The Recall Desk

Archive

May 2021 recalls

517 recalls were announced in May 2021.

What the numbers show

Critical
40
Severe
132
High
234
Moderate
95
Low
16

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

Which agencies issued them

401–500 of 517

  • ModerateFDA (Devices)·Z-1529-2021·2021-05-12

    LeMaitre Vascular Recalls LeverEdge Contrast Injectors Due to Packaging Particulates

    LeMaitre Vascular is recalling 616 LeverEdge Contrast Injectors because particulates in the packaging foam could contaminate the sterile field.

    Product
    LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used to perfuse contrast medias into the vessels for angiographic procedures, Catalog #: 4100-00.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1532-2021·2021-05-12

    Medtronic Abre Venous Self-expanding Sent System Recall for Incorrect Size Labeling

    Medtronic is recalling 23 Abre Venous Self-expanding Sent Systems because the device size is incorrectly printed on the device itself, though the packaging is labeled correctly.

    Product
    Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1527-2021·2021-05-12

    Medtronic Programmers Recalled for Longevity Estimation Error

    Medtronic is recalling 2090 Carelink and 29901 Encore programmers due to a potential longevity estimation error in specific pacing configurations.

    Product
    Programmers - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. 2090 Carelink 2. 29901 Encore
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1519-2021·2021-05-12

    Oto Med Recalls Sheehy Bone Dust Collectors Due to Packaging Defects

    Oto Med Inc is recalling 13,335 Sheehy Bone Dust Collectors because holes were found in the sterile Tyvek pouches during internal testing.

    Product
    Grace Medical REF S-2500 *** SHEEHY BONE DUST COLLECTOR *** Stainless steel filter - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0479-2021·2021-05-12

    Natrol Melatonin 3 mg Tablets Recalled for Mislabeling as ALA 300 mg

    Natrol LLC is recalling one lot of Melatonin 3 mg tablets that were mislabeled as ALA 300 mg capsules. The recall covers 12,740 units distributed across multiple US states and international locations.

    Product
    Natrol Melatonin 3 mg, Tab 60 White bottle with purple flip-top cap. Fall asleep faster, Stay asleep longer, 100$ Drug Free 1 Tablet 20 minutes before bedtime. Manufactured by Natrol LLC. Chatsworth, CA 91311 USA
    Category
    Drug
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-1520-2021·2021-05-12

    Oto Med Recalls Bone Dust Collectors Due to Sterile Pouch Defects

    Oto Med Inc is recalling 5,092 Grace Medical Cox Bone Dust Collectors because holes were found in the sterile Tyvek pouches during internal testing.

    Product
    Grace Medical REF S-3500 *** COX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0474-2021·2021-05-12

    Thai Home Sweet Chili Paste Recalled for Acidified Food Rule Violations

    Jansala & Foods LLC is recalling Thai Home Sweet Chili Paste for failing to follow acidified food regulations. The product was distributed to retailers in California, Oregon, and Washington.

    Product
    Thai Home brand Sweet Chili Paste (Num Prik Pao) packaged in glass jars. Net weight 6.5 oz (180g). Refrigerate after opening. UPC 8616080004054 Manufactured by: Jansala & Foods LLC 1813 NE 2nd Avenue Portland, OR [email protected] Distributed by: Earthly Gourmet 2143
    Category
    Food
    Distribution
    3 states
  • SevereNHTSA·21V332000·2021-05-11

    E-One Fire Apparatus Recalled for Fuel Rail Leak Fire Risk

    E-One Incorporated is recalling 2017-2021 fire apparatus vehicles because a defective sealing washer may cause a fuel leak, increasing the risk of fire.

    Product
    E-ONE — E-ONE TYPHOON N, CYCLONE II, CYCLONE N, QUEST II
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V335000·2021-05-11

    Ducati Recalls Monster Motorcycles Due to Rear Brake Hose Heat Damage Risk

    Ducati is recalling certain Monster 821 and 1200 motorcycles because rear brake hoses may suffer heat damage, potentially causing brake failure and increasing crash risk.

    Product
    DUCATI — DUCATI MONSTER 1200, MONSTER 821
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V334000·2021-05-11

    Rosenbauer Fire Trucks Recalled for Fuel Rail Leak Fire Risk

    Rosenbauer America is recalling 2016-2021 fire trucks because a fuel rail leak could cause a fire. Owners should contact the dealer for a free repair.

