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All Product Recalls

49,195 recalls from FDA (high severity)

Source:AllCPSCFDAUSDASeverity:AllCriticalHighMedium
High RiskFDA
Beijing Syntech Laser Co., Ltd
Beijing Syntech Laser APOLLO V+ Medical Platform surgical lasers
Surgical Devices·11 affected·Jul 3, 2017
High RiskFDA
Publix Supermarkets, Inc. (deli Kitchen)
Publix Greenwise Cashew Butter, NET WT 16 oz (1 lb) 454g, Distributed by Publix Super Markets, Inc, Lakeland, FL 33802
Dairy·414 affected·Jun 30, 2017
High RiskFDA
Sorin Group Usa, Inc.
STOCKERT Heater-Cooler System 3T, 120V/60 Hz
Medical Devices·7,546 affected·Jun 30, 2017
High RiskFDA
Alcon Research, Ltd.
ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery
Medical Devices·429 affected·Jun 30, 2017
High RiskFDA
R82 A/s
Heron toilet and bath chair Model 880505-01 & 880505-11
Medical Devices·687 affected·Jun 30, 2017
High RiskFDA
Sorin Group Usa, Inc.
STOCKERT Heater-Cooler System 3T, 230 V
Medical Devices·7,546 affected·Jun 30, 2017
High RiskFDA
Zoll Medical Corporation
731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator are indicated for use in the management o...
Medical Implants·46 affected·Jun 30, 2017
High RiskFDA
Alcon Research, Ltd.
ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery
Medical Devices·367 affected·Jun 30, 2017
High RiskFDA
Carefusion 303, Inc.
VersaSafe Plastic Cannula - 11 Gauge, Model 9391-0200 Product Usage: Used with secondary IV sets or syringes with a female luer lock ...
Surgical Devices·1,546,800 affected·Jun 30, 2017
High RiskFDA
Sorin Group Usa, Inc.
STOCKERT Heater-Cooler System 3T, 208V/60 Hz
Medical Devices·7,546 affected·Jun 30, 2017
High RiskFDA
Sorin Group Usa, Inc.
STOCKERT Heater-Cooler System 3T, 240V/60 Hz
Medical Devices·7,546 affected·Jun 30, 2017
High RiskFDA
Sorin Group Usa, Inc.
SORIN GROUP, SMART PERFUSION PACK, SMART 1/4" PEDS PACK, REF 627262502, STERILE EO, Rx Only, 1 EA
Medical Devices·4 affected·Jun 29, 2017
High RiskFDA
Sorin Group Usa, Inc.
SORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 627255003, STERILE EO, Rx Only, 1 EA
Medical Devices·98 affected·Jun 29, 2017
High RiskFDA
Medtronic Navigation, Inc.
Medtronic ENT Prgm 9734636 Add Fusion Nav AxiEM, reusable, Rx. This kit includes 9733908 (which includes 9733452 containing 9733449, Str...
Surgical Devices·6 affected·Jun 29, 2017
High RiskFDA
Medtronic Navigation, Inc.
Medtronic Instrument Set EM ENT, Ref. #9733452 and #9733452-G02, reusable, RX. This kit contains 9733449, Straight Suction, 9733450, 70...
Surgical Devices·13 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Alanine Aminotransferase (ALT) reagent chemistry assays; ALT intended to measure the activity of the enzyme alanine amino transfera...
Diagnostic Devices·33,233 affected·Jun 29, 2017
High RiskFDA
Medtronic Navigation, Inc.
Spine Referencing Instrumentation, Set, Contains Spinous Process Clamps, Short and Tall When used with a Medtronic StealthStation Naviga...
Medical Devices·2,051 affected·Jun 29, 2017
High RiskFDA
Sorin Group Usa, Inc.
NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA, NOT FOR CLINICAL USE
Medical Devices·1 affected·Jun 29, 2017
High RiskFDA
Boston Scientific Corporation
SQ-RX 1010 Pulse Generator, Rx. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of l...
Cardiac Devices·12,450 affected·Jun 29, 2017
High RiskFDA
Medtronic Navigation, Inc.
Medtronic Suction 9734308 Small AxiEM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The ...
Surgical Devices·60 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Thyroxine (T4) assay; (Product Number: K6065/10445101) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Diagnostic Devices·19,991 affected·Jun 29, 2017
High RiskFDA
Medtronic Navigation, Inc.
Spine Referencing Instrumentation, Double Spinous Process Clamp, Short When used with a Medtronic StealthStation Navigation System, the ...
