The Recall Desk

Archive

January 2021 recalls

307 recalls were announced in January 2021.

What the numbers show

Critical
9
Severe
102
High
139
Moderate
44
Low
13

Of the 307 recalls this month scored against our rubric, 3% are Critical, 33% are Severe.

1–100 of 307

  • SevereNHTSA·21V031000·2021-01-29

    2021 BMW X5, X6, X7 Steering Column Defect Recall

    BMW is recalling certain 2021 X5, X6, and X7 models due to a defect in the steering column shaft universal joint that may not be tightened to specifications, potentially affecting vehicle handling and control.

    Product
    BMW — BMW X6, X5, X7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V033000·2021-01-29

    Mercedes-Benz Recalls 2019 GLA 250 for Transmission Control Defect

    Mercedes-Benz is recalling 2019 GLA 250 vehicles because the transmission control unit power supply may interrupt, causing the vehicle to shift into neutral while driving.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLA 250
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V035000·2021-01-29

    Tesla Recalls Model S and X for Display Memory Wear

    Tesla is recalling 2012-2018 Model S and 2016-2018 Model X vehicles because center display memory wear can cause loss of rearview camera and turn signals.

    Product
    TESLA — TESLA MODEL S, MODEL X
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V034000·2021-01-29

    2021 Mercedes-Benz ISOFIX Bracket May Be Missing From Child Restraint Anchor

    Mercedes-Benz is recalling certain 2021 A220, A35 AMG, and CLA250 vehicles because the ISOFIX child seat anchoring bracket on the right-rear seat may be missing the right-side anchoring bar, preventing proper restraint of child car seats.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ A 220, CLA 250, AMG A35
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V032000·2021-01-29

    Mercedes-Benz Recalls C-Class Models for Front Seat Belt Retraction Issue

    Mercedes-Benz is recalling 2017-2021 C300, AMG C43, and AMG C63 vehicles because front seat belts may not fully retract, potentially discouraging use and increasing crash injury risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ C 300, AMG C43, AMG C63
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V028000·2021-01-28

    Jeep Gladiator Manual Transmission Clutch Assembly Overheat and Fire Risk

    Chrysler is recalling certain 2021 Jeep Gladiator vehicles with manual transmissions. The clutch pressure plate may overheat and fracture, increasing the risk of fire and potential loss of drive.

    Product
    JEEP — JEEP GLADIATOR, WRANGLER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V030000·2021-01-28

    Autocar Xpeditor Seat Belt Harness Defect May Cause Engine Stall

    Autocar is recalling certain 2018-2021 Xpeditor vehicles because the seat belt harness may chafe and short circuit the engine, causing unexpected stalling that could lead to crashes.

    Product
    AUTOCAR — AUTOCAR XPEDITOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0850-2021·2021-01-27

    Penumbra JET 7 Reperfusion Catheter Recalled for Potential Tip Damage

    Penumbra Inc. is recalling JET 7 Reperfusion Catheters because distal tip damage could cause vessel injury or death during use.

    Product
    Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7L138KIT The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0851-2021·2021-01-27

    Penumbra JET 7MAX Kits Recalled for Potential Vessel Damage Risk

    Penumbra Inc. is recalling JET 7MAX Kits because catheter tip damage during use could cause vessel damage, leading to patient injury or death.

    Product
    Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Delivery Device + Hi-Flow Aspiration Tubing REF J7XKIT132 The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspirat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0215-2021·2021-01-27

    Listeria-contaminated cookie dough recalled from Rhino Foods, Inc.

    FDA is recalling 20 lb. ready-to-eat chocolate chip cookie dough due to possible Listeria monocytogenes contamination.

    Product
    AF01886 NTFA No egg Ready-to-Eat Chocolate Chip Cookie Dough Dough- 20 lb. sold frozen
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-0848-2021·2021-01-27

    Penumbra JET 7 Reperfusion Catheter Recalled for Potential Tip Damage

    Penumbra Inc. is recalling 3,368 JET 7 Reperfusion Catheters because the distal tip may become damaged during use, posing a risk of vessel damage and patient injury or death.

    Product
    Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7 The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump to the site of occlusion to assist in the ef
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0879-2021·2021-01-27

    Boston Scientific Recalls Emblem S-ICD Subcutaneous Electrodes Due to Fracture Risk

    Boston Scientific is recalling Emblem S-ICD Subcutaneous Electrodes because fractures may prevent the device from delivering therapy.

    Product
    EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0849-2021·2021-01-27

    Penumbra JET 7 Reperfusion Catheter Recalled for Potential Vessel Damage

    Penumbra Inc. is recalling JET 7 Reperfusion Catheters because distal tip damage could cause vessel injury or death during use.