    Product
    ROSENBAUER — ROSENBAUER WARRIOR, AVENGER, COMMANDER, COMMERCIAL M2-106
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V333000·2021-05-11

    KME Custom Chassis Recalled for Potential Fuel Rail Leak Fire Risk

    Kovatch Mobile Equipment Corp. is recalling 2012-2021 KME Custom Chassis vehicles because a sealing washer defect may cause high-pressure fuel leaks, increasing the risk of fire.

    Product
    KME — KME CUSTOM CHASSIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V330000·2021-05-10

    Eldorado Recalls 2017-2020 Models Due to Fuel Rail Leak Risk

    Eldorado is recalling 2017-2020 Axess, EZRM, and XHF vehicles because a sealing washer may not seat correctly, allowing the high-pressure fuel rail to leak and increasing fire risk.

    Product
    ELDORADO — ELDORADO XHF, EZRM, AXESS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V331000·2021-05-10

    Kia Recalls Optima and Sorento Models for Brake Fluid Leak Fire Risk

    Kia is recalling 2013-2015 Optima and 2014-2015 Sorento vehicles because brake fluid may leak inside the Hydraulic Electronic Control Unit, creating a fire risk.

    Product
    KIA — KIA OPTIMA, SORENTO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V328000·2021-05-10

    2021 Peterbilt Brake Chamber Defect May Increase Crash Risk

    PACCAR is recalling certain 2021 Peterbilt 348 and 579 vehicles due to brake chamber defects. Incorrectly assembled springs may cause pressure loss and increase crash risk.

    Product
    PETERBILT — PETERBILT 579, 348
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V329000·2021-05-10

    Spartan Fire Recalls 2009-2021 Metrostar and Gladiator Emergency Vehicles

    Spartan Fire is recalling 2009-2021 Metrostar and Gladiator emergency vehicles because a corroded solenoid may cause loss of water pressure, increasing injury risk.

    Product
    SPARTAN FIRE — SPARTAN FIRE GLADIATOR, METROSTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V324000·2021-05-07

    Ford Recalls 2019 Transit Vehicles Due to Rear Axle Flange Warping

    Ford is recalling 2019 Transit T150, T250, and T350 vehicles with aluminum wheels because a warped axle flange may cause wheel studs to fracture and the wheel to detach.

    Product
    FORD — FORD TRANSIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V327000·2021-05-07

    Thomas Built Buses Recalls Saf-T-Liner HDX School Buses for Fuel Leak Risk

    Daimler Trucks North America is recalling 2018-2021 Thomas Built Buses Saf-T-Liner HDX school buses because a sealing washer defect may cause high-pressure fuel leaks, increasing fire risk.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER HDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V326000·2021-05-07

    Western Star 4700 and Freightliner fuel rail defect recall

    Daimler Trucks North America recalls 2018-2021 Western Star 4700 and Freightliner trucks due to fuel rail assembly defects that could leak and cause fires in certain conditions.

    Product
    FREIGHTLINER — FREIGHTLINER, FCCC, WESTERN STAR 108SD, XB CHASSIS, XC CHASSIS, 114SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V325000·2021-05-07

    Airstream Globetrotter Travel Trailers Cabinet Door Adhesive Failure Recall

    Airstream is recalling 2020-2021 Globetrotter travel trailers because adhesive on overhead cabinet doors may fail, causing the doors to fall and potentially injure occupants.

    Product
    AIRSTREAM — AIRSTREAM GLOBETROTTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·21742·2021-05-06

    CFMOTO Recalls 2021 CFORCE 800XC ATVs Due to Crash Hazard

    CFMOTO is recalling about 2,050 2021 CFORCE 800XC ATVs because the electronic power steering can malfunction, causing loss of control and posing a crash hazard.

    Product
    2021 CFORCE 800XC All-Terrain Vehicles (ATVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V322000·2021-05-06

    Oshkosh Recalls 2021 S-Series Vehicles Due to Axle Detachment Risk

    Oshkosh is recalling 2021 S-Series vehicles because auxiliary axles may not be properly secured and could detach, increasing the risk of a crash.

    Product
    OSHKOSH — OSHKOSH S-SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V323000·2021-05-06

    Spartan Fire Recalls 2017-2020 Gladiator and MetroStar Vehicles for Fuel Leak

    Spartan Fire is recalling 2017-2020 Gladiator and MetroStar vehicles because a sealing washer may not seat correctly, causing a high-pressure fuel rail leak that increases fire risk.

