The Recall Desk

Archive

November 2020 recalls

382 recalls were announced in November 2020.

What the numbers show

Critical
11
Severe
85
High
183
Moderate
78
Low
25

Of the 382 recalls this month scored against our rubric, 3% are Critical, 22% are Severe.

Which agencies issued them

301–382 of 382

  • LowFDA (Devices)·Z-0417-2021·2020-11-11

    Synthes SynMesh Cages Recalled for Incorrect Statutory Labeling

    Synthes (USA) Products LLC is recalling 18 units of SynMesh Cages due to incorrect statutory labeling. The devices were distributed only in Japan.

    Product
    3.0MM LOCKING SCREW LOW PROFILE (TI) Product Number: 495-491 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suit
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0415-2021·2020-11-11

    Synthes Vertebral Body Replacement Device Recalled for Labeling Error

    Synthes (USA) Products LLC is recalling 7 units of the Standard Ring 17mm x 22mm (Ti) vertebral body replacement device due to an incorrect statutory label.

    Product
    STANDARD RING 17MM X 22MM (TI) Product Number: 495-405 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to th
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-0064-2021·2020-11-11

    Teligent Pharma Recalls Fluocinonide Ointment Due to Impurity

    Teligent Pharma is recalling Fluocinonide Ointment USP 0.05% due to out-of-specification impurity results.

    Product
    Fluocinonide Ointment USP 0.05%, packaged in: a) 15 gm tube, NDC 52565-0040-15, b) 30 gm tube, NDC 52565-0040-30 c) 60 gram tube, NDC 52565-0040-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0412-2021·2020-11-11

    Synthes SynMesh Cage System Recalled for Incorrect Labeling

    Synthes (USA) Products LLC is recalling 4 units of the SynMesh Cage System because the statutory label incorrectly stated 'general medical device' instead of 'specially controlled medical device'.

    Product
    END RING 17MM X 22MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495.394 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration th
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0416-2021·2020-11-11

    Synthes SynMesh Cage System Recalled for Incorrect Labeling

    Synthes (USA) Products LLC is recalling 6 units of the SynMesh Cage System because the statutory label incorrectly identified the device as a 'general medical device' instead of a 'specially controlled medical device.'

    Product
    STANDARD RING 22MM X 28MM (TI) Product Number: 495-406 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to t
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0406-2021·2020-11-11

    Synthes Recalls SYN MESH Cages Due to Incorrect Labeling

    Synthes (USA) Products LLC is recalling 9 units of SYN MESH vertebral body replacement devices because the statutory label incorrectly identifies them as 'general medical device' instead of 'specially controlled medical device.'

    Product
    SYNMESH 17MM X 22MM 88MM HEIGHT (TI) Product Number: 495-374 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suit
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0409-2021·2020-11-11

    Synthes SynMesh Cage System Recalled for Incorrect Statutory Labeling

    Synthes (USA) Products LLC is recalling 18 units of the SynMesh Cage System because the statutory label incorrectly identified the device as a 'general medical device' instead of a 'specially controlled medical device.'

    Product
    END RING 12MM DIA/0 DEG (TI) Product Number: 495.385 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the
    Category
    Medical Device
    Distribution
    0 states
  • SevereNHTSA·20V692000·2020-11-10

    Ford Recalls Explorer, Taurus, and Edge for Drive Axle Bracket Failure

    Ford is recalling 2014-2016 Explorer, 2014-2015 Taurus, and 2014 Edge vehicles because a front drive axle bracket may fail, risking loss of park function or motive power.

    Product
    FORD — FORD TAURUS, EXPLORER, EDGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V695000·2020-11-10

    2021 Winnebago Micro Minnie Trailers Undersized Axles Recall

    Winnebago is recalling certain 2021 Micro Minnie trailers equipped with undersized axles that may break under the vehicle's weight, potentially causing serious injury or death.

    Product
    WINNEBAGO — WINNEBAGO MICRO MINNIE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·21024·2020-11-10

    Kohl's Recalls SONOMA Goods For Life Three-Wick Candles Due to Fire Hazards

    Kohl's is recalling approximately 512,000 SONOMA Goods For Life three-wick candles because high flames can ignite wax or break glass, posing fire and burn risks.

