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.

Which agencies issued them

101–200 of 449

  • LowFDA (Devices)·Z-1426-2021·2021-04-28

    HeartWare HVAD System Manual Updates for Carrying Cases and Driveline Cover

    Heartware, Inc. is updating the Instructions for Use and Patient Manual for the HVAD System to clarify carrying case care, driveline cover orientation, and controller power-up sequences.

    Product
    Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these system components: HVAD Sterile Implant Kit, Model Numbers: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, MCS1705PU HVAD Controller Kit, Model Numbers: 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 14
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V297000·2021-04-27

    Mitsubishi Fuso Recalls FEC7T Trucks for Rear Leaf Spring Defect

    Mitsubishi Fuso is recalling 2019-2021 FEC7T trucks because the rear leaf spring may break, creating a road hazard and increasing crash risk.

    Product
    MITSUBISHI FUSO — MITSUBISHI FUSO FEC7T
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V292000·2021-04-26

    Keystone Recalls 2021 Passport Trailers Due to Underrated Safety Chains

    Keystone is recalling specific 2021 Passport trailers because the installed safety chains are underrated for the vehicle's weight rating, which could allow the trailer to detach from the tow vehicle.

    Product
    KEYSTONE — KEYSTONE PASSPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V294000·2021-04-26

    2021 LOOK, Pace, and Cargo Express Trailers Recalled for Axle Bracket Defect

    LGS Industries is recalling 2021 LOOK, Pace, and Cargo Express trailers because an axle bracket may separate, affecting stability and increasing crash risk.

    Product
    CARGO EXPRESS — CARGO EXPRESS, LOOK, PACE CARGO TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V295000·2021-04-26

    Multiple Audi vehicles recalled for defective rear axle suspension lock nuts

    Audi is recalling certain 2019-2021 vehicles for rear axle lock nuts that may break from stress corrosion. A broken lock nut can cause axle misalignment, loss of control, and increased crash risk.

    Product
    AUDI — AUDI S5 CABRIOLET, S5, S4, RS 7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·015-2021·2021-04-24

    More Than Gourmet Recalls Beef and Veal Broth Due to Hydraulic Oil Contamination

    More Than Gourmet is recalling beef and veal broth products that may contain hydraulic oil. No illnesses have been reported.

    Product
    Ajinomoto Health & Nutrition North America — More Than Gourmet, Inc. Recalls Beef And Veal Broth And Stock Products Due To Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·014-2021·2021-04-23

    Super World Trading Recalls Ineligible Imported Ready-to-Eat Fish Chips

    Super World Trading Inc. is recalling approximately 26,270 pounds of ready-to-eat fish chips imported from China because the country is ineligible to export processed products to the U.S.

    Product
    Super World Trading Inc. Recalls Ineligible Ready-To-Eat Siluriformes Products Imported From China
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V288000·2021-04-23

    Mercedes-Benz Recalls 2020-2021 GLE and GLS Models for Fire Risk

    Mercedes-Benz is recalling certain 2020-2021 GLE and GLS vehicles because incorrectly installed air conditioner drain hoses may cause water intrusion, leading to electrical short circuits and fire.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLE 350, GLE 450, GLS 450, GLS 580 4MATIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V290000·2021-04-23

    Rosenbauer Fire Trucks Recalled for Excessively Bright Rear Lights

    Rosenbauer America is recalling specific fire trucks because rear lights may be too bright, potentially blinding other drivers and increasing crash risk.

    Product
    ROSENBAUER — ROSENBAUER COMMANDER, COMMERCIAL 7400, COMMERCIAL M2-106, COMMERCIAL HV613
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V287000·2021-04-23

    2021 Coachmen Catalina Travel Trailer Recall for Fire Risk

    Forest River is recalling 2021 Coachmen Catalina travel trailers because an incorrectly gauged battery wire may melt and cause a fire.

    Product
    COACHMEN — COACHMEN CATALINA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V285000·2021-04-22

    Blue Bird Recalls 2022 Transit Buses Due to Air Brake Defect

    Blue Bird is recalling 96 2022 Vision and All American transit buses because a check valve defect may cause unintended spring brake application, increasing crash risk.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN TRANSIT BUS, VISION TRANSIT BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V284000·2021-04-22

    Blue Bird Recalls 2020-2022 School Buses Due to Brake Valve Defect

    Blue Bird is recalling 2020-2022 Vision and All American school buses because a check valve may fail to isolate air, potentially causing unintended spring brake application and increasing crash risk.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN SCHOOL BUS, VISION SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V282000·2021-04-22

    HME Recalls 2013-2021 Vehicles Due to Wiring Insulation Defect

    HME is recalling 2013-2021 AF1, 1871, and SFO vehicles because cracked wiring insulation may cause aerial controls to fail, creating a shock risk.

