The Recall Desk

Archive

August 2021 recalls

482 recalls were announced in August 2021.

What the numbers show

Critical
11
Severe
122
High
293
Moderate
54
Low
2

Of the 482 recalls this month scored against our rubric, 2% are Critical, 25% are Severe.

401–482 of 482

  • HighNHTSA·21V615000·2021-08-06

    2022 Volkswagen Taos Engine Stall Software Defect Recall

    Volkswagen recalls 2022 Taos all-wheel-drive vehicles for a software defect that may cause engine stall when stopping, increasing crash risk. Dealers will update the engine control unit software free of charge.

    Product
    VOLKSWAGEN — VOLKSWAGEN TAOS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V610000·2021-08-05

    Tiffin Wayfarer motorhomes 2017-2022 hitch extension failure and detachment risk

    Tiffin is recalling 2017-2022 Wayfarer motorhomes because the hitch extension may fail under stress, causing the hitch to detach and increasing crash risk. Dealers will inspect and replace the hitch and reinforce the frame rail extension at no charge.

    Product
    TIFFIN — TIFFIN WAYFARER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V611000·2021-08-05

    Cadillac CT4 and CT5 roof rail air bags installation defect

    General Motors is recalling 2020-2022 Cadillac CT4 and CT5 vehicles because roof rail side-curtain air bags may not have been installed correctly. Improper installation could prevent proper deployment during a crash.

    Product
    CADILLAC — CADILLAC CT4, CT5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V613000·2021-08-05

    2021 Maserati Tire Placard Recall: Incorrect Pressure Information

    Maserati is recalling certain 2021 Ghibli and Quattroporte vehicles with 21-inch tires due to incorrect tire pressure information on the placard. Improper tire inflation could affect vehicle stability and control.

    Product
    MASERATI — MASERATI GHIBLI, QUATTROPORTE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V606000·2021-08-05

    2021 Audi RS Q8 rear seat belt retractors may deactivate prematurely

    Certain 2021 Audi RS Q8 vehicles have rear seat belt retractors that may deactivate prematurely, preventing child restraint systems from securing properly. Dealers will repair affected components free of charge.

    Product
    AUDI — AUDI, VOLKSWAGEN A6, Q8, A4, A5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V612000·2021-08-05

    2022 Chevrolet Equinox and Terrain tire recall for tread separation risk

    General Motors is recalling 2021-2022 Chevrolet Equinox and GMC Terrain vehicles with certain Hankook tires that may have insufficient curative agent, risking tread separation and loss of vehicle control.

    Product
    CHEVROLET — CHEVROLET, GMC EQUINOX, TERRAIN, TERRAIN NA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·027-2021·2021-08-05

    Blount Fine Foods Recalls Chicken Tortilla Soup Due to Foreign Matter

    Blount Fine Foods is recalling specific lots of Panera BREAD at HOME Chicken Tortilla Soup due to possible contamination with pieces of gray nitrile glove.

    Product
    Blount Fine Foods Corp. — Blount Fine Foods Corp. Recalls Chicken Soup Products Due To Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0802-2021·2021-08-04

    Randall Navy Beans recalled due to non-functioning temperature devices

    Randall Foods is recalling Randall Navy Beans in 48 oz and 15.4 oz glass jars due to lack of functioning temperature indicating devices in retorts during processing.

    Product
    RANDALL NAVY BEANS 48OZ glass jars UPC 070095000506; RANDALL NAVY BEANS 15.4OZ glass jars UPC 070095000537
    Category
    Food
    Distribution
    22 states
  • SevereCPSC·21175·2021-08-04

    LG Energy Solution Recalls RESU10H Home Batteries for Fire Hazard

    LG Energy Solution Michigan is recalling about 10,000 RESU10H lithium-ion residential energy storage batteries because they can overheat and catch fire, emitting harmful smoke. The firm has received five reports of batteries smoking and catching fire, resulting in property damage and one injury.

    Product
    LG Chem "RESU10H" Lithium-Ion Residential Energy Storage System Batteries
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·21176·2021-08-04

    Sling Loungers Recalled for Amputation, Laceration, and Pinching Hazard

    About 155,000 True Living Sling Loungers sold at Dollar General are recalled because the frames can collapse unexpectedly, causing amputation and laceration injuries when fingers get caught in metal folding joints. Three amputations or lacerations have been reported.

    Product
    True Living Sling Loungers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0798-2021·2021-08-04

    Randall and Hurst's Great Northern Beans Recalled for Temperature Device Failure

    Randall Foods, Inc. is recalling Randall and Hurst's brand Great Northern Beans due to non-functioning temperature indicating devices in the canning equipment, which could allow underprocessed product to reach consumers.