    Product
    SONOMA Goods For Life branded three-wick candles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V694000·2020-11-10

    Land Rover Recalls 2019-2020 Discovery Models for Electrical Faults

    Jaguar Land Rover is recalling 2019-2020 Discovery vehicles because a loose battery ground stud may cause electrical power loss or vehicle shutdown while driving.

    Product
    LAND ROVER — LAND ROVER DISCOVERY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·21027·2020-11-10

    Sunjoy Oakmont LP Fire Pit Tables Recalled for Fire Hazard

    Sunjoy is recalling Oakmont LP fire pit tables sold at Big Lots because an incorrectly installed hose can melt and ignite, posing a fire hazard.

    Product
    Oakmont LP fire pit tables
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·21028·2020-11-10

    Ring Recalls 2nd Generation Video Doorbells Due to Fire Hazard

    Ring is recalling approximately 350,000 2nd Generation Video Doorbells because incorrect installation screws can cause the battery to overheat, posing fire and burn risks.

    Product
    Ring Video Doorbells (2nd Generation)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·21029·2020-11-10

    Wintergreen Essential Oil Recalled for Non-Child-Resistant Packaging

    Bolek's Craft Supplys is recalling Crafty Bubbles Wintergreen Essential Oil because the bottles do not meet child-resistant packaging requirements, posing a poisoning risk to young children.

    Product
    Crafty Bubbles Wintergreen Essential Oil
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·21026·2020-11-10

    Arena Swim Snorkels Recalled by CPSC Due to Choking Hazard

    Arena North America is recalling specific swim snorkels because they can release material that poses a choking hazard. One report of a piece being inhaled has been received.

    Product
    Arena Swim Snorkels Pro II and Swim Snorkels II
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·21025·2020-11-10

    Salsa Cutthroat Bicycles Recalled Due to Fork Crack Injury Hazard

    Quality Bicycle Products is recalling Salsa Cutthroat bicycles because the fork legs can crack or break, posing a fall hazard to riders.

    Product
    Salsa Cutthroat Bicycles and Forks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·20V691000·2020-11-10

    2021 Ford F-650 and F-750 Transmission Cooling Line Fire Risk Recall

    Ford is recalling certain 2021 F-650 and F-750 vehicles because the transmission oil cooler line may contact the air conditioning compressor pulley, potentially causing a transmission fluid leak that could lead to an engine compartment fire.

    Product
    FORD — FORD F-650, F-750
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V690000·2020-11-09

    Thomas Built Buses Minotour Recalled for Wheelchair Lift Safety Defect

    Daimler Trucks North America is recalling 2008-2021 Thomas Built Buses Minotour school buses because the wheelchair lift may allow the vehicle to move, increasing injury risk.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES MINOTOUR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V689000·2020-11-06

    Autocar Xpeditor and Legend suspension bolts may fail and disconnect

    Autocar is recalling 2020-2021 Xpeditor and Legend vehicles because transverse torque rod mounting bolts may not be properly tightened. If bolts fail and disconnect, vehicles could lose suspension control, increasing crash risk.

    Product
    AUTOCAR — AUTOCAR LEGEND, XPEDITOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20E083000·2020-11-06

    First Light Recalls Illuminated School Bus Stop Signs Due to Seal Defect

    First Light Safety Products is recalling illuminated school bus stop signs sold for specific bus models between April and October 2020. A defective weather seal may allow contaminants to enter, potentially causing electrical shorts and rendering the signs inoperable.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V687000·2020-11-06

    2020-2021 Autocar Xpeditor ground cable may cause engine stall

    Certain 2020-2021 Autocar Xpeditor vehicles with X12N engines may have a ground cable that is too short and could fail, causing engine stall without restart capability. Autocar will replace the cable free of charge.

    Product
    AUTOCAR — AUTOCAR XPEDITOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V686000·2020-11-05

    Freightliner Recalls Econic SD Trucks for Electrical Fire Risk

    Daimler Trucks North America is recalling 2019-2021 Freightliner Econic SD vehicles because damaged electrical cables may cause a fire or engine stall.

