Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Icu Medical, Inc.
Single Line Transpac IV Monitoring Kit w/03 ml Squeeze Flush Device, CSP and Blue Stripe Tubing, Item No. 011-46108-38 Transpac Trifur...
Medical Devices·640 affected·Jul 18, 2014
High RiskFDA
Gambro Renal Products, Incorporated
X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541
Medical Devices·401,451 affected·Jul 18, 2014
High RiskFDA
Smith & Nephew, Inc.
RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the ...
Medical Devices·19,499 affected·Jul 18, 2014
High RiskFDA
Gambro Renal Products, Incorporated
Prismaflex HF 1000. Product number 107140. Each set is packaged in a plastic pouch, 4 pouches per carton box
Medical Devices·401,451 affected·Jul 18, 2014
High RiskFDA
Gambro Renal Products, Incorporated
Prisma HF1000 preset (new design). Product number 107639. Each set is packaged in a plastic pouch, 4 pouches per carton box
Medical Devices·401,451 affected·Jul 18, 2014
High RiskFDA
Gambro Renal Products, Incorporated
Prismaflex M100. Product number 106697. Each set is packaged in a plastic pouch, 4 pouches per carton box
Medical Devices·401,451 affected·Jul 18, 2014
High RiskFDA
Gambro Renal Products, Incorporated
PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment Kit per carton box, Product Number 800480, Batch
Medical Devices·401,451 affected·Jul 18, 2014
High RiskFDA
Icu Medical, Inc.
Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device and 2 CSP, Item No. 011-46106-72 Transpac Trifurcated moni...
Medical Devices·900 affected·Jul 18, 2014
High RiskFDA
Icu Medical, Inc.
Single Transpac IT Monitoring Kit w/03 ml Flush Device, Needleless Valve, Macrodrip, Item No. 011-46106-29 Transpac Trifurcated monito...
Medical Devices·200 affected·Jul 18, 2014
High RiskFDA
Icu Medical, Inc.
Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap, Patient Mount, Item No. 011-46104-42 Transpac Tri...
Medical Devices·1,560 affected·Jul 18, 2014
High RiskFDA
Icu Medical, Inc.
Transpac IT w/3 ML/HR Macrodrip, Arterial Pressure Tubing and CSP, Item No. 011-46106-96 Transpac Trifurcated monitoring kit with Safe...
Medical Devices·100 affected·Jul 18, 2014
High RiskFDA
Smith & Nephew, Inc.
RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are use...
Medical Devices·45,466 affected·Jul 18, 2014
High RiskFDA
Gambro Renal Products, Incorporated
Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a plastic pouch, 4 pouches per carton box
Medical Devices·401,451 affected·Jul 18, 2014
High RiskFDA
Gambro Renal Products, Incorporated
Prisma M100 PRE pump infusion set. Product number 107791. Each set is packaged in a plastic pouch, 4 pouches per carton box
Medical Devices·401,451 affected·Jul 18, 2014
High RiskFDA
Gambro Renal Products, Incorporated
Prisma M60 POSTDILUTION set. Product number 104183. Each set is packaged in a plastic pouch, 4 pouches per carton box
Medical Devices·401,451 affected·Jul 18, 2014
High RiskFDA
Icu Medical, Inc.
Transpac IT w/10 cc Safeset Reservoir, 03 ml Flush Device, 2 CSP and Red Stripe Tubing, Item No. 011-46112-21 Transpac Trifurcated mon...
Medical Devices·50 affected·Jul 18, 2014
High RiskFDA
Tomotherapy Incorporated
TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 1.2.0, 1.2.1 and 1.2.2 (Hi-Art¿ 4.2.0, 4...
Medical Devices·322 affected·Jul 17, 2014
High RiskFDA
Genesis Bps, Llc.
Pedi-Pak Pedi-Syringe Filter 60 mL Becton Dickinson/Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and delive...
Medical Devices·7,272 affected·Jul 17, 2014
High RiskFDA
Pentax Medical Company
PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
Medical Devices·98 affected·Jul 17, 2014
High RiskFDA
Tomotherapy Incorporated
TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 2.0.0 and 2.0.1 (Hi-Art¿ 5.0.0 and 5.0.1...
Medical Devices·168 affected·Jul 16, 2014
High RiskFDA
Novocol, Inc.
Darby Dental Supply Compolite Bond SE Self-Etch/Light-Curing. This product is used to adhere restorative material to the tooth during re...
Medical Devices·24 affected·Jul 16, 2014
High RiskFDA
Baxter Healthcare Corp
***Baxter***Buretrol Solution Set***105" (2.7 m)***150 mL Burette***Drip Chamber Filter Valve***3 Injection Sites Male Luer Lock Adapter...
Medical Devices·234,196 affected·Jul 14, 2014
High RiskFDA
Baxter Healthcare Corp
***Baxter***Non-DEHP***BURETROL Solution Set 105" (2.7 m), 150 mL Burette***Drip Chamber Filter Valve 3 Luer Activated Valves***Male Lu...
