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All Product Recalls

49,209 recalls (high severity)

Source:AllCPSCFDAUSDASeverity:AllCriticalHighMedium
High RiskFDA
Nephron Pharmaceuticals Corporation Dba Nephron Sterile Compounding Center
PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9% Sodium Chloride Injection-200 mL Total Dose: (400 mcg/200 mg)/200 mL, Rx Onl...
Injectable Drugs·615 affected·Oct 9, 2019
High RiskFDA
Medivators, Inc.
Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXTU, packaged as Contents 1, 10, 50. Tubing for Olympus 140/240, 160/260, 180...
Medical Devices·53,790 affected·Oct 9, 2019
High RiskFDA
Medivators, Inc.
Medivators Endo carry-on Procedure Kit REF CPK-100222-0002 - Product Usage: is intended to be used with an air or CO2 source and/or a pu...
Medical Devices·53,790 affected·Oct 9, 2019
High RiskFDA
Medivators, Inc.
Medivators EndoGator REF 100651. Kit for Olympus 140/160/180/190 Series GI Endoscopes for CO2 Connection with Endogator EGP-100, Olympus...
Medical Devices·53,790 affected·Oct 9, 2019
High RiskFDA
Nextremity Solutions
Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number: STRM-NL-3550ST - Product Usage: The Stratum Foot Plating S...
Medical Devices·49 affected·Oct 9, 2019
High RiskFDA
Stryker Sustainability Solutions
Zimmer Tourniquet Cuff 30" (Blue), PLC Dual Port, Single Bladder, Item Number: 60-7070-105, UDI: 00885825013868, Reprocessed Tourniquet C...
Medical Devices·90 affected·Oct 9, 2019
High RiskFDA
Medivators, Inc.
Medivators EndoGator REF 100650. Kit for Olympus 140/160/180/190 Series GI Endoscopes forCO2 Connection with Olympus OFP or Boston Scien...
Medical Devices·53,790 affected·Oct 9, 2019
High RiskFDA
Draegar Medical Systems, Inc.
Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862,...
Medical Devices·12,204 affected·Oct 9, 2019
High RiskFDA
Medivators, Inc.
Medivators Endo Smartcap Endoscope Tubing. REF100145CO2, packaged as Contents 1, 10, 50 and found in BMP-C145CO2. Tubing for Olympus ...
Medical Devices·53,790 affected·Oct 9, 2019
High RiskFDA
Medivators, Inc.
Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXT, packaged as Contents 1, 10, 50, and found in BMP-C145CO2EXT. Tubing for O...
Medical Devices·53,790 affected·Oct 9, 2019
High RiskFDA
Blue Bell Creameries, L.p.
Blue Bell Butter Crunch Ice Cream packaged in a 1/2 Gallon (2 Qts) paperboard cup & lid (4 units per corrugated sleeve, 77 sleeves per pa...
Dairy·1,626 affected·Oct 8, 2019
High RiskFDA
Dole Packaged Foods, Llc
Dole Crushed Pineapple in 100% pineapple juice Manufactured For Dole Packaged Foods, LLC Westlake Village, CA 91361 Product of The ...
Beverages·3,746 affected·Oct 7, 2019
High RiskFDA
Mylan Laboratories Limited (sterile Products Division)
Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103; NDC 67457-445-60.
Injectable Drugs·19,165 affected·Oct 7, 2019
High RiskFDA
Baylis Medical Company Inc.
TorFlex Transseptal Guiding Sheath ; Model numbers: TF8-32-63-45, TF8-32-63-55, TF8-32-63-90, TF8-32-63-135, TF85-32-63-37, TF85-32-63-45...
Medical Devices·59,067 affected·Oct 7, 2019
High RiskFDA
Beckman Coulter, Inc.
UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) - Product Usage: The intended use is as follows...
Medical Devices·1,056 affected·Oct 7, 2019
High RiskFDA
Implant Direct Sybron Manufacturing Llc
Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213
Medical Implants·72 affected·Oct 7, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
Software versions syngo CT VB20 running on the following Siemens SOMATOM CT Scanner. SOMATOM Force (Model #10742326), SOMATOM Definiti...
Medical Devices·305 affected·Oct 7, 2019
High RiskFDA
Nova Ortho-med Inc
Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red)
Medical Devices·10,898 affected·Oct 7, 2019
High RiskFDA
Baylis Medical Company Inc.
NRG RF Transseptal Kit; Model No.s : NTK-710-8545, NTK-710-8555, NTK-711-8545, NTK-711-8555, NTK-711-8590, NTK-P711-8545, NTK-P711-8555, ...
Medical Devices·59,067 affected·Oct 7, 2019
High RiskFDA
Edwards Lifesciences, Llc
Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usage: The HemoSphere oximetry cable is a multi-use device that ...
Respiratory Devices·35 affected·Oct 7, 2019
High RiskFDA
Smith & Nephew, Inc.
LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN InterTAN nails are indicated for fractures of the femur includ...
Medical Devices·116 affected·Oct 7, 2019
High RiskFDA
Gullah Gourmet, Inc.
Nana's Been a Nut Bread NET WT. 11oz/311.74g cloth bag CONTAINS WHEAT AND SOY. MADE ON EQUIPMENT THAT MAKES PRODUCTS CONTAINING WHEAT, EG...