    Product
    Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7KIT The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0236-2021·2021-01-27

    Complete Pharmacy Recalls Human Chorionic Gonadotropin Due to Lack of Potency Testing

    Complete Pharmacy and Medical Solutions is recalling 1,144 vials of Human Chorionic Gonadotropin 5,000 IU because the product lacked required potency testing.

    Product
    HUMAN CHORIONIC GONADOTROPIN 5,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved. Complete Pharmacy & Medical Solutions 5829 NW 158th St, Miami Lakes, FL 33014 Tel: 305-397-2035
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0873-2021·2021-01-27

    Medtronic Recalls Neonatal Delta Valve Shunt Assemblies Due to Catheter Defect

    Medtronic is recalling specific Neonatal Delta Valve Shunt Assemblies because a manufacturing defect may cause the ventricular catheter to disconnect, leading to shunt malfunction.

    Product
    REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.5, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems designed to provide controlled CSF flow from the ventricles of the brain into the p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V027000·2021-01-27

    Audi Recalls One 2019 Q3 for Steering Rack Defect

    Audi is recalling one 2019 Q3 vehicle because a production deviation may prevent a steering component from engaging properly, increasing the risk of a crash.

    Product
    AUDI — AUDI Q3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0872-2021·2021-01-27

    Medtronic Recalls Neonatal Delta Valve Shunt Assemblies Due to Catheter Defect

    Medtronic is recalling Neonatal Delta Valve Shunt Assemblies because a manufacturing defect may cause the ventricular catheter to disconnect from the valve, leading to shunt malfunction.

    Product
    REF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Performance Level 2.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems designed to provide controlled CSF flow from the ventricles of the brain into the p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0868-2021·2021-01-27

    Laerdal Compact Suction Unit Recalled for Potential Suction Loss

    Laerdal Medical is recalling 5,035 Compact Suction Units (LCSU 4) because component failures may cause the device to lose suction, potentially delaying treatment or causing suffocation.

    Product
    Laerdal Compact Suction Unit (LCSU 4), Catalog Numbers 880051, 880061, 881151, 880052, 880062, 881152 - Product Usage: It is intended for intermittent operation to remove secretions, blood or vomit from a patient s airway to allow ventilation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0871-2021·2021-01-27

    Medtronic Recalls Neonatal Delta Valve Shunt Assemblies Due to Catheter Defect

    Medtronic is recalling 95 Neonatal Delta Valve Shunt Assemblies because a manufacturing defect may cause the ventricular catheter to disconnect from the valve, leading to shunt malfunction.

    Product
    REF 27219-1 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems designed to provide controlled CSF flow from the ventricles of the brain into the p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0876-2021·2021-01-27

    Steris Reliance Vision Washer/Disinfector Recalled for Fire Risk

    Steris is recalling Reliance Vision Single-Chamber Washer/Disinfector units because a faulty electrical contactor may cause the drying chamber to overheat, potentially leading to smoke or fire.

    Product
    Reliance Vision Single-Chamber Washer/Disinfector - Product Usage: intended for use in the cleaning and intermediate level disinfection of soiled reusable utensils, trays, glassware, bedpans and urinals, rubber and plastic goods, simple hard-surfaced rigid surgical instruments, s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0232-2021·2021-01-27

    American Health Packaging Recalls Nitrofurantoin Capsules for Dissolution Failure

    American Health Packaging is recalling 1,948 cartons of Nitrofurantoin Capsules USP 100 mg because they failed dissolution specifications. The recall is nationwide.

    Product
    Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton (10 capsules x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC Carton: 68084-446-01; NDC Blister Card: 68084- 446-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0208-2021·2021-01-27

    JR Simplot Recalls Frozen Potatoes Due to Undeclared Wheat

    JR Simplot is recalling 400 cases of Spud-Queen Lattice Cut frozen potatoes distributed in Alabama and Mississippi because the product contains undeclared wheat.

    Product
    SPUD-QUEEN LATTICE CUT - SKIN ON FROZEN POTATOES, master case SKU 10071179 041290. Distributed by Mid America Potato Company P.O. BOX 9386 BOISE, ID. Each case contains 6/4.5 lbs. packages (net wt. 27 lbs.). Product is a foodservice item and product is packaged in a clear ba
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0234-2021·2021-01-27

    Complete Pharmacy Recalls Human Chorionic Gonadotropin Due to Potency Testing Deviations

    Complete Pharmacy and Medical Solutions is recalling 1,182 vials of Human Chorionic Gonadotropin because the product lacked required potency testing.

