The Recall Desk

Archive

August 2020 recalls

436 recalls were announced in August 2020.

What the numbers show

Critical
25
Severe
99
High
182
Moderate
122
Low
8

Of the 436 recalls this month scored against our rubric, 6% are Critical, 23% are Severe.

Which agencies issued them

301–400 of 436

  • HighFDA (Devices)·Z-2767-2020·2020-08-12

    Boss Instruments Recalls DeBakey Needle Holders Due to Plate Breakage Risk

    Boss Instruments is recalling 96 DeBakey needle holders because the tungsten carbide plate can break under pressure, posing a risk to patients and medical staff.

    Product
    BOSS DeBakey "Gator-Grip" Needle Holder 2 mm tip, 9", Part Numbers 50-2503 and 51-2503 - Product Usage: Endoscopic cleaning brushes are single use devices intended to clean the interior of endoscopes after endoscopy procedures. The brush is threaded through the biopsy valve and p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2718-2020·2020-08-12

    CareFusion Alaris Pump Module 8100 Recalled for Cleaning Agent Damage

    CareFusion 303, Inc. is recalling Alaris Pump Module Model 8100 units because cleaning agents may damage connectors, causing therapy interruptions.

    Product
    Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2717-2020·2020-08-12

    CareFusion Alaris System PC Unit Model 8015 Infusion Pump Recall

    CareFusion 303, Inc. is recalling Alaris System PC Unit Model 8015 infusion pumps because cleaning agents may damage connectors, potentially interrupting therapy or monitoring.

    Product
    Alaris System PC Unit Model 8015, a modular infusion pump and monitoring system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2763-2020·2020-08-12

    Boston Scientific Recalls Captivator Polypectomy Snares Due to Cutting Defect

    Boston Scientific is recalling specific lots of Captivator Polypectomy Snares because they may fail to cut and remove polyps, potentially leading to prolonged procedures or tissue damage.

    Product
    Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2722-2020·2020-08-12

    CareFusion Alaris SpO2 Modules Recalled for Cleaning-Related Connector Damage

    CareFusion 303, Inc. is recalling Alaris SpO2 Modules because cleaning agents may damage connectors, causing infusion or monitoring interruptions.

    Product
    Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2720-2020·2020-08-12

    CareFusion Alaris PCA Module 8120 Recalled for Cleaning Agent Damage

    CareFusion 303, Inc. is recalling 83,532 Alaris PCA Module Model 8120 units because cleaning agents may damage connectors, causing therapy interruptions.

    Product
    Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2740-2020·2020-08-12

    CareFusion Alaris System PC Unit Model 8000 Infusion Pump Recall

    CareFusion is recalling Alaris System PC Unit Model 8000 infusion pumps because loose or missing screws may cause power loss and therapy interruption.

    Product
    Alaris System PC Unit Model 8000 modular infusion pump and monitoring system
    Category
    Medical Device
    Distribution
    55 states
  • HighFDA (Devices)·Z-2719-2020·2020-08-12

    CareFusion Alaris Syringe Module Recall Due to Cleaning Agent Damage

    CareFusion 303, Inc. is recalling Alaris Syringe Module Model 8110 units because cleaning agents may damage connectors, potentially interrupting infusion therapy or monitoring.

    Product
    Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2755-2020·2020-08-12

    Siemens Luminos dRF Max Recalled for Software Collision and Image Errors

    Siemens is recalling 49 Luminos dRF Max units due to software defects that may cause system collisions or incorrect diagnostic images.

    Product
    SIEMENS Healthineers Luminos dRF Max Model: 10762471- Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2759-2020·2020-08-12

    Boston Scientific Recalls Captivator Polypectomy Snares Due to Cutting Failure

    Boston Scientific is recalling Captivator Polypectomy Snares because they may fail to cut and remove polyps, potentially causing tissue damage or bleeding.

    Product
    Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2748-2020·2020-08-12

    Teleflex Pleur-Evac Chest Drainage Devices Recalled for Packaging Risk

    Teleflex Medical Inc. is recalling Pleur-Evac chest drainage devices because sterile packaging may be compromised, potentially affecting sterility.