    Product
    SPARTAN FIRE — SPARTAN FIRE METROSTAR, GLADIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0343-2021·2021-05-05

    FDA Recalls Chloraprep One-Step Antiseptic Due to Fungal Contamination

    CareFusion 213, LLC is recalling Chloraprep One-Step antiseptic applicators because fungal growth breached package integrity. The product is distributed nationwide and internationally.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0471-2021·2021-05-05

    Golden Medal Mushroom Inc. Recalls Enoki Mushrooms for Listeria

    Golden Medal Mushroom Inc. is recalling Enoki Mushrooms after Michigan state sampling detected Listeria monocytogenes.

    Product
    Enoki Mushroom Product of Korea Net Wt. 200 g/7.05 oz. UPC: 809165 582015 Clear plastic bag with green band of color across the bottom of the bag, Golden Medal Mushroom Inc., 1811 Sacramento St., Los Angeles, CA 90021 Keep Refrigerated; Cook through before eating.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0344-2021·2021-05-05

    ChloraPrep One-Step Recalled for Fungal Contamination and Package Breach

    CareFusion 213, LLC is recalling ChloraPrep One-Step applicators because fungal growth breached package integrity. The product is a sterile skin antiseptic.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0345-2021·2021-05-05

    CareFusion Recalls ChloraPrep Antiseptic Applicators Due to Fungal Contamination

    CareFusion 213, LLC is recalling ChloraPrep One-Step antiseptic applicators because fungal growth breached package integrity under labeled storage conditions.

    Product
    ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 26040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0346-2021·2021-05-05

    CareFusion Recalls ChloraPrep Antiseptic Due to Fungal Contamination

    CareFusion is recalling ChloraPrep antiseptic applicators because fungal growth breached package integrity. The product is non-sterile, but the breach compromises the sterility of the applicators.

    Product
    ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each, 25 applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-11 Cat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0354-2021·2021-05-05

    Triple SupremeZen Gold 3500 Recalled for Unapproved Active Ingredients

    Na Na Collection is recalling Triple SupremeZen Gold 3500 capsules because FDA analysis found unapproved active ingredients tadalafil and/or sildenafil.

    Product
    Triple SupremeZen Gold 3500, Packaged in paper packaging with a pill blister,1 capsule per box, Distributed by VIEW LIFE Distributors Los Angeles CA 90005 UPC 7 15122 05089 4
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·21E042000·2021-05-05

    B&W Recalls Stainless Steel Locking Receiver Hitch Pins

    B&W Custom Truck Beds is recalling 5/8-inch stainless steel locking receiver hitch pins because the lock can be removed without a key, allowing the ball mount to detach.

    Product
    TRAILER HITCHES recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0352-2021·2021-05-05

    Imperial Extreme 2000 Capsules Recalled for Unapproved Active Ingredients

    S & B Story LLC is recalling Imperial Extreme 2000 Capsules because FDA analysis found unapproved ingredients tadalafil and sildenafil.

    Product
    Imperial Extreme 2000 Capsules, 2000 mg, 1 count blister cards, distributed S&B Shopper LLC. Little Ferry, NJ UPC 7 18122 04073 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0348-2021·2021-05-05

    ChloraPrep One-Step Recalled for Potential Fungal Growth and Package Breach

    CareFusion 213, LLC is recalling ChloraPrep One-Step applicators due to a lack of assurance of sterility. The product may allow fungal growth at labeled storage conditions, potentially breaching package integrity.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0351-2021·2021-05-05

    Namoo Enterprise Recalls PremierZen Black 5000 Capsules for Unapproved Ingredients

    Namoo Enterprise LLC is recalling PremierZen Black 5000 capsules because FDA analysis found unapproved ingredients tadalafil and sildenafil.

    Product
    PremierZen Black 5000 capsules, 1 capsule per card/24 capsules per box, Distributed by New Premier Group Los Angeles CA 90006 UPC 7 2817542189 4
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1496-2021·2021-05-05

    Siemens Recalls Artis Angiography Systems Due to Belt Corrosion

    Siemens is recalling 3,320 Artis angiography systems in the US because belt corrosion may cause system failure or unintended C-Arm movement.

