Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548380 (XMD P/N 70-0050-514) The EndoVive 3s Low Profile Balloon is intended to ...
Medical Devices·205 affected·Dec 23, 2015
High RiskFDA
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548310 (XMD P/N 70-0050-A12) The EndoVive 3s Low Profile Balloon is intended to ...
Medical Devices·40 affected·Dec 23, 2015
High RiskFDA
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548570 (XMD P/N 70-0050-816) The EndoVive 3s Low Profile Balloon is intended to ...
Medical Devices·91 affected·Dec 23, 2015
High RiskFDA
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548370 (XMD P/N 70-0050-414) The EndoVive 3s Low Profile Balloon is intended to ...
Medical Devices·323 affected·Dec 23, 2015
High RiskFDA
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548280 (XMD P/N 70-0050-712) The EndoVive 3s Low Profile Balloon is intended to ...
Medical Devices·32 affected·Dec 23, 2015
High RiskFDA
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548640 (XMD P/N 70-0050-F16) The EndoVive 3s Low Profile Balloon is intended to ...
Medical Devices·31 affected·Dec 23, 2015
High RiskFDA
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00549420 (XMD P/N 70-0050-C22) The EndoVive 3s Low Profile Balloon is intended to ...
Medical Devices·126 affected·Dec 23, 2015
High RiskFDA
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00549430 (XMD P/N 70-0050-D22) The EndoVive 3s Low Profile Balloon is intended to ...
Medical Devices·40 affected·Dec 23, 2015
High RiskFDA
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548930 (XMD P/N 70-0050-C20) The EndoVive 3s Low Profile Balloon is intended to ...
Medical Devices·40 affected·Dec 23, 2015
High RiskFDA
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00549510 (XMD P/N 70-0050-724) The EndoVive 3s Low Profile Balloon is intended to ...
Medical Devices·43 affected·Dec 23, 2015
High RiskFDA
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00549380 (XMD P/N 70-0050-822) The EndoVive 3s Low Profile Balloon is intended to ...
Medical Devices·36 affected·Dec 23, 2015
High RiskFDA
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548490 (XMD P/N 70-0050-G14) The EndoVive 3s Low Profile Balloon is intended to ...
Medical Devices·37 affected·Dec 23, 2015
High RiskFDA
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M005489490 (XMD P/N 70-0050-524) The EndoVive 3s Low Profile Balloon is intended to...
Medical Devices·34 affected·Dec 23, 2015
High RiskFDA
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548250 (XMD P/N 70-0050-412) The EndoVive 3s Low Profile Balloon is intended to ...
Medical Devices·38 affected·Dec 23, 2015
High RiskFDA
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548820 (XMD P/N 70-0050-120) The EndoVive 3s Low Profile Balloon is intended to ...
Medical Devices·40 affected·Dec 23, 2015
High RiskFDA
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548360 (XMD P/N 70-0050-314) The EndoVive 3s Low Profile Balloon is intended to ...
Medical Devices·331 affected·Dec 23, 2015
High RiskFDA
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548760 (XMD P/N 70-0050-B18) The EndoVive 3s Low Profile Balloon is intended to ...
Medical Devices·37 affected·Dec 23, 2015
High RiskFDA
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548530 (XMD P/N 70-0050-416) The EndoVive 3s Low Profile Balloon is intended to ...
Medical Devices·189 affected·Dec 23, 2015
High RiskFDA
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548590 (XMD P/N 70-0050-A16) The EndoVive 3s Low Profile Balloon is intended to ...
Medical Devices·40 affected·Dec 23, 2015
High RiskFDA
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00548260 (XMD P/N 70-0050-512) The EndoVive 3s Low Profile Balloon is intended to ...
Medical Devices·39 affected·Dec 23, 2015
High RiskFDA
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00549320 (XMD P/N 70-0050-222) The EndoVive 3s Low Profile Balloon is intended to ...
Medical Devices·33 affected·Dec 23, 2015
High RiskFDA
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00549360 (XMD P/N 70-0050-622) The EndoVive 3s Low Profile Balloon is intended to ...
Medical Devices·35 affected·Dec 23, 2015
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Endoscope; ED-530XT Operation Manual 'Operation and Preparation' and 'Cleaning, Disinfection and Storage'
Medical Devices·1,473 affected·Dec 23, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo Plaza Picture archiving and communication system. Software only. PACS intended to display, process, read, report, communicate, di...
Medical Devices·68 affected·Dec 22, 2015
High RiskFDA
Ultradent Products, Inc.
InterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and 5.5mm, part # 4012 Product Usage: InterGuard is a preve...
Medical Devices·157 affected·Dec 22, 2015
High RiskFDA
Baxter Corporation Englewood
Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syringe Filler (ASF)
Medical Devices·4,695 affected·Dec 21, 2015
High RiskFDA
Northeast Laboratory Services, Inc.
NEL- GBS Medium (Broth 3 ml Fill 13 x 100 mm Screw Cap Tube Catalog No.: T8000; For the selective enrichment and screening of Beta-Hemo...
Medical Devices·11,720 affected·Dec 21, 2015
High RiskFDA
Northeast Laboratory Services, Inc.
NEL GBS Medium 20 ml in 100x15mm plate (Standard Petri Dish) Catalog No.: P8000; For the selective enrichment and screening of Beta-Hemo...
Medical Devices·9,300 affected·Dec 21, 2015
High RiskFDA
Cyberonics, Inc
VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.
Medical Devices·4,935 affected·Dec 18, 2015
CriticalFDA
Neocoil, Llc
NeoCoil 3.0T GEM Flex Coil. The 3.0T GEM Flex coil system includes three sizes of coil arrays and one interface box. 3.0T GEM Flex, ...
Medical Devices·2,121 affected·Dec 18, 2015
High RiskFDA
Endochoice, Inc.
Fuse 1C Colonoscope
Medical Devices·253 affected·Dec 18, 2015
High RiskFDA
Value Plastics, Inc.
Custom Assembly, Custom FCFFM x/8.2 cm Tubing Extension, Model Number: FCA026-001, Manufactured by: Value Plastics dba Nordson MEDICAL, ...
Medical Devices·33,000 affected·Dec 18, 2015
High RiskFDA
Stryker Spine
Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manufactured by : Stryker Spine SAS France Used to facilitat...
Medical Devices·31 affected·Dec 18, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
BrightView are gamma cameras; Designed for single or dual detector nuclear imaging.
Medical Devices·677 affected·Dec 17, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
BrightView XCT & BrightView XCT Upgrade, gamma cameras; For Single Proton Emission Computed Tomography.
Medical Devices·427 affected·Dec 17, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
BrightView X are gamma cameras; Designed for single or dual detector nuclear imaging.
Medical Devices·117 affected·Dec 17, 2015
High RiskFDA
Merge Healthcare, Inc.
RadSuite, a picture archive and communications system. Model Numbers Versions 5.30.0, 5.30.1, 5.30.2, 5.30.2 SB0344, 5.30.3, 5.30.4, 5.30...
Medical Devices·164 affected·Dec 17, 2015
High RiskFDA
Ge Inspection Technologies, Lp
GE Inspection Technologies, LP, Cabinet X-ray system used for industrial quality control.
Medical Devices·55 affected·Dec 16, 2015
High RiskFDA
Maquet Datascope Corp - Cardiac Assist Division
Cardiosave Hybrid and rescue IABP
Medical Devices·1,243 affected·Dec 16, 2015
High RiskFDA
Mitsubishi Heavy Industries, Ltd., Hiroshima Machinery Work
MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions an...
Medical Devices·25 affected·Dec 15, 2015
High RiskFDA
Fresenius Medical Care Renal Therapies Group, Llc
Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111
Medical Devices·14,094 affected·Dec 15, 2015
High RiskFDA
Globalmed Logistix
Lipogems SPA Aspiration Cannulae, intended for aspiration of adipose tissue. LGC 13G (13G x 185mm), Sterile.
Medical Devices·118 affected·Dec 15, 2015
High RiskFDA
Bd Diagnostic
BD Viper LT software, version 3.00H
Medical Devices·2 affected·Dec 14, 2015
High RiskFDA
Benlan, Inc.
MED-RX Single Use REF 54-3680R, 8 FR. x 36" (91CM) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral ...
Medical Devices·120 affected·Dec 11, 2015
High RiskFDA
Ascom Us, Inc.
Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0).
Medical Devices·319 affected·Dec 10, 2015
High RiskFDA
Iba Dosimetry Gmbh
IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2
Medical Devices·0 affected·Dec 10, 2015
High RiskFDA
Elekta, Inc.
MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delive...
Medical Devices·399 affected·Dec 9, 2015
High RiskFDA
Zimmer Biomet, Inc.
Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58 mm Length; Zimmer Periarticular Locking Plate System 2.4mm Locking Scre...
Medical Devices·400 affected·Dec 9, 2015