    Product
    Pleur-Evac Adult-Ped Wet, LF Intl Eng, product code: A-8000I - Product Usage: CHEST DRAINAGE: To evacuate air and/or fluid from the chest cavity or mediastinum. To help prevent air and/or fluid from re-accumulating in the chest cavity or mediastinum. To help re-establish and main
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2754-2020·2020-08-12

    BD MAX SARS-CoV-2 Reagents Recalled for Potential False Positive Results

    Becton Dickinson is recalling BD MAX SARS-CoV-2 Reagents due to elevated rates of potential false positive results, which could delay diagnosis and increase exposure risk.

    Product
    BD MAX SARS-CoV-2 Reagents, Cat. No. 445003 (UDI 00382904450038) and 445003-01 (UDI (01)603829044500301) - Product Usage: intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasophar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2760-2020·2020-08-12

    Boston Scientific Recalls Captivator Polypectomy Snares Due to Cutting Defect

    Boston Scientific is recalling specific lots of Captivator Polypectomy Snares because they may fail to cut and remove polyps, potentially causing tissue damage or bleeding.

    Product
    Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1488-2020·2020-08-12

    Vilvet Pharmaceuticals Recalls VILEVEV MB Urinary Antiseptic Due to cGMP Deviations

    Vilvet Pharmaceuticals is voluntarily recalling 1,716 bottles of VILEVEV MB Urinary Antiseptic due to current Good Manufacturing Practice (cGMP) deviations.

    Product
    VILEVEV MB Urinary Antispetic (81.0 mg methenamine, 40.8 mg sodium phosphate monobasic and 10.8 mg methylene blue, 0.12 mg hyoscyamine sulfate and 32.4 mg phenyl salicylate), Rx Only, 90 Tablets per Bottle, Manufactured for: Vilvet Pharmaceuticals, Inc., Chester Springs, PA 19425
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2749-2020·2020-08-12

    Teleflex Pleur-Evac Chest Drainage Devices Recalled for Packaging Compromise

    Teleflex Medical Inc. is recalling Pleur-Evac chest drainage devices because sterile packaging may be compromised, potentially affecting sterility.

    Product
    Pleur-Evac Adult-Ped Wet, LF Eng/Spanish, product code: A-8000I-06 - Product Usage: CHEST DRAINAGE: To evacuate air and/or fluid from the chest cavity or mediastinum. To help prevent air and/or fluid from re-accumulating in the chest cavity or mediastinum. To help re-establish an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2753-2020·2020-08-12

    Randox Lipase Assay Substrate Recalled for Imprecision in Quality Control

    Randox Laboratories is recalling specific batches of Lipase R2 Substrate due to confirmed imprecision in quality control and patient samples.

    Product
    Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2747-2020·2020-08-12

    Siemens DCA Vantage Barcode Scanner Recalled for Data Integrity Issues

    Siemens Healthcare is recalling 1,800 DCA Vantage Handheld Barcode Scanners because they may fail to verify check digits or incorrectly process barcodes, potentially leading to data errors.

    Product
    DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZWW external accessory to DCA Vantage Analyzer US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2752-2020·2020-08-12

    Randox Lipase Assay Buffer Recalled for Imprecision in Quality Control

    Randox Laboratories is recalling specific batches of Lipase Colorimetric R1 Buffer due to confirmed imprecision in quality control and patient samples.

    Product
    Randox Lipase Assay: Lipase Colorimetric R1 Buffer - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2751-2020·2020-08-12

    Randox Lipase Assay Reagent Recalled for Imprecision in Quality Control and Patient Samples

    Randox Laboratories is recalling specific batches of Lipase Colorimetric Reagent due to confirmed imprecision in quality control and patient samples.

    Product
    Randox Lipase Assay: Lipase Colorimetric Reagent - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1487-2020·2020-08-12

    Vilvet Pharmaceuticals Recalls VILAMIT MB Due to cGMP Deviations

    Vilvet Pharmaceuticals is recalling 11,640 bottles of VILAMIT MB capsules due to current Good Manufacturing Practice (cGMP) deviations. The recall is voluntary and nationwide.