    Product
    RANDALL GREAT NORTHERN BEANS 48OZ glass jar UPC 070095000100; RANDALL GREAT NORTHERN BEANS 24OZ glass jar UPC 070095000117; RANDALL GREAT NORTHERN BEANS 15.4OZ glass jar UPC 070095000131; RANDALL ORGANIC GREAT NORTHERN BEANS 48OZ glass jar UPC 070095005105; Hurst's Fully Cooked G
    Category
    Food
    Distribution
    22 states
  • SevereFDA (Food)·F-0800-2021·2021-08-04

    Randall Mixed Beans Recall Due to Temperature Control Failure

    Randall Foods, Inc. is recalling Randall Mixed Beans in 48oz, 24oz, and 15.4oz glass jars due to lack of functioning temperature indicating devices in retorts used during processing. The affected products were distributed to retail locations in 22 states.

    Product
    RANDALL MIXED BEANS 48OZ glass jars UPC 070095000407; RANDALL MIXED BEANS 24OZ glass jars UPC 070095000414; RANDALL MIXED BEANS 15.4OZ glass UPC 070095000430
    Category
    Food
    Distribution
    22 states
  • SevereFDA (Devices)·Z-2158-2021·2021-08-04

    Zippie Voyage Early Intervention Stroller Seating System Detachment

    Sunrise Medical is recalling the Zippie Voyage early intervention stroller due to unexpected seating system detachment that can cause falls and injury. Approximately 4,741 devices are affected worldwide.

    Product
    Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assisting a disabled person while providing supportive elements for assisted transportation and seating for a child or small adult not to exceed 75 pounds.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2005-2021·2021-08-04

    Recirculator 8.0s Disposable Lavage Kit recalled for potential aluminum ion release

    Eight Medical International BV is recalling the Recirculator 8.0s Disposable Lavage Kit due to potential aluminum ion release during warming therapy that may expose patients under certain use conditions.

    Product
    Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016. Hyperthermic Perfusion System intended to raise the temperature of the thoracic or peritoneal cavity to a target temperature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0799-2021·2021-08-04

    Randall Pinto Beans Recall Due to Temperature Control Defect

    Randall Foods, Inc. is recalling Randall Pinto Beans in three sizes (48oz, 24oz, and 15.4oz glass jars) distributed across 22 states due to lack of functioning temperature-indicating devices in retorts used during processing.

    Product
    RANDALL PINTO BEANS 48OZ glass jars UPC 070095000209; RANDALL PINTO BEANS 24OZ glass jars UPC 070095000216; RANDALL PINTO BEANS 15.4OZ glass jars UPC 070095000230
    Category
    Food
    Distribution
    22 states
  • SevereFDA (Food)·F-0862-2021·2021-08-04

    Old Souls Farm Basil Recall Due to Listeria Contamination

    Old Souls Farms LLC is recalling basil products in multiple sizes and packaging formats distributed to Ohio and Kentucky because rainwater containing Listeria monocytogenes came into contact with the product.

    Product
    Old Souls Farm Basil 1 lb, 1 oz, 10 lbs,25 lbs, 3 -1 lbs, 4 oz, and Living clamshells - 1oz 18 per case, 5oz 6 per case bulk bags - 1lb is 3 per case, 10lbs 1 per case, 25lbs 1 per case living are packed in plastic sleeves - 10 per case
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0805-2021·2021-08-04

    Randall Ultimate 4-Bean Mix Recalled for Lack of Temperature Indicators

    Randall Foods, Inc. is recalling Randall Ultimate 4-Bean Mix in 48 oz glass jars due to non-functioning temperature indicating devices in retorts used during processing, which may affect proper sterilization.

    Product
    RANDALL ULITMATE 4-BEAN MIX 48OZ glass jars UPC 070095000902
    Category
    Food
    Distribution
    22 states
  • SevereFDA (Food)·F-0865-2021·2021-08-04

    Old Souls Farm Romaine recalled for potential Listeria contamination

    Old Souls Farm Romaine lettuce is being recalled due to potential contamination with Listeria monocytogenes from rainwater that contacted the product. The recall affects romaine distributed to Ohio and Kentucky.

    Product
    Old Souls Farm Romaine 3 lbs and 5 oz clamshells - 1oz 18 per case, 5oz 6 per case bulk bags - 1lb is 3 per case, 10lbs 1 per case, 25lbs 1 per case living are packed in plastic sleeves - 10 per case
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0861-2021·2021-08-04

    Old Souls Farm Arugula Recalled for Listeria Contamination

    Old Souls Farms LLC is recalling arugula products due to positive detection of Listeria monocytogenes in rainwater that contacted the product. The affected produce was distributed to Ohio and Kentucky.