    Product
    Artis systems - Product Usage: an angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Model Numbers: System Material # AXIOM Artis FC 05904433; AXIOM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0353-2021·2021-05-05

    FDA Recalls PremierZen Platinum 5000 for Unapproved Active Ingredients

    Na Na Collection is recalling PremierZen Platinum 5000 capsules because FDA analysis detected unapproved active ingredients tadalafil and/or sildenafil.

    Product
    PremierZen Platinum 5000, Packaged in paper packaging with a pill blister, 1 capsule per box, Distributed by New Premier Group Los Angeles CA 90006
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereCPSC·21124·2021-05-05

    Scott Fetzer Recalls Wayne WaterBUG GLOW Pumps Due to Fire and Shock Hazards

    Scott Fetzer Consumer Brands is recalling Wayne WaterBUG GLOW pumps because water exposure can cause short circuits, posing fire, burn, and electrical shock risks.

    Product
    WAYNE WaterBUG GLOW Multi-Use Submersible Water Removal Pumps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0347-2021·2021-05-05

    ChloraPrep One-Step Recalled for Potential Fungal Growth and Sterility Breach

    CareFusion 213, LLC is recalling ChloraPrep One-Step applicators due to potential fungal growth that may breach package integrity and compromise sterility.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0468-2021·2021-05-05

    Champlain Chocolate Company Recalls Organic Chocolate Bunnies for Undeclared Almonds

    Champlain Chocolate Company is recalling Organic Mr. Goodtime Bunny chocolate products because they may contain undeclared almonds. Consumers in nine states should check their products.

    Product
    "Basket Country Bunny ORG" that contains the Organic Mr. Goodtime Bunyy***NET WT 3.35 LBS (1.4kg)***INGREDIENTS: *Milk, *Dark, AND *WHITE CHOCOLATE (*SUGAR, *MILKK POWDER, *COCOA BUTTER, *CHOCOLATE LIQUOR, *COCOA POWDER (PROCESSED WITH ALKALI), *SOYBEAN LECITHIN, *VANILLA EXTRACT
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-0457-2021·2021-05-05

    Twin City Foods Recalls Frozen Corn for Allergen Cross-Contact

    Twin City Foods is recalling Signature Select Golden Corn Sweet due to possible egg and wheat allergen cross-contact during packaging.

    Product
    Signature Select Golden Corn Sweet, frozen, packed in poly film bags. 12/16 oz. packages per case. UPC 2113009152. Signature Select Golden Corn Sweet, frozen, packed in poly film bags, 12/32 oz. packages per case. UPC 2113009021. Product of USA. Products is DISTRIBUTED BY BETTE
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0470-2021·2021-05-05

    Backcountry Mills Recalls G4G Low Carb Pancake Mix for Salmonella Risk

    Backcountry Mills LLC is recalling G4G Low Carb Pancake & Waffle Mix due to potential Salmonella contamination. The product was distributed in Texas.

    Product
    G4G Low Carb Pancake & Waffle Mix, Keto Friendly Just Add Water Net Wt 12 ounces, 6pack Case UPC 860000241427 packaged in a rigid cardboard box
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0458-2021·2021-05-05

    Torn & Glasser Recalls Dark Chocolate Espresso Beans for Undeclared Walnuts

    Torn & Glasser, Inc. is recalling Dark Chocolate Espresso Beans because the product contains walnuts that are not declared on the label.

    Product
    Dark Chocolate Expresso Beans; Net Wt. 12 oz. (340g), Best if used by 11-19-2021. Contains Soy, May Contain Milk. Packed in a facility that processes on share equipment with Peanuts, Tree Nuts, Milk, Wheat and Egg. UPC: 0 72488 99868 1 Packed by Torn & Glasser, Los An
    Category
    Food
    Distribution
    30 states
  • HighFDA (Drugs)·D-0355-2021·2021-05-05

    Grace Healthcare Recalls Compressed Oxygen Cylinders Due to Manufacturing Deviations

    Grace Healthcare Medical, Inc. is voluntarily recalling 35,838 compressed oxygen cylinders nationwide due to cGMP deviations. The recall was initiated in April 2021.

