The Recall Desk

Archive

May 2021 recalls

517 recalls were announced in May 2021.

What the numbers show

Critical
40
Severe
132
High
234
Moderate
95
Low
16

Of the 517 recalls this month scored against our rubric, 8% are Critical, 26% are Severe.

201–300 of 517

  • HighNHTSA·21V372000·2021-05-20

    Newmar Motorhomes Recalled for Fuel Rail Seal Defect and Fire Risk

    Newmar is recalling 1,294 motorhomes from 2017-2022 due to a defective fuel rail sealing washer that could cause fuel leaks and increase fire risk. Dealers will inspect and replace the affected rails at no cost.

    Product
    NEWMAR — NEWMAR MOUNTAIN AIRE, DUTCH STAR, VENTANA, NEW AIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V373000·2021-05-20

    2021 Nissan Armada Fuel Pump Module Replacement Recall

    Nissan is recalling 2020-2021 Armada and INFINITI QX80 vehicles with V8 engines due to fuel pump module defects. The impeller can swell and bind, causing fuel pump failure and potential engine stall, increasing crash risk.

    Product
    NISSAN — NISSAN, INFINITI ARMADA, QX80
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0792-2021·2021-05-19

    Nature's Sunshine Recalls Vegan Protein Meal Replacement for Potential Milk Traces

    Nature's Sunshine Products is recalling specific lots of Love & Peas Protein Rich Meal Replacement because an ingredient may contain traces of milk, posing a risk to consumers avoiding dairy.

    Product
    Love & Peas Protein Rich Meal Replacement, Sugar Free, 1 LB 9 OZ (713 G) bag, Nature's Sunshine Products, Inc., Spanish Fork, Utah, 84660 (800) 223-8225, naturessunshine.com, UPC 0 99904 03087 9
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0487-2021·2021-05-19

    T. Marzetti Blanched Penne Rigati Recalled for Undeclared Egg Allergen

    T. Marzetti is recalling Blanched Penne Rigati because it contains an undeclared egg allergen. The product was distributed to a single consignee in California.

    Product
    Blanched Penne Rigati 8oz plastic bag 40 bags per case
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-0373-2021·2021-05-19

    Chloraprep One-Step Applicator Recalled for Loose Endcap Releasing Glass Shards

    CareFusion 213, LLC is recalling Chloraprep One-Step applicators because the endcap may fall off during activation, releasing glass shards into the solution.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1541-2021·2021-05-19

    Meridian Revogene RNA Software Upgrade Kits Recalled Due to False Negatives

    Meridian Bioscience is recalling 124 Revogene RNA Software Upgrade Kits because the FDA withdrew the Emergency Use Application after false negative results were reported.

    Product
    Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalog Number: 610240 IVD used to install the Revogene System Software version 4.2.0, import the Revogene Instrument Control Protocol file for RNA-based assay, and install the Assay Definition File (ADF) f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V369000·2021-05-19

    2021–2022 Heavy-Duty Trucks Recalled for Loose Tie Rod Assembly Components

    Daimler Trucks North America is recalling certain 2021–2022 heavy-duty trucks including Freightliner and Western Star models due to potentially loose tie rod clamps. Loose or detached tie rod ends could cause steering loss and increase crash risk.

    Product
    FCCC — FCCC, WESTERN STAR, FREIGHTLINER XB CHASSIS, S2, MT CHASSIS, 5700
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1553-2021·2021-05-19

    ReWalk Robotics Recalls Powered Exoskeletons Due to Fire Risk

    Argo Medical Technologies is recalling ReWalk Personal and R Systems exoskeletons after reports that the waistpack battery packs caught fire while charging.

    Product
    ReWalk Personal 6.0, ReWalk Personal 5.0 and ReWalk R Systems orthotically fits to the lower limbs and part of the upper body and is intended to enable individuals with spinal cord injury at levels T7 to L5 to perform ambulatory functions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1540-2021·2021-05-19

    Meridian Revogene SARS-CoV-2 Test Recalled Due to False Negative Results

    Meridian Bioscience is recalling 376 Revogene SARS-CoV-2 test kits because the FDA withdrew the Emergency Use Application after false negative results were reported.