    Product
    HME — HME AF1, SFO, 1871
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21738·2021-04-22

    Kawasaki Recalls 2021 BRUTE FORCE 750 ATVs Due to Fire Hazard

    Kawasaki is recalling about 70 2021 BRUTE FORCE 750 ATVs because loose fuel pump bolts can cause fuel leaks and fire. No injuries have been reported.

    Product
    BRUTE FORCE® 750 All-Terrain Vehicles (ATVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V281000·2021-04-22

    International RH and LT trucks recalled for engine connecting rod failure

    Navistar is recalling certain 2019-2021 International LT and RH trucks due to wrist pin cracks that can cause connecting rod failure and engine stalls. Affected owners should contact their dealer for free repair.

    Product
    INTERNATIONAL — INTERNATIONAL LT, RH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V280000·2021-04-22

    2020-2021 Dodge Durango Side Air Bag Fastener Recall

    Chrysler is recalling 2020-2021 Dodge Durango vehicles because the side curtain air bag fastener may be loose or missing. A loose fastener could cause incorrect air bag deployment, increasing injury risk.

    Product
    DODGE — DODGE DURANGO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V286000·2021-04-22

    2021 Nissan Rogue brake caliper defect poses crash risk

    Nissan is recalling 2021 Rogue vehicles because the rear brake calipers may be missing an internal bushing, causing brake fluid to leak and reducing braking performance, increasing the risk of a crash.

    Product
    NISSAN — NISSAN ROGUE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0359-2021·2021-04-21

    Spartan Chemical Recalls Lite'n Foamy Hand Sanitizer Due to Microbial Contamination

    Spartan Chemical is recalling 19,044 containers of Lite'n Foamy Lemon Blossom Hand Sanitizer because a lot tested positive for Burkholderia multivorans.

    Product
    Lite'n Foamy Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1%), Net Contents: 18 oz/ 532 ml per foam pump container, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA. UPC 7 53727 26288 5 SKU# 333806 NDC:
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0614-2021·2021-04-21

    Novo Nordisk Recalls Levemir Insulin Pens Due to Temperature Abuse

    Novo Nordisk is recalling Levemir FlexTouch insulin pens stored below 32°F, which may cause lack of efficacy and damage to the cartridge and pen-injectors.

    Product
    LEVEMIR — LEVEMIR (INSULIN DETEMIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0428-2021·2021-04-21

    Harris Teeter Cookies & Creme Cake Recalled for Undeclared Hazelnuts

    Harris Teeter is recalling 3-layer Cookies & Creme Cakes because they contain undeclared hazelnuts. The product was distributed in eight states and D.C.

    Product
    HARRIS TEETER FRESH FOODS MARKET 3 Layer COOKIES & CREME CAKE NET WT 48 OZ (3 LB) 1.36kg packages PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC MATTHEWS, NC 28105 UPC: 0 72036 95224 0
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Drugs)·D-0611-2021·2021-04-21

    Novo Nordisk Recalls Fiasp Insulin Pens Due to Temperature Abuse

    Novo Nordisk is recalling Fiasp insulin pen samples stored below 32°F. The temperature abuse may cause lack of efficacy and damage to the cartridge and pen-injectors.

    Product
    FIASP — FIASP (INSULIN ASPART INJECTION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0621-2021·2021-04-21

    Novo Nordisk Recalls TRESIBA Insulin Pens Due to Temperature Abuse

    Novo Nordisk is recalling specific lots of TRESIBA insulin pens because they were stored below 32°F, which may reduce efficacy and damage the device.

    Product
    TRESIBA — TRESIBA (INSULIN DEGLUDEC)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0616-2021·2021-04-21

    Novo Nordisk Recalls Insulin Diluting Medium Due to Temperature Abuse

    Novo Nordisk Inc is recalling samples of Insulin Diluting Medium for NovoLog because storage below 32°F may cause lack of efficacy and damage to cartridges and pen-injectors.

