The Recall Desk

Archive

April 2021 recalls

449 recalls were announced in April 2021.

What the numbers show

Critical
28
Severe
96
High
217
Moderate
95
Low
13

Of the 449 recalls this month scored against our rubric, 6% are Critical, 21% are Severe.

401–449 of 449

  • HighFDA (Food)·F-0372-2021·2021-04-07

    Haug Fresh Mini 7 Layer Dip Tray Recalled for Listeria Risk

    J & J Distributing Company is recalling Haug Fresh Mini 7 Layer Dip Trays due to potential Listeria monocytogenes contamination.

    Product
    Haug Fresh Mini 7 Layer Dip Tray, Net Wt. 22oz (624g), UPC 6 10014 16414 0, Packed and Distributed by J&J Distributing, St Paul Mn 55103
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-1259-2021·2021-04-07

    Smisson-Cartledge ThermaCor 1200 Disposable Sets Recalled for Aluminum Leaching Risk

    Smisson-Cartledge Biomedical is recalling ThermaCor 1200 Disposable Sets due to a toxicological risk assessment indicating potential aluminum ion leaching into warmed fluids.

    Product
    ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1309-2021·2021-04-07

    CareFusion Recalls BD Alaris Infusion Pump Keypads Due to Fluid Ingress

    CareFusion is recalling BD Alaris Infusion Pump Module Keypads and Door Assembly Kits because fluid ingress can cause unresponsive or stuck keys, potentially delaying medication infusion.

    Product
    BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Parts: 49000239; 49000346; 49000438; 49000439.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1323-2021·2021-04-07

    Nuvasive PRECICE STRYDE Intramedullary Nail Recall for Biological Safety Concerns

    Nuvasive Specialized Orthopedics is recalling PRECICE STRYDE intramedullary nails due to complaints of adverse events potentially related to biological safety, including pain and bony abnormalities.

    Product
    PRECICE STRYDE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1330-2021·2021-04-07

    Siemens ACUSON Sequoia Ultrasound Systems Recalled for Incorrect Delivery Date Calculations

    Siemens is recalling 1,172 ACUSON Sequoia ultrasound systems because a software error may calculate incorrect Estimated Dates of Delivery, potentially influencing clinical decisions.

    Product
    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-1318-2021·2021-04-07

    EPIX Therapeutics Recalls DiamondTemp Ablation Catheters Due to Labeling Errors

    EPIX Therapeutics is recalling 60 units of DiamondTemp Unidirectional Large Curve Ablation Catheters because packaging and instructions list incorrect catheter sizes, posing a risk of blood clots or air emboli.

    Product
    EPIX Therapeutics DiamondTemp Unidirectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF: CEDT200L, Sterile EO, UDI: 00812499030259
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1333-2021·2021-04-07

    Biocare Medical IntelliPath FLX Automated Staining Instrument Recall

    Biocare Medical is recalling 72 IntelliPath FLX instruments due to a software defect that may cause random movement and buffer dispensing errors.

    Product
    BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL containing software version 3.5.3.1
    Category
    Medical Device
    Distribution
    15 states
  • HighCPSC·21103·2021-04-07

    Epicure Recalls Glass Prep Bowls Due to Laceration Hazard

    Epicure is recalling glass prep bowls that may shatter during use, posing a laceration hazard. Consumers should stop using the product and contact Epicure for a free replacement.

    Product
    Epicure Prep Bowls (Set of Four)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·21102·2021-04-07

    RH Recalls Children's Bath Wraps for Flammability Standard Violations

    RH is recalling approximately 55,700 children's bath wraps in the U.S. because they fail to meet federal flammability standards for children's sleepwear, posing a risk of burn injuries.

    Product
    Animal, Heathered Plush and Luxe Sherpa Children's Bath Wraps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1305-2021·2021-04-07

    Medtronic Recalls Implantable Cardioverter Defibrillators Due to Shortened Replacement Time

    Medtronic is recalling specific Evera and Visia ICD models because a small percentage may experience a shortened Recommended Replacement Time to End of Service interval.