    Product
    Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) qualitative test run on the Revogene¿ instrument for the detection of SARS-CoV-2 nucleic acid from nasopharyngeal swab (NPS) specimens from individuals susp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V366000·2021-05-19

    International and IC Bus commercial vehicles recalled for fuel rail assembly defect

    Navistar is recalling certain 2018-2021 International and IC Bus commercial vehicles due to a fuel rail assembly defect. A sealing washer may not seat correctly, allowing fuel leaks that could ignite.

    Product
    INTERNATIONAL — INTERNATIONAL, IC BUS DURASTAR, WORKSTAR, HV, MV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·21137·2021-05-19

    Cheyenne Mainstay Folding Chairs and Barstools Recalled for Fall Hazard

    Cheyenne Products is recalling about 795,000 Mainstay folding chairs and barstools because a weld can break, posing a fall hazard. Consumers should stop using them and contact Cheyenne for a refund.

    Product
    Cheyenne Products Mainstay folding metal padded chairs and barstools
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1582-2021·2021-05-19

    ICU Medical Recalls Sprios Male Luer Administration Sets Due to Leakage

    ICU Medical is recalling specific lots of Sprios male luer administration sets due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF 011-H2864-HSR 180 cm (71 IN)APPX 11.5ml, PUR AMBR, Spiros, CAMERA, REG. FLUSSO, BCV, Y-Clave - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserte
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1545-2021·2021-05-19

    GE Healthcare Recalls NM/CT 850 Scanners Due to Radiation Exposure Shift

    GE Healthcare is recalling NM/CT 850 scanners because a specific workflow may cause a 5cm shift in CT radiation exposure, potentially requiring patient re-scans.

    Product
    NM/CT 850 Nuclear Medicine / CT Scanners
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0486-2021·2021-05-19

    Blount Fine Foods Recalls Panera Lobster Bisque for Undeclared Egg

    Blount Fine Foods is recalling 17,992 units of Panera Lobster Bisque because the product contains undeclared noodle with egg. The recall covers 20 states.

    Product
    Panera Lobster Bisque, 16 oz.
    Category
    Food
    Distribution
    20 states
  • HighFDA (Devices)·Z-1583-2021·2021-05-19

    ICU Medical Recalls Spiros Transfer Sets Due to Molding Defect

    ICU Medical is recalling Spiros transfer sets due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF 011-H3597 42 cm (16.5 IN) APPX 2.6ml, PUR TRANSFER SET, Clave ADDITIVE PORT, BCV, Spiros - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1579-2021·2021-05-19

    ICU Medical Recalls Sprios Male Luer Administration Sets Due to Molding Defect

    ICU Medical is recalling specific lots of Sprios male luer administration sets due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF CH3020 40" (102 cm) Appx. 4.8 ml, 20 Drop Admin Set w/In-Line Chamber, 2 Spiros", Hanger - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1573-2021·2021-05-19

    ICU Medical Recalls Oncology Kits Due to Molding Defect

    ICU Medical is recalling specific lots of Oncology Kits with Spinning Spiros due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF CL3946 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1568-2021·2021-05-19

    ICU Medical Recalls Spinning Spiros Male Luers Due to Molding Defect

    ICU Medical is recalling specific lots of Spinning Spiros Closed Male Luers because a molding defect may cause leakage in the inactivated position.

    Product
    REF 20130-01 Spinning Spiros Closed Male Luer, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1566-2021·2021-05-19

    ICU Medical Recalls Spiros Male Luer Extensions Due to Leakage

    ICU Medical is recalling Spiros male luer extensions due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHON VALVE, Spiros LOT 5125197 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1584-2021·2021-05-19

    ICU Medical Recalls Sprios IV Adapters Due to Leakage Defect

    ICU Medical is recalling specific lots of Sprios IV adapters because a molding defect may cause leakage in the inactivated position.