    Product
    Old Souls Farm Arugula 5oz, 2lbs, and living oz are packed in clamshells - 1oz 18 per case, 5oz 6 per case lbs are packed in bulk bags - 1lb is 3 per case, 10lbs 1 per case, 25lbs 1 per case living are packed in plastic sleeves - 10 per case
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0864-2021·2021-08-04

    Old Souls Farm Green Bibb Lettuce Recalled for Listeria Risk

    Old Souls Farms LLC is recalling Green Bibb lettuce products distributed to Ohio and Kentucky due to rainwater testing positive for Listeria monocytogenes that came into contact with the product.

    Product
    Old Souls Farm Green Bibb 2 lbs, 5 oz, Living Heads clamshells - 1oz 18 per case, 5oz 6 per case bulk bags - 1lb is 3 per case, 10lbs 1 per case, 25lbs 1 per case living are packed in plastic sleeves - 10 per case
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0863-2021·2021-08-04

    Old Souls Farm Finstar Microgreens Recalled for Listeria Contamination

    Old Souls Farms LLC is recalling Finstar microgreens distributed to Ohio and Kentucky due to positive testing for Listeria monocytogenes in rainwater that contacted the product.

    Product
    Old Souls Farm Finstar 5 oz clamshells - 1oz 18 per case, 5oz 6 per case bulk bags - 1lb is 3 per case, 10lbs 1 per case, 25lbs 1 per case living are packed in plastic sleeves - 10 per case
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2157-2021·2021-08-04

    Zippie Voyage Early Intervention Stroller Seating System May Detach

    Sunrise Medical recalls Zippie Voyage early intervention strollers because the seating system may unexpectedly detach and fall, causing injury. Approximately 9,865 devices are affected.

    Product
    Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assisting a disabled person while providing supportive elements for assisted transportation and seating for a child or small adult not to exceed 75 pounds.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0803-2021·2021-08-04

    Randall Black Beans Recall: Non-Functioning Temperature Devices

    Randall Foods, Inc. is recalling Randall Black Beans in 48 oz, 24 oz, and 15.4 oz glass jars due to non-functioning temperature indicating devices in retorts used during production, which may affect product safety.

    Product
    RANDALL BLACK BEANS 48OZ glass jars UPC 070095000605; RANDALL BLACK BEANS 24OZ glass jars UPC 070095000612; RANDALL BLACK BEANS 15.4OZ glass jars UPC 070095000636
    Category
    Food
    Distribution
    22 states
  • SevereFDA (Food)·F-0795-2021·2021-08-04

    Backcountry Dried Apricots Recalled for Undisclosed Sulfites

    Lipari Foods Operating Company is recalling Backcountry Dried Apricots due to sulfites not being disclosed on the product label. The product was distributed to retail locations across 18 states.

    Product
    Backcountry Dried Apricots 9ounce plastic bag 12 packages per case
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Food)·F-0866-2021·2021-08-04

    Old Souls Farm Spring Mix recalled for Listeria contamination

    Old Souls Farms LLC is recalling spring mix products due to Listeria monocytogenes detected in rainwater that contacted the product. The affected products were distributed to Ohio and Kentucky.

    Product
    Old Souls Farm Spring Mix 1 lb, 2 lbs, and 5 oz clamshells - 1oz 18 per case, 5oz 6 per case bulk bags - 1lb is 3 per case, 10lbs 1 per case, 25lbs 1 per case living are packed in plastic sleeves - 10 per case
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0801-2021·2021-08-04

    Randall Kidney Beans Recall for Faulty Temperature Devices

    Randall Foods, Inc. is recalling Randall Kidney Beans in three sizes due to non-functioning temperature indicating devices in retorts, which may affect proper heat sterilization during processing.

    Product
    RANDALL KIDNEY BEANS 48OZ glass jars UPC 070095000308; RANDALL KIDNEY BEANS 24OZ glass jars UPC 070095000315; RANDALL KIDNEY BEANS 15.4OZ glass jars UPC 070095000339
    Category
    Food
    Distribution
    22 states
  • HighFDA (Food)·F-0797-2021·2021-08-04

    Amy's Tortilla Casserole Bowls Recalled for Rubber Gasket Pieces

    Amy's Kitchen is recalling Amy's Bowls Tortilla Casserole & Black Beans due to the potential presence of rubber gasket pieces from production equipment. Consumers should not eat the product and should dispose of it or return it to the store.

