Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 222 of 548
FDA Devices Moderate Apr 15, 2020
aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00
AAP Implantate Ag
FDA Devices Moderate Apr 15, 2020
BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.
Biomet, Inc.
FDA Devices Moderate Apr 15, 2020
GEM Microvascular Anastomotic Coupler Devices s intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical pr…
Baxter Healthcare Corporation
FDA Devices Moderate Apr 15, 2020
Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI: 15099590659561 - Product Usage: The Prompt Inoculation System-D…
Beckman Coulter Inc.
FDA Devices Moderate Apr 15, 2020
BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.
Biomet, Inc.
FDA Devices Moderate Apr 15, 2020
Thermage Face Tip 3.0, REF/UDI: TTNS3,00C3-400/UDI (01)000850608002377; REF TTNS3.00C3-600/UDI (01)000850608002384; REF TTNS3.00C3-900; UDI (01)00085…
Solta Medical Inc
FDA Devices Moderate Apr 15, 2020
BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.
Biomet, Inc.
FDA Devices Moderate Apr 15, 2020
Microbiologics QC SETS AND PANELS, YST Comprehensive QC Set, REF 5195P, containing Trichosporon dermatis, ATCC 204094, QR Code: (01)70845357030770, (…
Microbiologics Inc
FDA Devices Moderate Apr 15, 2020
BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182.
Biomet, Inc.
FDA Devices Moderate Apr 15, 2020
BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183.
Biomet, Inc.
FDA Devices Moderate Apr 15, 2020
BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412.
Biomet, Inc.
FDA Devices Moderate Apr 15, 2020
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM, Silicone, Sterile, Item 431194.
Biomet, Inc.
FDA Devices Moderate Apr 15, 2020
The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement of SHBG is a chemiluminescent immunoassay intended for th…
Qualigen Inc
FDA Devices Moderate Apr 15, 2020
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209.
Biomet, Inc.
FDA Devices Moderate Apr 15, 2020
ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu…
Radiometer Medical ApS
CPSC Moderate Apr 9, 2020
Pass & Seymour Recalls Commercial-Grade Electrical Receptacles Due to Burn Hazard
FDA Devices Critical Apr 8, 2020
LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The LeMaitre Over the Wire Embolectomy Cathe…
LeMaitre Vascular, Inc.
FDA Devices Moderate Apr 8, 2020
8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI: (01)00812926022345(17)231225 (10)TSL007202
Trilliant Surgical, LLC
FDA Devices Moderate Apr 8, 2020
Gentell Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is ind…
Gentell, Inc
FDA Devices Moderate Apr 8, 2020
Philips V60 Ventilators with Power Management PCBA part number 1055906
Respironics California, LLC
FDA Devices Moderate Apr 8, 2020
Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
Maquet Cardiovascular Us Sales, Llc
FDA Devices Moderate Apr 8, 2020
Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Tiger Cannulated Screw System, Model 210-00-001;…
Trilliant Surgical, LLC
FDA Devices Moderate Apr 8, 2020
Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a segmentation measurement tool REF/Model: 850-20003 Soft…
Butterfly Network, Inc.
FDA Devices Moderate Apr 8, 2020
Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Gridlock Plating System, Model 310-01-100. The firm…
Trilliant Surgical, LLC
FDA Devices Moderate Apr 8, 2020
Expression MR400 MRI Patient Monitoring System Model Number: 866185 Software version number: 01.03.00, 01.04.00, 01.05.00, and 01.07.00 - Product …
Philips North America, LLC
FDA Devices Moderate Apr 8, 2020
Gentell Hydrogel Ag 4oz. Tube, model no. - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Silver Antimicrobial Wound…
Gentell, Inc
FDA Devices Moderate Apr 8, 2020
Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, D…
Karl Storz Endoscopy
FDA Devices Moderate Apr 8, 2020
LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 3011790-XXX/, U3011790-XXX - Product Usage: The LIFEPAK 500 A…
Physio-Control, Inc.
FDA Devices Moderate Apr 8, 2020
Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Disco Subtalar Implant System, Model 112-00-001. Th…
Trilliant Surgical, LLC
FDA Devices Moderate Apr 8, 2020
NAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissue Protector is a reusable instrument designed to, when used as instructe…
Smith & Nephew, Inc.
FDA Devices Moderate Apr 8, 2020
natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph
Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
FDA Devices Moderate Apr 8, 2020
Gentell Hydrogel Ag 2x2, model no GEN-11220 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indi…
Gentell, Inc
FDA Devices Moderate Apr 8, 2020
Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC-11129-115, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: St…
Stryker Neurovascular
FDA Devices Moderate Apr 8, 2020
BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm, Sterile EO, Rx only, Mfr. Bard Peripheral Vascular, Inc., Ref W04200, …
Bard Peripheral Vascular Inc
FDA Devices Moderate Apr 8, 2020
Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated for primary, fracture, or revision total shoulder repla…
Biomet, Inc.
FDA Devices Moderate Apr 8, 2020
Instructions for Use and Surgical Cleaning Sterilization Protocol for Trilliant Surgical Ltd Twist Sublatar Implant System, Model 112-00-001. The fi…
Trilliant Surgical, LLC
FDA Devices Moderate Apr 8, 2020
Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Ltd Tiger Large Cannulated Screw System, Model 2…
Trilliant Surgical, LLC
FDA Devices Moderate Apr 8, 2020
Merits E604 Pilot Navigator Stairlift - Product Usage: To transport patients up stairs.
Merits Holdings Co. dba Merits Health Products, Inc.
FDA Devices Moderate Apr 8, 2020
Stryker Neurovascular, AXS Vecta 74 Aspiration Catheter, Ref. Catalog No. INC-11597-115, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: St…
Stryker Neurovascular
FDA Devices Moderate Apr 8, 2020
Butterfly iQ Ultrasound System containing the Auto EF(Ejection Fraction) Tool REF/Model: 850-20003 UDI: (01)00866646000206 Software versions 1.10.…
Butterfly Network, Inc.
FDA Devices Moderate Apr 8, 2020
Gentell Hydrogel Ag 4x8, model no. GEN-11820 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is ind…
Gentell, Inc
FDA Devices Moderate Apr 8, 2020
TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0 and 4.1.1. Intended: For in vitro coagulation studies
Haemonetics Corporation
FDA Devices Moderate Apr 1, 2020
Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
Medtronic MiniMed
FDA Devices Moderate Apr 1, 2020
Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
Medtronic MiniMed
FDA Devices Moderate Apr 1, 2020
Precision Xtra Blood Glucose & Ketone Monitoring System, UDI: 00093815715023, 00093815988144
Abbott Diabetes Care, Inc.
FDA Devices Critical Apr 1, 2020
Imager II 5F Angiographic Catheters, 5 units per package.
Boston Scientific Corporation
FDA Devices Critical Apr 1, 2020
ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
Micro Therapeutics Inc, Dba Ev3 Neurovascular
FDA Devices Moderate Apr 1, 2020
Dexcom G6 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicate…
Dexcom Inc
FDA Devices Moderate Apr 1, 2020
Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max. screen size Part number 3FCM1
Skytron, Div. The KMW Group, Inc
FDA Devices Moderate Apr 1, 2020
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Techn…
Capintec Inc