    Product
    REF 034-H2629 Appx 1.0 ml, Adaptador universal para sistemas IV con Spiros" - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V370000·2021-05-19

    Thomas Built School Buses Recalled for Loose Tie Rod Defect

    Daimler Trucks is recalling 2021-2022 Thomas Built school buses due to loose tie rod clamps that could cause steering failure. Approximately 479 vehicles are affected.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER HDX, SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V367000·2021-05-19

    Navistar Recalls 2019-2021 IC Bus RE School Buses for Fuel Leak Risk

    Navistar is recalling 2019-2021 IC Bus RE School Buses because a sealing washer may not seat correctly, causing the high-pressure fuel rail to leak and increasing fire risk.

    Product
    IC BUS — IC BUS RESB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1546-2021·2021-05-19

    GE Healthcare Recalls NM/CT 860 Scanners Due to Radiation Exposure Shift

    GE Healthcare is recalling NM/CT 860 scanners because a specific protocol may cause a 5cm shift in radiation exposure, potentially requiring patient re-scans.

    Product
    NM/CT 860 Nuclear Medicine / CT Scanners
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1551-2021·2021-05-19

    Bard PowerPort duo MRI Implantable Port Recalled for Catheter Function Issues

    Bard Peripheral Vascular Inc is recalling 189 units of PowerPort duo MRI Implantable Ports due to potential catheter flushing difficulties and septum dislodgement.

    Product
    PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829570, UDI: (01) 00801741027192 - Product Usage: The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood produc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1548-2021·2021-05-19

    Atos Medical Recalls Provox Life Night HME Devices Due to Insertion Risk

    Atos Medical AB is recalling Provox Life Night HME devices because they may be incorrectly inserted, potentially blocking the patient's stoma.

    Product
    Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a tracheostoma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1549-2021·2021-05-19

    Abbott NeuroTherm Radiofrequency Generator Recalled for Capacitor Failure

    Abbott is recalling 318 NeuroTherm NT2000iX Radiofrequency Generators due to potential capacitor failure that may cause output loss or smoky odors.

    Product
    NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1547-2021·2021-05-19

    GE Healthcare Recalls NM/CT 870 DR Scanners for Radiation Exposure Shift

    GE Healthcare is recalling NM/CT 870 DR scanners because a specific workflow may cause a shift in CT radiation exposure range, potentially requiring patient re-scans.

    Product
    NM/CT 870 DR Nuclear Medicine / CT Scanners
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21136·2021-05-19

    IKEA Recalls PLA Bowls, Plates, and Mugs Due to Burn Hazard

    IKEA is recalling HEROISK and TALRIKA bowls, plates, and mugs made of PLA material because they can become brittle and break, causing hot contents to leak and burn consumers.

    Product
    IKEA Recalls Bowls, Plates, and Mugs Due to Burn Hazard
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1543-2021·2021-05-19

    Step-Har Medical Recalls Alaris Pump Modules with Impacted Bezel Repair Parts

    Step-Har Medical is recalling two Alaris Pump Modules serviced with non-original bezel repair parts that may crack or separate, potentially causing infusion errors.

    Product
    Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1530-2021·2021-05-19

    St. Jude Medical Recalls Assurity and Endurity Pacemakers Due to Moisture Ingress

    St. Jude Medical is recalling Assurity and Endurity pacemakers because a manufacturing issue with epoxy mixing may allow moisture to enter the device, potentially causing malfunction.

    Product
    ASSURITY Pulse Generator REF PM**** SN ********* ST. JUDE MEDICAL Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1552-2021·2021-05-19

    Bard PowerPort duo M.R.I. Implantable Port Recall for Catheter Issues

    Bard Peripheral Vascular Inc. is recalling 287 PowerPort duo M.R.I. Implantable Ports due to catheter flushing difficulties and septum dislodgement.

    Product
    PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 5829502, UDI: (01)00801741027406 - Product Usage: The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood product
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0791-2021·2021-05-19

    Nature's Sunshine Recalls Vegan Meal Replacement for Potential Milk Traces

    Nature's Sunshine Products is recalling specific lots of Love & Peas Protein Rich Meal Replacement because an ingredient may contain traces of milk, despite the product being labeled vegan and dairy-free.