    Product
    Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR, Evera S DR, Evera MRI XT DR, Evera MRI S DR, Evera XT VR, Evera S VR and Evera MRI S VR models; 2) Visia family: Visia AF ICD, Visia AF S ICD, Visia AF MRI ICD, and Visia AF MRI S ICD models. Impla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1260-2021·2021-04-07

    ThermaCor 1200 Disposable Sets Recalled for Potential Aluminum Leaching

    Smisson-Cartledge Biomedical is recalling ThermaCor 1200 Disposable Sets due to a toxicological risk assessment indicating potential aluminum ion leaching into warmed fluids.

    Product
    ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1328-2021·2021-04-07

    Alcon Custom Ophthalmic Surgical Procedure Packs Recalled for Mold

    Alcon is recalling 249,853 custom ophthalmic surgical procedure packs because mold was found on gowns included in the packages.

    Product
    Alcon Custom Ophthalmic Surgical Procedure Packs
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1258-2021·2021-04-07

    ThermaCor 1200 Disposable Sets Recalled for Potential Aluminum Leaching

    Smisson-Cartledge Biomedical is recalling ThermaCor 1200 Disposable Sets because a toxicological assessment found potential for aluminum ions to leach into warmed fluids.

    Product
    ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1306-2021·2021-04-07

    Medtronic Recalls CRT-D Devices Due to Shortened Replacement Time

    Medtronic is recalling specific CRT-D implantable cardioverter defibrillators because a small percentage may experience a shortened time before the device reaches end of service.

    Product
    Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D): 1) Viva family: Viva XT CRT-D, Viva XT Quad CRT-D, Viva S CRT-D, Viva Quad S CRT-D and Viva Quad C CRT-D models; 2) Claria family: Claria MRI CRT-D and Claria MRI Quad CRT-D models; 3)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0375-2021·2021-04-07

    J & J Distributing Recalls Taco Dip for Listeria Risk

    J & J Distributing Company is recalling 8-ounce Kwik Trip Taco Dip due to potential Listeria monocytogenes contamination. The product was distributed to 46 retail locations in eight states.

    Product
    Taco Dip [Kwik Trip], Net Wt. 8oz (227g), UPC 0 38232 36091 3, Distributed By H. Brooks & Co. Mpls MN 55112
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-0371-2021·2021-04-07

    Earthgrown Mini Taco Dip Recalled for Listeria Contamination Risk

    J & J Distributing Company is recalling Earthgrown Mini Taco Dip due to potential Listeria monocytogenes contamination. The product was distributed to 46 retail locations in eight states.

    Product
    Earthgrown Mini Taco Dip, Net Wt. 8oz. (227g), UPC 6 10014 22341 0, Packed By J&J Distributing Inc. 653 Rice St, St Paul, MN 55103
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-1324-2021·2021-04-07

    Nuvasive Precice Bone Transport Nail Recalled for Biological Safety Concerns

    Nuvasive Specialized Orthopedics is recalling 226 Precice Bone Transport nails due to complaints of pain and bony abnormalities related to biological safety.

    Product
    Precice Bone Transport - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1342-2021·2021-04-07

    Diasorin Recalls LIAISON 1-84 PTH Assay Due to Falsely Elevated Results

    Diasorin Inc. is recalling LIAISON 1-84 PTH Assay kits because the system may produce falsely elevated parathyroid hormone results.

    Product
    LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of parathyroid hormone (1-84) in human serum and EDTA plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1329-2021·2021-04-07

    Oscor SafeSheath ULTRALITE 10F Recalled for Potential Open Sterile Seal

    Oscor, Inc. is recalling 500 units of the AngioDynamics SafeSheath ULTRALITE 10F due to a potential open seal on the sterile product.

    Product
    AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1314-2021·2021-04-07

    DePuy ATTUNE Knee Implant Recall for Damaged Packaging

    DePuy Orthopaedics is recalling ATTUNE and MBT tibial base components used in knee replacements due to potential damaged packaging.

    Product
    ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant without a porous coating. The tibial component may
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1312-2021·2021-04-07

    LumiraDx Coronavirus Antigen Test Strips Recalled for False Positives

    LumiraDx is recalling 2,186 coronavirus antigen test strips because two lots failed quality control testing and produced false positives.