    Product
    HUMAN CHORIONIC GONADOTROPIN 11,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved. Complete Pharmacy & Medical Solutions 5829 NW 158th St, Miami Lakes, FL 33014 Tel: 305-397-2035
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V026000·2021-01-27

    Volkswagen Atlas and Cross Sport steering knuckle fracture recall

    Front steering knuckles in certain Volkswagen Atlas and Atlas Cross Sport vehicles may fracture, causing loss of vehicle control and increasing crash risk. Volkswagen will inspect and replace affected knuckles free of charge.

    Product
    VOLKSWAGEN — VOLKSWAGEN ATLAS CROSS SPORT, ATLAS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0238-2021·2021-01-27

    Edge Pharma Recalls Ceftazidime Sterile Ophthalmic Solution Due to Sterility Concerns

    Edge Pharma, LLC is recalling 48 syringes of Ceftazidime Sterile Ophthalmic Solution because the media used for sterility testing was expired, compromising the assurance of sterility.

    Product
    Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25mg / 0.5ml (22.5mg/ml) 0.5ml per syringe. KEEP FROZEN UNTIL USE AND PROTECT FROM LIGHT SINGLE USE SYRINGE FOR INTRAOCULAR INJECTION Edge Pharma, LLC is an FDA-registered 503B outsourcing facility. This
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0883-2021·2021-01-27

    Roche Cobas Infinity Software Error May Allow Unreliable Lab Results

    Roche is recalling 76 licenses of Cobas Infinity software due to an error that may remove quality flags, allowing unreliable test results to be reported.

    Product
    A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data Catalog Number: 07154003001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0212-2021·2021-01-27

    GH Foods Recalls Smoked Mozzarella Pasta Salad Kit for Egg Allergen Labeling

    GH Foods CA LLC is recalling Smoked Mozzarella Pasta Salad Kits sold at Whole Foods because the ingredient 'Eggs' was not listed on the retail scale label.

    Product
    Smoked Mozzarella Pasta Salad Kit 2/5 lb. UPC: 20826766840186 Sold at Whole Foods Stores
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0217-2021·2021-01-27

    Khee Trading Recalls Frozen Tuna Ground Meat Due to Histamine Levels

    Khee Trading, Inc. is recalling 189 cartons of frozen tuna ground meat due to potential elevated levels of histamine. The product was distributed in Minnesota, California, New York, Illinois, and Texas.

    Product
    Frozen Tuna Ground Meat - Khee Trading Brand Product of Vietnam 22 Lb. Cartons (2 x 11 lb.)
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0209-2021·2021-01-27

    GH Foods Recalls Asian Noodle Salad Kit for Missing Egg Allergen Labeling

    GH Foods CA LLC is recalling Asian Noodle Salad Kits because the ingredient 'Eggs' was not listed on the retail scale label, despite a 'may contain' warning.

    Product
    Asian Noodle Salad Kit 2/5 lb. Keep refrigerated Amazon UPC: 826767000000; Whole Foods UPC: 20826766840025 Sold at Amazon Stores and Whole Foods Stores
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0214-2021·2021-01-27

    Spinach and Orzo Pasta Kit Recalled Due to Missing Egg Allergens on Scale Label

    The Spinach and Orzo Pasta Kit was recalled because eggs were not listed on the scale label at retail stores, creating a potential allergen cross-contamination risk.

    Product
    Spinach and Orzo Pasta Kit 2/5 lb. UPC: 20826766840209 Sold at Whole Foods Stores
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0216-2021·2021-01-27

    JTM Food Group Recalls Macaroni and Cheese for Possible Metal Shavings

    JTM Provisions Co Inc is recalling JTM Food Group brand Ready to Eat White Cheddar Macaroni & Cheese due to possible metal shavings.

    Product
    JTM FOOD GROUP brand READY TO EAT WHITE CHEDDAR MACARONI & CHEESE in 5 lb. plastic bags, 6 bags per case.
    Category
    Food
    Distribution
    15 states
  • HighFDA (Devices)·Z-0882-2021·2021-01-27

    Biomet Recalls A.L.P.S. Clavicle Plating System Due to Drill Fracture Risk

    Biomet is recalling 174 A.L.P.S. Clavicle Plating Systems because instruments may cold weld, preventing disassociation and increasing the chance of drill fracture.

    Product
    A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004 - Product Usage: indicated for fixation of fractures, osteotomies and non-unions of the clavicle including osteopenic bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0211-2021·2021-01-27

    GH Foods Italian Pasta Salad Kit Recalled for Missing Egg Allergen Labeling

    GH Foods CA LLC is recalling Italian Pasta Salad Kits sold at Whole Foods and Amazon because the label failed to list eggs as an ingredient, despite a 'may contain' warning.