    Product
    Oxygen, Compressed, USP UN 1072, packaged in cylinders labeled as: a) M6 Medical Gas Cylinder, b) C Medical Gas Cylinder; c) D Medical Gas Cylinder; d) E Medical Gas Cylinder; e) M Medical Gas Cylinder; f) H Medical Gas Cylinder, Rx only, Grace Healthcare 1418 31st Avenue Gulfpo
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0473-2021·2021-05-05

    Jose Madrid Strawberry Mild Salsa Recalled for Undeclared Anchovy Allergen

    Michael Zakany LLC is recalling Jose Madrid Strawberry Mild Salsa because it contains anchovy, a major allergen, that is not listed on the label.

    Product
    Jose Madrid Salsa - Strawberry Mild Salsa 13oz glass jars, 12 jars per case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1487-2021·2021-05-05

    Baxter Spectrum IQ Infusion Pump Recalled for Defective AC Power Adapter

    Baxter Healthcare is recalling 408 Spectrum IQ infusion pumps because a potentially defective AC power adapter may fail over time.

    Product
    Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the controlled administration of fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1513-2021·2021-05-05

    DJ Orthopedics Recalls Ultrasling Pro Arm Sling Due to Failed Rivet

    DJ Orthopedics is recalling Ultrasling Pro arm slings because a rivet at the chafe tab failed. The defect could compromise the device's ability to immobilize the arm.

    Product
    DONJOY REF:11-0472-9 ULTRASLING PRO ER/IR 30, UNIVERSAL, Rx ONLY, UDI: (01)00190446683674 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0469-2021·2021-05-05

    Richelieu Foods Recalls Tuscan Garden Ranch Dressing Due to Labeling Error

    Richelieu Foods is recalling Tuscan Garden Ranch Dressing sold at ALDI because incorrect labels failed to disclose milk and egg ingredients.

    Product
    Tuscan Garden Ranch Dressing, packaged in 16 oz bottles, Dist. & Sold Exclusively by ALDI, Batavia, IL packaged in 12 bottles per case
    Category
    Food
    Distribution
    14 states
  • HighFDA (Devices)·Z-1509-2021·2021-05-05

    B. Braun Recalls Filtered Triple-Leg Extension Sets Due to Occlusion Risk

    B. Braun Medical is recalling 1,900 Filtered Triple-Leg Extension Sets because they may become occluded or unable to prime.

    Product
    Filtered Triple-Leg Extension Set - Intravascular administration set. Product Catalog number: 477034 - Product Usage: The extension set is a sterile, single-use intravascular direct injection, intermittent infusion, continuous infusion or aspiration of fluids and medications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1506-2021·2021-05-05

    Datascope Cardiosave Hybrid IABP Recalled for Cybersecurity Vulnerabilities

    Datascope Corp. is recalling Cardiosave Hybrid IABP devices due to cybersecurity vulnerabilities in a TCP/IP software library that may cause loss of communication to hospital systems.

    Product
    Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0349-2021·2021-05-05

    CareFusion Recalls ChloraPrep Antiseptic Applicators Due to Fungal Growth Risk

    CareFusion 213, LLC is recalling ChloraPrep One-Step antiseptic applicators because fungal growth may breach package integrity. The product was distributed in the US and 12 other countries.

    Product
    ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 26040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1518-2021·2021-05-05

    Omnia Soft Tissue Punch Recalled Due to Inadequate Sterilization

    Omnia SRL is recalling dental soft tissue punches because the contract manufacturer reported inadequate sterilization processes at their facility since 2016.

    Product
    Omnia Soft Tissue Punch is a dental instrument designed to remove with precision a circular section of oral soft tissue (e.g., gum, palatal mucosa) during dental surgery, typically to allow access to a site for drilling and dental/orthodontic implant placement without the use of
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Drugs)·D-0350-2021·2021-05-05

    CareFusion Recalls ChloraPrep Antiseptic Applicators Due to Fungal Growth Risk

    CareFusion 213, LLC is recalling ChloraPrep With Tint antiseptic applicators because fungal growth may breach package integrity at labeled storage conditions.

    Product
    ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each, 25 applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-11 Cat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1488-2021·2021-05-05

    Luminex VERIGENE Processor SP Recalled for Potential False-Negative Pathogen Results

    Luminex is recalling VERIGENE Processor SP units because they may produce false-negative results for specific enteric pathogens when used with the VERIGENE Enteric Pathogens Nucleic Acid Test Kit.

