Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment (A1c_3) r...
Medical Devices·32 affected·Jul 20, 2016
High RiskFDA
Integra Lifesciences Corp.
Integra External Fixation System Universal Wire Fixation Bolt - 17.5 mm Catalogue #12224218 ; Integra External Fixation System Universal ...
Medical Devices·495 affected·Jul 20, 2016
High RiskFDA
Integra Lifesciences Corp.
Integra External Fixation System Slotted Post - Small Catalogue #12224228; Integra External Fixation System Slotted Post Large Catalogue ...
Medical Devices·111 affected·Jul 20, 2016
High RiskFDA
Medtronic Sofamor Danek Usa Inc
TIBIAL TRAY , SIZE 5, REF 90-SRK-200500, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
Medical Devices·1 affected·Jul 18, 2016
High RiskFDA
Medtronic Sofamor Danek Usa Inc
TIBIAL TRAY , SIZE 2, REF 90-SRK-200200, QTY: 1, STERILE R, total knee replacement .
Medical Devices·3 affected·Jul 18, 2016
High RiskFDA
Aribex Inc
NOMAD Pro Packaged X-Ray System, Part Number 08500009; NOMAD Pro Vet Packaged X-Ray System, Part Number 08500011; NOMAD Pro Packaged X-Ra...
Medical Devices·16,871 affected·Jul 18, 2016
High RiskFDA
Medtronic Navigation, Inc.
S7 MACH FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. ...
Medical Devices·27 affected·Jul 18, 2016
High RiskFDA
Aribex Inc
NOMAD Pro2 Packaged X-Ray System, Part Number 08500021; NOMAD Pro2 Packaged X-Ray System Black, Part Number 08500022; NOMAD Pro2 Vet Pack...
Medical Devices·16,871 affected·Jul 18, 2016
High RiskFDA
Medtronic Sofamor Danek Usa Inc
RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 5R, REF 90-SRK-311500, QTY: 1, STERILE R,
Medical Devices·0 affected·Jul 18, 2016
High RiskFDA
Medtronic Navigation, Inc.
FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product...
Medical Devices·27 affected·Jul 18, 2016
High RiskFDA
Medtronic Navigation, Inc.
Synergy Cranial S7. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. ...
Medical Devices·27 affected·Jul 18, 2016
High RiskFDA
Medtronic Sofamor Danek Usa Inc
RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 4R, REF 90-SRK-311400, QTY: 1, STERILE R,
Medical Devices·3 affected·Jul 18, 2016
High RiskFDA
Medtronic Sofamor Danek Usa Inc
TIBIAL TRAY , SIZE 4, REF 90-SRK-200400, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
Medical Devices·2 affected·Jul 18, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas p 471 centrifuge unit calculator/data processing module, for clinical use Product Usage: The cobas p312 pre-analytical system ...
Medical Devices·9,014 affected·Jul 15, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
VS II Aliquoter System calculator/data processing module, for clinical use Product Usage: Elecysy 411 analyzer is a fully automated,...
Medical Devices·9,014 affected·Jul 15, 2016
High RiskFDA
Elekta, Inc.
MOSAIQ Oncology Information System
Medical Devices·383 affected·Jul 15, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
URISYS 2400 Urine Analyzer Automated Urinalysis System Product Usage: The RSD 800 is a computer-controlled stand-alone sorting syste...
Medical Devices·9,014 affected·Jul 15, 2016
High RiskFDA
Topcon Medical Laser Systems, Inc
Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The system can perform single shot photocoagulation as is performed ...
Medical Devices·205 affected·Jul 15, 2016
High RiskFDA
Hill-rom, Inc.
Affinity Four Birthing Bed Model P3700 The primary packaging is pictured below, and utilizes a metal packing brace, standard corruga...
Medical Devices·94 affected·Jul 15, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
RSD 800 Sorting System calculator/data processing module, for clinical use Product Usage: The cobas 8000 Modular Analyze Series is a...
Medical Devices·9,014 affected·Jul 15, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas p 501 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage: The MODULAR PRE-ANALYTICS system...
Medical Devices·9,014 affected·Jul 15, 2016
High RiskFDA
Ethicon Endo-surgery Inc
Endoscopic Articulating Linear Cutter, ATB35. Standard 35 MM. The ENDOPATH ETS-Flex Endoscopic Articulating Linear Cutter has applicatio...
Medical Devices·105 affected·Jul 15, 2016
High RiskFDA
Diagnostic Hybrids, Inc.
MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum.
Medical Devices·1,004 affected·Jul 14, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, computed tomography x-ray system
Medical Devices·1 affected·Jul 13, 2016
High RiskFDA
Mckesson Medical Imaging Group
McKesson Radiology, versions 12.1.1 and 12.2 McKesson Radiology (MR) is a Picture Archiving Communication System (PACS). It is a me...
Medical Devices·164 affected·Jul 12, 2016
High RiskFDA
C.r. Bard, Inc.
SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK Stabilization Device
Medical Devices·2,690 affected·Jul 11, 2016
High RiskFDA
American National Mfg Inc
Panacea Air Pro Mattress Control Unit, Model: Platinum 5000, US Model Number 5000. Use with alternating pressure air flotation mattress.