    Product
    Italian Pasta Salad Kit 2/5 lb. UPC: 20826766811377 Sold at Whole Foods Stores
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0213-2021·2021-01-27

    GH Foods Spinach and Basil Pasta Salad Kit Recalled for Egg Allergen Mislabeling

    GH Foods CA LLC is recalling Spinach and Basil Pasta Salad Kits because the ingredient 'Eggs' was not listed on the retail scale label, despite a 'may contain' warning.

    Product
    Spinach and Basil Pasta Salad Kit 2/5 lb. UPC: 20826766811438 Sold at Whole Foods Stores
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0870-2021·2021-01-27

    Boston Scientific Recalls Five ACUITY Universal Cutters Due to Sterilization Failure

    Boston Scientific is retrieving five ACUITY Universal Cutters that did not undergo the required sterile processing procedure.

    Product
    ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate guide catheter removal after the Boston Scientific coronary venous lead is positioned.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0210-2021·2021-01-27

    GH Foods Pesto Pasta Salad Kit Recalled for Missing Egg Allergen Labeling

    GH Foods CA LLC is recalling Pesto Pasta Salad Kits because the ingredient 'Eggs' was not listed on the retail scale label, despite a 'may contain' warning.

    Product
    Pesto Pasta Salad Kit 2/5 lb. Keep refrigerated UPC: 826767000000 Sold at Amazon Stores
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0881-2021·2021-01-27

    Abbott i-STAT EG7+ Cartridges Recalled for Ionized Calcium Test Inaccuracy

    Abbott Point Of Care Inc. is recalling i-STAT EG7+ cartridges because the ionized calcium test may report higher than expected results if stored at room temperature for specific periods.

    Product
    Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement of sodium, potassium, ionized calcium, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood. List Number: 03P76-25
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0875-2021·2021-01-27

    Beckman Coulter Recalls SARS-CoV-2 IgG Quality Control Cards

    Beckman Coulter is recalling 276 units of ACCESS SARS-CoV-2 IgG Quality Control cards due to a label error regarding standard deviation values.

    Product
    ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0866-2021·2021-01-27

    Skeletal Kinetics Recalls OsteoVation Bone Filler Kits Due to Labeling Discrepancy

    Skeletal Kinetics is recalling 2 units of OsteoVation Inject Bone Filler Kits because of a discrepancy between the Mixing Instruction Card and the Instructions for Use.

    Product
    OsteoVation, Inject Bone Filler Kits, 5cc (part number 390-2005, manufacturing lot number 1129957) - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0226-2021·2021-01-27

    Piping Rock Organic Coconut Oil Recalled for Potential Mold Contamination

    Piping Rock Health Products is recalling 296 jars of Fitness Labs Organic Coconut Oil due to potential mold contamination. The product was distributed in 34 states and Washington, D.C.

    Product
    FITNESS LABS***Organic***Coconut Oil***Extra Virgin***16 fl. oz. (473 mL)***Carefully Designed and Distributed by Piping Rock Health Products, LLC Ronkonkoma, NY 11779***
    Category
    Food
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0880-2021·2021-01-27

    Abbott i-STAT CG8+ Cartridges Recalled for Ionized Calcium Test Inaccuracy

    Abbott is recalling i-STAT CG8+ cartridges because the ionized calcium test may report higher than expected results if stored at room temperature for specific periods.

    Product
    Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized calcium, glucose, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood List Number: 03P88-25
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0867-2021·2021-01-27

    Skeletal Kinetics Recalls OsteoVation Bone Filler Kits Due to Labeling Discrepancy

    Skeletal Kinetics is recalling 49 units of OsteoVation bone filler kits because the mixing instructions on the card do not match the Instructions for Use.

    Product
    OsteoVation, Inject, Bone Filler Kits 10cc (part number 390-2010, manufacturing lot 1130303) - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0874-2021·2021-01-27

    Smiths Medical Recalls Portex Acapella DH Vibratory PEP Devices

    Smiths Medical ASD Inc. is recalling 4,440 Portex Acapella DH Vibratory PEP Devices because shipping boxes may contain the wrong model number.

    Product
    Portex Acapella DH Vibratory PEP Device - Product Usage: a single patient use device that provides Positive Expiratory Pressure (PEP) Therapy for patients who have Cystic Fibrosis, COPD, asthma, and lung diseases with secretory problems, and patients with atelectasis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0869-2021·2021-01-27

    Magstim Recalls Neurosign 100 Intraoperative Nerve Monitors for Voltage Configuration Error

    The Magstim Company Limited is recalling seven Neurosign 100 Intraoperative Nerve Monitors because they were configured for 240V power instead of the required 120V for the US.