    Product
    VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticle probe technology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1503-2021·2021-05-05

    Trinity Biotech Captia Measles IgM Kit Recalled for Invalid Run Risk

    Clark Laboratories is recalling 80 kits of the Trinity Biotech Captia Measles IgM Kit because the positive control may run high, resulting in invalid runs and necessitating retesting.

    Product
    Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of Measles igM antibodies in human serum of patients suspected of measles (rubeola) infection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V318000·2021-05-05

    2021 and 2020 Porsche Cayenne passenger airbag may fail to deploy

    Porsche is recalling certain 2020-2021 Cayenne models because the passenger seat heating element may not be installed, preventing proper airbag calibration and risking airbag deployment failure.

    Product
    PORSCHE — PORSCHE redundant CAYENNE E-HYBRID, CAYENNE E-HYBRID, CAYENNE GTS, CAYENNE S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V321000·2021-05-05

    Volkswagen Recalls 46 Internal-Use Vehicles for Regulatory Compliance Concerns

    Volkswagen is recalling 46 internal-use vehicles sold without confirmation of compliance with federal safety standards. The vehicles may have been modified and could fail to meet safety requirements.

    Product
    VOLKSWAGEN — VOLKSWAGEN GOLF R, CC, E-GOLF, GOLF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V319000·2021-05-05

    Spartan RV Chassis fuel rail may leak, increasing fire risk

    Shyft Group recalls 2017-2022 Spartan RV Chassis K2 and K3 models. A fuel rail defect may cause leaks that pose a fire risk when an ignition source is present.

    Product
    SPARTAN — SPARTAN K2, K3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V320000·2021-05-05

    Triple E RV Recalls 2020-2021 Models Due to Generator Wiring Hazard

    Triple E RV is recalling specific 2020-2021 Unity, Wonder, and Serenity models because generator fan damage to wiring may cause electrical shock.

    Product
    TRIPLE E RV — TRIPLE E RV, TRIPLE E WONDER, SERENITY, UNITY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21125·2021-05-05

    CPSC Recalls Kolcraft Inclined Sleeper Accessories Due to Suffocation Risk

    CPSC is recalling Kolcraft inclined sleeper accessories due to a risk of infant suffocation. Consumers should stop using the accessory immediately and contact Kolcraft for a refund or voucher.

    Product
    Inclined sleeper accessory included with Kolcraft Cuddle 'n Care 2-in-1 Bassinet & Incline Sleepers and Preferred Position 2-in-1 Bassinet & Incline Sleepers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0467-2021·2021-05-05

    Champlain Chocolate Company Recalls Organic Mr. Goodtime Bunny for Undeclared Almonds

    Champlain Chocolate Company is recalling Organic Mr. Goodtime Bunny chocolate products because they may contain undeclared almonds. The recall affects 443 units distributed in nine states.

    Product
    Organic Mr. Goodtime Bunny***NET WT 3.35 LBS (1.4kg)***INGREDIENTS: *Milk, *Dark, AND *WHITE CHOCOLATE (*SUGAR, *MILK POWDER, *COCOA BUTTER, *CHOCOLATE LIQUOR, *COCOA POWDER (PROCESSED WITH ALKALI), *SOYBEAN LECITHIN, *VANILLA EXTRACT, AND *VANILLA POWDER). CONTAINS MILK AND SOYB
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-1499-2021·2021-05-05

    ConMed Infinity ACL Tibial Guides Recalled for Potential Misalignment

    ConMed Corporation is recalling three Infinity ACL Tibial Elbow and Tip Guides due to potential lateral misalignment that could affect surgical accuracy.

    Product
    KIT_INFINITY_BASE Custom Procedural Kit - Italy, containing Infinity ACL Tibial Elbow and Tip Guides product line, KTE100 and KTT100. For use in open and arthroscopic procedures for knee ligament reconstruction The procedural kits have no kit specific labeling. Each produc
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0456-2021·2021-05-05

    Raley's Salt & Vinegar Potato Chips Recalled for Undeclared Milk Allergen

    Shearer's Snacks is recalling Raley's Salt & Vinegar Flavored Potato Chips because the packaging fails to declare milk (lactose) as an ingredient.

    Product
    Raley's Salt & Vinegar Flavored Potato Chips 9.5oz flexible plastic packaging 11 bags per case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1514-2021·2021-05-05

    Donjoy Ultrasling Pro AB Arm Sling Recalled for Failed Rivet

    DJ Orthopedics is recalling Donjoy Ultrasling Pro AB arm slings due to a failed rivet at the chafe tab.