    Product
    Love & Peas Protein Rich Meal Replacement, 1 LB 8 OZ (675 G) bag, Nature's Sunshine Products, Inc., Spanish Fork, Utah, 84660 (800) 223-8225, naturessunshine.com, UPC 0 99904 03082 4
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1544-2021·2021-05-19

    Infusion Pump Repair Recalls Alaris Pump Modules with Impacted Bezel Parts

    Infusion Pump Repair is recalling 15 Alaris Pump Modules, Model 8100, serviced with non-original bezel repair parts. The parts may crack or separate, causing infusion errors.

    Product
    Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1531-2021·2021-05-19

    St. Jude Medical Recalls Endurity Pacemakers Due to Epoxy Manufacturing Issue

    St. Jude Medical is recalling 95,042 Endurity pacemakers because a manufacturing issue with epoxy may allow moisture ingress, potentially causing device malfunction.

    Product
    ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0490-2021·2021-05-19

    Hershey Chocolate Shell Topping Recalled for Undeclared Almond Allergen

    The Hershey Company is recalling specific bottles of Chocolate Shell Topping that were incorrectly filled with almond-containing product.

    Product
    Hershey s Chocolate Shell Topping plastic bottles in cases labelled Heath Shell Topping, 7.25 oz., 6 bottles per case
    Category
    Food
    Distribution
    12 states
  • HighFDA (Devices)·Z-1550-2021·2021-05-19

    Bard PowerPort duo MRI Implantable Port Recalled for Catheter Function Issues

    Bard Peripheral Vascular Inc. is recalling 2,194 PowerPort duo M.R.I. Implantable Ports due to potential catheter flushing, infusion, and aspiration difficulties, as well as septum dislodgement.

    Product
    PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829500, UDI: (01) 00801741027185 - Product Usage: The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood produc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1570-2021·2021-05-19

    ICU Medical Recalls Sprios Administration Sets Due to Molding Defect

    ICU Medical is recalling specific lots of Sprios administration sets because a molding defect may cause leakage in the inactivated position.

    Product
    REF CL3011 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or cathe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1562-2021·2021-05-19

    Musculoskeletal Transplant Foundation Recalls AFT Straight Tubes Due to Filling Error

    Musculoskeletal Transplant Foundation is recalling AFT Straight Tubes that were filled only halfway instead of three-quarters, which may cause surgery delays.

    Product
    AFT Straight Tube (3/4 Filled) - Human Allograph Tissue for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. It can be used in the: extremities, pelvis, and spine Item Number: 227007
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1565-2021·2021-05-19

    ICU Medical Recalls Oncology Kits Due to Molding Defect and Leakage

    ICU Medical is recalling specific lots of Oncology Kits due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF CH3397 Oncology Kit w/Spiros¿, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0485-2021·2021-05-19

    South Coast Baking Recalls Chocolate Chip Cookie Cakes Due to Packaging Particles

    South Coast Baking Co. is recalling 12-inch chocolate chip cookie cakes because loose CPET packaging particles may be embedded in the product.

    Product
    SCB 12" Chocolate Chip Cookie Cake In CPET Tray with lid. Keep Frozen 0 Degrees F. Net Wt. 36.00 lbs. (16.33 kg) Case count: 25 Item # 167557 Allergen Warning: Contains: Egg, Milk, Soy, Wheat Do no consume raw. Bake time and temP Oven 330F x 12-16 minutes
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1590-2021·2021-05-19

    ICU Medical Recalls Spinning Spiros Male Luers Due to Leakage Defect

    ICU Medical is recalling specific lots of Spinning Spiros Closed Male Luers because a molding defect may cause leakage in the inactivated position.

    Product
    REF K7040-001 Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1563-2021·2021-05-19

    Randox Calibration Serum Level 3 Recalled for Bilirubin Bias

    Randox Laboratories is recalling 98 kits of Calibration Serum Level 3 (CAL 3) due to a positive bias in bilirubin measurements.