    Product
    INSULIN DILUTING MEDIUM FOR NOVOLOG — INSULIN DILUTING MEDIUM FOR NOVOLOG (WATER INJECTION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0427-2021·2021-04-21

    Surtidoras Bakery Recalls Oreo 3-Milk Cakes for Undeclared Hazelnut

    Surtidoras Bakery Inc is recalling two Oreo 3-Milk Cakes sold in Washington due to undeclared hazelnut in the topping.

    Product
    Oreo 3-Milk Cake (Oreo Tres Leches Cake). Cake net wt. 2.80 lbs. (1.27kg). Cake is packaged in rigid plastic dome, individually labeled, and sold in grab and go retail refrigerated display case.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0619-2021·2021-04-21

    Novo Nordisk Recalls TRESIBA Insulin Pens Due to Temperature Abuse

    Novo Nordisk is recalling TRESIBA (insulin degludec) prefilled pens because they were stored below 32°F, which may reduce efficacy and damage the device.

    Product
    TRESIBA — TRESIBA (INSULIN DEGLUDEC)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1385-2021·2021-04-21

    Recall of Covidien Signia Stapler Reloads Due to Safety Interlock Failure

    FDA is recalling specific lots of Covidien Signia stapler reloads because a safety interlock may fail, allowing empty reloads to be fired.

    Product
    Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm Vascular/Thin 8 mm - Short Item Code:SIGSDS30CTVT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0612-2021·2021-04-21

    Novo Nordisk Recalls Fiasp Insulin Due to Temperature Abuse

    Novo Nordisk is recalling Fiasp insulin cartridges stored below 32°F, which may cause lack of efficacy and damage to the cartridge and pen-injectors.

    Product
    FIASP — FIASP (INSULIN ASPART INJECTION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V271000·2021-04-21

    2021 Porsche Cayenne recalled for rear axle suspension defect

    Porsche is recalling certain 2021 Cayenne models because lock nuts on the rear axle may break due to stress corrosion, potentially causing loss of control and crash risk.

    Product
    PORSCHE — PORSCHE CAYENNE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1414-2021·2021-04-21

    Roche cobas Liat Analyzer Respiratory Virus Panel Recall

    Roche is recalling the cobas Liat Analyzer respiratory virus panel due to invalid or false positive results for SARS-CoV-2 and Influenza A/B.

    Product
    cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0361-2021·2021-04-21

    Spartan Chemical Recalls Antiseptic Hand Cleaner Due to Manufacturing Deviations

    Spartan Chemical Co Inc is recalling 400 gallons of Antiseptic Hand Cleaner due to CGMP deviations. The product was distributed nationwide in the US, Puerto Rico, and Mexico.

    Product
    ANTISEPTIC HAND CLEANER — ANTISEPTIC HAND CLEANER (CHLOROXYLENOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1384-2021·2021-04-21

    Recall of Covidien Signia Vascular Stapler Reloads Due to Safety Interlock Failure

    FDA recalls 11,391 units of Covidien Signia vascular stapler reloads because a safety interlock may fail, allowing empty reloads to fire and cause tissue injury.

    Product
    Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30 mm Vascular 8 mm - Short Item Code: SIGSDS30CTV
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1410-2021·2021-04-21

    K2M Chesapeake Cervical Drill Guide Inserter Recalled for Interference Defect

    K2M, Inc. is recalling the Chesapeake Cervical-Ti 10mm Drill Guide Inserter due to an interference condition that may cause spinal cord injury or screw misalignment.

    Product
    Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine) Catalog number: 3608-90033
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0615-2021·2021-04-21

    Novo Nordisk Recalls Insulin Diluting Medium Due to Temperature Abuse

    Novo Nordisk is recalling specific samples of Insulin Diluting Medium for NovoLog because they were stored below 32°F, potentially causing lack of efficacy and damage to the cartridge and pen-injectors.

    Product
    INSULIN DILUTING MEDIUM FOR NOVOLOG — INSULIN DILUTING MEDIUM FOR NOVOLOG (WATER INJECTION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1383-2021·2021-04-21

    FDA Recalls Covidien Signia Stapler Reloads Due to Safety Interlock Failure

    FDA is recalling specific lots of Covidien Signia stapler reloads because a safety interlock may fail, allowing empty reloads to be fired and causing tissue injury.