    Product
    Coronavirus antigen detection test system - Product Usage: intended for the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2 directly from nasal swab samples collected from individuals suspected of COVID-19 by their healthcare provider within the first twel
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1316-2021·2021-04-07

    DePuy ATTUNE Rotating Platform Total Knee System Recalled for Damaged Packaging

    DePuy Orthopaedics is recalling 355 units of the ATTUNE Rotating Platform Total Knee System due to potential damaged packaging. The affected tibial bases are used in cemented total knee arthroplasty.

    Product
    The ATTUNE¿ Rotating Platform (RP) Total Knee System - Product Usage: consists of multiple components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1327-2021·2021-04-07

    Stryker Harmonic ACE +7 Shears Recalled for Lack of Regulatory Clearance

    Stryker is recalling 102 units of Harmonic ACE +7 Shears because they were distributed without receiving regulatory clearance.

    Product
    Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced Hemostasis 5mm Diameter x 36cm - Product Usage: indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be us
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1326-2021·2021-04-07

    Philips SureSigns Patient Monitors Recalled for Pediatric Heart Rate Accuracy Issues

    Philips is recalling SureSigns VM4, VM6, and VM8 patient monitors in China because they fail to meet Chinese standards for heart rate accuracy in pediatric mode.

    Product
    Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. (CHINA only) SureSigns VM4 (863063, 863085) SureSigns VM6 (863064,
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1315-2021·2021-04-07

    DePuy Orthopaedics Recalls Mobile Bearing Total Knee Systems Due to Packaging Damage

    DePuy Orthopaedics is recalling specific lots of the LCS COMPLETE P.F.C. SIGMA RP Mobile Bearing Total Knee System because of potential damaged packaging.

    Product
    The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage: consists of three components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1310-2021·2021-04-07

    Arthrex Recalls Cannulated Drill Bits Due to Incorrect Color Indicator

    Arthrex, Inc. is recalling 9 units of 5.0 mm cannulated drill bits because the color indicator on the shaft is the incorrect color.

    Product
    Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0314-2021·2021-04-07

    Cardinal Health Recalls Tremfya Injection Due to Temperature Abuse

    Cardinal Health Inc. is voluntarily recalling 48 boxes of Tremfya (guselkumab) Injection due to temperature abuse. The affected product was distributed to Alabama, Louisiana, Mississippi, and Tennessee.

    Product
    TREMFYA — TREMFYA (GUSELKUMAB)
    Category
    Drug
    Distribution
    4 states
  • HighNHTSA·21V241000·2021-04-06

    Mercedes-Benz and Freightliner Sprinter Recalled for Steering Hose Defect

    Daimler Vans USA is recalling 2019-2020 Sprinter vans because hydraulic power steering hoses may detach, causing fluid leaks and loss of steering assist.

    Product
    FREIGHTLINER — FREIGHTLINER, MERCEDES-BENZ SPRINTER (VS30), SPRINTER 2500, SPRINTER 3500, SPRINTER 4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V242000·2021-04-06

    Arcimoto Electric Motorcycles Recalled for Inverter Firmware Defect

    Arcimoto is recalling 2019-2021 FUV, 2020-2021 Deliverator and Roadster, and 2021 Rapid Responder motorcycles. A firmware defect in the inverter may cause the vehicle's battery to shutdown without warning, increasing the risk of a crash.

    Product
    ARCIMOTO — ARCIMOTO FUV, ROADSTER, DELIVERATOR, RAPID RESPONDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V236000·2021-04-05

    2021 Forest River Flagstaff and Rockwood Fifth Wheels Pin Box Defect

    Forest River is recalling certain 2021 Flagstaff and Rockwood fifth wheels due to pin box defects. The pin box may be under-rated for the vehicle's gross weight rating, increasing crash risk.

    Product
    FOREST RIVER — FOREST RIVER ROCKWOOD, FLAGSTAFF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • LowNHTSA·21V237000·2021-04-05

    Mercedes-Benz Sprinter VIN Mismatch Recall

    Daimler Vans USA is recalling one 2019 Mercedes-Benz Sprinter because its VIN numbers do not match, potentially preventing owners from receiving safety recall notices.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ SPRINTER (VS30)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V234000·2021-04-04

    2021 INFINITI Q50 and Q60 Engine Control Module Software Defect

    INFINITI is recalling 2021 Q50 and Q60 vehicles for an Engine Control Module software defect that may cause engine stall and increase crash risk. Dealers will reprogram the ECM software free of charge.

