Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Fresenius Medical Care Renal Therapies Group, Llc
Fresenius 2008K2 Series : Hemodialysis System
Medical Devices·60,151 affected·Dec 21, 2016
High RiskFDA
Fresenius Medical Care Renal Therapies Group, Llc
Fresenius 2008T Series Hemodialysis System
Medical Devices·65,361 affected·Dec 21, 2016
RecallFDA
Beckman Coulter Inc.
AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1250, ODL25250 AutoMate 2500, ODL25255 Automate 2550. Auto...
Medical Devices·4 affected·Dec 21, 2016
High RiskFDA
Agfa Healthcare Corp.
Agfa Healthcare NX 3.0.8950 Imaging Processing Software
Medical Devices·221 affected·Dec 21, 2016
CriticalFDA
Zimmer Biomet, Inc.
Comprehensive Reverse Shoulder System Humeral Tray Model 115340
Medical Devices·4,388 affected·Dec 20, 2016
High RiskFDA
Becton Dickinson & Company
Eclipse Hypodermic Needle
Medical Devices·263 affected·Dec 20, 2016
High RiskFDA
Beckman Coulter Inc.
DxH 600 Coulter Cellular Analysis System, Catalog No. B23858
Medical Devices·1,282 affected·Dec 19, 2016
High RiskFDA
In2bones, Sas
SCREW 02.7-12MM LOCKING, REF W27 ST112: a) DRP, b) NEO, In2Bones, 28 chemin du petit bois, 69130 Ecully - France The NEOVIEW¿ Plating ...
Medical Devices·19 affected·Dec 19, 2016
High RiskFDA
In2bones, Sas
NEO SCREW 02.7-14MM LOCKING, REF W27 ST114, In2Bones, 28 chemin du petit bois, 69130 Ecully - France The NEOVIEW¿ Plating System is int...
Medical Devices·40 affected·Dec 19, 2016
High RiskFDA
Zimmer Biomet, Inc.
RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall +3mm Liners Size 23 item XL-108323 ArComXL MaxRom +3mm Liners ...
Medical Devices·36 affected·Dec 19, 2016
High RiskFDA
In2bones, Sas
NEOVIEW(R) SCREWS SET, REF W27 ST900, STERILE R The NEOVIEW¿ Plating System is intended for fixation of intra-articular and extraarticu...
Medical Devices·26 affected·Dec 19, 2016
High RiskFDA
Zimmer Biomet, Inc.
Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComXL Bearings item XL-200152
Medical Devices·19 affected·Dec 19, 2016
High RiskFDA
Beckman Coulter Inc.
UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B68304
Medical Devices·4,657 affected·Dec 19, 2016
High RiskFDA
Baxter Healthcare Corporation
APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in the treatment of patients with renal failure to provide PD...
Medical Devices·8,640 affected·Dec 16, 2016
High RiskFDA
Biomerieux Sa
ETEST Doripenem DOR32 FOAM packaging, Product Name: Etest Doripenem DOR 0.002-32. ETEST is a quantitative technique for determining the...
Medical Devices·0 affected·Dec 15, 2016
High RiskFDA
Biomerieux Sa
ETEST Ceftriaxone TXL32 FOAM packaging, Product Name: ETEST Ceftriaxone TX 0.002-32(low). ETEST is a quantitative technique for determin...
Medical Devices·0 affected·Dec 15, 2016
High RiskFDA
Zimmer Biomet, Inc.
Vanguard Total Knee, PUNCH THRU TRL PLATES, 63 MM Item No: 32-487261, 67 MM Item No: 32-487262, 71 MM Item No: 32-487263, 75 MM Item No: ...
Medical Devices·26 affected·Dec 15, 2016
High RiskFDA
Biomerieux Sa
ETEST Vancomycin VA 256 FOAM packaging, Product Name: ETEST Vancomycin VA 0.016-256. ETEST is a quantitative technique for determining t...
Medical Devices·0 affected·Dec 15, 2016
High RiskFDA
Infraredx, Inc.
TVC Imaging System model TVC-MC9 , for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiog...
Medical Devices·7 affected·Dec 15, 2016
High RiskFDA
Biomerieux Sa
ETEST Ceftazidime TZ256 Foam packaging, Product Name: ETEST Ceftazidime TZ 0.016-256. ETEST is a quantitative technique for determining ...
Medical Devices·0 affected·Dec 15, 2016
High RiskFDA
Biomerieux Sa
ETEST Gentamicin GM256 FOAM packaging, Product Name: ETEST Gentamicin GM 0.016-256(low). ETEST is a quantitative technique for determini...
Medical Devices·0 affected·Dec 15, 2016
High RiskFDA
Biomerieux Sa
Ciprofloxacin CI 32 Foam packaging, Product Name: ETEST Ciprofloxacin CI 0.002-32. ETEST is a quantitative technique for determining the...
