301342
Medical Devices·12 affected·Jun 2, 2021
High RiskFDA
Biomet, Inc.
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size C, 70 MM Item Number: 11-301333
Medical Devices·12 affected·Jun 2, 2021
High RiskFDA
Biomet, Inc.
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 60 MM Item Number: 11-301315
Medical Devices·7 affected·Jun 2, 2021
High RiskFDA
Ossur Americas
OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobilization to the cervical spine. REF: MJS-101; MJSR-101
Medical Devices·10,469 affected·Jun 1, 2021
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Medtronic Reveal LINQ LNQ11 / PA96000
Medical Devices·666,210 affected·Jun 1, 2021
High RiskFDA
Covidien, Lp
Palindrome RT Repair Kit 15 FR TAL 55cm, Sterile, Item Code 8888541155
Medical Devices·0 affected·May 28, 2021
High RiskFDA
Covidien, Lp
Palindrome RT Repair Kit 15 FR TAL 44cm, Sterile, Item Code 8888541144
Medical Devices·0 affected·May 28, 2021
High RiskFDA
Covidien, Lp
Palindrome RT Repair Kit 15 FR TAL 33cm, Sterile, Item Code 8888541133
Medical Devices·0 affected·May 28, 2021
High RiskFDA
Covidien, Lp
Palindrome RT Repair Kit 15 FR TAL 23cm, Sterile, Item Code 8888541123
Medical Devices·0 affected·May 28, 2021
High RiskFDA
Covidien, Lp
Palindrome RT Repair Kit 15 FR TAL 19cm, Sterile, Item Code 8888541119
Medical Devices·0 affected·May 28, 2021
High RiskFDA
Southwest Technologies Inc
Stimulen Collagen Moisturizing Lotion, ST9555B
Medical Devices·2,016 affected·May 28, 2021
High RiskFDA
Cell Marque Corporation
Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, IVD, CE, GTIN: 00841683104513
Medical Devices·2 affected·May 27, 2021
RecallFDA
Mindray Ds Usa, Inc. Dba Mindray North America
3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115-047566-00 /115-060044-00) and TM80 Te...
Medical Devices·804 affected·May 27, 2021
High RiskFDA
Stryker Gmbh
Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-13 (SPI Elast. Sleeve 8-13), Catalog Number 18061407S
Medical Devices·52 affected·May 27, 2021
High RiskFDA
Edwards Lifesciences, Llc
Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using et...
Medical Devices·290 affected·May 26, 2021
High RiskFDA
Ion Beam Applications S.a.
Proteus 235-Proton Therapy System
Medical Devices·5 affected·May 26, 2021
High RiskFDA
Edwards Lifesciences, Llc
Edwards TruWave 3 cc/VAMP Jr Kit, REF: VMP426PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)57460691950547
Medical Devices·50 affected·May 26, 2021
High RiskFDA
Edwards Lifesciences, Llc
Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691944782
Medical Devices·1,679 affected·May 26, 2021
High RiskFDA
Medline Industries Inc
Cotton Rounds/Pads under the following brand names: 1. BEAUTY 360 Extra Large Premium Cotton Ovals - two textures soft and strong 100 c...
Medical Devices·214,035 affected·May 25, 2021
High RiskFDA
Remote Diagnostic Technologies Ltd.
Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Part No. - 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. Produ...
Medical Devices·510 affected·May 25, 2021
High RiskFDA
Sunstar Americas, Inc.
SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by...
Medical Devices·124,064 affected·May 21, 2021
High RiskFDA
Ge Healthcare, Llc
CARESCAPE PDM-Masimo SpO2. Physiological data monitor.
Medical Devices·111,728 affected·May 21, 2021
CriticalFDA
Vero Biotech, Llc
GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860
Medical Devices·465 affected·May 19, 2021
High RiskFDA
Coopervision Inc.
SPECSAVERS UMERE TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blocker
Medical Devices·60 affected·May 19, 2021
High RiskFDA
Coopervision Inc.
AQUATECH PLUS 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker
Medical Devices·720 affected·May 19, 2021
High RiskFDA
Coopervision Inc.
FRESH DAY 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blocker
Medical Devices·180 affected·May 19, 2021
High RiskFDA
Coopervision Inc.
CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
Medical Devices·450 affected·May 19, 2021
High RiskFDA
Coopervision Inc.
CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
Medical Devices·90 affected·May 19, 2021
High RiskFDA
Coopervision Inc.
CLARITI 1 DAY TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blocker
Medical Devices·1,260 affected·May 19, 2021
High RiskFDA
Caption Health
Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873), UDI: (01)008600...
Medical Devices·15 affected·May 19, 2021
High RiskFDA
Stryker Spine
Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962
Medical Devices·559 affected·May 18, 2021
High RiskFDA
Adria Srl
Herniatome, 17G x 15cm, Lumbar Type, Model Number 5091745
Medical Devices·0 affected·May 17, 2021
High RiskFDA
Adria Srl
Herniatome, 17G x 9cm, Cervical Type, Model Number 5091749
Medical Devices·0 affected·May 17, 2021
CriticalFDA
Deroyal Industries Inc
DeRoyal Angio Cath Removal Tray, REF 89-9936.02
Medical Devices·60 affected·May 14, 2021
High RiskFDA
Brainlab Ag
ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients ...
Medical Devices·22 affected·May 14, 2021
High RiskFDA
Stryker Medical Division Of Stryker Corporation
Prime Fifth Wheel Stretcher-stretcher may be used for minor procedures and short-term stay (treatment and recovery, Model 1105, Part Numb...
Medical Devices·3 affected·May 12, 2021
High RiskFDA
Cardioquip, Llc
CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103
Medical Devices·1,478 affected·May 12, 2021
High RiskFDA
Stryker Medical Division Of Stryker Corporation
Proform- support surface is used to assist in the prevention and treatment of all categories/stages of pressure ulcers, Model Number: 271...
Medical Devices·1 affected·May 12, 2021
High RiskFDA
Stryker Medical Division Of Stryker Corporation
Prime Big Wheel Stretcher-used as a short-term outpatient clinical evaluation, treatment, minor procedure, and short-term outpatient reco...
Medical Devices·1 affected·May 12, 2021
High RiskFDA
Stryker Medical Division Of Stryker Corporation
S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number: 30...
Medical Devices·4 affected·May 12, 2021
High RiskFDA
Stryker Medical Division Of Stryker Corporation
Michael Graves with Stryker Highback Chair-intended for pediatric and adult person guest and patient seating use in an indoor medical set...
Medical Devices·1 affected·May 12, 2021
High RiskFDA
W L Gore & Associates, Inc.
Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile EO, for the following Referen...
Medical Devices·0 affected·May 12, 2021
High RiskFDA
Stryker Medical Division Of Stryker Corporation
InTouch 2131-intended to support a human patient in an acute care setting, Model Number: 2131000000, Part #1460000000¿¿¿¿¿¿¿
Medical Devices·2 affected·May 12, 2021