    Product
    Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-1576-2021·2021-05-19

    ICU Medical Recalls 20mL Syringes Due to Potential Leakage Defect

    ICU Medical is recalling specific lots of 20mL syringes with Spinning Spiros due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF CH2020 20mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1536-2021·2021-05-19

    Fresenius AquaBplus Water Purification System Recalled for Installation Error

    Fresenius Medical Care is recalling 27 AquaBplus water purification systems because an installation guideline error may reduce the effectiveness of heat disinfection.

    Product
    AquaBplus and AquaBplus B2 Water Purification System - Product Usage: Intended for use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis or related therapies. Fresenius P/N 24-2500-0 All 3 uni
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1561-2021·2021-05-19

    Remel Bile Esculin Azide Agar Recalled for Growth of E. faecalis

    Remel Inc is recalling Bile Esculin Azide Agar with Vancomycin because the media allows growth of E. faecalis ATCC 29212.

    Product
    Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package - Product Usage: use in qualitative procedures as a screening method for primary isolation and presumptive identification of vancomycin-resistance enterococci (VRE) from surveillance cultures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1567-2021·2021-05-19

    ICU Medical Recalls Spiros Administration Sets Due to Molding Defect

    ICU Medical is recalling specific lots of Spiros administration sets because a molding defect may cause leakage in the inactivated position.

    Product
    REF 20124-01 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger LOT 5142971 - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1589-2021·2021-05-19

    ICU Medical Recalls IV Administration Sets Due to Molding Defect

    ICU Medical is recalling specific lots of IV administration sets because a molding defect may cause leakage in the inactivated position.

    Product
    REF CH3762 35" (89 cm) Appx 3.9 ml, 10 Drop Admin Set w/Integrated Clave" Drip Chamber, Clave", Spiros" w/Red Cap, Bag Hanger - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1586-2021·2021-05-19

    ICU Medical Recalls Spinning Spiros Male Luers Due to Molding Defect

    ICU Medical is recalling specific lots of Spinning Spiros male luers because a molding defect may cause small amounts of leakage in the inactivated position.

    Product
    REF 20130-01 Spinning Spiros¿ Closed Male Luer, Red Cap REF CH2000S-PC Spinning Spiros¿ Closed Male Luer, Purple Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1585-2021·2021-05-19

    ICU Medical Recalls Spiros Closed Male Luer Due to Leakage Defect

    ICU Medical is recalling Spiros Closed Male Luer devices due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF 20120-01 Spiros" Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0489-2021·2021-05-19

    Botanic Choice Green Tea Extract Recalled for Incorrect Labeling

    Indiana Botanic Gardens is recalling 455 units of Botanic Choice Green Tea Leaf Extract because the product label lists an incorrect active ingredient.

    Product
    Botanic Choice Green Tea Leaf Extract (3:1 Extract), Alcohol Free Liquid Extract, 1 FLOZ., in glass jar with dropper, UPC 703308200164
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1571-2021·2021-05-19

    ICU Medical Recalls Sprios Administration Sets Due to Molding Defect

    ICU Medical is recalling specific lots of Sprios administration sets due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF CL3028T 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, 0.2 Micron Filter, Spiros , Bag Hanger, Drop-In Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the admi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1569-2021·2021-05-19

    ICU Medical Recalls Spinning Spiros Closed Male Luer Due to Leakage

    ICU Medical is recalling certain lots of Spinning Spiros Closed Male Luer devices due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1578-2021·2021-05-19

    ICU Medical Recalls Sprios Administration Sets Due to Molding Defect

    ICU Medical is recalling specific lots of Sprios administration sets due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF CH3011 30" (76 cm) Appx 3.3 mL, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Red Cap, Bag Hanger - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1587-2021·2021-05-19

    ICU Medical Recalls Bag Spike Adapters Due to Molding Defect

    ICU Medical is recalling specific lots of Bag Spike Adapters due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF CH3034 5" (13 cm) Bag Spike Adapter w/Spiros" w/Red Cap, Vented Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1560-2021·2021-05-19

    Haag-Streit LENSTAR LS900 Software Recall for Data Mixing Errors

    Haag-Streit USA Inc is recalling Eyesuite 9.3.1 software for LENSTAR LS900 devices due to potential mixing of patient names and examination data.

