Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Spetzler Claw Tip, Universal - 5450-800-311 Spetzler Open Angle Micro Claw Tip, Universal - 5450-800-313 The Spetzler Claw" Tips ar...
Medical Devices·140 affected·Mar 22, 2016
High RiskFDA
Leica Microsystems, Inc.
Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566. Intended for the qualitative identification by light microsc...
Medical Devices·290 affected·Mar 22, 2016
High RiskFDA
Medscience Inc
AllergiEnd ST-9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST-9 Multiple Well Test Tray (Item (1001). Contents: 8 applicato...
Medical Devices·11,400 affected·Mar 22, 2016
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
Vortex MEDICAL AngioVac Circuit, REF/UPN VTX3100, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are...
Medical Devices·339 affected·Mar 21, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 14mm Sterile. For use in total knee arthropl...
Medical Devices·0 affected·Mar 17, 2016
RecallFDA
Cygnus Medical
Cygnus Medical First StepBedside ADDWATER Kit,non-sterile. First Step in cleaning flexible endoscopes. SKU# EP-6W (The First Step 50...
Medical Devices·39 affected·Mar 17, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 18mm Sterile For use in total knee arthropla...
Medical Devices·0 affected·Mar 17, 2016
High RiskFDA
Terumo Medical Corporation
PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNACLE¿ TIF TIP" Introducer Sheath PINNACLE¿ R/O II Radiopaque ...
Medical Devices·1,370,995 affected·Mar 16, 2016
High RiskFDA
Optovue, Inc.
iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0.0.127 (USA only) and 2016.1.0.127 (out of US) Opthalmic:...
Medical Devices·40 affected·Mar 16, 2016
CriticalFDA
Invacare Corporation
Invacare¿ Foot Section for Semi & Full Electric Beds, Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intende...
Medical Devices·3,050 affected·Mar 15, 2016
CriticalFDA
Invacare Corporation
Invacare¿ Bariatric Bed with mattress and rails , Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to...
Medical Devices·2,702 affected·Mar 15, 2016
CriticalFDA
Invacare Corporation
Invacare¿ Bariatric Bed w/o mattress & rails, Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to pro...
Medical Devices·2,184 affected·Mar 15, 2016
High RiskFDA
Polymer Technology Systems, Inc.
PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers
Medical Devices·6,467 affected·Mar 15, 2016
High RiskFDA
Philips Electronics North America Corporation
Philips Healthcare System X-ray Tomography Computed :
Medical Devices·1,363 affected·Mar 15, 2016
CriticalFDA
Mevion Medical Systems, Inc.
MEVION S250 for Proton Radiation Therapy
Medical Devices·5 affected·Mar 15, 2016
High RiskFDA
Olympus Corporation Of The Americas
EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF used with an Olympus video system center, light source, documentation equipment mo...
Medical Devices·0 affected·Mar 15, 2016
High RiskFDA
Roche Molecular Systems, Inc.
cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian Translation Instructions for Use
Medical Devices·8 affected·Mar 15, 2016
High RiskFDA
Navilyst Medical, Inc., An Angiodyamics Company
Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001454560, Rx ONLY & 2) 5F, UPN M001454610, Rx ONLY. The Va...
Medical Devices·328 affected·Mar 14, 2016
High RiskFDA
Navilyst Medical, Inc., An Angiodyamics Company
BioFlo PICC with ENDEXO and PASV Valve Technology, MST-45 Kit, 6F-55cm, UPN H965458440 , Rx ONLY The Xcela PICC with PASV, Xcela Hybrid ...
Medical Devices·2 affected·Mar 14, 2016
High RiskFDA
Ossur H / F
Ossur Lil Angel Vest P2 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders ...
Medical Devices·435 affected·Mar 14, 2016
High RiskFDA
Ossur H / F
Ossur Lil Angel Vest P3 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders ...
Medical Devices·435 affected·Mar 14, 2016
High RiskFDA
Navilyst Medical, Inc., An Angiodyamics Company
Vaxcel PICC with PASV MST-60 Kit under the following labels: 1) 3F, UPN H965454360, Rx ONLY, 2) 4F, UPN M001454590, Rx ONLY, 3) 5F, UPN's...
Medical Devices·5,566 affected·Mar 14, 2016
High RiskFDA
Navilyst Medical, Inc., An Angiodyamics Company
Vaxcel PICC with PASV Intermediate Safety MST Kit under the following labels: 1) 3F, UPN H965454370, 2) 4F UPN M001455940 & 3) 5F UPN M00...
Medical Devices·1,127 affected·Mar 14, 2016
High RiskFDA
Navilyst Medical, Inc., An Angiodyamics Company
BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458980, Rx ONLY The Xcela PICC with PASV, Xcela H...
Medical Devices·190 affected·Mar 14, 2016
High RiskFDA
Ossur H / F
Ossur Lil Angel Vest P3 Sorbatex. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorder...