Medical Devices·11,184 affected·Jul 14, 2014
High RiskFDA
Ortho Development Corporation
Tibila Insert UC, Balanced Knee System, REF163-3YYY Product Usage: UHMWPE component used in TKA procedures to serve as a tibial beari...
Medical Devices·13 affected·Jul 11, 2014
High RiskFDA
Amerx Health Care Corp.
Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads size 2x2 4 Ply Pads; CAT # A5002. Wound management.
Medical Devices·21,108 affected·Jul 11, 2014
High RiskFDA
Amerx Health Care Corp.
Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets 1g. each; CAT # A2003. Wound management.
Medical Devices·1,740 affected·Jul 11, 2014
High RiskFDA
Amerx Health Care Corp.
Amerigel Wound Dressing Maximum Strength CAT# A2001. Wound management.
Medical Devices·382,620 affected·Jul 11, 2014
High RiskFDA
Beevers Manufacturing & Supply, Inc.
Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonata...
Medical Devices·240 affected·Jul 11, 2014
High RiskFDA
Ortho Development Corporation
Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY Product Usage: UHMWPE component used in TKA and revision TKA procedures t...
Medical Devices·1 affected·Jul 11, 2014
High RiskFDA
Medical Positioning Inc
Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # 1017. Product Usage: Used to conduct syncop...
Medical Devices·20 affected·Jul 10, 2014
High RiskFDA
Philips Ultrasound, Inc.
QLAB 10.1 Core Module PN 453561728001. QLAB Quantification Software is a software application package designed to view and quantify imag...
Medical Devices·59 affected·Jul 9, 2014
High RiskFDA
Teleflex Medical
Emerald Fiberoptic Blade, Macintosh 4, Teleflex Medical. A rigid laryngoscope is a device used to examine and visualize a patient's uppe...
Medical Devices·120 affected·Jul 9, 2014
High RiskFDA
Richard Wolf Medical Instruments Corp.
The Hulka Clip is a sterile packaged medical device that carries a two year expiration date. It is packaged two clips per procedural tray...
Medical Devices·73 affected·Jul 9, 2014
High RiskFDA
Gyrus Medical, Inc
Gyrus ACMI Falope-Ring Dilator, item 000878-4. The Falope-Ring Dilator is a conical plastic device that is a component of the Falope-Rin...
Medical Devices·507 affected·Jul 8, 2014
CriticalFDA
Smiths Medical Asd, Inc.
H4051 Endo Tube Holder, Pedi 2.5mm Pediatric Endotracheal Intubation Kit
Medical Devices·135,518 affected·Jul 7, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport w...
Medical Devices·21,799 affected·Jul 7, 2014
High RiskFDA
Becton Dickinson & Company
BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 mm, Catalog #REF 362753, Lot #4063409 with expiry 03/2015, in...
Medical Devices·296,160 affected·Jul 3, 2014
CriticalFDA
Hospira Inc.
The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cass...
Medical Devices·4,656 affected·Jul 2, 2014
RecallFDA
Carestream Health Inc.
INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
Medical Devices·1,633 affected·Jul 2, 2014
RecallFDA
Carestream Health Inc.
Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
Medical Devices·1,633 affected·Jul 2, 2014
High RiskFDA
Smith & Nephew, Inc.
TRIGEN(R) INTERTAN(TM) 10MM X 18 CM NAIL, 125o, REF 71675201, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) I...
Medical Devices·601 affected·Jul 2, 2014
High RiskFDA
Dynarex Corporation
CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label, 100 per case --- Manufactured for: Dynarex Corporat...
Medical Devices·208 affected·Jul 2, 2014
High RiskFDA
Perkinelmer Health Sciences, Inc.
Panthera-Puncher 9 . Panthera-Puncher 9 is a sample transfer instrument for professional use. The sample, a dried blood disk, is ext...
Medical Devices·144 affected·Jul 1, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens syngo Imaging XS, version VA70A or higher Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to ...
Medical Devices·141 affected·Jun 30, 2014
RecallFDA
Steris Corporation
Reliance 1227 Cart and Utensil Washer/Disinfector Product Usage: Usage: The Reliance 1227 Cart and Utensil Washer/Disinfector is int...
Medical Devices·37 affected·Jun 30, 2014
High RiskFDA
Teleflex Medical
RUSCH, TruLite, One-Piece Disposable Laryngoscope Handle Blade Combination, Non-Sterile, Rx Only, Distributed by: Teleflex Medical.
Medical Devices·6,246 affected·Jun 30, 2014
High RiskFDA
Brainlab Ag
Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brainlab Digital Lightbox. A system for the dis...
Medical Devices·154 affected·Jun 27, 2014
High RiskFDA
Perkinelmer Health Sciences, Inc.
PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 Specimen Gate Screening Center is in...
Medical Devices·13 affected·Jun 27, 2014