    Product
    VILAMIT MB (118 mg methenamine, 36 mg phenyl salicylate, 40.8 mg sodium phosphate monobasic, 10.0 mg methylene blue and 0.12 mg hyoscyamine sulfate), Rx Only, 100 Capsules per Bottle, Manufactured for: Vilvet Pharmaceuticals Inc., Chester Springs, PA 18425, NDC 71186-002-35.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2746-2020·2020-08-12

    Smith & Nephew Recalls SUTUREFIX ULTRA Suture Due to Packaging Error

    Smith & Nephew is recalling 868 units of SUTUREFIX ULTRA Suture because a packaging error caused an XL drill to be included instead of the correct S drill.

    Product
    SUTUREFIX ULTRA Suture, Product number 72203855
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-2744-2020·2020-08-12

    Sutter Swyng Non-Stick Bipolar Forceps Recalled for Incorrect Package Insert Labeling

    Sutter Medizintechnik GmbH is recalling 1,337 units of Sutter Swyng non-stick bipolar forceps because the package insert incorrectly displays the Ethylene Oxide sterilization symbol instead of the irradiation symbol.

    Product
    Sutter Swyng non-stick bipolar forceps - Product Usage: single-use re electrosurgical instruments. The bipolar for-ceps are provided with bayonet-style handle design with straight or angled tips and different total lengths. They are to be connected through an appropriate bipolar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1143-2020·2020-08-12

    Vitamin Shoppe Recalls Calcium Citrate Plus Magnesium & Vitamin D Supplements

    Vitamin Shoppe is recalling specific bottles of Calcium Citrate Plus Magnesium & Vitamin D because sample analysis revealed the product is sub-potent for Vitamin D.

    Product
    The Vitamin Shoppe Calcium Citrate Plus Magnesium & Vitamin D. 100 count (VS-1086; UPC:6653601086), 300 count (VS-1087; UPC: 6653601087), and 600 count (VS-1123; UPC: 6653601123).
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·20V472000·2020-08-11

    Triumph Recalls 2019-2020 Motorcycles Due to Wiring Harness Defect

    Triumph is recalling 2019-2020 Street Scrambler and Street Twin motorcycles because a misrouted wiring harness may contact the frame, causing the engine to stall and increasing crash risk.

    Product
    TRIUMPH — TRIUMPH STREET SCRAMBLER, STREET TWIN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V470000·2020-08-10

    Ford Recalls 2020 Lincoln Corsair for Rear Coil Spring Clearance Issue

    Ford is recalling 2,965 2020 Lincoln Corsair vehicles because rear coil springs may lack sufficient clearance, potentially breaking and affecting vehicle handling.

    Product
    LINCOLN — LINCOLN CORSAIR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V467000·2020-08-10

    Ford Recalls 2020 F-150 Trucks Due to Starter Motor Fire Risk

    Ford is recalling 2020 F-150 vehicles because an incorrect attachment nut on the starter motor may cause electrical arcing and increase the risk of a fire.

    Product
    FORD — FORD F-150
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·019-2020·2020-08-10

    Mr. Wok Foods Recalls Meat and Poultry for Undeclared Allergens

    Mr. Wok Foods is recalling approximately 242,640 pounds of frozen meat and poultry products due to misbranding and undeclared allergens.

    Product
    Mr Wok Foods Inc. dba Maxfield Foods — Mr. Wok Foods, Inc. Recalls Multiple Meat and Poultry Products due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V471000·2020-08-10

    BMW Recalls Motorcycles Due to Fuel Pump Flange Crack Risk

    BMW is recalling specific motorcycles because a fuel pump flange may crack, causing a fuel leak that increases fire risk.

    Product
    BMW — BMW K1200 GT, HP2 SPORT, K1200 S, K1200 R SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20T015000·2020-08-10

    Linglong Americas Recalls Venezia Crusade HT Tires Due to Sidewall Separation

    Linglong Americas Inc. is recalling specific Venezia Crusade HT tires because they may experience lower sidewall separation, which can lead to sudden tire failure and increase the risk of a crash.

    Product
    TIRES:SIDEWALL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V468000·2020-08-10

    Entegra Qwest motorhome wiring defect may cause airbag malfunction

    Jayco is recalling 2020-2021 Entegra Qwest motorhomes and related Jayco models because front seat wiring harnesses may be routed incorrectly, creating a risk of unexpected or failed airbag deployment.

