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All Product Recalls

49,209 recalls (high severity)

Source:AllCPSCFDAUSDASeverity:AllCriticalHighMedium
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
High RiskFDA
Intuitive Surgical, Inc.
da Vinci S Surgical System (IS4000) user manual English and OUS. Product Usage: The Intuitive Surgical Endoscope Instrument Control S...
Cardiac Devices·248 affected·Mar 16, 2016
High RiskFDA
Nuwati Herbals Inc
Nuwati Herbals SeeLessO'Me Diet and Weight Management Tea packaged in two different size amber glass jars with Net Wt 3 oz. or Net Wt 6 o...
Beverages·2,600 affected·Mar 15, 2016
High RiskFDA
Merit Medical Systems, Inc.
Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to create the primary puncture in the interatrial septum when pa...
Cardiac Devices·25 affected·Mar 15, 2016
High RiskFDA
Ge Medical Systems, Llc
GE Healthcare, Aisys and Aisys CS2. Intended to provide general inhalation anesthesia and ventilator support to a wide range of patien...
Respiratory Devices·952 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
Ventlab Llc
STAT-Check Resuscitation Bag Manual Emergency Resuscitation Bag with Carbon dioxide gas analyzer Intended for use in various clinical s...
Respiratory Devices·2,430 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
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
King Soopers Bakery
Bakery Fresh Goodness Apple Strudel 5 count, 24oz, packaged in Plastic container, distributed by King Soopers Bakery, Denver, CO.
Food·411 affected·Mar 14, 2016
High RiskFDA
Meditech Laboratories, Inc
Formula 0 (PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
Injectable Drugs·1,320 affected·Mar 14, 2016
High RiskFDA
Meditech Laboratories, Inc
Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Pol...
Injectable Drugs·1,320 affected·Mar 14, 2016
High RiskFDA
Meditech Laboratories, Inc
Formula 9 (Papaverine 0.9 mg, Phentolamine 0.1 mg, Atropine 0.01 mg, PGE 20 mcg/mL) Injection, 5 mL vial, Rx only, Meditech Laboratories,...
Injectable Drugs·1,320 affected·Mar 14, 2016
High RiskFDA
Impax Laboratories, Inc.
Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC, Middlesex, NJ ...
Oral Drugs·67,428 affected·Mar 14, 2016
High RiskFDA
Meditech Laboratories, Inc
Formula 3 (Papaverine 20 mg, Phentolamine 3 mg, Atropine 0.2 mg, PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, In...
Injectable Drugs·1,320 affected·Mar 14, 2016
High RiskFDA
Impax Laboratories, Inc.
Dextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottle, Rx only, Manufactured and Distributed by: CorePharma, LLC, Middlesex, NJ 0...
Oral Drugs·18,936 affected·Mar 14, 2016
High RiskFDA
Meditech Laboratories, Inc
Formula 1 (Papaverine 1.8 mg, Phentolamine 0.2 mg, Atropine 0.02 mg, PGE 18 mcg/mL) Injection, 5 mL vial, Rx only, Meditech Laboratories,...
Injectable Drugs·1,320 affected·Mar 14, 2016
High RiskFDA
Meditech Laboratories, Inc
Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc...
Injectable Drugs·1,320 affected·Mar 14, 2016
High RiskFDA
Meditech Laboratories, Inc
Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL), 5 mL vials, Meditech Laboratories, Inc., 3200 Polaris Ave...
Drugs·1,320 affected·Mar 14, 2016
High RiskFDA
Navilyst Medical, Inc., An Angiodyamics Company
Vaxcel PICC with PASV Catheter Kit under the following labels: 1) 3F, UPN H965454350, Rx ONLY, 2) 4F, UPN M001454550, Rx ONLY & 3) 5F, UP...
Surgical Devices·2,716 affected·Mar 14, 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
Navilyst Medical, Inc., An Angiodyamics Company
Xcela PICC with PASV Valve Technology Catheter Kit, 6F-55cm, UPN H965457410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PA...
Surgical Devices·150 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
BioFlo PICC with ENDEXO and PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965458410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid...
Surgical Devices·60 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
Xcela Hybrid PICC with PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965952410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC...
Surgical Devices·2 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
Navilyst Medical, Inc., An Angiodyamics Company
BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, Catheter Kit, UPN H965459410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid P...
Surgical Devices·10 affected·Mar 14, 2016
High RiskFDA
Terumo Cardiovascular Systems Corporation
CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blood gas monitor Product Usage: The CDL System 500 provid...
Respiratory Devices·222 affected·Mar 14, 2016
High RiskFDA
Naturmed Inc Dba Institute For Vibrant Living
All Day Energy Greens Fruity (ADEGF), Great Fruity Taste!, Net Wt 10.5 oz (299g), UPC Code 893320002096 and 893320002423.
Produce·376,878 affected·Mar 11, 2016
High RiskFDA
Naturmed Inc Dba Institute For Vibrant Living
All Day Energy Greens (ADEG), Original Flavor, Net Wt 11.36 oz (322g), UPC Code 893320002096
Food·563,499 affected·Mar 11, 2016
High RiskFDA
Smith & Nephew, Inc.
TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 4 LEFT, STERILE R, REF 12 000 017, S&N 7500272, Smith & Nephew Orthopaedics AG...
Medical Implants·24 affected·Mar 11, 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
High RiskFDA
Smith & Nephew, Inc.
TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000 019, S&N 7500274, Smith & Nephew Orthopaedics AG...
Medical Implants·15 affected·Mar 11, 2016
High RiskFDA
Smith & Nephew, Inc.
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 2 RIGHT, STERILE R, REF 12 000 009, S&N 7500264, Smith & Nephew Orthopaedics ...
Medical Implants·1 affected·Mar 11, 2016