    Product
    Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm - Long Item Code: SIGSDL45CTVT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0332-2021·2021-04-21

    Lupin Recalls Cefprozil Oral Suspension Due to Superpotent Drug Concerns

    Lupin Pharmaceuticals is recalling specific lots of Cefprozil for Oral Suspension because the drug may be superpotent. The recall covers bottles distributed nationwide in the USA and Puerto Rico.

    Product
    CEFPROZIL — CEFPROZIL (CEFPROZIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0613-2021·2021-04-21

    Novo Nordisk Recalls Fiasp Insulin Samples Due to Temperature Abuse

    Novo Nordisk is recalling Fiasp (insulin aspart injection) samples stored below 32°F, which may cause lack of efficacy and damage to the cartridge and pen-injectors.

    Product
    FIASP — FIASP (INSULIN ASPART INJECTION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0623-2021·2021-04-21

    Novo Nordisk Recalls Xultophy 100/3.6 Due to Temperature Abuse

    Novo Nordisk is recalling Xultophy 100/3.6 samples stored below 32°F. The temperature abuse may cause lack of efficacy and damage to the cartridge and pen-injectors.

    Product
    XULTOPHY 100/3.6 — XULTOPHY 100/3.6 (INSULIN DEGLUDEC AND LIRAGLUTIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0620-2021·2021-04-21

    Novo Nordisk Recalls TRESIBA Insulin Samples Due to Temperature Abuse

    Novo Nordisk is recalling TRESIBA (insulin degludec) samples stored below 32°F, which may cause lack of efficacy and damage to the cartridge and pen-injectors.

    Product
    TRESIBA — TRESIBA (INSULIN DEGLUDEC)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1398-2021·2021-04-21

    Siemens ADVIA 2120 Autosampler Recalled for Sample Identification Mismatch

    Siemens Healthcare Diagnostics is recalling 195 ADVIA 2120 automated hematology analyzers worldwide due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1388-2021·2021-04-21

    Siemens ADVIA 2120 Autosampler Recalled for Sample Identification Mismatch

    Siemens is recalling ADVIA 2120 Autosamplers due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - US, automated hematology analyzer -automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21115·2021-04-21

    Metal Ware Recalls NESCO Coffee Bean Roasters Due to Fire Hazard

    Metal Ware is recalling NESCO Coffee Bean Roasters because they can overheat and cause fires. Consumers should stop using the units and contact the company for a refund.

    Product
    Coffee Bean Roasters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1428-2021·2021-04-21

    Stryker PINPOINT Video Processor Recalled for Flickering and Reboots

    Stryker is recalling PINPOINT Video Processors/Illuminators that may flicker, lose image, or reboot unexpectedly.

    Product
    Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD Medical Device, UDI: (01) 00858701006049 - Product Usage: used with both the SPY-PHI and PINPOINT systems, the intended use for both imaging systems are being documented here.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1422-2021·2021-04-21

    Krishe Dasky Disposable Sampling Tubes Recalled for Missing Validation Data

    Krishe Inc is recalling Dasky Disposable Sampling Tubes because verification and validation data for the virus transport medium was not provided to the FDA prior to sale.

    Product
    Dasky Disposable Sampling Tube, REF VSM03, Contents: Sterile 0.85% Saline - 50, Nasal Swab - 50 , Package Insert - 1, IVD, CE
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1403-2021·2021-04-21

    Siemens ADVIA 2120i Hematology Analyzer Recalled for Barcode Mismatch

    Siemens Healthcare is recalling 27 ADVIA 2120i hematology analyzers because a software defect may cause sample identification mismatches with 14-character barcodes.

    Product
    ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1393-2021·2021-04-21

    Siemens ADVIA 2120i Hematology Analyzer Recalled for Barcode Mismatch

    Siemens Healthcare Diagnostics is recalling ADVIA 2120i automated hematology analyzers because 14-character barcodes may cause sample identification mismatches.

    Product
    ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - US, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1421-2021·2021-04-21

    Krishe Dasky Disposable Sampling Tubes Recalled for Missing Validation Data

    Krishe Inc is recalling Dasky Disposable Sampling Tubes because verification and validation data for the virus transport medium was not provided to the FDA prior to sale.