    Product
    FREIGHTLINER — FREIGHTLINER ECONIC SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V683000·2020-11-05

    Land Rover Recalls 2020 Models Due to Electrical Fire Risk

    Jaguar Land Rover is recalling 2020 Discovery Sport and Range Rover Evoque MHEV vehicles because an electrical short-circuit could cause a fire.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER EVOQUE, DISCOVERY SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V685000·2020-11-05

    Nissan Recalls 2020 Altima Vehicles Due to Over-Cured Tires

    Nissan is recalling 2,214 2020 Altima S vehicles because specific Continental tires may be over-cured, increasing the risk of a crash.

    Product
    NISSAN — NISSAN ALTIMA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V684000·2020-11-05

    2020 Chevrolet Silverado 1500 Overcured Tire Recall May Increase Crash Risk

    General Motors is recalling certain 2020 Chevrolet Silverado 1500 vehicles with overcured Continental tires that may experience sudden air loss or tread separation, increasing crash risk.

    Product
    GMC — GMC, CHEVROLET, BUICK ACADIA, TRAVERSE, ENCLAVE, XT5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V681000·2020-11-04

    Volvo Recalls S60 and S80 Vehicles Due to Air Bag Inflator Defect

    Volvo is recalling 2001-2003 S60 and S80 vehicles because the driver-side air bag inflator may rupture, sending metal fragments into the vehicle.

    Product
    VOLVO — VOLVO S60, S80
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0054-2021·2020-11-04

    Bausch Health Recalls Subpotent Hydrocortisone Butyrate Cream

    Bausch Health is recalling 35,424 tubes of Hydrocortisone butyrate Cream, 0.1%, because the product was found to be subpotent.

    Product
    Hydrocortisone butyrate Cream, 0.1%, 15-gram tubes, Rx Only, Manufactured for Oceanside Pharmaceuticals a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA, By: Ferndale Laboratories, Inc. Ferndale, MI 48220, NDC 68682-270-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0050-2021·2020-11-04

    RemedyRepack Recalls Metformin Hydrochloride Extended Release Due to NDMA Impurity

    RemedyRepack Inc. is recalling Metformin Hydrochloride Extended Release 750 mg tablets because of detected NDMA impurity levels above acceptable intake limits.

    Product
    Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA NDC 70518-2480-00
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0290-2021·2020-11-04

    GORE TAG CONFORMABLE Thoracic Stent Graft Recall for Deployment Issue

    W L Gore is recalling GORE TAG CONFORMABLE Thoracic Stent Grafts because a secondary deployment fiber attachment prevented completion of deployment via the access hatch.

    Product
    GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V682000·2020-11-04

    Toyota and Lexus Recall Vehicles for Fuel Pump Failure Risk

    Toyota is recalling over 1.5 million vehicles because a fuel pump defect may cause the engine to stall while driving, increasing crash risk.

    Product
    LEXUS — LEXUS, TOYOTA RX350, LC500, LS500, LS HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V678000·2020-11-04

    Certain 2020-2021 BMW X5, X6, X7 models: suspension weld separation

    Certain 2020-2021 BMW X5, X6, X7, and related models have a front axle support weld that may separate, potentially affecting vehicle handling and control and increasing crash risk.

    Product
    BMW — BMW X6 M, X5, X6, X7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V680000·2020-11-04

    Transcraft Recalls Platform Trailers Due to Detaching Wheel Stops

    Transcraft is recalling 2016-2021 Platform trailers because adjustable wheel stops may detach, increasing the risk of crash or injury.

    Product
    TRANSCRAFT — TRANSCRAFT PLATFORM TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0293-2021·2020-11-04

    Pentax 9310HD Digital Video Capture Module Recalled for Software Error

    Pentax of America Inc is recalling 39 units of the 9310HD Digital Video Capture Module due to a software issue that may copy patient exam videos to the wrong record.

    Product
    9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0283-2021·2020-11-04

    Intuitive Surgical Recalls da Vinci Xi Endoscope Controller for Calibration Error

    Intuitive Surgical is recalling one da Vinci Xi Endoscope Controller because improper calibration may cause the endoscope tip to reach higher temperatures, potentially leading to thermal tissue injury.

    Product
    da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601-16 (UDI: 00886874114193) is included in the IS 4000 Vision Cart, Model Number: 381121-31 (UDI 00886874110898) - Product Usage: used with an endoscope, surgical instruments, and accessories to perform mi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21021·2020-11-04

    Target Recalls Cat & Jack Toddler Boots Due to Choking Hazard

    Target is recalling approximately 122,500 Cat & Jack toddler boots because the toggle can detach, posing a choking hazard to children.