Medical Devices·0 affected·Dec 15, 2016
High RiskFDA
Biomerieux Sa
ETEST Cephalotin CE 256 Foam packaging, Product Name: ETEST Cephalothin CE 0.016-256. ETEST is a quantitative technique for determining ...
Medical Devices·0 affected·Dec 15, 2016
High RiskFDA
Organ Recovery Systems, Inc.
SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143
Medical Devices·4,806 affected·Dec 14, 2016
High RiskFDA
Medline Industries Inc
14 mm Distraction Pin, Exagg Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction P...
Medical Devices·1,031 affected·Dec 14, 2016
High RiskFDA
Medline Industries Inc
16 mm Distraction Pin, Titanium, Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distracti...
Medical Devices·198 affected·Dec 14, 2016
High RiskFDA
Medline Industries Inc
12 mm Distraction Pin, Blunt Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction P...
Medical Devices·300 affected·Dec 14, 2016
High RiskFDA
Medline Industries Inc
16 mm [or 18 mm] Distraction Pin, Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distract...
Medical Devices·2,112 affected·Dec 14, 2016
High RiskFDA
Ion Beam Applications S.a.
Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 is a medical device designed to produce and...
Medical Devices·6 affected·Dec 13, 2016
High RiskFDA
Medtronic Navigation, Inc.
AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG tray sealed with a Tyvek lid and then placed in a shelf car...
Medical Devices·111 affected·Dec 12, 2016
High RiskFDA
Olympus Corporation Of The Americas
Uretero-reno videoscope URF-V2 and URF-V2R endoscope and accessories The URF-V2/V2R endoscopes are intended for use in endoscopic diag...
Medical Devices·1,627 affected·Dec 12, 2016
High RiskFDA
Olympus Corporation Of The Americas
URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope
Medical Devices·3,461 affected·Dec 12, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalm...
Medical Devices·182 affected·Dec 9, 2016
High RiskFDA
Philips Electronics North America Corporation
Velara Generator with an old Firmware version used with the Philips Integris BH5000
Medical Devices·59 affected·Dec 9, 2016
High RiskFDA
Smiths Medical Asd Inc.
Smiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Sterilized using ethylene oxide.
Medical Devices·641,070 affected·Dec 9, 2016
High RiskFDA
Trilliant Surgical Ltd.
Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product is a component of a system indicated for the fix...
Medical Devices·50 affected·Dec 8, 2016
High RiskFDA
Stanmore Implants Worldwide Ltd.
Tibial Component Fixed Hinge Small Long; Tibial Component Fixed Hinge Small Short The product is a component is a systems that is intend...
Medical Devices·13 affected·Dec 7, 2016
High RiskFDA
Stanmore Implants Worldwide Ltd.
Femoral Integral Shaft & Stem 15x27 HA Coated; Femoral Integral Shaft & Stem 15x30 HA Coated; Femoral Integral Shaft & Stem 30x27 H...
Medical Devices·15 affected·Dec 7, 2016
High RiskFDA
Medacta Usa Inc
Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480mm, Type Straight, Mat Co-Cr-Mo The rods act as a conne...
Medical Devices·82 affected·Dec 7, 2016
High RiskFDA
Stanmore Implants Worldwide Ltd.
DF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem 15x36x44; DF Coated Integral Shaft & Stem 30x30x38; DF...
Medical Devices·15 affected·Dec 7, 2016
High RiskFDA
Stanmore Implants Worldwide Ltd.
Femoral Shaft L=120mm; Femoral Shaft L=135mm; Femoral Shaft L=150mm The product is a component is a systems that is intended for the rep...
Medical Devices·11 affected·Dec 7, 2016
High RiskFDA
Accuray Incorporated
CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI. Radiology: The CyberKnife Robotic Radiosurgery System is indicated for t...
Medical Devices·115 affected·Dec 6, 2016
High RiskFDA
Acumed Llc
OPT Croutons is a synthetic bone substitute designed for the repair of bony defects and is made of pure beta-tricalcium phosphate. The tr...
Medical Devices·83 affected·Dec 5, 2016
CriticalFDA
Invacare Corporation
Bariatric Bed - BARPKG-IVC 1633
Medical Devices·0 affected·Dec 2, 2016
CriticalFDA
Invacare Corporation
Junction Box - 1104343 and 1193560
Medical Devices·161 affected·Dec 2, 2016
High RiskFDA
Elekta, Inc.
MOSAIQ Oncology Information System The product is used to manage workflows for treatment planning and delivery. It supports informati...
Medical Devices·47 affected·Dec 2, 2016
CriticalFDA
Invacare Corporation
Bariatric Bed - BAR600IVC
Medical Devices·411 affected·Dec 2, 2016
High RiskFDA
Polymer Technology Systems
A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, 3062
Medical Devices·500 affected·Dec 2, 2016