    Product
    DONJOY REF:11-0473-9 ULTRASLING PRO AB, UNIVERSAL, Rx ONLY, UDI: (01)00190446683681 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1491-2021·2021-05-05

    Boston Scientific Recalls Upsylon Y Mesh Kit Due to Sterility Concerns

    Boston Scientific is recalling Upsylon Y Mesh Kits because pinholes may breach the sterile barrier, potentially rendering the device non-sterile and causing post-operative infection.

    Product
    UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device - Product Usage: intended for use as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy, laparoscopic or robotic approach Material No.M0068318220 Individually packaged Upsylon Y Mesh (UPN M0068
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1498-2021·2021-05-05

    ConMed Infinity Tray Custom Procedural Kit Recalled for Misaligned Guides

    ConMed Corporation is recalling two Infinity Tray Custom Procedural Kits in Canada and Italy because the tip guides may be misaligned, potentially affecting surgical accuracy.

    Product
    INFINITY_TRAY Custom Procedural Kit - Canada. containing Infinity ACL Tibial Elbow and Tip Guides product line, KTE100 and KTT100. For use in open and arthroscopic procedures for knee ligament reconstruction. The procedural kits have no kit specific labeling. Each product w
    Category
    Medical Device
    Distribution
    0 states
  • HighCPSC·21123·2021-05-05

    TJX Recalls Infant Sleep Bags Due to Suffocation Risk

    TJX is recalling infant sleep bags sold at T.J. Maxx, Marshalls, and Sierra because the neck opening is too large, posing a suffocation risk.

    Product
    Infant Sleep Bags
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1490-2021·2021-05-05

    Boston Scientific Recalls Colpassist Vaginal Positioning Device Due to Sterility Risk

    Boston Scientific is recalling Colpassist Vaginal Positioning Devices due to potential pinholes that may compromise sterility and cause post-operative infection.

    Product
    Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and manipulation of the vagina during the procedure. Material No. M0068318210
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0464-2021·2021-05-05

    Vitafusion Melatonin Recalled for Potential Metallic Mesh Presence

    Church & Dwight is recalling Vitafusion Melatonin products due to the potential presence of a metallic mesh material.

    Product
    vitafusion Melatonin 140ct, 3 Pack 140 CT vitafusion Melatonin 44ct , 3Pack 44CT
    Category
    Consumer Product
    Distribution
    0 states
  • HighFDA (Devices)·Z-1517-2021·2021-05-05

    Philips Recalls Xper Flex Cardio Monitors Due to Performance Issues

    Philips is recalling Xper Flex Cardio monitors due to software issues that may cause display delays, freezing, or incorrect data.

    Product
    Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor) devices - intended for use by professional healthcare providers for complete physiologic/hemodynamic monitoring Service numbers associated with FC2010: Xper Flex Cardio 2010 Rev A 453564241901 Xper
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1512-2021·2021-05-05

    Donjoy Ultrasling Pro Arm Sling Recalled for Failed Rivet

    DJ Orthopedics is recalling Donjoy Ultrasling Pro arm slings because a rivet at the chafe tab failed, potentially compromising the device's ability to immobilize the arm.

    Product
    DONJOY REF:11-0471-9 ULTRASLING PRO ER/IR 15, UNIVERSAL, Rx ONLY, UDI: (01) 00190446683667 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1516-2021·2021-05-05

    Smiths Medical Recalls ACE MDI Spacers Due to Labeling Errors

    Smiths Medical ASD Inc. is recalling 250 units of ACE MDI Spacers with Small Masks because shipping box labels may be incorrect.

    Product
    ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the delivery of aerosolized medications from metered dose inhaler canisters and with mechanically ventilated patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1511-2021·2021-05-05

    Donjoy Ultrasling Pro Arm Sling Recalled for Failed Rivet

    DJ Orthopedics is recalling Donjoy Ultrasling Pro arm slings because a rivet at the chafe tab may fail. The recall covers units distributed in the US and several international countries.

    Product
    DONJOY REF:11-0447-9-ULTRASLING PRO, UNIVERSAL, Rx ONLY, UDI:(01)00190446673552 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1494-2021·2021-05-05

    Coltene Whaledent Recalls TMS LINK PLUS Self-Threading Dental Pins

    Coltene Whaledent Inc is recalling TMS LINK PLUS Self-Threading Dental Pins because incorrect pins were packaged and distributed. The recall affects 65 packs of 20 pins.