    Product
    Dasky Disposable Sampling Tube, REF VSM02, Contents: Transport Media - 50, Nasal swab - 50, Package Insert - 1, IVD, CE
    Category
    Medical Device
    Distribution
    4 states
  • HighNHTSA·21V277000·2021-04-21

    2022 Kia Carnival fuel rail defect increases fire risk

    2022 Kia Carnival vehicles may have damaged fuel rail tubes that could leak fuel, increasing the risk of fire. Kia will inspect and replace affected fuel rails free of charge.

    Product
    KIA — KIA CARNIVAL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V272000·2021-04-21

    Airstream Recalls 2021 Interstate Coaches Due to Wiring Fire Risk

    Airstream is recalling 2021 Interstate touring coaches because an undersized radio wiring harness wire may melt, increasing the risk of a fire.

    Product
    AIRSTREAM — AIRSTREAM INTERSTATE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21E035000·2021-04-21

    Weldon V-Mux Vista IV LCD Display Recall for Electrical Defect

    Akron Brass is recalling Weldon V-Mux Vista IV LCD displays used in emergency vehicles due to a defect that may cause the screen to lock up or become nonfunctional.

    Product
    ELECTRICAL SYSTEM: INSTRUMENT CLUSTER/PANEL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1419-2021·2021-04-21

    FDA Recalls 222 Units of Covidien Tri-Staple 2.0 Reinforced Intelligent Reloads

    FDA is recalling 222 units of Covidien Tri-Staple 2.0 Reinforced Intelligent Reloads due to a potential packaging defect that could compromise sterility and increase infection risk.

    Product
    Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with Signia stapling system. Staple line reinforcement has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis. It
    Category
    Medical Device
    Distribution
    13 states
  • HighNHTSA·21V275000·2021-04-21

    Airstream Recalls 2020-2021 Interstates Due to Incorrect Weight Rating Label

    Airstream is recalling 2020-2021 Interstate vehicles because the Gross Vehicle Weight Rating label may list incorrect occupant cargo capacity, potentially leading to vehicle overload.

    Product
    AIRSTREAM — AIRSTREAM INTERSTATE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21116·2021-04-21

    Brompton Recalls Electric Folding Bicycles Due to Software Malfunction Hazard

    Brompton Bicycle Inc. is recalling about 600 electric folding bicycles because a software malfunction can cause the motor to continue providing assistance when the rider is not pedaling, posing fall and injury hazards.

    Product
    Brompton Electric Folding Bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·21114·2021-04-21

    BRAV USA Recalls Swix Youth Jackets Due to Strangulation Hazards

    BRAV USA is recalling Swix Focus Down Jackets Jr. because hood and waist drawstrings pose strangulation and entrapment risks to children.

    Product
    Swix branded Focus Down Jackets Jr.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1396-2021·2021-04-21

    Siemens ADVIA 2120 Hematology Analyzer Recalled for Barcode Mismatch

    Siemens Healthcare is recalling 132 ADVIA 2120 hematology analyzers because a software defect may cause sample identification mismatches with 14-character barcodes.

    Product
    ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1382-2021·2021-04-21

    Sunstar Butler Clear Dip Recalled for Burkholderia Contamination

    Sunstar Americas is recalling 19,471 bottles of Butler Clear Dip due to potential contamination with Burkholderia contaminans.

    Product
    SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1413-2021·2021-04-21

    Roche Recalls cobas SARS-CoV-2 and Influenza Assay Reagents

    Roche is recalling cobas SARS-CoV-2 & Influenza A/B assay reagents because they may produce invalid or false positive results.

    Product
    cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas Liat System, Catalog Number: 09211101190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1395-2021·2021-04-21

    Siemens ADVIA 2120i Autosampler Recalled for Barcode Mismatch

    Siemens Healthcare Diagnostics is recalling 185 ADVIA 2120i Dual Aspirate Autosamplers due to potential sample identification mismatches with 14-character barcodes.

    Product
    ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - US, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1394-2021·2021-04-21

    Siemens ADVIA 2120i Hematology Analyzer Recalled for Barcode Mismatch

    Siemens Healthcare Diagnostics is recalling 8 ADVIA 2120i automated hematology analyzers due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - US, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1405-2021·2021-04-21

    Siemens ADVIA 2120i Autosampler Recalled for Sample Identification Mismatch

    Siemens Healthcare is recalling 674 ADVIA 2120i Dual Aspirate Autosamplers due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1397-2021·2021-04-21

    Siemens ADVIA 2120 Autosampler Recalled for Barcode Mismatch

    Siemens Healthcare is recalling 283 ADVIA 2120 Dual Aspirate Autosamplers due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1407-2021·2021-04-21

    Medline Stat-Site B-HB Diluent Recalled for Potential Test Inaccuracy

    Medline Industries is recalling Stat-Site B-HB Diluent because shipment compromise may cause false test results.