    Product
    Amy's Bowls, Tortilla Casserole & Black Beans; Made with organic tomatoes & Black Beans. NET WT 9.5 oz. (269g); gluten Free - Perishable - keep frozen; UPC: 0 42272 00168 2 (individual box) Case UPC: 1-00-42272-00168-9 Microwave or regular oven. In trays with plastic overlay, in
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-2139-2021·2021-08-04

    GE CARESCAPE PDM monitor SpO2 display freezes during extended use

    GE Healthcare's CARESCAPE PDM-Masimo SpO2 physiological monitor displays can freeze after extended use without power down, preventing real-time oxygen saturation monitoring.

    Product
    CARESCAPE PDM-Masimo SpO2. Physiological data monitor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2156-2021·2021-08-04

    Affinity Four Birthing Bed Latch Mechanism Defect Poses Fall Risk

    The latch mechanism on the Lift-Off foot section of certain Affinity Four Birthing Beds may be damaged, potentially causing improper engagement and creating a fall risk for patients. Hill-Rom is recalling approximately 1,096 affected beds.

    Product
    Affinity Four Birthing Bed-used as a birthing bed for women of child bearing age in an LDR (Labor, Delivery, Recovery) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor and Delivery market Model Numbers: P3700B, P3700C, P3700D, & P3700E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2141-2021·2021-08-04

    OxyMask O2 Adult oxygen tubing disconnect hazard recalled

    Southmedic recalled OxyMask O2 Adult oxygen masks (Model OM-1125-14, Lot W73887) due to potential oxygen tubing disconnection that could interrupt oxygen delivery.

    Product
    OxyMask O2 Adult REF OM-1125-14
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2136-2021·2021-08-04

    Medtronic Endurant IIs stent graft system marker detachment recall

    Medtronic is recalling 21 Endurant IIs stent graft systems due to radiopaque marker bond detachment during device deployment. The defect could affect surgical visualization and device positioning.

    Product
    Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft System REF ESBF3614C103EE and ESBF3214C103E. Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2134-2021·2021-08-04

    Diagnostic Genetic Probe Recalled for Unexpected Chromosome Signals

    Cytocell Ltd. is recalling CytoCell DiGeorge/VCFS genetic probes that may display unexpected chromosome signals, potentially causing misdiagnosis. Affected reagents were distributed to laboratories in multiple US states and Canada.

    Product
    CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in vitro diagnostics
    Category
    Medical Device
    Distribution
    7 states
  • HighNHTSA·21E071000·2021-08-04

    Enerco Propane Regulators Recalled Due to Fire Risk

    Enerco Group is recalling specific propane regulators that may fail, causing excessive gas pressure and increased fire risk.

    Product
    EQUIPMENT:RECREATIONAL VEHICLE/TRAILER:LPG SYSTEMS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·21V604000·2021-08-04

    Newmar Motorhomes Recalled for Potential Fuel Leak and Fire Risk

    Newmar Corporation is recalling certain 2021-2022 motorhomes (New Aire, Ventana, and Dutch Star) with Cummins L9 diesel engines due to potential fuel leaks that could increase fire risk. Affected owners should contact Newmar customer service at 1-800-731-8300 for free fuel hose replacement.

    Product
    NEWMAR — NEWMAR NEW AIRE, DUTCH STAR, VENTANA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21174·2021-08-04

    Two Million Dehumidifiers Recalled for Fire and Burn Hazards

    About 2 million dehumidifiers manufactured by New Widetech under multiple brand names are recalled because they can overheat and catch fire, posing fire and burn hazards. Consumers should stop using them immediately.

    Product
    Dehumidifiers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·21V608000·2021-08-04

    2021 Porsche Taycan Seat Belt Retractor Defect May Prevent Child Restraint Securing

    Porsche is recalling certain 2021 Taycan models because the seat belt automatic locking retractors may deactivate early, preventing child restraint systems from securing properly during a crash.

    Product
    PORSCHE — PORSCHE 911, PANAMERA 4S, PANAMERA 4 E-HYBRID, PANAMERA TURBO S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V609000·2021-08-04

    Peterbilt 220 Recall for Stator Assembly Wire Crimping Defect

    PACCAR is recalling 2020 Peterbilt 220 trucks with Meritor 14Xe ePowertrains due to insufficiently crimped stator wires that may cause overheating and loss of drive power.

