Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Lymol Medical Corporation
LYMOL Medical Elite X Class Rigid Bronchoscope System, Part No. BD2410, BB2701, BB2702, BB2401, BB2402, BA2700, BT2000, BT2101, BT2103, B...
Medical Devices·309 affected·Jul 29, 2021
High RiskFDA
Hitachi Healthcare Americas Corporation
ECHELON MRI System
Medical Devices·472 affected·Jul 29, 2021
High RiskFDA
Hitachi Healthcare Americas Corporation
ECHELON Oval MRI System
Medical Devices·472 affected·Jul 29, 2021
High RiskFDA
Corin Ltd
Corin Unity Knee CS Insert, Size 5 / 9.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125182, Sterile, and Corin Unity Knee CS Insert, Si...
Medical Devices·2 affected·Jul 28, 2021
High RiskFDA
Corin Ltd
Corin BIOLOX Delta Mod Head, diameter 28mm Medium 0mm, 12/14 Taper, REF 104.2805, Sterile, a component of the Trinity Acetabular System.
Medical Devices·4 affected·Jul 28, 2021
High RiskFDA
Corin Ltd
Corin MetaFix Hip Stem, Size 1, Short Neck, 135 degrees, Collared Hip Stem, REF 579.0201, Sterile.
Medical Devices·2 affected·Jul 28, 2021
High RiskFDA
Corin Ltd
Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile.
Medical Devices·5 affected·Jul 28, 2021
High RiskFDA
Corin Ltd
Corin Unity Knee Patella, Size 3 / 8.5mm, Centered Dome 3 PEG-UHMWPE, REF 112.018.06, Sterile, a component of the Unity Total Knee System.
Medical Devices·1 affected·Jul 28, 2021
High RiskFDA
Corin Ltd
Corin Unity Knee Augments, Size 5, 6 & 7 / 10mm Thick, Femoral Posterior Augment, REF 1122370, Sterile, a component of the Unity Total Kn...
Medical Devices·1 affected·Jul 28, 2021
High RiskFDA
Versea Diagnostics Llc
FaStep COVID-19 IgG/IgM Rapid Test Device Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human ven...
Medical Devices·563,290 affected·Jul 27, 2021
High RiskFDA
Clarus Medical, Llc
Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002
Medical Devices·858 affected·Jul 27, 2021
High RiskFDA
Philips Respironics, Inc.
Trilogy Evo Universal, Product number DS2000X11B
Medical Devices·10,000 affected·Jul 26, 2021
High RiskFDA
Philips Respironics, Inc.
Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15...
Medical Devices·101 affected·Jul 26, 2021
High RiskFDA
Aspen Surgical Products, Inc.
Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400
Medical Devices·124 affected·Jul 23, 2021
High RiskFDA
Boston Scientific Corporation
TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)
Medical Devices·4,980 affected·Jul 23, 2021
High RiskFDA
Biomimetic Therapeutics, Llc
AUGMENT Injectable Kit, 3cc, Model K30003010, Lot 1706343
Medical Devices·499 affected·Jul 23, 2021
High RiskFDA
Merge Healthcare, Inc.
Merge Hemo, Software packages 10.2, 10.3, and 10.4
Medical Devices·326 affected·Jul 23, 2021
High RiskFDA
Baxter Healthcare Corporation
Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management an...
Medical Devices·1,976 affected·Jul 22, 2021
High RiskFDA
Baxter Healthcare Corporation
Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c) 107144 (TPE2000 SET) d) 115307 (M 150 S...
Medical Devices·64,275 affected·Jul 22, 2021
High RiskFDA
Implant Resource Inc
MPR Slotted Mallet, labeling etched onto devices as follows: Medical Products Resource 800.524.5194 www.m-p-r.com MPR-1120-1000 (...
Medical Devices·6 affected·Jul 21, 2021
High RiskFDA
Merit Medical Systems, Inc.
MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018" (0.46 mm), STERILE EO, Sing...
