Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Circulatory Technology Inc
The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 A device that isolates pressure tranducers from blo...
Medical Devices·20 affected·Jul 1, 2016
RecallFDA
Circulatory Technology Inc
The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the extracorporeal circuit and provide co...
Medical Devices·958 affected·Jul 1, 2016
High RiskFDA
Integra Lifesciences Corp.
Integra External Fixation System Rocker Bottom Model # 12225400. For use in the treatment of bone conditions amenable to treatment by ...
Medical Devices·27 affected·Jul 1, 2016
High RiskFDA
Nidek Inc
OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The OPTICAL BIOMETER AL-Scan is a measuring device that can ...
Medical Devices·17 affected·Jul 1, 2016
High RiskFDA
Vision Rt Ltd
TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to pr...
Medical Devices·47 affected·Jun 30, 2016
High RiskFDA
Stryker Howmedica Osteonics Corp.
Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of the first femoral nailing systems to offer an option for eit...
Medical Devices·1 affected·Jun 30, 2016
High RiskFDA
Vision Rt Ltd
AlignRT¿ Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to th...
Medical Devices·47 affected·Jun 30, 2016
High RiskFDA
Zimmer Biomet Spine, Inc
Zyston¿ Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.
Medical Devices·5 affected·Jun 30, 2016
High RiskFDA
Arjohuntleigh Polska Sp. Z.o.o.
ArjoHuntleigh Sara Combilizer; Intended to facilitate early immobilization, rehabilitation, and care of patients.
Medical Devices·106 affected·Jun 29, 2016
High RiskFDA
Winco Mfg., Llc
TransMotion Medical, TMM3 Series Video-Fluoroscopy Swallow Study Stretcher-Chair. Intended use is to provide the caregiver a single pl...
Medical Devices·264 affected·Jun 29, 2016
High RiskFDA
Winco Mfg., Llc
TransMotion Medical, TMM4 Series Multi-Purpose Treatment Chair. Intended use is to provide the caregiver a single platform for receivi...
Medical Devices·264 affected·Jun 29, 2016
High RiskFDA
Chg Hospital Beds Inc
Spirit Plus Bed, A-C Powered Hospital Bed
Medical Devices·4,308 affected·Jun 28, 2016
High RiskFDA
Medtronic Xomed, Inc.
NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually packaged.
Medical Devices·3,752 affected·Jun 28, 2016
High RiskFDA
Synthes (usa) Products Llc
Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with St...
Medical Devices·41 affected·Jun 28, 2016
High RiskFDA
Conmed Corporation
CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8190 The CORE Trumpe...
Medical Devices·0 affected·Jun 27, 2016
High RiskFDA
Conmed Corporation
CORE¿ Suction Irrigation Handpiece without Probe for Single Solution Bags, Catalog Number CD8300 The CORE Trumpet (CD81XX, CD83XX, and C...
Medical Devices·0 affected·Jun 27, 2016
High RiskFDA
Conmed Corporation
CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution Bags, Catalog Number CD8185 The CORE Trumpet (CD81XX...
Medical Devices·0 affected·Jun 27, 2016
High RiskFDA
Conmed Corporation
CORE¿ Trumpet Handpiece only, Catalog Number CD8450 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological lapa...
Medical Devices·0 affected·Jun 27, 2016
High RiskFDA
Conmed Corporation
CORE¿ Suction Irrigation Handpiece without Probe for Single Solution or Dual Bags, Catalog Number CD8302 The CORE Trumpet (CD81XX, CD83X...
Medical Devices·0 affected·Jun 27, 2016
High RiskFDA
Cardinal Health
The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas, Electrolyte and Metabolite Analysis.
Medical Devices·884,993 affected·Jun 27, 2016
High RiskFDA
Danville Materials, Inc.
Perioscopy Sheath: Part number: 1008; The Perioscopy Sheath is a single-use sterile component used with the Perioscopy System, wh...
Medical Devices·2,123 affected·Jun 24, 2016
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
2.3MM Tapered Router, Product Number 5407-FA2-023 A router is a cutting accessory used in the following medical applications: Neuro; Sp...
Medical Devices·3,163 affected·Jun 24, 2016
CriticalFDA
Baxter Healthcare Corp.
Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106N, 0.8 cm x 8...
Medical Devices·32,763 affected·Jun 24, 2016
High RiskFDA
Perkinelmer, Inc
Perkin Elmer RoboRack 25ul, Clear, Non-Conductive, Filter Tips, Pre-sterilized Item Number: 6000689. Supplied for use with JANUS Auto...
Medical Devices·595 affected·Jun 24, 2016
CriticalFDA
The Anspach Effort, Inc.
Light Adaptor for Small Battery Drive and Small Battery Drive II.
Medical Devices·1,833 affected·Jun 24, 2016
CriticalFDA
The Anspach Effort, Inc.