    Product
    PETERBILT — PETERBILT 220
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V603000·2021-08-04

    Lamborghini Recalls 2021 Urus for Rear Seat Belt Retract Defect

    Lamborghini is recalling 2021 Urus vehicles because middle-rear seat belt retractors may deactivate early, preventing child restraints from securing properly.

    Product
    LAMBORGHINI — LAMBORGHINI URUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2148-2021·2021-08-04

    Contact Lens Recall: Misaligned Axis Mark May Cause Blurred Vision

    CooperVision is recalling SPECSAVERS UMERE TORIC daily disposable contact lenses with UV blocker due to a manufacturing defect in which misaligned axis marks may cause blurred vision.

    Product
    SPECSAVERS UMERE TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blocker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V607000·2021-08-04

    2021 Volkswagen ID.4 rear seat belt assemblies may not secure child restraints

    Certain 2021 Volkswagen ID.4 vehicles have rear seat belt assemblies without proper automatic locking function, preventing child restraint systems from securing correctly. Dealers will inspect and replace affected assemblies at no cost.

    Product
    VOLKSWAGEN — VOLKSWAGEN ID.4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2144-2021·2021-08-04

    Contact Lens Axis Mark Misalignment May Cause Blurred Vision

    CooperVision's AQUATECH PLUS 1 DAY TORIC contact lenses (lot R0121629) have misaligned axis marks that may cause blurred vision in patients.

    Product
    AQUATECH PLUS 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2150-2021·2021-08-04

    Contact lens recall: misaligned axis mark may cause blurred vision

    CooperVision is recalling CLARITI 1 DAY TORIC contact lenses (Lot W0106167) due to misaligned axis marks that may cause blurred vision. The recall affects 450 lenses distributed across select U.S. states and multiple countries.

    Product
    CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2146-2021·2021-08-04

    CooperVision CLARITI 1 DAY TORIC contact lenses recalled for axis mark misalignment

    CooperVision is recalling CLARITI 1 DAY TORIC daily disposable contact lenses due to misaligned axis marks that can cause blurred vision. Affected lenses in lot U0108833 were distributed in seven US states and internationally.

    Product
    CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2135-2021·2021-08-04

    Medtronic Endurant II Stent Graft Marker Detachment During Deployment

    Medtronic recalls Endurant II stent graft systems: the radiopaque marker bond may detach during deployment. The recall affects 18 devices in U.S. and international distribution. No illnesses or injuries reported.

    Product
    Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE, ETCF3636C49EE, ETBF3216C166EE, and ETUF3614C102E. Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2161-2021·2021-08-04

    OEC Elite Mobile C-Arm Recalled for Battery Depletion

    GE OEC Medical Systems is recalling 3,570 OEC Elite mobile C-arm imaging systems worldwide due to potential early depletion of the battery that monitors X-ray tube temperature, which could render the system inoperable.

    Product
    OEC Elite mobile C-arm - Product Usage: intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2140-2021·2021-08-04

    Heater Cooler Unit Recall Due to Potential Bacterial Contamination Risk

    Maquet Medical Systems USA is recalling 33 Heater Cooler Unit (HCU 30) devices due to potential water contamination in device circuits that could introduce Mycobacteria or other bacteria. The devices were distributed to nine U.S. states.

    Product
    Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extracorporeal circulation and for blankets with which patients can be warmed or cooled.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2149-2021·2021-08-04

    CLARITI 1 DAY TORIC Contact Lenses Recalled Due to Axis Mark Misalignment

    CooperVision is recalling CLARITI 1 DAY TORIC contact lenses (Lot W0106167) due to misaligned axis marks that can cause blurred vision. Affected patients should discontinue use and contact their eye care provider.

    Product
    CLARITI 1 DAY TORIC -DIAGNOSTIC Power-07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2151-2021·2021-08-04

    CooperVision Contact Lenses Recalled for Misaligned Axis Mark

    CooperVision is recalling MEDIFLEX ELITE 1 DAY TORIC daily disposable contact lenses (lot W0106167) due to misaligned axis marks that can cause blurred vision.

    Product
    MEDIFLEX ELITE 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2160-2021·2021-08-04

    OEC 3D Imaging X-Ray Systems Recalled for Coin Cell Battery Depletion

    GE OEC Medical Systems is recalling certain OEC 3D Imaging fluoroscopic X-ray systems due to potential premature depletion of the coin cell battery used to monitor X-ray tube temperature, which could cause the system to become inoperable.

    Product
    OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Usage: designed to provide fluoroscopic and digital spot images of adult and pediatric populations during diagnostic, interventional, and surgical procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2138-2021·2021-08-04

    RayStation radiation treatment planning system positioning error recall

    RayStation versions 9A through 11A may set initial delivery positions incorrectly during setup beam localization. Five units are affected; no patient injuries reported.