    Product
    Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1575-2021·2021-05-19

    ICU Medical Recalls Smallbore Extension Sets Due to Molding Defect

    ICU Medical is recalling specific lots of smallbore extension sets because a molding defect may cause leakage in the inactivated position.

    Product
    REF CL4151 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1588-2021·2021-05-19

    ICU Medical Recalls Spiros Administration Sets Due to Molding Defect

    ICU Medical is recalling specific lots of Spiros administration sets because a molding defect may cause small amounts of leakage in the inactivated position.

    Product
    REF CH3235 30" (76 cm) Appx 4.1 ml, Yellow 20 Drop Admin Set w/15 Micron Filter, Spiros" - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1577-2021·2021-05-19

    ICU Medical Recalls Spinning Spiros Syringes Due to Leakage Defect

    ICU Medical is recalling specific lots of 60mL Spinning Spiros syringes because a molding defect may cause leakage in the inactivated position.

    Product
    REF CH2060 60mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0372-2021·2021-05-19

    Sun Pharmaceutical Recalls Metformin Hydrochloride Tablets Due to Foreign Substance

    Sun Pharmaceutical Industries is recalling 50,868 bottles of Metformin Hydrochloride Extended-Release Tablets because activated carbon was found in the product.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1574-2021·2021-05-19

    ICU Medical Recalls Oncology Kits Due to Potential Leakage Defect

    ICU Medical is recalling specific lots of Oncology Kits because a molding defect may cause small amounts of leakage in the inactivated position.

    Product
    REF CL3960 Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros ; w/ChemoLock; Syringe Transfer Set w/MicroClave, w/ChemoLock Port - Product Usage: provides access for the administration of fluids from a container to a pa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1572-2021·2021-05-19

    ICU Medical Recalls Oncology Kits Due to Molding Defect

    ICU Medical is recalling specific lots of REF CL3538 Oncology Kits because a molding defect may cause small amounts of leakage in the inactivated position.

    Product
    REF CL3538 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1580-2021·2021-05-19

    ICU Medical Recalls Smallbore Trifuse Extension Sets Due to Leakage Defect

    ICU Medical is recalling specific lots of Smallbore Trifuse Extension Sets because a molding defect may cause leakage in the inactivated position.

    Product
    REF CH3625 5" (13 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 ChemoClave (Purple, Green Rings), Spiros w/Red Cap, 3 Clamps - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1581-2021·2021-05-19

    ICU Medical Recalls Admin Sets Due to Potential Leakage Defect

    ICU Medical is recalling specific lots of REF 011-CH3967 Admin Sets due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF 011-CH3967 Admin Set w/ClaveTM, SpirosTM - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0484-2021·2021-05-19

    BTREX PLUS Dietary Supplement Recalled for Damaged Tablets

    Lopez Gonzalez Santana Corporation is recalling BTREX PLUS dietary supplements due to damaged tablets, a cGMP deviation.

    Product
    BTREX PLUS, Dietary Supplement 100 Caplets
    Category
    Food
    Distribution
    0 states
  • LowFDA (Devices)·Z-1554-2021·2021-05-19

    Medical Action Industries Recalls Central Line Dressing Change Kits

    Medical Action Industries is recalling Central Line Dressing Change Kits due to a potential breach in the package integrity of a component.

    Product
    Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V364000·2021-05-18

    MCI Recalls Diesel Buses Due to Fuel Rail Leak Fire Risk

    Motor Coach Industries is recalling specific 2017-2021 MCI diesel buses because a fuel rail leak could cause a fire.

    Product
    MCI — MCI D4000ISTV, J3500, D4000, D4005
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V365000·2021-05-18

    New Flyer Recalls Buses Due to Fuel Rail Leak Fire Risk

    New Flyer is recalling certain 2016-2021 XD and XDE series buses because a fuel rail leak could cause a fire.