    Product
    Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product Usage: indicated for use in stimulating and monitoring cranial motor nerves, especially the facial nerve (VII), during ENT surgical procedures.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0235-2021·2021-01-27

    Complete Pharmacy Recalls Human Chorionic Gonadotropin Due to Potency Testing Failures

    Complete Pharmacy and Medical Solutions is recalling 2,418 vials of Human Chorionic Gonadotropin because the product lacked required potency testing.

    Product
    HUMAN CHORIONIC GONADOTROPIN 6,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved. Complete Pharmacy & Medical Solutions 5829 NW 158th St, Miami Lakes, FL 33014 Tel: 305-397-2035
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0237-2021·2021-01-27

    Complete Pharmacy Recalls Human Chorionic Gonadotropin Due to Lack of Potency Testing

    Complete Pharmacy and Medical Solutions is recalling 2,400 vials of Human Chorionic Gonadotropin 1,250 IU due to a lack of potency testing.

    Product
    HUMAN CHORIONIC GONADOTROPIN 1,250 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved. Complete Pharmacy & Medical Solutions 5829 NW 158th St, Miami Lakes, FL 33014 Tel: 305-397-2035
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0884-2021·2021-01-27

    Exactech Equinoxe Humeral Stem Recalled for Incorrect Instructions

    Exactech is recalling 14 Equinoxe Humeral Stem devices because packages may include incorrect Instructions For Use (IFU).

    Product
    Equinoxe Humeral Stem, Primary, Press Fit, 11mm
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0233-2021·2021-01-27

    Allergan Recalls Refresh Relieva Preservative-Free Eye Drops for Missing Labeling

    Allergan is recalling Refresh Relieva Preservative-Free eye drops because the packaging is missing the instructions for use insert.

    Product
    REFRESH RELIEVA PRESERVATIVE FREE — REFRESH RELIEVA PRESERVATIVE FREE (CARBOXYMETHYLCELLULOSE SODIUM AND GLYCERIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0877-2021·2021-01-27

    Roche uPath software 1.1 recalled for incorrect measurement calculations

    Roche Molecular Systems is recalling uPath software 1.1 because measurement values are incorrectly calculated in Split View mode when slides have different magnifications.

    Product
    uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
    Category
    Medical Device
    Distribution
    2 states
  • HighNHTSA·21V024000·2021-01-26

    2021 Subaru Outback CVT Select Lever Cable Defect Recall

    Subaru is recalling 2021 Outback and Impreza models due to an improperly tightened CVT select lever cable nut that may loosen, causing the gear selector to malfunction and increasing crash risk.

    Product
    SUBARU — SUBARU OUTBACK, IMPREZA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V025000·2021-01-26

    Nissan Recalls 2020 INFINITI QX50 for Illegible Tire Placard

    Nissan is recalling 2020 INFINITI QX50 vehicles because the tire and loading information placard may be illegible, potentially leading to incorrect tire installation or overloading.

    Product
    INFINITI — INFINITI QX50
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21E005000·2021-01-25

    Brembo Brake Pads Recalled for Potential Friction Material Detachment

    Brembo is recalling specific brake pads that may corrode and detach, potentially increasing stopping distance and crash risk.

    Product
    SERVICE BRAKES, HYDRAULIC:FOUNDATION COMPONENTS:DISC:PADS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V021000·2021-01-21

    2021 Dutchmen Voltage Recreational Trailers Recalled for Incorrect Tire Pressure Label

    Keystone RV Company is recalling 2020–2021 Dutchmen Voltage recreational trailers because the Federal Identification Tag lists incorrect tire pressure (110 PSI instead of 95 PSI), which could cause tire overinflation and increase crash risk.

    Product
    DUTCHMEN — DUTCHMEN VOLTAGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V022000·2021-01-21

    2021 Dutchmen Voltage recreational trailers recalled for mislabeled tire pressure

    Keystone RV Company is recalling 2021 Dutchmen Voltage trailers because the Federal Identification Tag incorrectly lists tire pressure as 95 PSI instead of 110 PSI, which could cause underinflated tires and increase crash risk.

    Product
    DUTCHMEN — DUTCHMEN VOLTAGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·003-2021·2021-01-21

    Bob Evans Pork Sausage Recalled for Possible Foreign Matter Contamination

    Bob Evans Farms is recalling approximately 4,200 pounds of raw Italian pork sausage due to possible contamination with thin blue rubber.

    Product
    BEF Foods, Inc. — Bob Evans Farms Inc. Recalls Pork Sausage Product Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-0235-2021·2021-01-20

    Divvies Vanilla Cupcakes Recalled for Undeclared Milk and Egg

    Divvies LLC is recalling specific lots of vegan vanilla cupcakes because they contain undeclared milk and egg ingredients.