    Product
    RayStation (Radiation Treatment Planning System) : RayStation 9A, 9B, 9B SP1, 10A, 10A SP1, 10B and 11A, in combination with RayCare Model Numbers/ UDI: RayStation 9.0 (9.0.0.113) 07350002010174; RayStation 9.1 (9.1.0.933) 07350002010266; RayStation 9.1 Service Pack 1 (
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2154-2021·2021-08-04

    Daily Toric Contact Lenses Recalled for Misaligned Axis Mark

    CooperVision is recalling SOFMED BREATHABLES 1 DAY TORIC contact lenses (Lot W0106167) due to misaligned axis marks that can cause blurred vision. Affected lenses were distributed in the US and internationally.

    Product
    SOFMED BREATHABLES 1 DAY TORIC Power-07.00 -1.75/ 170 Daily Disposable Contact Lens with UV blocker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2137-2021·2021-08-04

    Infusomat Space Pump Administration Set Recalled for Inverted Anti-Free Flow Clip

    B. Braun Medical is recalling the Infusomat Space Volumetric Pump Administration Set due to a defect where the anti-free flow clip may be inverted, potentially causing unintended medication flow. No injuries have been reported.

    Product
    Infusomat Space Volumetric Pump Administration Set, Product Code 490100
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2163-2021·2021-08-04

    Coaxial Interventional Needles recalled for potential sterilization failure

    Coaxial Interventional Needles from INNOVATIVE TOMOGRAPHY PRODUCT GMBH may not be properly sterilized. Multiple lot numbers are affected and should not be used.

    Product
    Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. KIR 23/05, Length 50 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/05N, Length 50 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/07, Length 75 mm, Diameter 2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0796-2021·2021-08-04

    Dole Fresh Picked Blueberries Recalled for Cyclospora Contamination

    Dole Fresh Picked Blueberries are being recalled after the Canadian Food Inspection Agency detected Cyclospora cayetanensis in the product. The recall affects multiple package sizes distributed across several U.S. states and Canadian provinces.

    Product
    Dole Fresh Picked-Emballes frais Blueberries/Bleuets: Packed in clear plastic container in the following sizes; 18 oz. - UPC: 0 71430 01154 6; Pint (16 oz.): UPC: 0 71430 01151 5; 6 oz. UPC: 07143001150 8; 24 oz. UPC: 071430011155 3 Distributed by Dole Berry Co, Winterha
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0818-2021·2021-08-04

    f'real Made to Order Shake Base Recalled for Undeclared Milk

    Rich Products Corp is recalling f'real Made to Order Shake Base because the outer label incorrectly identifies the product as "Smoothie Base," failing to disclose the presence of milk. Consumers with milk allergies or sensitivities face a potential health risk.

    Product
    f'real Made to Order Shake Base - 8 fl oz (237ml) cups Out packaging may read 'Smoothie-base' Lid may read ' Shake-base' 12 individual cups packed into a shrink-wrapped pulp tray
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-2155-2021·2021-08-04

    Proteus 235-Proton Therapy System May Deliver Unintended Radiation

    The Proteus 235-Proton Therapy System may deliver proton therapy without prescribed beam gating if the user forgets to select the trigger input. This could cause radiation to be positioned incorrectly.

    Product
    Proteus 235-Proton Therapy System
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2166-2021·2021-08-04

    Medical inflation device recalled due to handle separation risk

    Merit Medical Systems is recalling basixALPHA Inflation Devices due to a design flaw where the syringe handle can separate when withdrawn, affecting device functionality.

    Product
    basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0806-2021·2021-08-04

    Eat Gangster Oatmeal Cookie Mix Recalled for Salmonella Contamination

    Eat Gangster Oatmeal Schmoatmeal Cookie Mix has been recalled due to potential Salmonella contamination in tigernut flour, an ingredient used in the product. The affected 8.5 oz bags were distributed nationwide.

    Product
    Eat GANGSTER, Oatmeal Schmoatmeal Cookie Mix, 8.5 Oz, Eat GANGSTER LLC, Wichita, KS, UPC 0 51497 13952 0
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0807-2021·2021-08-04

    Choujuki White Bread recalled for undeclared milk allergen

    Choujuki White Bread (6 slices, 13.9 oz) is being recalled because labeling failed to declare milk as an allergen. The milk is a sub-ingredient of the margarine used in the product.

