Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
OSTOSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Blue; Part Number: 72201994 Biodegradable suture anchor
Medical Devices·6,373 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
TWINFIX ULTRA PLLA/HA 5.5 mm Suture Anchor with 3 ULTRABRAID Suture: Part Number: 72202603 Biodegradable suture anchor
Medical Devices·0 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
TWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202626 Biodegradable suture anchor
Medical Devices·3,827 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
TWINFIX Ultra PLLA/HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black: Part Number: 72202602 Biodegradable suture anchor
Medical Devices·7,148 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
BIORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture; Part Number: 72200774 Biodegradable suture anchor
Medical Devices·24,574 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
BIORAPTOR 2.9 mm Suture Anchor, pack of 1 ULTRABRAID Suture: 72200689 Biodegradable suture anchor
Medical Devices·240 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
TWINFIX Ultra PLLA/HA 6.5 mm with 3 ULTRABRAID Suture; Part Number: 72202610 Biodegradable suture anchor
Medical Devices·1,643 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
TWINFIX Ultra HA 6.5 mm with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202631 Biodegradable suture anchor
Medical Devices·708 affected·Aug 6, 2013
High RiskFDA
B. Braun Medical, Inc.
Outlook Safety Infusion System Burette Set. For intravenous fluid administration.
Medical Devices·900 affected·Aug 5, 2013
High RiskFDA
3m Company/3m Espe Dental Products
3M ESPE Unitek Primary Stainless Steel Crowns (First Primary UL4), Product code 902150 (Kit- 112 crowns/kit) and 900114 (Refill- 5 crowns...
Medical Devices·3,409 affected·Aug 5, 2013
High RiskFDA
3m Company - Health Care Business
3M Scotchcast, Wet or Dry Cast Padding, Catalog Numbers WDP2, WDP3, WDP4, and WDP6. Intended for use in constructing casts for eithe...
Medical Devices·1,207 affected·Aug 5, 2013
High RiskFDA
Getinge Usa Inc
Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and 61301606637 (100 Pack), STEAM --- Manufactured f...
Medical Devices·61,301,606,636 affected·Aug 2, 2013
High RiskFDA
Villa Radiology Systems Llc
Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capable of routine radiographs and general fluoro...
Medical Devices·22 affected·Aug 2, 2013
High RiskFDA
Nidek Inc
NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management softwa...
Medical Devices·86 affected·Aug 1, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous...
Medical Devices·374 affected·Aug 1, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudo...
Medical Devices·369 affected·Jul 31, 2013
High RiskFDA
Depuy Spine, Inc.
PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation...
Medical Devices·102 affected·Jul 31, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Large Buttress Compression Nut For Blade Guide Sleeve TFN is in...
Medical Devices·135 affected·Jul 31, 2013
High RiskFDA
Depuy Spine, Inc.
PIPELINE LS ACCESS SYSTEM, Holding Clip The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue ...
Medical Devices·198 affected·Jul 31, 2013
High RiskFDA
Depuy Spine, Inc.
PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated The PIPLINE LS Dilators and Holding Clip are intended for sequential dilation o...
Medical Devices·118 affected·Jul 31, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of large bones and large bone fragments and f...
Medical Devices·166 affected·Jul 31, 2013
High RiskFDA
Synthes Usa Hq, Inc.
2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and f...
Medical Devices·98 affected·Jul 31, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject PMMA cement into vertebral bodies during Vertebroplasty proce...
Medical Devices·40 affected·Jul 30, 2013
High RiskFDA
Synergetics Inc
Synergetics 25 gauge Soft Tip Cannula, packaged in 6 units per box. Catalog number: 30.08.25. Single-use 25 gauge cannula used in vitr...
Medical Devices·48 affected·Jul 30, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the proximal femur.
Medical Devices·17 affected·Jul 30, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures
Medical Devices·14 affected·Jul 30, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right Product Usage: Intended for fixation of complex intra-and extra-art...
Medical Devices·11 affected·Jul 30, 2013
High RiskFDA
Getinge Disinfection
Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product Usage: The washer disinfector is used in healthcare faciliti...
Medical Devices·143 affected·Jul 30, 2013
High RiskFDA
Smith & Nephew, Inc., Endoscopy Div.
High Flow Irrigation Extender; Part Number 72201021. Arthroscopic accessories are indicated for use in access of the joint capsule.
Medical Devices·203 affected·Jul 30, 2013
High RiskFDA
Ge Healthcare, Llc
Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer. The Datex-Ohmeda Tec 6 Plus and Tec 6 Plus NAD Variant is an elec...
Medical Devices·31,443 affected·Jul 29, 2013
High RiskFDA
Sarken, Inc.
SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
Medical Devices·0 affected·Jul 29, 2013
High RiskFDA
Sarken, Inc.
SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
Medical Devices·0 affected·Jul 29, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
100/120V AC, Advanced Perfusion System 1 Product Usage: The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporea...
Medical Devices·1,657 affected·Jul 26, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Pall AL6X Arterial Blood Line Filter, labeled in part Terumo Cardiovascular Systems Corporation, packaged as part of a Terumo Card...
Medical Devices·15,817 affected·Jul 26, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo¿ Advanced Perfusion System 1 (APS1, System 1) Description: 220/240V AC Product Usage: The Terumo¿ Advanced Perfusion System 1...
Medical Devices·1,657 affected·Jul 26, 2013
High RiskFDA
Carestream Health, Inc.
DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY 14608 Catalog Numbers 1019397, 1023415, 1023423 --- Made...
Medical Devices·23 affected·Jul 26, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
220/240V AC, Advanced Perfusion System 1 Product Usage: The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporea...
Medical Devices·1,657 affected·Jul 26, 2013
High RiskFDA
Medtronic Navigation, Inc.
Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 and BI-700-00028 The 0-arm Imaging System is a mobile x-ra...
Medical Devices·449 affected·Jul 25, 2013
High RiskFDA
Advanced Sterilization Products
STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization System is a low temperature general purpose sterilizer used to ...
Medical Devices·1,923 affected·Jul 25, 2013
High RiskFDA
Hemocue Ab
HemoCue¿ Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, Sweden
Medical Devices·42,330 affected·Jul 25, 2013
High RiskFDA
Nestle Healthcare Nutrition
Nestle Nutrition, Compat, Enteral Feeding Tube, sterile, 8 French (REF 08310400), 10 French (REF 08310600), and 12 French (REF 08310500)....
Medical Devices·37,310 affected·Jul 24, 2013
High RiskFDA
Orthopediatrics Corp
3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to pre-drill a hole in bone prior to placement of a...
Medical Devices·68 affected·Jul 24, 2013
High RiskFDA
Elekta, Inc.
Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is part of the class of medical devices that ar...
Medical Devices·89 affected·Jul 23, 2013
High RiskFDA
Philips Medical Systems (cleveland) Inc
MX 16-Slice CT Scanner System. Used as a whole-body computed tomography X-Ray system.
Medical Devices·326 affected·Jul 22, 2013
High RiskFDA
Atrium Medical Corporation
C-QUR Edge Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
Medical Devices·1,501 affected·Jul 19, 2013
High RiskFDA
Blue Belt Technologies Mn
Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO. Product Usage: The intended use of this device ...
Medical Devices·60 affected·Jul 19, 2013
High RiskFDA
Atrium Medical Corporation
C-QUR V-Patch Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
Medical Devices·95,286 affected·Jul 19, 2013
High RiskFDA
Atrium Medical Corporation
C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficiencies.
Medical Devices·32,834 affected·Jul 19, 2013