    Product
    "Divvies Vegan and Nut Free Vanilla Cupcakes with Vanilla Frosting ***Net. Wt. 6 oz. "
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0735-2021·2021-01-20

    Recall of Lotus Edge Valve System Transcatheter Aortic Valve Prosthesis Due to Deployment Locking Failure

    Boston Scientific recalls 278 Lotus Edge Valve Systems due to a failure in visual inspection that prevents proper valve locking during deployment, potentially preventing delivery system release.

    Product
    Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVS250, GTIN 08714729940821, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
    Category
    Medical Device
    Distribution
    38 states
  • SevereFDA (Devices)·Z-0734-2021·2021-01-20

    Boston Scientific Recalls Lotus Edge Valve Systems Due to Deployment Failure Risk

    Boston Scientific is recalling 207 Lotus Edge Valve Systems because a visual inspection error could prevent the delivery system from releasing during deployment.

    Product
    Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVS230, GTIN 08714729940814, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
    Category
    Medical Device
    Distribution
    38 states
  • SevereFDA (Devices)·Z-0852-2021·2021-01-20

    Philips Emission Computed Tomography System Software Defect Recall

    Philips is recalling 2,714 Emission Computed Tomography Systems due to a software defect that may cause image misdiagnosis and incorrect patient treatment.

    Product
    Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0831-2021·2021-01-20

    Fresenius Naturalyte Liquid Acid concentrate bottles recalled for conductivity deviation

    Fresenius Medical Care is recalling Naturalyte Liquid Acid concentrate bottles due to conductivity deviations and calcium concentration below specification.

    Product
    Naturalyte Liquid Acid concentrate bottles, Product Code 08-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0656-2021·2021-01-20

    Siemens Artis Medical Imaging Systems Recalled for Radiation Safety Defect

    Siemens is recalling Artis zee, Artis Q, and Artis Pheno systems because the Air Kerma Rate can exceed regulatory limits when frame rates are increased during continuous release.

    Product
    Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0813-2021·2021-01-20

    Fresenius Recalls NaturaLyte Liquid Acid Concentrate Bottles

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate bottles because sodium and/or calcium levels were below manufacturing specifications.

    Product
    NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0838-2021·2021-01-20

    Fresenius Naturalyte Liquid Acid Concentrate Recalled for Conductivity Deviation

    Fresenius Medical Care is recalling Naturalyte Liquid Acid concentrate bottles due to conductivity deviations and calcium concentration below manufacturing specifications.

    Product
    Naturalyte Liquid Acid concentrate bottles, Product Code 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0736-2021·2021-01-20

    Boston Scientific Recalls Lotus Edge Valve Systems Due to Release Failure Risk

    Boston Scientific is recalling 386 Lotus Edge Valve Systems because a visual inspection error could prevent the delivery system from releasing during deployment.

    Product
    Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVS270, GTIN 08714729940838, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
    Category
    Medical Device
    Distribution
    38 states
  • SevereFDA (Drugs)·D-0227-2021·2021-01-20

    Nostrum Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

    Nostrum Laboratories is recalling Metformin Hydrochloride Extended-Release Tablets, 750 mg, because the product contains N-Nitrosodimethylamine (NDMA) above acceptable intake levels.

    Product
    Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120, NDC: 29033-056-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V016000·2021-01-20

    RAM 4500 and 5500 Recalled for Rear Brake Line Wear Risk

    Custom Truck And Body Works is recalling 2020 RAM 4500 and 5500 vehicles because a rear brake line may wear, causing brake failure.

    Product
    RAM — RAM 4500, 5500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V017000·2021-01-20

    2021 Thomas Built Buses Recall for Brake Caliper Bolt Tightening Defect

    Daimler Trucks North America is recalling 2021 Thomas Built Buses Saf-T-Liner HDX and EFX school buses because a brake caliper bolt may be incorrectly tightened, potentially reducing brake effectiveness.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER EFX, SAF-T-LINER HDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0729-2021·2021-01-20

    Boston Scientific Recalls Lotus Edge Valve Systems Due to Deployment Defect

    Boston Scientific is recalling 319 Lotus Edge Valve Systems because a visual inspection failure may prevent the delivery system from releasing during deployment.

    Product
    Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVSUS250, GTIN 08714729960911, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
    Category
    Medical Device
    Distribution
    38 states
  • SevereFDA (Devices)·Z-0816-2021·2021-01-20

    Fresenius NaturaLyte Liquid Acid Concentrate Recall for Low Sodium Levels

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate bottles because sodium and/or calcium levels were below manufacturing specifications.