    Product
    Choujuki White Bread 6 slices: Net Wt. 13.9 oz. (374g) Ingredients: White Flour, Sugar, Margarine, Yeast Extract, Salt, Rice Flour, Vinegar. Contains Wheat. Keep Frozen at or below 18 degrees C Distributed by Hatsune JPN Inc., Torrance, CA Product of Japan/
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2162-2021·2021-08-04

    Coaxial Interventional Needles Recalled for Potential Sterilization Defects

    INNOVATIVE TOMOGRAPHY PRODUCT GMBH is recalling Coaxial Interventional Needles distributed in California due to potential sterilization defects. Needles labeled as sterile may not have been adequately sterilized, creating infection risks.

    Product
    Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. KIM 22/05, Length 50 mm, diameter 22G/0,7 mm; Article no. KIM 22/07,Length 75 mm, diameter 22 G (0.7 mm); Article no. KIM 22/10, Length 100 mm, diameter 22 G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0804-2021·2021-08-04

    Randall Garbanzo Beans Recall: Defective Temperature Monitoring Devices

    Randall Foods is recalling Randall Garbanzo Beans in 24oz and 15.4oz glass jars due to non-functioning temperature indicating devices in retorts, which may affect proper food safety processing.

    Product
    RANDALL GARBANZO BEANS 24OZ glass jars UPC 070095000711; RANDALL GARBANZO BEANS 15.4OZ glass jars UPC 070095000735
    Category
    Food
    Distribution
    22 states
  • HighFDA (Devices)·Z-2143-2021·2021-08-04

    Contact Lens Recall: Misaligned Axis Mark May Cause Blurred Vision

    CooperVision is recalling CLARITI 1 DAY TORIC contact lenses with misaligned axis marks that may cause blurred vision. The defective lenses were distributed worldwide including multiple U.S. states.

    Product
    CLARITI 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2145-2021·2021-08-04

    Contact lens recall due to misaligned axis marking

    CooperVision Inc. is recalling FRESH DAY 1 DAY TORIC contact lenses (Lot R0121629) due to misaligned axis marks that may cause blurred vision in wearers.

    Product
    FRESH DAY 1 DAY TORIC Power -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2159-2021·2021-08-04

    Medtronic Vectris SureScan MRI lead kits recalled for incorrect labeling

    Medtronic Neuromodulation is recalling 1131 units of Vectris SureScan MRI lead kits with incorrect electrode spacing information on packaging labels. This could affect proper device installation.

    Product
    Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2164-2021·2021-08-04

    Semi-automatic Biopsy Needles Recalled Due to Sterilization Defect

    INNOVATIVE TOMOGRAPHY PRODUCT GMBH is recalling semi-automatic biopsy needles because labeled sterile units may not have been adequately sterilized. Affected devices distributed in California should not be used.

    Product
    Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. BIM 18/10, Length 100 mm, Diameter 18 G (1.25 mm); Article no. BIM 18/15, Length 150 mm, Diameter 18 G (1.25 mm); Article no. BIM 18/20, Length 200 mm, Diameter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2147-2021·2021-08-04

    CooperVision CLARITI Contact Lenses Recalled for Misaligned Axis Marks

    CooperVision is recalling CLARITI 1 DAY TORIC contact lenses (Lot U0108940) because misaligned axis marks can cause blurred vision in patients.

    Product
    CLARITI 1 DAY TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blocker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2152-2021·2021-08-04

    CooperVision CLARITI 1 DAY TORIC contact lenses recalled for axis misalignment

    CooperVision is recalling CLARITI 1 DAY TORIC contact lenses (Lot W0106186) due to misaligned placement of the axis mark, which can cause blurred vision.

    Product
    CLARITI 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blocker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2153-2021·2021-08-04

    Contact Lens Axis Mark Misalignment Causes Blurred Vision

    CooperVision's FRESH DAY 1 DAY TORIC contact lenses (lot W0106186) are recalled because misaligned axis marks can cause blurred vision. Affected lenses were distributed worldwide, including in the US, France, Brazil, and other countries.

    Product
    FRESH DAY 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blocker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0869-2021·2021-08-04

    Now Real Food Organic Steel Cut Oats Mislabeled with Wrong Product

    NOW Health Group Inc. is recalling a specific lot of Organic Steel Cut Oats that may contain Organic Beet Sugar instead of the labeled product. Affected consumers should not consume the product.