    Product
    Cat & Jack "Himani" and "Jaren" Toddler Boots
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0285-2021·2020-11-04

    Philips Recalls Sterilizable Defibrillator Paddles Due to Undetected Failure Mode

    Philips is recalling 2,202 sterilizable defibrillator paddles because standard periodic checks may fail to detect a specific failure mode in switchless internal models.

    Product
    Philips Sterilizable Defibrillator Paddles, Switchless Internal Paddles, Model Numbers M1741A, M1742A, M1743A, M1744A - Product Usage: used in pairs to transmit a controlled electrical shock from an external defibrillator directly to the exposed heart muscle of a post-pubescent p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21018·2020-11-04

    Rogue Home Timers Recalled by CPSC Due to Fire Hazard

    Coulter Ventures is recalling Rogue Home Timers because the lithium-ion battery can overheat and burn, posing a fire hazard.

    Product
    Rogue Home Timers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0291-2021·2020-11-04

    GORE TAG Stent Graft Recalled Due to Delivery Catheter Removal Issue

    W.L. Gore is recalling GORE TAG stent grafts because the delivery catheter could not be withdrawn after implantation.

    Product
    GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0292-2021·2020-11-04

    Pentax 9372HD Digital Capture Software Recall for Patient Data Error

    Pentax of America Inc. is recalling 39 units of the 9372HD Digital Capture system due to a software issue that may copy exam videos to the wrong patient.

    Product
    9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V679000·2020-11-04

    Thor Motor Coach Recalls 2010-2011 Four Winds Montecito Motorhomes

    Thor Motor Coach is recalling 2010-2011 Four Winds Montecito motorhomes because a transfer switch may fail due to heat, increasing fire risk.

    Product
    FOUR WINDS — FOUR WINDS MONTECITO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0309-2021·2020-11-04

    Battelle Recalls Critical Care Decontamination System N95 Respirators

    Battelle Memorial Institute is recalling 898 N95 respirators decontaminated by its Critical Care Decontamination System. The recall is due to a failure to maintain required condensation levels during the decontamination cycle.

    Product
    Critical Care Decontamination System (CCDS) Compatible N95 respirators - Product Usage: Used in decontaminating compatible N95 respirators2 for multiple-user3 reuse by healthcare personnel (HCP)4 to prevent exposure to pathogenic biological airborne particulates when there are
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0301-2021·2020-11-04

    Smith & Nephew Recalls 5.5MM Arthrogarde Hip Access Cannula

    Smith & Nephew is recalling 143 units of 5.5MM Arthrogarde Hip Access Cannulas because the J Lock feature was manufactured incorrectly, preventing proper locking into irrigation extenders or arthroscopes.

    Product
    5.5MM Arthrogarde Hip Access Cannula
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-0299-2021·2020-11-04

    RTI Surgical Recalls Streamline MIS Navigation System Taps Due to Binding

    RTI Surgical is recalling 420 units of Streamline MIS Navigation System Taps because they have experienced binding with other devices.

    Product
    Streamline MIS Navigation System Taps, Catalog Nos. 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNTAP-55-MDN 04-CANNTAP-65-MDN 04-CANNTAP-75-MDN 04-CANNTAP-85-MDN 04-CTAP-TT-65-MDN 04-S-FINDER-MDN 05-SCREWINS-CL-MDN 05-SIMPDRIVER-MDN Product Usage: i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-11042020-01·2020-11-04

    Kwik Trip Spaghetti and Meatballs Recalled for Metal Contamination

    USDA FSIS issued a public health alert for Kwik Trip spaghetti and meatballs in marinara sauce due to possible metal contamination. Consumers should not eat these products.

    Product
    Kwik Trip, Inc. — FSIS Issues Public Health Alert for Spaghetti and Meatballs in Marinara Sauce Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0284-2021·2020-11-04

    Philips Recalls Sterilizable Defibrillator Paddles Due to Undetected Failure Mode

    Philips is recalling 8,942 sterilizable defibrillator paddles because standard checks may miss a specific failure mode. An updated test procedure is available to detect the issue.