    Product
    Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test cards to dilute specimens containing high levelsof B-hydroxybutrate into the test range.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1399-2021·2021-04-21

    Siemens ADVIA 2120 Autosampler Recalled for Barcode Mismatch

    Siemens is recalling 43 ADVIA 2120 automated hematology analyzers worldwide due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1389-2021·2021-04-21

    Siemens ADVIA 2120 Autosampler Recalled for Barcode Mismatch

    Siemens is recalling 7 ADVIA 2120 automated hematology analyzers due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - US, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1390-2021·2021-04-21

    Siemens ADVIA 2120i Hematology Analyzer Recalled for Sample Identification Mismatch

    Siemens is recalling 15 ADVIA 2120i automated hematology analyzers because a software defect may cause sample identification mismatches with 14-character barcodes.

    Product
    ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - US, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0425-2021·2021-04-21

    Starwest Botanicals Wood Betony Herb Recalled for E. coli Presence

    Starwest Botanicals is recalling specific lots of Wood Betony Herb due to the presence of E. coli species.

    Product
    Starwest Botanicals Item#: 209617-34, Item# 209617-31 Wood Betony Herb C/S Organic Stackys Officinalis Origin: Croatia Daily serving size: Pour 8-12 oz of boiling water (212F) over 1 tsp. of tea. Steep 3-4 minutes. Net. weight: 4 oz. (113.4g) Lot#: P92769, Net weight: 1 l
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1381-2021·2021-04-21

    VGlove Nitrile Examination Gloves Recalled for Containing Latex

    HUBO International is recalling VGlove Nitrile examination gloves because they contain latex instead of nitrile, posing a risk to latex-allergic individuals.

    Product
    VGlove NITRILE *** Protect Your Life 100 Patient examination gloves
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1411-2021·2021-04-21

    FDA Recalls 59,828 Covidien Surgiwand II Suction and Irrigation Devices

    The FDA is recalling 59,828 units of the Covidien Surgiwand II Suction and Irrigation Device due to a manufacturing defect that generates particulate matter inside the tubing.

    Product
    Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22 Product Number/CFN: 178083, 178093, 178094
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-1400-2021·2021-04-21

    Siemens ADVIA 2120i Hematology Analyzer Recalled for Sample Identification Mismatch

    Siemens Healthcare Diagnostics is recalling 969 ADVIA 2120i automated hematology analyzers because 14-character barcodes may cause sample identification mismatches.

    Product
    ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1391-2021·2021-04-21

    Siemens ADVIA 2120i Autosampler Recalled for Barcode Mismatch

    Siemens is recalling 187 ADVIA 2120i Dual Aspirate Autosamplers due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - US, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1392-2021·2021-04-21

    Siemens ADVIA 2120i Analyzer Recalled for Sample Identification Mismatch

    Siemens Healthcare Diagnostics is recalling ADVIA 2120i automated hematology analyzers because 14-character barcodes may cause sample identification mismatches.

    Product
    ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - US, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1404-2021·2021-04-21

    Siemens ADVIA 2120i Hematology Analyzer Recalled for Barcode Mismatch

    Siemens Healthcare Diagnostics is recalling 572 ADVIA 2120i automated hematology analyzers due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1387-2021·2021-04-21

    Siemens ADVIA 2120 Autosampler Recalled for Sample Identification Mismatch

    Siemens is recalling 32 ADVIA 2120 Dual Aspirate Autosamplers due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - US, automated hematology analyzer -automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1386-2021·2021-04-21

    Siemens ADVIA 2120 Hematology Analyzer Recalled for Sample Identification Mismatch

    Siemens Healthcare Diagnostics is recalling ADVIA 2120 automated hematology analyzers due to potential sample identification mismatches with 14-character barcodes.

    Product
    ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1401-2021·2021-04-21

    Siemens ADVIA 2120i Autosampler Recalled for Barcode Mismatch Risk

    Siemens is recalling 1,452 ADVIA 2120i Dual Aspirate Autosamplers worldwide due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1402-2021·2021-04-21

    Siemens ADVIA 2120i Hematology Analyzer Recalled for Barcode Mismatch

    Siemens is recalling 33 ADVIA 2120i automated hematology analyzers because a potential sample identification mismatch may occur with 14-character barcodes.