    Product
    JAYCO — JAYCO, ENTEGRA MELBOURNE PRESTIGE, QWEST, MELBOURNE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20E054000·2020-08-10

    Kiel Recalls Avance Passenger Seats Due to Seat Belt Defect

    Kiel is recalling specific Avance passenger seats for motorcoaches because the seat belt retractors may not function properly, increasing injury risk in a crash.

    Product
    SEATS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V464000·2020-08-07

    Mercedes-Benz Recalls 2020 GLE 450 for Windshield Bonding Defect

    Mercedes-Benz is recalling one 2020 GLE 450 because the windshield may not be bonded correctly, which could reduce the effectiveness of the passenger air bag in a crash.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLE 450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V463000·2020-08-07

    American Hauler Recalls 2018 Trailers Due to Axle Weld Failures

    American Hauler is recalling 2018 Air-Lite, Arrow, Falcon/XC, and Night Hawk trailers because spindle weld failures on the axles may increase the risk of a crash or injury.

    Product
    AMERICAN HAULER — AMERICAN HAULER FALCON/XC, NIGHT HAWK, AIR-LITE, ARROW
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V466000·2020-08-07

    2017-2021 Freightliner Business Class M2 trucks recalled for electrical harness defect

    Daimler Trucks North America is recalling certain 2017-2021 Freightliner Business Class M2 trucks because the engine harness may contact and chafe, potentially short-circuiting and causing engine stall during operation.

    Product
    FREIGHTLINER — FREIGHTLINER BUSINESS CLASS M2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V465000·2020-08-07

    BMW Recalls 2020 X5 and X7 Models Due to Starter Motor Bolt Risk

    BMW is recalling 21 vehicles because an extra bolt in the starter motor could fall into the transmission, causing an engine stall and increasing crash risk.

    Product
    BMW — BMW X7, X5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-08072020-01·2020-08-07

    USDA Issues Public Health Alert for Blue Grass Sausage Due to Listeria

    USDA issued a public health alert for Blue Grass Provisions ready-to-eat sausages due to possible Listeria contamination. Products were produced in April 2020 and are past their use-by dates.

    Product
    Blue Grass Provisions Co. Inc. — FSIS Issues Public Health Alert for Ready to Eat Sausage Products due to Possible Listeria Contamination
    Category
    Food
    Distribution
    4 states
  • HighNHTSA·20V461000·2020-08-06

    GM Recalls 2020 Chevrolet Corvette for Front Trunk Release Defect

    General Motors is recalling 2020 Chevrolet Corvette vehicles because the front trunk release button may fail to function after the vehicle is shut off for ten minutes, potentially trapping a person inside.

    Product
    CHEVROLET — CHEVROLET CORVETTE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20769·2020-08-06

    REVIVE Essential Oils Recalled for Non-Child-Resistant Packaging and Poisoning Risk

    REVIVE is recalling specific essential oils and blends because the packaging is not child-resistant, posing a risk of poisoning if swallowed by young children.

    Product
    REVIVE Wintergreen and Birch Essential Oils and REVIVE Sore No More, Ache Away and Breeze Essential Oil Blends
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V459000·2020-08-05

    Kia Recalls 2019 Forte Vehicles Due to Axle Driveshaft Defect

    Kia is recalling 2019 Forte vehicles because the left front axle driveshaft may not have been heat-treated, which can cause it to break and increase crash risk.

    Product
    KIA — KIA FORTE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1046-2020·2020-08-05

    Winter Gardens Spinach Artichoke Dip Recalled for Undeclared Egg Allergen

    Winter Gardens Quality Foods is recalling Spinach Artichoke Dip due to undeclared egg. The product was distributed to Whole Foods Market in the Mid-Atlantic region.

    Product
    Whole Foods Spinach Artichoke Dip ,4-12 oz containers, Lot # 248 Manufactured on 7/8/2020 Use By: 07/26/2020
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1427-2020·2020-08-05

    MasterPharm Recalls Progesterone Capsules Due to Processing Control Deficiencies

    MasterPharm LLC is recalling 600 capsules of Progesterone (Modified Release) 150 mg due to a lack of processing controls.

    Product
    Progesterone (Modified Release) 150 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2725-2020·2020-08-05

    Medline Recalls ClearPro Trach T-Piece Closed Suction Catheters

    Medline is recalling 680 units of ClearPro Trach T-Piece Closed Suction Catheters because the catheter may come apart from the device assembly during use.