    Product
    Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles, Model Numbers M4741A, M4742A, M4743A, M4744A - Product Usage: used in pairs to transmit a controlled electrical shock from an external defibrillator directly to the exposed heart muscle of a post-pubescent pat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0072-2021·2020-11-04

    Eishindo Cup Jelly Mini Recalled for Choking Hazard

    Hadson (Toko) Trading Co., Inc. is recalling Eishindo brand Cup Jelly (Mini) because the product poses a choking hazard.

    Product
    Eishindo brand "CUP JELLY (MINI); NET WT. 28.2oz (800g); 50pcs; INGREDIENTS: WATER, HIGH FRUCTOSE SYRUP, APPLE JUIC, CARAGEENAN, CITRIC ACID, ARTIFICIAL FLAVOR, FD&C YELLOW NO. 5 TARTRAZINE, FD&C YELLOW NO. 6 SUNSET YELLOW FCF, FD&C BLUE NO.1 BRILLIANT BLUE FCF AND FD&C RED NO. 4
    Category
    Food
    Distribution
    21 states
  • HighFDA (Devices)·Z-0305-2021·2020-11-04

    CMEAmerica BodyGuard Wall Charger Recalled for Charging Defect

    CME America LLC is recalling 27 BodyGuard Wall Chargers because they may not properly charge the infusion pump battery.

    Product
    CMEAmerica BodyGuard Wall Charger: Lot number 2019-0364, Mode/Catalogue number 151-143XL, *+B 01151143X L0/$$72019-0364/ 16D20191101/* Lot Number Label: BODYGUARD LOT 2019-0364 Manufacturing Date: 2019 - 11-01 , LABEL I.D. SM-0642 REV. 01, CMEAmerica Wall Charger Kit, REF 1
    Category
    Medical Device
    Distribution
    3 states
  • HighCPSC·21020·2020-11-04

    YETI Rambler Travel Mugs Recalled Due to Lid Ejection and Burn Hazards

    YETI is recalling Rambler 20 oz Travel Mugs with Stronghold Lids because the magnetic slider can eject, causing hot liquid to spill and posing burn risks.

    Product
    Rambler® 20 oz Travel Mugs with Stronghold Lids
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0286-2021·2020-11-04

    Boston Scientific Recalls Hurricane RX Biliary Balloon Catheters Due to Detachment Risk

    Boston Scientific is recalling Hurricane RX Biliary Balloon Dilatation Catheters because the black sheath may detach from the shaft. The recall covers 15,062 units in the US and 12,930 internationally.

    Product
    Hurricane RX Biliary Balloon Dilatation Catheter Catalog REF No. M00545890; M00545900; M00545910; M00545920; M00545930; M00545940; M00545950; M00545960 The device is a double lumen catheter with a balloon mounted at the distal tip. Dilatation balloon catheters are used to exe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0306-2021·2020-11-04

    GE Healthcare Recalls CT Scanners Due to Potential Image Artifacts

    GE Healthcare is recalling 64 CT scanners worldwide because incorrect settings may cause smudge artifacts that could be mistaken for pathology.

    Product
    Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0065-2021·2020-11-04

    Hu Chocolate-Covered Cashews Recalled for Undeclared Almonds

    Hu Products is recalling chocolate-covered cashews that may contain undeclared almonds. Consumers with tree nut allergies should not consume the product.

    Product
    Primary/Retail Package labeled in part: "Hu; CHOCOLATE-COVERED HUNKS CASHEWS + VANILLA BEAN; VEGAN; ORGANIC; PALEO; Net Wt. 4 oz (113g); Ingredients: organic cashews, organic cacao, organic unrefined coconut sugar, organic fair-trade cocoa butter, sea salt, organic vanilla bean;
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0053-2021·2020-11-04

    Boehringer Ingelheim Recalls Catapres Tablets Due to Dissolution Testing Anomaly

    Boehringer Ingelheim is recalling specific lots of Catapres tablets because an extraneous peak was observed during dissolution testing.

    Product
    Catapres (clonidine hydrochloride, USP) 0.3 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0011-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0069-2021·2020-11-04

    Happy Kid Gluten Free Fruit & Oat Bar Recalled for Mold Growth

    Nurture Inc. is recalling Happy Kid Gluten Free Fruit & Oat Bars due to mold growth. Consumers should stop eating the product and return it to the store.