    Product
    Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into the teeth or for lab use for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with an intraoral drill prior to installation. Model number/Cata
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1507-2021·2021-05-05

    Datascope Cardiosave Rescue IABP Recalled for Cybersecurity Vulnerabilities

    Datascope Corp. is recalling Cardiosave Rescue IABP units due to cybersecurity vulnerabilities in a TCP/IP software library that may cause loss of communication to hospital systems.

    Product
    Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1515-2021·2021-05-05

    Smiths Medical Recalls Palm Cups Due to Incorrect Shipping Box Labels

    Smiths Medical ASD Inc. is recalling 682 Palm Cups because shipping box labels may be incorrect. The devices are intended to mobilize bronchial secretions.

    Product
    Palm Cups - Product Usage: intended to be used to percuss the chest wall to mobilize the secretions within the bronchial tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1495-2021·2021-05-05

    Siemens Artis zee X-Ray System Recalled for Cabling Abrasion

    Siemens Medical Solutions is recalling 772 Artis zee ceiling-interventional Fluoroscopic X-Ray Systems due to increased cabling abrasion that may limit functionality and disrupt clinical treatment.

    Product
    Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 10094137
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1501-2021·2021-05-05

    Nextremity Solutions Recalls InCore Lapidus Disposable Kits Due to Drill Bushing Defect

    Nextremity Solutions is recalling 123 units of InCore Lapidus Disposable Kits because a drill bushing defect may prevent surgeons from completing the intended procedure.

    Product
    InCore Lapidus Disposable Kit 28mm Right, Part Number: IC-LAP-28R - Product Usage: Intended as a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis.
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-1497-2021·2021-05-05

    Siemens Recalls ARTIS X-Ray Systems Due to Software Issue

    Siemens is recalling 133 ARTIS X-ray systems due to a potential software issue that may require terminating planned procedures.

    Product
    Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not l
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1489-2021·2021-05-05

    Ortho-Clinical VITROS Black Reference Slides Recalled for Mislabeling

    Ortho-Clinical Diagnostics is recalling VITROS Black Reference Slides incorrectly labeled as White Reference Slides, which may cause analyzer delays.

    Product
    VITROS¿ Black Reference Slides CATALOG #: J02316 - Product Usage: The Black Reference Slide is a part/ tool used in the reflectometer correction factor adjustment procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1486-2021·2021-05-05

    Cardiac Assist Recalls Incorrectly Packaged Protek Solo Venous Dilator Sets

    Cardiac Assist, Inc. is recalling 13 Protek Solo Venous Dilator Sets due to incorrect packaging discovered in finished goods.

    Product
    Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization. Catalog #: 5840-2417 - LS Tandem Life Kit - V24/A17 Catalog #: 5840-2415 - LS Tandem Life Kit - V24/A15 Catalog #: 5740-2417 - TandemLife Kit - V24/A17 Catalog #: 5100-1422 - ProtekSolo Venous
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1500-2021·2021-05-05

    Nextremity Solutions Recalls InCore Lapidus Disposable Kits Due to Drill Bushing Defect

    Nextremity Solutions is recalling 111 units of the InCore Lapidus Disposable Kit 28mm Left because a drill bushing defect may prevent surgeons from completing the intended procedure.

    Product
    InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Usage: Intended as a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis.
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-1493-2021·2021-05-05

    Cytocell Recalls Chromosome X Alpha-Satellite Probes Due to Cross-Reactivity

    Cytocell Ltd. is recalling 89 Chromosome X Alpha-Satellite probes because users may observe additional signals at 9q34, contradicting the insert.

    Product
    Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1510-2021·2021-05-05

    Smith & Nephew Recalls Mislabeled CANNU-Flex SILK Interference Screws

    Smith & Nephew is recalling CANNU-Flex SILK Interference Screws because some boxes were mislabeled, containing 6mm x 20mm screws instead of the labeled 6mm x 30mm size.

    Product
    CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for interference fixation of bone-tendon-bone of soft tissue grafts in anterior cruciate ligament reconstruction, Part Number: 014208
    Category
    Medical Device
    Distribution
    Distributed nationwide

Looking for a different month? Back to 2021.