Dairy·673 affected·Oct 4, 2019
High RiskFDA
Baxter Healthcare Corporation
Prismaflex Control Unit, software versions below 7.21
Medical Devices·2,760 affected·Oct 4, 2019
High RiskFDA
Baxter Healthcare Corporation
Prismaflex Control Unit, software versions below 7.21
Medical Devices·986 affected·Oct 4, 2019
High RiskFDA
Randox Laboratories, Limited
Randox Liquid Cardiac Controls Catalogue Numbers CQ5053.
Cardiac Devices·6,702 affected·Oct 4, 2019
High RiskFDA
Icu Medical, Inc.
REF: Z2812, 121" 10 Drop Primary Set w/5 MicroClave, Remv 2 Gang 4-Way Stopcocks, Rotating Luer, 2 Ext, Sterile R, UDI: (01)00887709028074
Medical Devices·4,800 affected·Oct 4, 2019
High RiskFDA
Baxter Healthcare Corporation
Prismaflex Control Unit, software versions below 7.21
Medical Devices·1,014 affected·Oct 4, 2019
High RiskFDA
Icu Medical, Inc.
REF: Z2560, 100" 10 Drop Admin Set w/Hand Pump, 2 Clave", Rotating Luer, 1 Pressure Infusion (400psig) Ext, Purple Clamp, UDI: (01)(01)00...
Medical Devices·650 affected·Oct 4, 2019
High RiskFDA
Baxter Healthcare Corporation
Prismaflex Control Unit, software versions below 7.21
Medical Devices·336 affected·Oct 4, 2019
High RiskFDA
Icu Medical, Inc.
REF: B90240-50, 96" (244 cm) Appx 11.2 ml, 10 Drop Admin Set w/Coiled Tubing, Pre-Slit Port, Clave, Rotating Luer, Sterile R, UDI: (01)00...
Medical Devices·14,000 affected·Oct 4, 2019
High RiskFDA
Teleflex Medical
WECK Hem-O-Lok AutoEndo5, 5mm Automatic Endoscopie Hem-o-lok Applier, REF 543965 Automatic Endoscopic Surgical Ligating Clip Applie...
Surgical Devices·4,099 affected·Oct 4, 2019
High RiskFDA
Icu Medical, Inc.
REF: Z2850, 112" (284 cm) 10 Drop Primary set w/2 Clave, Remv 3 Gang 1o2 Manifold w/3 Clave, Baseplate, Rotating Luer w/Filter Cap, 1 Ext...
Medical Devices·25 affected·Oct 4, 2019
High RiskFDA
Baxter Healthcare Corporation
Prismaflex Control Unit, software versions below 7.21
Medical Devices·988 affected·Oct 4, 2019
High RiskFDA
Roche Diagnostics Operations, Inc.
Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi co...
Diagnostic Devices·82 affected·Oct 4, 2019
High RiskFDA
Teleflex Medical
WECK AutoEndo5, Automatic Hem-O-Lok Clip Applier, REF AE05ML Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devic...
Surgical Devices·34,491 affected·Oct 4, 2019
High RiskFDA
Randox Laboratories, Limited
Randox Liquid Cardiac Controls Catalogue Number CQ5051
Cardiac Devices·6,208 affected·Oct 4, 2019
High RiskFDA
Han Yang Corp.
Honey Donut (Yahk Gwa), brand name Han Yang, packaged in a white Styrofoam boat wrapped in plastic wrap, 8 pieces per package, net wt. 18...
Beverages·72 affected·Oct 3, 2019
High RiskFDA
G&c Food Distributors, Inc.
Frozen blackberries, packaged in 16 ounce (454 gram) plastic bags (12 bags per master case). Plastic bags labeled with: PREMIUM QUALI...
Beverages·299 affected·Oct 3, 2019
High RiskFDA
Cook Inc.
Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity.
Surgical Devices·202 affected·Oct 3, 2019
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Programmers & Remote Monitoring Software Apps: 29901 CareLink Encore Programmer
Medical Devices·6,713 affected·Oct 3, 2019
High RiskFDA
Datascope Corp.
Low Level Output Cable Interface to Philips Monitor For Use With Cardiosave and CS300 Intra-Aortic Balloon Pumps (IABPs), Part Number ...
Medical Devices·7 affected·Oct 3, 2019
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Programmers & Remote Monitoring Software Apps: CareLink SmartSync Device Manager
Medical Devices·874 affected·Oct 3, 2019
High RiskFDA
Philips North America, Llc
HeartStart XL+ Defibrillator/Monitor, Model 861290
Cardiac Devices·24,738 affected·Oct 3, 2019
High RiskFDA
Pfizer Inc.
10% LMD in 5% Dextrose Injection Dextran 40 in Dextrose Injection, USP, 500 mL bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC ...
Injectable Drugs·17,832 affected·Oct 2, 2019
High RiskFDA
Pega Medical Inc.
SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery
Surgical Devices·31 affected·Oct 2, 2019
High RiskFDA
Medicrea International
Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010
Medical Devices·14 affected·Oct 2, 2019
High RiskFDA
The Truck Farm, Llc
Tia Rita's Spicy Southwestern Green Chile Cornbread dry mix. Packaged in 13 oz (380 g) sealed plastic bags with paper label stapled over ...
Bakery & Grains·2,700 affected·Oct 1, 2019
High RiskFDA
Friendly Fruit Market Dba Sid Wainer & Son
Jansal Valley brand Energize Snack Mix NET WT 5 OZ (142 G) in plastic clamshells, Ingredients: apricots, almonds, banana chips, coconut, ...
Dairy·562 affected·Oct 1, 2019