    Product
    NEW FLYER — NEW FLYER XD35, XD60, XD40, XDE60
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V359000·2021-05-17

    Mercedes-Benz Recalls 2020 Sprinter Vans for Door Hinge Screw Issue

    Daimler Vans USA is recalling 2020 Mercedes-Benz Sprinter vans because front door hinge screws may not be tightened properly, increasing injury risk in a crash.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ SPRINTER 3500, SPRINTER 4500, SPRINTER 2500, SPRINTER 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V363000·2021-05-17

    Husqvarna 701 Enduro LR Recalled for Fuel Line Chafe Risk

    KTM is recalling 2020 Husqvarna 701 Enduro LR motorcycles because fuel lines may chafe and leak, increasing fire risk.

    Product
    HUSQVARNA — HUSQVARNA 701 ENDURO LR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·018-2021·2021-05-17

    Kraft Heinz Recalls Chef Francisco Soup Due to Undeclared Allergens

    Kraft Heinz is recalling Chef Francisco soup products because they contain undeclared milk and eggs. The mislabeled frozen soup was distributed to foodservice establishments nationwide.

    Product
    Kraft Heinz Foods Company — Kraft Heinz Foods Company Recalls Chef Francisco Soup Product Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·21V360000·2021-05-17

    Mercedes-Benz Recalls 2019 Sprinter Vans for Stability Control Software Update

    Daimler Vans USA is recalling 2019 Mercedes-Benz Sprinter vans with camper upfits because the Electronic Stability Control software was not updated for their higher center of gravity.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ SPRINTER (VS30)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V361000·2021-05-17

    2021 Ducati Scrambler Turn Signals May Not Flash Brightly Enough

    Ducati is recalling certain 2021 Scrambler 800 Night Shift motorcycles because the front and rear turn signal lights may not flash brightly enough, reducing visibility to other drivers and increasing crash risk.

    Product
    DUCATI — DUCATI SCRAMBLER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V358000·2021-05-17

    Sutphen Recalls One 2012 SP70 Vehicle for Display Lockup Issue

    Sutphen is recalling one 2012 SP70 vehicle because low voltage spikes may cause the LCD display to lock up, potentially delaying emergency efforts.

    Product
    SUTPHEN — SUTPHEN SP70
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V362000·2021-05-17

    2021 Porsche Taycan and Panamera Front Suspension Trailing Arm Defect Recall

    Porsche is recalling certain 2021 Taycan and Panamera models due to front lower trailing arms that may not be properly forged and could break, risking loss of vehicle control.

    Product
    PORSCHE — PORSCHE PANAMERA 4S E-HYBRID, PANAMERA 4S, PANAMERA 4 E-HYBRID, PANAMERA TURBO S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V352000·2021-05-14

    Gillig Recalls 2017-2020 Low Floor Vehicles Due to Fuel Leak Risk

    Gillig is recalling 2017-2020 Low Floor vehicles because a fuel rail leak could cause a fire. Owners should contact Gillig for a free inspection and repair.

    Product
    GILLIG — GILLIG LOW FLOOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V353000·2021-05-14

    Mercedes-Benz 2019-2021 G63 and G550 Rear Door Latch Defect

    Mercedes-Benz is recalling 2019-2021 G550 and G63 AMG vehicles for defective rear door latches that may not engage properly or open while driving, creating risk of injury or crashes. Dealers will replace the latches free of charge.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ G 550, AMG G63
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V350000·2021-05-14

    2021 Forest River Coachmen travel trailers recalled for brake failure risk

    Forest River is recalling certain 2021 Coachmen Spirit Travel Trailers due to a breakaway switch wiring defect that may prevent brakes from engaging. Approximately 39 units are affected.

    Product
    FOREST RIVER — FOREST RIVER COACHMEN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V351000·2021-05-14

    Nova Bus Recalls 2016-2020 LFS Models Due to Fuel Rail Leak Risk

    Nova Bus is recalling 2016-2020 LFS and LFS Artic vehicles because a defective sealing washer may cause high-pressure fuel leaks, increasing fire risk.