    Product
    ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1420-2021·2021-04-21

    Krishe Disposable Sampling Tubes Recalled for Missing Verification Data

    Krishe Inc is recalling 1.7 million disposable sampling tubes because verification and validation data for the virus transport medium was not provided to the FDA prior to sale.

    Product
    Disposable Sampling Tube, REF VSM01, Contents: Transport Media - 50, Nasal Swab - 50, Package Insert - 1, IVD, CE
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0617-2021·2021-04-21

    Novo Nordisk Recalls OZEMPIC Injection Pens Due to Temperature Abuse

    Novo Nordisk is recalling OZEMPIC sample pens stored below 32°F, which may cause lack of efficacy and damage to the cartridge and pen-injectors.

    Product
    OZEMPIC (semaglutide) injection, 2 mg/1.5 mL (1.34 mg/mL) Prefilled pen, 1 pen, Sample. Not for Resale, Rx only, Novo Nordisk Inc, Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-4132-90 (Pen), NDC 0169-4132-97 (Kit)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0360-2021·2021-04-21

    Spartan Chemical Recalls foamyiQ Hand Sanitizer Due to Manufacturing Deviations

    Spartan Chemical Company is voluntarily recalling 26,328 cartridges of foamyiQ Lemon Blossom Hand Sanitizer due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    foamyiQ Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1%), Net Contents: 42.27 oz/1250 ml per foam pump cartridge, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA. UPC 7 53727 26454 4 NDC: 64009-202-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1427-2021·2021-04-21

    RayStation Software Recall Due to Potential Data Synchronization Errors

    RaySearch Laboratories is recalling RayStation software versions 9A, 9B, 10A, and 10B because flags edited in RayCare may not update in RayTreat.

    Product
    RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service pack (10.0.1.52), 10B (10.1.0.613)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1417-2021·2021-04-21

    Vectornate Recalls MedSchenker Smart Transport Medium Due to Discoloration

    Vectornate USA Inc is recalling 130,000 MedSchenker Smart Transport Medium systems due to discoloration and turbidity caused by a longer monsoon season at the manufacturing facility.

    Product
    MedSchenker Smart Transport Medium (STM) System: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL - MULTIPURPOSE CULTURE MEDIUM - Product Usage: intended for the collection and transport of clinical specimens containing viruses, from the collection site to the testing laborator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1425-2021·2021-04-21

    Remel Haemophilus Test Medium Recalled for Reduced Organism Growth

    Remel Inc is recalling 19 units of Haemophilus Test Medium because lighter-than-normal growth may make antimicrobial test zones difficult to measure.

    Product
    Remel Haemophilus Test Medium(100mm) 10/PK, REF: R01503 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests wi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1408-2021·2021-04-21

    Biomerieux Recalls VIDAS CMV IgM Tests Due to Calibration Issues

    Biomerieux is recalling VIDAS CMV IgM test kits due to reported calibration issues. The recall affects 18,705 kits distributed nationwide and internationally.

    Product
    VIDAS¿ CMV IgM 30 Tests
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0618-2021·2021-04-21

    Novo Nordisk Recalls Saxenda Injection Samples Due to Temperature Abuse

    Novo Nordisk is recalling Saxenda (liraglutide) injection samples that were stored below 32°F. The temperature abuse may cause lack of efficacy and damage to the cartridge and pen-injectors.

    Product
    SAXENDA — SAXENDA (LIRAGLUTIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1429-2021·2021-04-21

    Boston Scientific Recalls MAMBA Flex 135 Microcatheters for Labeling Errors

    Boston Scientific is removing specific batches of MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging.

    Product
    MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are applied to the carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1423-2021·2021-04-21

    Krishe Dasky Disposable Sampling Tubes Recalled for Missing Validation Data

    Krishe Inc is recalling Dasky Disposable Sampling Tubes because verification and validation data for the virus transport medium was not provided to the FDA prior to sale.

    Product
    Dasky Disposable Sampling Tube, REF VSM04 (Saliva Collection Kit + VTM), 10 pcs, IVD, Sterile R
    Category
    Medical Device
    Distribution
    4 states

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