Medical Devices·373 affected·Jul 21, 2021
High RiskFDA
Angiodynamics, Inc.
Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US
Medical Devices·26 affected·Jul 20, 2021
CriticalFDA
Belmont Instrument Corporation
CritiCool, thermoregulation device
Medical Devices·158 affected·Jul 20, 2021
CriticalFDA
Ethicon Endo-surgery Inc
HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desi...
Medical Devices·68,960 affected·Jul 20, 2021
High RiskFDA
Angiodynamics, Inc.
Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USD
Medical Devices·16 affected·Jul 20, 2021
CriticalFDA
Welch Allyn Inc
Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human body temperature for patients having ages r...
Medical Devices·1,036,740 affected·Jul 20, 2021
High RiskFDA
Teleflex Medical Europe Ltd
RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 ...
Medical Devices·32,410 affected·Jul 16, 2021
High RiskFDA
Teleflex Medical Europe Ltd
RUSCH Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF numbers: a) 112082050 b) 112082055 c) 112082060 ...
Medical Devices·638,220 affected·Jul 16, 2021
High RiskFDA
Beckman Coulter Inc.
Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory inf...
Medical Devices·180 affected·Jul 15, 2021
High RiskFDA
Philips North America
(1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359)
Medical Devices·56 affected·Jul 15, 2021
High RiskFDA
Pentax Of America Inc
Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10; Gastroscope Fam...
Medical Devices·28,849 affected·Jul 14, 2021
High RiskFDA
Pentax Of America Inc
Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3...
Medical Devices·28,849 affected·Jul 14, 2021
High RiskFDA
Maquet Medical Systems Usa
Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchange...
Medical Devices·33 affected·Jul 14, 2021
High RiskFDA
Smith & Nephew Orthopaedics Ltd. (aurora)
smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.
Medical Devices·47 affected·Jul 14, 2021
CriticalFDA
Micro Therapeutics Inc,
EV3 Pipeline Flex Embolization Device with Flex Shield Technology
Medical Devices·16,169 affected·Jul 13, 2021
High RiskFDA
Ortho8, Inc.
CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, Not Sterile IP22, ...
Medical Devices·0 affected·Jul 9, 2021
High RiskFDA
Medtronic Neuromodulation
Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
Medical Devices·1,131 affected·Jul 9, 2021
High RiskFDA
Argon Medical Devices, Inc
Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture tool (0.040 Stylet o...
Medical Devices·20 affected·Jul 8, 2021
High RiskFDA
Sunrise Medical (us) Llc
Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assisting a disabled pers...
Medical Devices·9,865 affected·Jul 8, 2021
CriticalFDA
Baxter Healthcare Corporation
Dose IQ Safety Software used with Spectrum IQ Infusion Pump
Medical Devices·61 affected·Jul 7, 2021
High RiskFDA
Medline Industries Inc
Medline Arthroscopy Kit, convenience kit, REF DYNJ904304B, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
Medical Devices·286 affected·Jul 1, 2021
RecallFDA
Verathon, Inc.
GlideScope Go Monitors
Medical Devices·8,569 affected·Jul 1, 2021
High RiskFDA
Beckman Coulter Inc.
ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 mL QC2, 1 QC VALUE CARD, IVD, Rx Only, UDI: (01)15099590742737;
Medical Devices·544 affected·Jul 1, 2021
High RiskFDA
Beckman Coulter Inc.
ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only, UDI: (01)15099590743017
Medical Devices·3,672 affected·Jul 1, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
Medical Devices·7 affected·Jul 1, 2021
High RiskFDA
Medline Industries Inc
Medline Knee Arthroscopy Kit, convenience kit, REF DYNJ902838C, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01...
Medical Devices·286 affected·Jul 1, 2021
High RiskFDA
Beckman Coulter Inc.
ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713;
Medical Devices·3,672 affected·Jul 1, 2021
High RiskFDA
Ge Healthcare, Llc
Revolution Apex, Revolution CT with Apex Edition
Medical Devices·273 affected·Jun 30, 2021