    Product
    Happy Kid Gluten Free Fruit & Oat Bar Organic Blueberry & Raspberry. SKU: KB-BLRB-5. Ready-to-eat granola bar intended for toddler consumption. Each bar packaged in film (0.99 oz(28g) and packed in 5 pack box (Net Wt. 4.95 OZ (140g). UPC code: 819573014389.
    Category
    Food
    Distribution
    40 states
  • ModerateFDA (Drugs)·D-0302-2021·2020-11-04

    Jarrow Formulas Recalls N-A-C Capsules Due to Mislabeling

    Jarrow Formulas is recalling 533 units of N-A-C 500 mg capsules because they were mislabeled as a different product.

    Product
    N-A-C (N-Acetyl-L-Cysteine, 500 mg, 100 capsules; Veggie Caps, white HDPE bottle with RED label Product # 107002 UPC: 790011070023
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0052-2021·2020-11-04

    Boehringer Ingelheim Recalls Catapres Tablets Due to Dissolution Testing Anomaly

    Boehringer Ingelheim is recalling specific Catapres tablets because an extraneous peak was observed during dissolution testing. The recall covers products distributed nationwide and in Puerto Rico.

    Product
    Catapres (clonidine hydrochloride, USP) 0.2 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0007-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0070-2021·2020-11-04

    Capital Seaboard Recalls Frozen Raw Shrimp Due to Import Alert Violation

    Capital Seaboard is recalling Gracie's Pointe frozen raw shrimp because it was inadvertently released for distribution while under an FDA import alert.

    Product
    Gracie's Pointe frozen raw shrimp. 1. 8/12 Count Per Pound Tail On, UPC: 849558095034 2. 21/25 Count Per Pound Tail Off, UPC: 849558095065 3. 31/40 Count Per Pound Tail Off, UPC: 849558095072 4. 16/20 Count Per Pound EZ Peel UPC: 849558095003 5. 16/20 Count Per Pound Tail O
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-0068-2021·2020-11-04

    Happy Tot Gluten Free Oat Bars Recalled for Mold Growth

    Nurture Inc. is recalling Happy Tot Superfoods Gluten Free Oat Bars due to mold growth. The product is intended for toddler consumption.

    Product
    Happy Tot Superfoods Gluten Free Oat Bar Organic Bananas, Strawberries, & Sunflower Butter. SKU: TB-BASTSB-5 and TB-BASTSB-5-WM. Ready-to-eat granola bar intended for toddler consumption. Each bar packaged in film (0.88 oz (25g) and packed in a 5 pack box (net wt. 4.4 OZ (125
    Category
    Food
    Distribution
    40 states
  • ModerateFDA (Food)·F-0067-2021·2020-11-04

    Happy Tot Gluten-Free Oat Bars Recalled Due to Mold Growth

    Nurture Inc. is recalling Happy Tot Superfoods Gluten Free Oat Bars because mold growth was observed. The affected bars are intended for toddler consumption.

    Product
    Happy Tot Superfoods Gluten Free Oat Bar Organic Blueberries & Oatmeal. SKU: TB-BLOT-5 and TB-BLOT-5-WM. Ready-to-eat granola bar intended for toddler consumption. Each bar packaged in film (0.88 oz (25g) and packed in a 5 pack box (net wt. 4.4 OZ (125g). UPC code: 8195730150
    Category
    Food
    Distribution
    40 states
  • ModerateFDA (Devices)·Z-0287-2021·2020-11-04

    Boston Scientific Recalls Visual-ICE MRI Cryoablation System Mobile Connection Panel

    Boston Scientific is recalling one unit of the Visual-ICE MRI Cryoablation System Mobile Connection Panel due to an incorrectly installed base.

    Product
    Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP) - Product Usage: The system is computer-controlled with a touch screen user interface that allows the user to control and monitor the procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0297-2021·2020-11-04

    Quidel Triage BNP Calibrators Recalled Due to Shipment Compromise

    Medline Industries is recalling 26 Quidel Triage BNP Calibrators because the product was compromised during shipment. The recall affects domestic distribution in CA, NY, TX, and VA.

    Product
    The Quidel Triage BNP Calibrators
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0308-2021·2020-11-04

    Exactech Recalls Equinoxe Platform Fracture Stem Due to Incorrect Laser Marking

    Exactech is recalling 12 Equinoxe Platform Fracture Stems because they may be incorrectly laser marked as right stems when they are left stems.