Medical Devices·435 affected·Mar 14, 2016
High RiskFDA
Navilyst Medical, Inc., An Angiodyamics Company
Xcela PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965457430, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PAS...
Medical Devices·105 affected·Mar 14, 2016
High RiskFDA
Navilyst Medical, Inc., An Angiodyamics Company
Xcela PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965251290 & H965457420, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid ...
Medical Devices·568 affected·Mar 14, 2016
High RiskFDA
Navilyst Medical, Inc., An Angiodyamics Company
Xcela Hybrid PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN H965952440 & UPN H965952450, Rx ONLY The Xcela PICC ...
Medical Devices·357 affected·Mar 14, 2016
High RiskFDA
Navilyst Medical, Inc., An Angiodyamics Company
BioFlo PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458430 & UPN H965458840, Rx ONLY The Xcela PICC with PAS...
Medical Devices·438 affected·Mar 14, 2016
High RiskFDA
Navilyst Medical, Inc., An Angiodyamics Company
Vaxcel PICC with PASV IR-145 Kit under the following labels: 1) 4F, UPN M001454580, Rx ONLY, 2) 5F, UPN M001454630, Rx ONLY & 3) 6F, UPN ...
Medical Devices·2,260 affected·Mar 14, 2016
High RiskFDA
Navilyst Medical, Inc., An Angiodyamics Company
Xcela Hybrid PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965952430 & H965952470, Rx ONLY The Xcela PICC with PASV, Xcela ...
Medical Devices·100 affected·Mar 14, 2016
High RiskFDA
Navilyst Medical, Inc., An Angiodyamics Company
BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965458970, Rx ONLY The Xcela PICC with PASV, Xcela H...
Medical Devices·275 affected·Mar 14, 2016
High RiskFDA
Navilyst Medical, Inc., An Angiodyamics Company
Xcela Hybrid PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965952420 & UPN H965952460, Rx ONLY The Xcela PICC with PASV, Xc...
Medical Devices·157 affected·Mar 14, 2016
High RiskFDA
Integra Lifesciences Corporation
Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only Meshed Integra¿ Dermal Regeneration Template, (Integra temp...
Medical Devices·14 affected·Mar 11, 2016
RecallFDA
Datascope Corporation
Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992
Medical Devices·19 affected·Mar 11, 2016
High RiskFDA
Microaire Surgical Instruments, Llc
Pneumatic Impactor, General Surgery, With Microaire Hose Connector Professional Use, Medical Industry
Medical Devices·20 affected·Mar 11, 2016
RecallFDA
Datascope Corporation
Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588
Medical Devices·19 affected·Mar 11, 2016
High RiskFDA
Repro-med Systems, Inc.
Freedom60 Precision Flow Rate Tubing Sets, REF/Part Numbers F900, F2400, F60, F10, F275, F600, F45, F1200 F180.
Medical Devices·0 affected·Mar 10, 2016
High RiskFDA
Fresenius Medical Care Renal Therapies Group, Llc
Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: Models: Fresenius 2008K and 2008K2 Dialysate...
Medical Devices·8,384 affected·Mar 10, 2016
High RiskFDA
Merge Healthcare, Inc.
The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software.
Medical Devices·555 affected·Mar 10, 2016
High RiskFDA
Philips Visicu
eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure). For medical use b...
Medical Devices·9 affected·Mar 10, 2016
High RiskFDA
Repro-med Systems, Inc.
HIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ 24 Gauge 9mm Needles, REF/Part Numbers RMS22606, RMS22609, RMS22612, RMS12606, R...
Medical Devices·0 affected·Mar 10, 2016
High RiskFDA
Ferno-washington Inc
Poly-bags containing splint strap labeled with "Pediatric" sticker. Each strap kit contains adjustable length leg straps, ankle wrap, ...
Medical Devices·153 affected·Mar 10, 2016
High RiskFDA
Ferno-washington Inc
Poly-bags containing the strap labeled with "Adult" sticker. Each strap kit contains adjustable length leg straps, ankle wrap, a thigh...
Medical Devices·270 affected·Mar 10, 2016
High RiskFDA
Biomet, Inc.
All instrumentation associated with the Prelude PF Resurfacing Knee System.
Medical Devices·576 affected·Mar 9, 2016
High RiskFDA
Mindray Ds Usa, Inc. Dba Mindray North America
Panorama Patient Monitoring Network Mindray DS USA The Panorama Patient Monitoring can view recal time, store, print, graph and trend ...
Medical Devices·1,447 affected·Mar 9, 2016
High RiskFDA
Icu Medical, Inc.
Diana Automated Compounding System, Diana Onco Plus, Item No. ASN220 The Diana is an automated compounding device for the accurate, safe...
Medical Devices·36 affected·Mar 8, 2016
High RiskFDA
Icu Medical, Inc.
Diana Automated Compounding System, Final Assembly, Diana Onco Plus, Item No. CH5000, CH5000R The Diana is an automated compounding devi...
Medical Devices·47 affected·Mar 8, 2016