    Product
    NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2301-3 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0226-2021·2021-01-20

    Edge Pharma Recalls Methotrexate Syringes Due to Sterility Testing Concerns

    Edge Pharma, LLC is recalling 71 syringes of Methotrexate USP Sterile Solution for Injection because the media used for post-compounding sterility testing was expired.

    Product
    Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml (25mg/ml), 5 mL per syringe, Rx Only, SYRINGE FOR IM INJECTION, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178, Barcode 0544650505
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0222-2021·2021-01-20

    Paroex Oral Rinse Recalled for Potential Bacterial Contamination

    Sunstar Americas is recalling Paroex Oral Rinse due to potential Burkholderia cepacia complex contamination and manufacturing facility violations.

    Product
    Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 052376-021-04, Sunstar Americas, Inc., Schaumburg, IL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0728-2021·2021-01-20

    Boston Scientific Recalls Lotus Edge Valve Systems Due to Deployment Failure Risk

    Boston Scientific is recalling 219 Lotus Edge Valve Systems because a visual inspection error could prevent the delivery system from releasing during deployment.

    Product
    Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVSUS230, GTIN 08714729960904
    Category
    Medical Device
    Distribution
    38 states
  • SevereFDA (Devices)·Z-0828-2021·2021-01-20

    Fresenius Citrasate Liquid Acid Concentrate Recall Due to Low Sodium Levels

    Fresenius Medical Care is recalling 198 drums of Citrasate Liquid Acid concentrate because sodium and/or calcium levels were below manufacturing specifications.

    Product
    Citrasate Liquid Acid concentrate drums, Model Number 13-2251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0829-2021·2021-01-20

    Fresenius Citrasate Liquid Acid concentrate drums recalled for low sodium levels

    Fresenius Medical Care is recalling 176 drums of Citrasate Liquid Acid concentrate because sodium and/or calcium levels were below manufacturing specifications.

    Product
    Citrasate Liquid Acid concentrate drums, Model Number 13-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0203-2021·2021-01-20

    B&G Foods Recalls Garlic Powder With Undeclared Soy Allergen

    B&G Foods is recalling Food Club Garlic Powder because it contains bacon-flavored bits with undeclared soy, a major allergen.

    Product
    Food Club Garlic Powder, 5.37 ounce bottles, 12 bottles per case. " Best 324A0 C By NOV 19 22 / Best 325A0 By NOV 20 22
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0820-2021·2021-01-20

    Fresenius NaturaLyte Liquid Acid Concentrate Recall for Low Sodium Levels

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate bottles because sodium and/or calcium levels were below manufacturing specifications.

    Product
    NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0819-2021·2021-01-20

    Fresenius NaturaLyte Liquid Acid Concentrate Recall for Low Sodium Levels

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate bottles because sodium and/or calcium levels were below manufacturing specifications.

    Product
    NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3231-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0812-2021·2021-01-20

    Fresenius NaturaLyte Liquid Acid Concentrate Recall for Low Sodium Levels

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate bottles because sodium and/or calcium levels were below manufacturing specifications.

    Product
    NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1301-4 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0832-2021·2021-01-20

    Fresenius Naturalyte Liquid Acid concentrate bottles recalled for conductivity deviation

    Fresenius Medical Care is recalling Naturalyte Liquid Acid concentrate bottles due to deviations in sodium conductivity and calcium concentration.

    Product
    Naturalyte Liquid Acid concentrate bottles, Product Code 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0268-2021·2021-01-20

    Western Mixers Trail Mix Recalled for Undeclared Cashews

    Western Mixers is recalling specific lots of Goody Goody Trail Mix in California due to undeclared cashews, a tree nut allergen.

    Product
    First Street Goody Goody Trail Mix 10 oz. (283g)S&F Item#52892 Unit UPC# 797565204201; First Street Goody Goody Trail Mix 16 oz. (454g) S&F Item#52651 Unit UPC# 797565204225; Western Mixers Goody Goody Trail Mix 10 oz. (283g) Unit UPC# 797565210363 Packed in clear plasti
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0858-2021·2021-01-20

    GE Healthcare Recalls Optima NM/CT 640 Due to Loose Rotor Bearing Screws

    GE Healthcare is recalling seven Optima NM/CT 640 units because loose rotor bearing screws caused a bearing release in one field unit.

    Product
    Optima NM/CT 640, Model number 3101RL - Product Usage: intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0231-2021·2021-01-20

    SAMYANG Hot Chicken Flavor Sauce Recalled for Undeclared Allergens

    BLUE STONE IMPORT USA INC is recalling SAMYANG Hot Chicken Flavor Sauce because it contains undeclared wheat, egg, and milk.