    Product
    Equinoxe Platform Fracture Stem, 6.5mm, Right - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0303-2021·2020-11-04

    Microbiologics Recalls KWIK-STIK Klebsiella Pneumoniae Due to Incorrect Strain

    Microbiologics Inc is recalling KWIK-STIK Klebsiella pneumoniae units because the product was confirmed to be NDM-1 negative instead of the required NDM-1 positive strain.

    Product
    Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or f
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0304-2021·2020-11-04

    Microbiologics Recalls KWIK-STIK 2 Pack Due to Incorrect NDM-1 Strain

    Microbiologics Inc is recalling KWIK-STIK 2 Pack units where the NDM-1 positive strain was confirmed to be negative.

    Product
    Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or f
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0307-2021·2020-11-04

    Exactech Recalls Equinoxe Platform Fracture Stem Due to Incorrect Laser Marking

    Exactech is recalling 25 Equinoxe Platform Fracture Stems because they may be incorrectly laser marked as right stems instead of left stems.

    Product
    Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0294-2021·2020-11-04

    Bard 3F SL PowerMidline Kit Recalled for Missing Stylet Assembly

    Becton Dickinson is recalling 45 Bard 3F SL PowerMidline kits in Italy, Spain, and the UK because they lack the stylet/T-lock assembly listed on the label.

    Product
    Bard 3F SL PowerMidline Basic Kit CE-indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media Ref: P6153118
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0051-2021·2020-11-04

    Boehringer Ingelheim Recalls Catapres Tablets Due to Dissolution Testing Anomaly

    Boehringer Ingelheim is recalling Catapres tablets because an extraneous peak was observed during dissolution testing. The affected lots were distributed nationwide and in Puerto Rico.

    Product
    Catapres (clonidine hydrochloride, USP) 0.1 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0006-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0288-2021·2020-11-04

    Blue Ortho Recalls GPS Tracker Instructions Due to Sterilization Language

    Blue Ortho is recalling 3,471 GPS Tracker Instructions For Use documents because some low-temperature sterilization conditions were approved based on rational documents.

    Product
    Instructions For Use document of the GPS Trackers.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0300-2021·2020-11-04

    RTI Surgical Recalls Streamline TL Navigation System Taps Due to Binding

    RTI Surgical is recalling 420 units of Streamline TL Navigation System taps because they have experienced binding with other devices.

    Product
    Streamline TL Navigation System, Catalog Nos. 02-C-TAP-55-MDN 02-C-TAP-60-L-MDN 02-C-TAP-65-L-MDN 02-C-TAP-65-MDN 02-C-TAP-75-L-MDN 02-C-TAP-85-L-MDN 02-C-TAP-85-MDN 02-C-TAP-95-L-MDN 02-RS-INS-C-MDN 02-RS-INSERTER-MDN 02-SCREWINS-CL-MDN 02-SCREWINS-C-MDN 02-S-FIN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0295-2021·2020-11-04

    Becton Dickinson Recalls Bard 3F SL PowerMidline Full Kits

    Becton Dickinson is recalling Bard 3F SL PowerMidline Full Kits because they may lack the stylet/T-lock assembly, potentially causing procedural delays.

    Product
    Bard 3F SL PowerMidline Full Kit CE-indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media Ref: P6153208
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0302-2021·2020-11-04

    Microbiologics Recalls KWIK-STIK Klebsiella Pneumoniae Culture Units

    Microbiologics Inc is recalling KWIK-STIK Klebsiella pneumoniae units that were confirmed to be NDM-1 negative instead of the required NDM-1 positive strain.

    Product
    Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or f
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0298-2021·2020-11-04

    Siemens Artis one Fluoroscopic X-Ray Systems Recalled for Monitor Malfunction

    Siemens Medical Solutions is recalling 22 Artis one systems because the examination room monitor may become intermittently dysfunctional, causing display issues.

    Product
    Siemens Artis one systems with a Display Port transceiver-Fluoroscopic X-Ray System Model: 10848600 - Product Usage: he examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions. The Artis one can also support the acquisition
    Category
    Medical Device
    Distribution
    Distributed nationwide

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