Adaptor for Small Battery Drive and Small Battery Drive II. Product Usage: The Light Adaptor for Small Battery Drive (SBD) /Small Bat...
Medical Devices·1,833 affected·Jun 24, 2016
High RiskFDA
Becton, Dickinson And Company, Bd Biosciences
BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount tubes are used for determining absolute counts of leucocytes in...
Medical Devices·328 affected·Jun 24, 2016
High RiskFDA
The Metrix Company
AUTOCOMP6 XPS High Speed Compounder REF 58810
Medical Devices·16 affected·Jun 23, 2016
High RiskFDA
The Metrix Company
AUTOCOMP6 High Speed Compounder
Medical Devices·323 affected·Jun 23, 2016
High RiskFDA
The Metrix Company
AUTOCOMP6 XP High Speed Compounder REF 58810
Medical Devices·93 affected·Jun 23, 2016
High RiskFDA
The Metrix Company
Container fill and transfer sets, automatic fill compatible, 250 mL, 500 mL, 1000 mL, 1500 mL, 2000 mL, 3000 mL, or 4000 mL.
Medical Devices·18,366 affected·Jun 23, 2016
High RiskFDA
Varian Medical Systems, Inc.
Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on Varian's TrueBeam EDGE; Radiology: The AlignRT Plus syst...
Medical Devices·166 affected·Jun 23, 2016
High RiskFDA
Olympus Corporation Of The Americas
OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector
Medical Devices·2 affected·Jun 23, 2016
High RiskFDA
Varian Medical Systems, Inc.
Optical Surface Monitoring System{Align RT Plus} This is used on Varian's TrueBeam EDGE; Radiology: The AlignRT Plus system is indicat...
Medical Devices·21 affected·Jun 23, 2016
High RiskFDA
Philips Medical Systems Nederlands
Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 72...
Medical Devices·42 affected·Jun 23, 2016
High RiskFDA
The Metrix Company
Container fill and transfer sets, 250 mL, 500 mL, 1000 mL, 2000 mL, 3000 mL, or 4000 mL.
Medical Devices·137,598 affected·Jun 23, 2016
High RiskFDA
The Metrix Company
Dual Chamber Container fill with gravity/attached transfer sets, 250 mL / 1250 mL, 300 mL / 1700 mL, 500 mL / 2500 mL, 500 mL / 3500 mL
Medical Devices·18,474 affected·Jun 23, 2016
RecallFDA
Alere San Diego, Inc.
Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92404. Mononucleosis Rapid Test Device a simple test that uti...
Medical Devices·0 affected·Jun 22, 2016
High RiskFDA
Draeger Medical, Inc.
Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog # FR00105 (Babytherm 8010), 2M30404 (Babytherm 8004), non ste...
Medical Devices·1,599 affected·Jun 22, 2016
High RiskFDA
Lemaitre Vascular, Inc.
AnastoClip AC 8cm 35 Clips (1 Each} Large REF # 4000-07 The Anastoclip Clip applier consists of a rotating shaft and an integral car...
Medical Devices·471 affected·Jun 22, 2016
RecallFDA
Alere San Diego, Inc.
Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple test that utilizes an extract of bovine erythrocytes to qual...
Medical Devices·0 affected·Jun 22, 2016
RecallFDA
Alere San Diego, Inc.
Cardinal Health Mono Rapid Test, Catalog No. B1077-28, a simple test that utilizes an extract of bovine erythrocytes to qualitatively a...
Medical Devices·0 affected·Jun 22, 2016
High RiskFDA
Stanley Security Solutions Inc
Arial Wireless Water-Resistant Call Pendant The Arial Pendant tag is part of the Arial wireless emergency call management system. It en...
Medical Devices·500 affected·Jun 22, 2016
High RiskFDA
Olympus Scientific Solutions Americas
Olympus Scientific Solutions Americas Corporation (OSSA) Model: Analytical X-Ray System X -Ray Fluorescence. Intended to emit ioniz...
Medical Devices·2 affected·Jun 22, 2016
High RiskFDA
Lemaitre Vascular, Inc.
AnastoCiip Universal Clip Remover (6 Pack} REF# 4001-00 The Anastoclip Clip applier consists of a rotating shaft and an integral ca...
Medical Devices·40 affected·Jun 22, 2016
RecallFDA
Alere San Diego, Inc.
Signify Mono (Whole Blood, Serum, Plasma), Catalog No. 01P52-25 a simple test that utilizes an extract of bovine erythrocytes to qualit...
Medical Devices·0 affected·Jun 22, 2016
High RiskFDA
Lemaitre Vascular, Inc.
Anastoclip AC 8cm 35 Clips (1 Each} Medium REF # 4000-06 The Anastoclip Clip applier consists of a rotating shaft and an integral car...
Medical Devices·256 affected·Jun 22, 2016
CriticalFDA
Microport Orthopedics Inc.
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA41, SIZE 4+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE ...
Medical Devices·77 affected·Jun 21, 2016