    Product
    INFINITI — INFINITI Q60, Q50
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·pha-04022021-01·2021-04-02

    USDA Issues Public Health Alert for Raw Ground Chorizo Sausage

    USDA FSIS issued a public health alert for raw ground chorizo sausage due to possible contamination with hard crystalline material. No illnesses have been reported.

    Product
    FSIS Issues Public Health Alert for Raw Ground Chorizo Sausage Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·011-2021·2021-04-01

    Rong Shing Trading Recalls Ineligible Chinese Beef Hot Pot Base

    Rong Shing Trading Inc. is recalling approximately 3,365 pounds of Chinese-style hot pot base containing beef tallow imported from China, a country ineligible to export beef to the U.S.

    Product
    Rong Shing Trading Inc. Recalls Ineligible Beef Products Imported from China
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V229000·2021-04-01

    Mercedes-Benz Recalls Vehicles for Steering Shaft Bearing Separation Risk

    Mercedes-Benz is recalling specific 2017-2018 models because a steering shaft defect could cause loss of control. Dealers will inspect and replace the shaft free of charge.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLA 250, CLA250, AMG CLA45, AMG GLA45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V228000·2021-04-01

    Mercedes-Benz Recalls 2021 E-Class Models for Parking Sensor Defect

    Mercedes-Benz is recalling 2021 E350, E450, and AMG E63 vehicles because the parking control unit may fail to display the rearview camera or detect objects, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ E 350, E 450, AMG E63
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V226000·2021-04-01

    2021 International RH and LT Vehicles Parking Brake Defect

    Certain 2021 International RH and LT vehicles have a defective spring brake chamber that may allow the parking brake to malfunction, increasing crash risk. Navistar will replace the defective brake chambers at no cost.

    Product
    INTERNATIONAL — INTERNATIONAL RH, LT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V233000·2021-04-01

    Mack heavy trucks recalled for electronic stability control software malfunction

    Mack trucks (2018-2022) with electronic stability control may drift out of their lane at certain speeds, increasing crash risk. Dealers will reprogram the control units free of charge.

    Product
    MACK — MACK GRANITE (GR), GRANITE (GU), PINNACLE (CXU), PINNACLE (CHU)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V230000·2021-04-01

    2021 Mercedes-Benz Vehicles Recalled for Faulty Seat Switch

    2021 Mercedes-Benz vehicles are being recalled due to a faulty seat position switch that may prevent airbags and seatbelt force limiters from activating during a crash. MBUSA will replace the switches free of charge.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ CLS 450, C 300, E 350, AMG GT63S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V227000·2021-04-01

    2021 International Trucks Recalled for Air Brake Check Valve Manufacturing Defect

    Navistar recalls 2021 International trucks for defective air brake check valves that may cause unintended brake application and increase crash risk. The SC-3 valve's retainer is not properly seated.

    Product
    INTERNATIONAL — INTERNATIONAL RH, LT, HV, MV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V231000·2021-04-01

    2021 Mercedes-Benz GLB vehicles recalled for potentially detaching tailgate spoilers

    Mercedes-Benz is recalling certain 2021 GLB35 AMG and 2020–2021 GLB250 vehicles because the side spoilers on the tailgate might not have been installed correctly, allowing them to detach and create a road hazard.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLB 250, AMG GLB35
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21734·2021-04-01

    doTERRA Recalls Essential Oils Due to Non-Child-Resistant Packaging

    doTERRA is recalling 1.3 million bottles of Deep Blue, PastTense, and Deep Blue Touch essential oils because the packaging is not child-resistant, posing a poisoning risk.

    Product
    doTERRA Deep Blue, PastTense and Deep Blue Touch Essential Oils
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·21735·2021-04-01

    BATTOP Foldable Infant Bath Seats Recalled for Drowning Hazard

    BATTOP is recalling about 5,000 foldable infant bath seats sold on Amazon.com because they can tip over, posing a drowning risk to babies.

    Product
    Foldable Infant Bath Seats
    Category
    Consumer Product
    Distribution
    Distributed nationwide

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