    Product
    Now Real Food Organic Steel Cut Oats, 2 lb bag, code 6295, UPC 733739062956, packed 8 bags per case; case packaging is for Now Real Food Organic Beet Sugar 3lbs bags
    Category
    Food
    Distribution
    45 states
  • ModerateFDA (Food)·F-0808-2021·2021-08-04

    Del Monte Fresh Cut Golden Sweet Whole Kernel Corn Recall

    Del Monte Foods is recalling Del Monte Fresh Cut Golden Sweet Whole Kernel Corn due to post-process spoilage discovered in some containers during inspection at a distribution center.

    Product
    Del Monte Fresh Cut Golden Sweet Whole Kernel Corn; 15.25 oz. can (24 x 15.25 oz. cans per case) Case UPC  10024000163029 Can UPC - 024000163022 Distributed by Del Monte Foods, Walnut Creek, CA
    Category
    Food
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-2142-2021·2021-08-04

    ThermoScientific Oxoid Antimicrobial Susceptibility Discs Recalled for Out-of-Specification Performance

    Remel Inc. is recalling certain lots of ThermoScientific Oxoid Antimicrobial Susceptibility Discs because they were manufactured out of specification, potentially affecting laboratory test accuracy. The recall involves 327 units distributed nationwide and to Bermuda.

    Product
    ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United Kingdom
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0696-2021·2021-08-04

    Azelaic Acid 99.0+% Micro 500G Drug Recalled for cGMP Deviations

    API Solutions Inc. is voluntarily recalling Azelaic Acid 99.0+% Micro 500 Grams (Lot #AZA181105, Exp 11/09/2021) distributed in five states due to current Good Manufacturing Practice (cGMP) deviations identified during manufacturing.

    Product
    Azelaic Acid 99.0+% Micro 500 Grams, Distributed By: A.P.I. Solutions Daphne Alabama Manufactured by: Yicheng Chemicals Corp. China Distributed by: Syntec Pharma Corp New York
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0695-2021·2021-08-04

    Drug Recall: Estriol USP41 Micro Due to cGMP Deviations

    API Solutions Inc. is recalling Estriol USP41 Micro 25 Grams (Lot #ETL181001) due to cGMP deviations. The product was distributed to AL, AZ, CO, FL, and VA.

    Product
    Estriol USP41 Micro 25 Grams, Distributed by: A.P.I. Solutions 25309 Friendship Rd Daphne, AL Distributed by: Syntec Pharma Corp., NY MFT by: Wuhan Fortune Chemical Co., Ltd., China, NDC: 46144-300-01
    Category
    Drug
    Distribution
    5 states
  • SevereNHTSA·21V601000·2021-08-03

    Fuel hose leak recall in 2021-2022 Kenworth and Peterbilt trucks

    PACCAR is recalling 688 commercial trucks due to a fuel hose leak between the fuel pump and remote fuel filter head that increases fire risk. Free fuel hose replacement is being offered.

    Product
    KENWORTH — KENWORTH, PETERBILT T480, T280, T380, T370
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21E070000·2021-08-03

    Bendix Intellipark Electronic Control Unit Software Recall

    Bendix is recalling Intellipark Dash Electronic Control Units that may fail to activate the parking brake, causing vehicles to move unintentionally.

    Product
    PARKING BRAKE:ELECTRICAL:CONTROL MODULE:SOFTWARE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V595000·2021-08-02

    2021 Audi E-Tron: Unsecured glove box may interfere with air bag

    Volkswagen is recalling certain 2021 Audi E-Tron vehicles because the right hinge pin for the glove box cover may not be properly secured, potentially interfering with knee air bag deployment in a crash.

    Product
    AUDI — AUDI E-TRON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V599000·2021-08-02

    Software error may deactivate rear-view display in 2021 INFINITI Q60 vehicles

    A software error may disable the rear-view camera display in 2021 INFINITI Q60 vehicles, reducing rear visibility and increasing crash risk. Nissan will update the software at no cost.

    Product
    INFINITI — INFINITI Q50, QX80, Q60
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V596000·2021-08-02

    2022 Mitsubishi Outlander seat belt retractor defect affects child restraints

    Mitsubishi is recalling certain 2022 Outlander vehicles due to seat belt retractors that may deactivate early, preventing child restraint systems from securing properly. Owners should contact MMNA at 1-888-648-7820 for free replacement.

    Product
    MITSUBISHI — MITSUBISHI OUTLANDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V598000·2021-08-02

    2020 BMW X4 Engine Software Defect Disables Braking Assist

    BMW is recalling multiple 2020-2021 models, including the X4, due to engine management software that may disable braking assist. Owners should contact BMW at 1-800-525-7417 for a free software update.

    Product
    BMW — BMW, TOYOTA 745LE, X4, X3, M340I
    Category
    Vehicle
    Distribution
    Distributed nationwide

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