    Product
    ClearPro Trach T-Piece Closed Suction Catheter, Model DYNCPTP14T, 14 Fr 12.5 IN FOR TRACHEOSTOMY TUBE - Product Usage: Catheters are intended for endotracheal suction of adult patients with artificial airways. Single use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1412-2020·2020-08-05

    Saniderm Hand Sanitizer Recalled for Undeclared Methanol and Low Ethanol

    Polarized LLC is recalling Saniderm Advanced Hand Sanitizer because it contains undeclared methanol and less ethanol than labeled.

    Product
    Saniderm ADVANCED HAND SANITIZER, 70% Alcohol Content, 1 Liter bottles, Distributed by Polarized, LLC, Produced by Eskbiochem SA de CV, Mexico Japon 50, Celaya, Gto., Mexico, 38010. UPC 8 60003 63391 5.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1407-2020·2020-08-05

    Saniderm Hand Sanitizer Recalled for Undeclared Methanol Contamination

    UVT INC is recalling Saniderm Advanced Hand Sanitizer because it contains undeclared methanol. The product was distributed nationwide in the USA.

    Product
    Saniderm ADVANCED HAND SANITIZER, 70% Alcohol Content, 1 Liter bottles, Distributed by Polarized, LLC, Produced by Eskbiochem SA de CV, Mexico Japon 50, Celaya, Gto., Mexico, 38010. UPC 8 60003 63391 5.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2742-2020·2020-08-05

    OrthoPediatrics Recalls Spine Rods Due to Potential Fracture Risk

    OrthoPediatrics Corp is recalling 73 units of 6.0MM spine rods because incorrect laser etching may compromise strength and lead to unintended fracture.

    Product
    Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2729-2020·2020-08-05

    Teleflex Medical Recalls Rusch Greenlite Laryngoscopes Due to Welded Joint Breakage

    Teleflex Medical is recalling Rusch Greenlite laryngoscopes because the welded joint may break. The recall covers 20,600 units distributed nationwide.

    Product
    Rusch Greenlite Product Code: 004551002 GTIN: 14026704663115 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2737-2020·2020-08-05

    Hill-Rom Recalls Progressa Beds Due to Screw Tensile Strength Defect

    Hill-Rom is recalling 257 Progressa Beds because screws may not meet tensile strength requirements, posing a risk of serious injury to patients or users.

    Product
    Progressa Bed, Catalog No. P7500 - Product Usage: intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either Continuous Lateral Ro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1031-2020·2020-08-05

    Greenhead Lobster Products Recalls Fresh and Frozen Lobster Meat

    Greenhead Lobster Products is recalling fresh and frozen lobster meat products due to potential contamination with Listeria monocytogenes.

    Product
    1. FRESH CLAW AND KNUCKLE MEAT, 1 and 2 lbs. 2. FRESH CLAW, KNUCKLE, AND TAIL MEAT, 1 and 2 lbs 3. FROZEN CLAW AND KNUCKLE MEAT, 2 lb
    Category
    Food
    Distribution
    5 states
  • SevereNHTSA·20V455000·2020-08-05

    Blue Bird Recalls 2021 Transit Buses Due to Steering Wheel Nut Issue

    Blue Bird is recalling 2021 Vision and All American transit buses because the steering wheel nut may not be properly tightened, risking loss of vehicle control.

    Product
    BLUE BIRD — BLUE BIRD VISION TRANSIT BUS, ALL AMERICAN TRANSIT BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2738-2020·2020-08-05

    Hill-Rom Recalls 1,033 Centralia Smart+ Beds Due to Screw Defect

    Hill-Rom is recalling 1,033 Centralia Smart+ Beds because screws may not meet tensile strength requirements, posing a risk of serious injury.

    Product
    Centrella Smart+ Bed, Catalog No. P7900 - Product Usage: intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either Continuous Lat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V456000·2020-08-05

    Blue Bird Recalls 2021 School Buses Due to Steering Wheel Nut Issue

    Blue Bird is recalling 2021 Vision and All American school buses because the steering wheel nut may not be tightened properly, risking loss of control.