    Product
    NOVA BUS — NOVA BUS LFS ARTIC, LFS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V354000·2021-05-14

    Mercedes-Benz Recalls 2019-2021 Models for Multimedia Display Software Failure

    Mercedes-Benz is recalling 2019-2021 vehicles with faulty MBUX multimedia software that may disable the backup camera display. The defect violates Federal Motor Vehicle Safety Standard 111, and owners will receive a free software update.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLE 580, AMG GLC63, AMG GLC43, GLC 300
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V355000·2021-05-14

    VanLeigh Water Heater Housing Defect May Create Fire Risk

    VanLeigh is recalling certain 2019-2022 Vilano and 2019-2021 Beacon coaches because the water heater housing may not be properly sealed, allowing gas to enter the coach and creating a fire risk.

    Product
    VANLEIGH — VANLEIGH VILANO, BEACON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V356000·2021-05-14

    Motorhome Recall: Faulty Generator Regulator in 2020-2021 Roadtrek Models

    Roadtrek is recalling 2020-2021 Zion and Play motorhomes due to a faulty generator regulator that may damage the battery and cause electrical system failure. This creates a risk of injury from battery cap detachment or acid spill.

    Product
    ROADTREK — ROADTREK ZION SRT, PLAY, ZION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V357000·2021-05-14

    Freightliner Cascadia Halogen Headlight Bulbs May Dislodge and Cause Fire Risk

    Daimler Trucks North America is recalling 2017–2022 Freightliner Cascadia vehicles with halogen headlight assemblies. During bulb replacement, the bulb may dislodge and contact other components, causing melting and increasing fire risk.

    Product
    FREIGHTLINER — FREIGHTLINER CASCADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·PHA-05142021-01·2021-05-14

    USDA Issues Public Health Alert for Ineligible Frozen Fish Imported from Brazil

    USDA FSIS issued a public health alert for approximately 165 pounds of frozen fish imported from Brazil, a country ineligible to export these products to the U.S.

    Product
    FSIS Issues Public Health Alert for Ineligible Siluriformes Products Imported From Brazil
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereCPSC·21746·2021-05-13

    BRP Recalls 2021-2022 Ski-Doo Snowmobiles Due to Fire Hazard

    Bombardier Recreational Products is recalling about 2,400 model year 2021-2022 Ski-Doo snowmobiles because an overheating muffler can cause a fire.

    Product
    Model Year 2021-2022 Ski-Doo snowmobiles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·21V348000·2021-05-13

    Prevost Recalls 2021 X3 Commuter Coaches Due to Seat Belt Assembly Defect

    Prevost is recalling 2021 X3 Commuter Coaches because incorrectly assembled seat belts at flip-up seats may sit improperly on wheelchair users, increasing injury risk.

    Product
    PREVOST — PREVOST X3-45 COMMUTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21745·2021-05-13

    The Lye Guy Recalls Sodium and Potassium Hydroxide for Packaging Defects

    The Lye Guy is recalling sodium and potassium hydroxide products because the packaging is not child-resistant and labels violate federal hazardous substance requirements.

    Product
    The Lye Guy Sodium Hydroxide and Potassium Hydroxide
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·21744·2021-05-13

    Polaris Recalls 2021 RZR PRO XP Vehicles Due to Fire Hazard

    Polaris is recalling about 32 Model Year 2021 RZR PRO XP and RZR PRO XP 4 off-road vehicles because a missing copper seal washer can cause an oil leak and fire hazard.

    Product
    Model Year 2021 RZR PRO XP and RZR PRO XP 4 (ROVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21747·2021-05-13

    Leisure Time Recalls Brutus Swing Sets Due to Injury Hazard

    Leisure Time Products is recalling about 9,000 Brutus metal swing sets because the swing hanger attachment can fail, causing the swing to fall.

    Product
    Backyard Discovery Big Brutus, Little Brutus and Mini Brutus metal A-frame swing sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide

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