Medical Devices·2,051 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Thyroxine (T4) assay (Product Number: DF65/10444908) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Diagnostic Devices·10,056 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended to quantitatively measure Ammonia levels in human plasma (hep...
Diagnostic Devices·7,014 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Aspartate Aminotransferase (AST) assay (Product Number: DF41A/10444959) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Diagnostic Devices·181,072 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Salicylate (SAL) reagent chemistry assay; use in the quantitative determination of salicylate in human serum and plasma (lithium h...
Diagnostic Devices·1,667 affected·Jun 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
PPS RingLoc+ Acetabular Shell, RNGLC+ LTD HOLE SHELL SZ62 The Porous Plasma Spray (PPS) Ringloc¿+ Acetabular System is intended to re...
Medical Devices·15 affected·Jun 29, 2017
High RiskFDA
Sorin Group Usa, Inc.
SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA-3D, (a) REF 044042600 AND (b) REF 044011200, STERILE EO, Rx Only, 1 EA
Medical Devices·733 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Glucose (GLUC) assay (Product Number: DF40/10444973) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Diabetes Devices·80,466 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Ammonia (AMM) assay; (Product Number: DF119/10711991) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Diagnostic Devices·37,923 affected·Jun 29, 2017
High RiskFDA
Boston Scientific Corporation
EMBLEM MRI S-ICD Model 219, Subcutaneous-Implantable Cardioverter Defibrillator, Rx. Product Usage: The S-ICD system is intended ...
Medical Implants·9,200 affected·Jun 29, 2017
High RiskFDA
Medtronic Navigation, Inc.
Medtronic Curved Suction 90 9733451 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. Th...
Surgical Devices·75 affected·Jun 29, 2017
High RiskFDA
Sorin Group Usa, Inc.
SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx Only, 1 EA
Medical Devices·52 affected·Jun 29, 2017
High RiskFDA
Sorin Group Usa, Inc.
SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STERILE EO, Rx Only, 1 EA
Medical Devices·524 affected·Jun 29, 2017
High RiskFDA
Sorin Group Usa, Inc.
SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Only, 1 EA
Medical Devices·1 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Creatine Kinase MB (MBI) assay; (Product Number: K3032/10464339) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Diagnostic Devices·3,130 affected·Jun 29, 2017
High RiskFDA
Medtronic Navigation, Inc.
Spine Referencing Instrumentation, Double Spinous Process Clamp, Tall When used with a Medtronic StealthStation Navigation System, the S...
Medical Devices·2,051 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Syva Emit 2000 Sirolimus Assay (Product Number: 8S019UL/10445401) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Diagnostic Devices·226 affected·Jun 29, 2017
High RiskFDA
Sorin Group Usa, Inc.
SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, STERILE EO, Rx Only, 1 EA
Medical Devices·8 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Aspartate Aminotransferase (AST) assay; (Product Number: K2014/10445148) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Diagnostic Devices·32,744 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Syva Emit 2000 Tacrolimus Assay (Product Number: 8R019UL/10445397) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Diagnostic Devices·10,067 affected·Jun 29, 2017
High RiskFDA
Medtronic Navigation, Inc.
Medtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX. This kit contains 9734308, Small Straight suction. The firm name ...
Surgical Devices·8 affected·Jun 29, 2017
High RiskFDA
Medtronic Navigation, Inc.
Spine Referencing Instrumentation, Spinous Process Clamp, Tall When used with a Medtronic StealthStation Navigation System, the Spine Re...
Medical Devices·2,051 affected·Jun 29, 2017
High RiskFDA
Sorin Group Usa, Inc.
SORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK, REF 627374101, STERILE EO, Rx Only, 1 EA
Medical Devices·5 affected·Jun 29, 2017
High RiskFDA
Medtronic Navigation, Inc.
Medtronic Instrument Kit 9733908 Fusion ENT, reusable, RX. This kit includes Kit 9733452 (containing 9733449, Straight Suction, 9733450,...
Surgical Devices·15 affected·Jun 29, 2017
High RiskFDA
Sorin Group Usa, Inc.
NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS, REF 044043700, 1 EA, NOT FOR CLINICAL USE
Medical Devices·1 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Creatine Kinase MB (MBI) assay (Product Number: DF32/10464510) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Diagnostic Devices·30,446 affected·Jun 29, 2017
High RiskFDA
Taylor Farms Texas, Inc.
Starbucks PB & J Fruit and Veggies 7.4 oz. (210 g) UPC: 7 62111 23607 4
Produce·961 affected·Jun 28, 2017