Medical Devices·31 affected·Jul 11, 2016
High RiskFDA
Trumpf Medical Systems, Inc.
Operating Table TruSystem 7000 U, Material Number 1604788; Operating Table TruSystgem 7000 U (MB), Material Number 1604786 Patient posit...
Medical Devices·84 affected·Jul 10, 2016
High RiskFDA
Trumpf Medical Systems, Inc.
Mobile Column TruSystem 7500, Material Number 1717023; Mobile Column TruSystem 5500, Material Number 1607822 Patient positioning during ...
Medical Devices·84 affected·Jul 10, 2016
High RiskFDA
Trumpf Medical Systems, Inc.
Floor Mounting Column TS 7500 U, Material Number 1730732; Floor Mounting Column ARTIS, Material Number 1501878 Patient positioning duri...
Medical Devices·84 affected·Jul 10, 2016
High RiskFDA
Trumpf Medical Systems, Inc.
Stationary Column TruSystem 7599, Material Number 1717020 Patient positioning during surgery, ranging from anesthesia induction to act...
Medical Devices·84 affected·Jul 10, 2016
High RiskFDA
Elekta, Inc.
Medical Linear Accelerator
Medical Devices·553 affected·Jul 8, 2016
High RiskFDA
Nakanishi Inc.
Diamond Coated Tips and Burs are accessories to the air powered dental handpiece (S-MAX pico) The intended use of the tips is based on t...
Medical Devices·4,284 affected·Jul 8, 2016
High RiskFDA
Nakanishi Inc.
Diamond Coated Tips and Burs are accessories to the Ultrasonic Scaler (VARIOS 350 LUX, VARIOS 350, VARIOS 150 LUX, VARIOS 150). The int...
Medical Devices·30,719 affected·Jul 8, 2016
High RiskFDA
Philips Electronics North America Corporation
UNIQ 1.0: UNIQ FD10, 722026; UNIQ FD10/10, 722027; UNIQ FD20, 722028; UNIQ FD20/10 biplane, 722029; UNIQ FD10 OR Table, 722033; UNIQ FD10...
Medical Devices·1,536 affected·Jul 7, 2016
High RiskFDA
Philips Electronics North America Corporation
Allura Xper with release R8.2: Allura Xper FD10, 722026; Allura Xper FD10/10, 722027; Allura Xper FD20, 722028; Allura Xper FD20/10 bi...
Medical Devices·1,536 affected·Jul 7, 2016
High RiskFDA
Smith & Nephew, Inc.
SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, smith&nephew Total hip components are indicated...
Medical Devices·185 affected·Jul 6, 2016
High RiskFDA
The Binding Site Group, Ltd.
Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit.
Medical Devices·809 affected·Jul 5, 2016
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
RePlant¿ Angled Abutment Part Number 6050-52-60
Medical Devices·205 affected·Jul 5, 2016
High RiskFDA
Zimmer Surgical Inc
Zimmer¿ Air Dermatome II Width Plate, 2 inch. Part # 885120200. Width plate is packaged inside of a padded-foam corrugate box. A product...
Medical Devices·90 affected·Jul 4, 2016
High RiskFDA
Zimmer Surgical Inc
Zimmer¿ Air Dermatome II Handpiece w/o Hose, item number 00-8851-001-01. The Zimmer Air Dermatome II handpiece and width plates are pa...
Medical Devices·220 affected·Jul 4, 2016
High RiskFDA
Zimmer Surgical Inc
Zimmer¿ Air Dermatome II Width Plate, 1.5 inch. Part #00-8851-215-00. Width plate is packaged inside of a padded-foam corrugate box. ...
Medical Devices·60 affected·Jul 4, 2016
High RiskFDA
Zimmer Surgical Inc
Zimmer¿ Air Dermatome II Width Plate, 3 inch. Part #00-8851-203-00. Width plate is packaged inside of a padded-foam corrugate box. A pro...
Medical Devices·90 affected·Jul 4, 2016
High RiskFDA
Zimmer Surgical Inc
Zimmer¿ Air Dermatome II Handpiece, item number 00-8851-001-00. The Zimmer Air Dermatome II handpiece and width plates are packaged i...
Medical Devices·630 affected·Jul 4, 2016
High RiskFDA
Zimmer Surgical Inc
Zimmer¿ Air Dermatome II Width Plate, 4 inch. Part #00-8851-204-00. Width plate is packaged inside of a padded-foam corrugate box. A pro...
Medical Devices·110 affected·Jul 4, 2016
CriticalFDA
Carefusion 2200 Inc
DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16. Des...
Medical Devices·10 affected·Jul 1, 2016
High RiskFDA
Sunrise Medical (us) Llc
Quickie Q7 wheelchair. Model EIR4 Physical Medicine. The Quickie Q7 series of wheelchair's intended use is to provide mobility to per...
Medical Devices·12,142 affected·Jul 1, 2016
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
120 V Neptune 3 Rover, Model Number: 0703-001-000
Medical Devices·78 affected·Jul 1, 2016