Skip to main content
High RiskFDA
Angiodynamics, Inc.
BioFlo Midline Catheter and BioFlo Maximal Barrier Kits - Product Usage: These introducers are used for the percutaneous introduction of ...
Surgical Devices·119,723 affected·May 4, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Enzymatic Creatinine, Siemens Material Number 10471520, UDI Number 00842768030512 - Product Usage: use in the quantitative dete...
Medical Devices·8,261 affected·May 4, 2020
CriticalFDA
Mondelez Global Llc
RITZ Cheese Cracker Sandwiches , Family Size , (21.6 oz. carton)
Dairy·9,110 affected·May 1, 2020
CriticalFDA
Jason Pharmaceuticals, Inc. T/a Medifast
Optavia, Old Fashioned Maple & Brown Sugar Oatmeal . 1.13 oz./ 32 g pouch, Multi-layer Kraft paper/aluminum pouches, Seven pouches per c...
Food·24,923 affected·May 1, 2020
High RiskFDA
Biomet
Biomet Screw Instrument Tray 6.5/80MM- Surgical Tray Product Code: 246111003
Surgical Devices·705 affected·May 1, 2020
High RiskFDA
Biomet
Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument Product Code: 14235
Surgical Devices·136 affected·May 1, 2020
High RiskFDA
Covidien Llc
Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 16FR 5CCCC2W, Product Code: 50516ICT - Product Usage: ...
Surgical Devices·480 affected·Apr 30, 2020
High RiskFDA
Elekta, Inc.
Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: is indicated for radiation therapy treatments an...
Medical Devices·32 affected·Apr 30, 2020
High RiskFDA
Normand-info S.a.s.u.
Remisol Advance running Software Version 1.12 The Normand Info Remisol Advance Data Manager collects and manages data and workflow for...
Medical Devices·663 affected·Apr 30, 2020
High RiskFDA
Cook Inc.
Pressure Monitoring Set, C-PMS, G02838
Medical Devices·6,792 affected·Apr 30, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-Ray System) as follows: Artis Q floor Model: 1084828...
Diagnostic Devices·15 affected·Apr 30, 2020
High RiskFDA
Covidien Llc
Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, Premium, Urine Meter, 16 Fr/Ch (5.3 mm), 5 mL Catheter P...
Surgical Devices·46,828 affected·Apr 30, 2020
High RiskFDA
Covidien Llc
Dover 100% Silicone Premium Urine Meter Foley Tray, 400mL, 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Lu...
Surgical Devices·3,470 affected·Apr 30, 2020
High RiskFDA
Covidien Llc
Dover 400mL, 100% Silicone Premium Urine Meter Foley Tray, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with L...
Surgical Devices·23,587 affected·Apr 30, 2020
High RiskFDA
Diasol, Inc
DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS
Medical Devices·212 affected·Apr 30, 2020
High RiskFDA
Covidien Llc
Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray, 18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-connected to 2000 ...
Surgical Devices·0 affected·Apr 30, 2020
High RiskFDA
Covidien Llc
Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 18FR 5CCCC2W, Product Code: 50518ICT - Product Usage: f...
Surgical Devices·0 affected·Apr 30, 2020
High RiskFDA
Medtronic Inc.
MiniMed 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK - Product Usage: indicated for continuous or periodic monit...
Diabetes Devices·391 affected·Apr 30, 2020
High RiskFDA
Hill-rom, Inc.
Centrella Smart+ Bed, Catalog Number P7900
Medical Devices·4,381 affected·Apr 30, 2020
High RiskFDA
Covidien Llc
Dover 100% Silicone Foley Catheter with Temperature 16FR 5CC2W, Product Code: 50516T - Product Usage: for Drainage of the Urinary bladde...
Surgical Devices·3,012 affected·Apr 30, 2020
High RiskFDA
Ricker Hill Farms, Inc.
RICKER HILL ORCHARDS APPLE CIDER McIntosh Blend, 1 GAL (128 FL OZ) and 1/2 GAL (64 FL OZ); UPC: 0 74613 80009 8; MADE IN MAINE; KEEP REFR...
Produce·455 affected·Apr 29, 2020
High RiskFDA
Thermo Fisher Scientific (monterrey)
Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Catalog Number: 07 0006 The specimen containers are used fo...
Medical Devices·78,600 affected·Apr 29, 2020
High RiskFDA
Glaxosmithkline Consumer Healthcare Holdings
Benefiber Healthy Shape Prebiotic Fiber Supplement, 500G UPC 886790018872
Supplements·29,844 affected·Apr 28, 2020
High RiskFDA
Ge Healthcare, Llc
Giraffe Incubator with installed Servo Oxygen module. Infant incubator.