    Product
    SAMYANG Buldak Hot Chicken Flavor Sauce - Extremely Spicy, Hot Chili Sauce, Net Wt.: 200g (7.05oz)
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0206-2021·2021-01-20

    Netuno Caribbean Red Snapper Recalled for Potential Salmonella Contamination

    Netuno USA, Inc. is recalling 500 cases of Caribbean Red Snapper due to potential Salmonella contamination. The product was distributed in Puerto Rico.

    Product
    NETUNO Caribbean Red Snapper, Net Weight 10 Lbs (4.54 Kg), Item 101229, Product Must be Fully Cooked Prior to Consumption, 1.5-2.0 LB
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0833-2021·2021-01-20

    Fresenius Naturalyte Liquid Acid concentrate bottles recalled for conductivity deviation

    Fresenius Medical Care is recalling Naturalyte Liquid Acid concentrate bottles due to deviations in sodium conductivity and calcium concentration.

    Product
    Naturalyte Liquid Acid concentrate bottles, Product Code 08-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0825-2021·2021-01-20

    Fresenius NaturaLyte Liquid Acid concentrate drums recalled for low sodium levels

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate drums because sodium and/or calcium levels were below manufacturing specifications.

    Product
    NaturaLyte Liquid Acid concentrate drums, Model Number 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0854-2021·2021-01-20

    GE Healthcare Recalls 12 NM/CT 860 Systems Due to Loose Rotor Bearing Screws

    GE Healthcare is recalling 12 NM/CT 860 systems because loose rotor bearing screws caused a bearing release in one field unit.

    Product
    GE NM/CT 860 system Model Number H3908AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0837-2021·2021-01-20

    Fresenius Naturalyte Liquid Acid concentrate bottles recalled for conductivity deviation

    Fresenius Medical Care is recalling Naturalyte Liquid Acid concentrate bottles due to deviations in conductivity and calcium concentration.

    Product
    Naturalyte Liquid Acid concentrate bottles, Product Code 08-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0861-2021·2021-01-20

    Siemens Atellica CH 930 Analyzer Software Recall for Discrepant Results

    Siemens Healthcare Diagnostics is recalling Atellica CH 930 Analyzers with software version 1.23.2 or lower because multiple software issues may lead to the reporting of discrepant patient results.

    Product
    Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11067000 - Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0805-2021·2021-01-20

    Siemens Uroskop Omnia X-ray System Recalled for Support Arm Risk

    Siemens is recalling six Uroskop Omnia X-ray systems because the monitor support arm may become dislodged after intense, long-term use.

    Product
    Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery).
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0855-2021·2021-01-20

    GE Healthcare Recalls NM/CT 870 CZT Systems Due to Loose Rotor Screws

    GE Healthcare is recalling 12 NM/CT 870 CZT systems because loose rotor bearing screws may cause a bearing to release.

    Product
    GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·21V015000·2021-01-20

    2021 Keystone Crossroads Redwood Recreational Trailers U-bolt Suspension Recall

    Keystone RV Company is recalling certain 2021 Crossroads Redwood recreational trailers because U-bolts on the rear axles may have been improperly torqued, causing them to loosen and the axle to shift, which increases crash risk.

    Product
    KEYSTONE — KEYSTONE CROSSROADS REDWOOD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0232-2021·2021-01-20

    SAMYANG Buldak Hot Chicken Flavor Sauce Recalled for Undeclared Allergens

    Blue Stone Import USA Inc. is recalling SAMYANG Buldak Hot Chicken Flavor Sauce due to undeclared wheat, egg, and coconut oil.

    Product
    SAMYANG Buldak Hot Chicken Flavor Sauce - Carbonara, Hot Chili Sauce, Net Wt.: 200g (7.05oz)
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0835-2021·2021-01-20

    Fresenius Naturalyte Liquid Acid Concentrate Recall for Conductivity Deviation

    Fresenius Medical Care is recalling Naturalyte Liquid Acid concentrate bottles due to conductivity deviations and low calcium levels.

    Product
    Naturalyte Liquid Acid concentrate bottles, Product Code 08-2301-3 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0204-2021·2021-01-20

    Frozen Ground Tuna Recalled for Elevated Histamine Levels

    Ocean Providence Minneapolis LLC is recalling 790 lbs of frozen ground tuna due to elevated histamine levels. The product was distributed in five states.

    Product
    Frozen Ground Tuna, Wild Caught, Production Date: 06/01/2020. Product of Vietnam, Net Wt: 11 lbs. x 2: 22 lbs. Imported by Khee Trading, Inc., Compton, CA 90221 The ground tuna comes in a 22 lb. master carton that has two 11 lb. inner cartons. Inner cartons have 11 packs of
    Category
    Food
    Distribution
    5 states

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