Respiratory Devices·5,883 affected·Apr 28, 2020
High RiskFDA
Ge Healthcare, Llc
Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer.
Respiratory Devices·5,883 affected·Apr 28, 2020
CriticalFDA
Condies Foods, Inc.
43559 SNDW Chicken Sandwich on White Single, vacuumed pack bag, Clam shell. Label UPC: 50777444804, Condies Foods Inc. PO Box 18548. Sa...
Meat & Poultry·61 affected·Apr 27, 2020
CriticalFDA
Condies Foods, Inc.
43237 ROLL chicken salad on croissant single, vacuumed pack bag, Clam shell. Label UPC: 50777445351, Condies Foods Inc. PO Box 18548. ...
Meat & Poultry·104 affected·Apr 27, 2020
High RiskFDA
Defibtech, Llc
DDU-2450 Lifeline ECG Model Numbers DDU-A2450EN DDU-E2450DE DDU-E2450EN DDU-E2450FR DDU-E2450TH Cat. No. DCF-A2460EN DCF-A2463...
Cardiac Devices·860 affected·Apr 27, 2020
High RiskFDA
Defibtech, Llc
DDU-2300 Lifeline/ReviveR View, Model Numbers DDU-C2300EN, DDU-C2300CA, DDU-A2300EN, DDU-E2300EN Catalog Numbers CCD-A1006RX CCD-A101...
Cardiac Devices·860 affected·Apr 27, 2020
High RiskFDA
Philips North America, Llc
Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for the termination ...
Cardiac Devices·260 affected·Apr 27, 2020
High RiskFDA
Argon Medical Devices, Inc
Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 - Product Usage: The Skater Introduc...
Surgical Devices·15,795 affected·Apr 26, 2020
High RiskFDA
Middle East Bakery, Inc.
Joseph's Gluten Free Original Wrap, 4 wraps, Net. Wt. 5.6 oz., UPC Code: 074117-003612
Food·7,133 affected·Apr 25, 2020
RecallFDA
Dr. Reddy's Laboratories, Inc.
Esomeprazole Magnesium Delayed Release Capsules USP, 40 mg*, 1000-count bottles, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bach...
Oral Drugs·1,752 affected·Apr 24, 2020
RecallFDA
The Harvard Drug Group
Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufactured by: Lupin Limited, Pi...
Oral Drugs·678 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert Label:050608000/ 00803622123382
Medical Devices·240 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
Vein Irrigation Cannula with blunt tip. ASY VIC, STERILE 25/CS REF/ GTIN for Insert Label: VIC/ 00803622133107
Medical Devices·325 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert Label:050529000/ 00803622123351
Medical Devices·768 affected·Apr 24, 2020
High RiskFDA
Deroyal Industries Inc
DeRoyal Sterile Custom Kits packaged as a Piggy Back with the BD PosiFlush SF Saline Flush Syringe, labeled as follows: a. H* Vein Pack ...
Cardiac Devices·352 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
Sterile Disposable Connectors ASY STR CONN 1/4 STRLE 24. REF/ GTIN for Insert Label:050504000/ 00803622123221
Medical Devices·48 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
Sterile Disposable Connectors ASY S CONN 3/16X1/8 RDR ANLD24 REF/ GTIN for Insert Label:050513000/ 00803622123252
Medical Devices·72 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
Sterile Disposable Connectors ASY Y CONN 3/8 X 3/8 X 3/8 24 REF/ GTIN for Insert Label:050526000/ 00803622123320
Medical Devices·984 affected·Apr 24, 2020
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Bone Void Filler, Small - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The...
Medical Devices·36 affected·Apr 24, 2020
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. T...
Medical Devices·41 affected·Apr 24, 2020
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Bone Void Filler, Large - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The...
Medical Devices·6 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
Sterile Disposable Connectors ASY CONN EQUAL 3/16 WYE 24 REF/ GTIN for Insert Label:050523000/ 00803622123290
Medical Devices·24 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
3/8X3/8X3/8 Y CONN, STRL REF/ GTIN for Insert Label:EC2105S/ 00803622129285
Medical Devices·220 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
1/4X3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2140S/ 00803622129315
Medical Devices·420 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
3/8 STR CONN, STRL REF/ GTIN for Insert Label:EC2130S/ 00803622129292
Medical Devices·860 affected·Apr 24, 2020