    Product
    BLUE BIRD — BLUE BIRD VISION SCHOOL BUS, ALL AMERICAN SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2704-2020·2020-08-05

    United Imaging uCT 530 CT System Recalled for Sharp Metal Edge

    Shanghai United Imaging Healthcare is recalling four uCT 530 Computed Tomography X-ray Systems because uneven metal edge overlap may create a sharp edge.

    Product
    Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-08052020-01·2020-08-05

    USDA Alerts on Ready-to-Eat Meat and Poultry with Recalled Onions

    USDA FSIS issued a public health alert for ready-to-eat meat and poultry products containing onions recalled due to possible Salmonella Newport contamination.

    Product
    Taylor Farms TX, Inc. — FSIS Issues Public Health Alert for Ready-to-Eat Meat and Poultry Products Containing FDA-Regulated Onions that have been Recalled due to Possible Salmonella Newport Contamination
    Category
    Food
    Distribution
    5 states
  • HighNHTSA·20V458000·2020-08-05

    Thor Motor Coach Motorhomes Recalled: Pedestal Bolts May Fail During Crash

    Thor Motor Coach is recalling 2020-2021 Daybreak, 2018-2021 Four Winds, and 2018-2021 Chateau motorhomes because barrel chair pedestals are secured with bolts of the wrong size. In a crash, these pedestals could separate, causing seat belt anchorages to fail and increasing injury risk.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH redundant FOUR WINDS, redundant CHATEAU, DAYBREAK, FOUR WINDS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1032-2020·2020-08-05

    Happy Colon Yum Shortbread Cookie Recalled for Undeclared Milk

    Happy Colon Foods is recalling Yum Shortbread Cookies because they contain butter but do not list milk as an ingredient.

    Product
    Happy Colon Yum Shortbread Cookie 0.98oz UPC 56817 00704
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-2726-2020·2020-08-05

    Teleflex Rusch Greenlite Laryngoscopes Recalled for Welded Joint Breakage

    Teleflex Medical Inc. is recalling Rusch Greenlite laryngoscopes because the welded joint may break. The recall affects 75,320 units distributed nationwide.

    Product
    Rusch Greenlite Product Code: 004550002 GTIN: 14026704663061 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2712-2020·2020-08-05

    TTDEYE Radial Brown Colored Contact Lenses Recalled for Lack of FDA Clearance

    Chengdu Ai Qin E-commerce Co., Ltd is recalling TTDEYE Radial Brown colored contact lenses because they were distributed without FDA clearance.

    Product
    TTDEYE (brand) Radial Brown, B16112109 - Product Usage: Colored contact lenses
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2715-2020·2020-08-05

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications is recalling two Proteus 235 proton therapy systems because aborted irradiations cannot be resumed due to a software loading issue.

    Product
    Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-1413-2020·2020-08-05

    Lupin Recalls Lisinopril Tablets Due to Foreign Tablet Presence

    Lupin Pharmaceuticals is recalling specific bottles of 10 mg Lisinopril tablets because 20 mg tablets were found inside. Consumers should stop using the affected product.

    Product
    LISINOPRIL — LISINOPRIL (LISINOPRIL)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-2705-2020·2020-08-05

    United Imaging uCT 550 CT Systems Recalled for Sharp Metal Edges

    Shanghai United Imaging Healthcare is recalling three uCT 550 Computed Tomography X-ray Systems because uneven metal edges on the mylar strip may create sharp edges.

    Product
    Computed Tomography X-ray System; Model uCT 550; Rx; UDI: (01) GTIN: 06971576831036 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2724-2020·2020-08-05

    Medline Recalls ClearPro T-Piece Closed Suction Catheters Due to Assembly Failure

    Medline Industries is recalling 2,440 units of ClearPro T-Piece Closed Suction Catheters because reports indicate the catheter may come apart from the device assembly during use.

    Product
    ClearPro T-Piece Closed Suction Catheter, Model DYNCPTP14, 14 Fr 21.3 IN FOR ENDOTRACHEAL TUBE - Product Usage: Catheters are intended for endotracheal suction of adult patients with artificial airways. Single use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2714-2020·2020-08-05

    TTDEYE Devil Red Colored Contact Lenses Recalled for Lack of FDA Clearance

    Chengdu Ai Qin E-commerce Co., Ltd. is recalling TTDEYE Devil Red colored contact lenses because they were distributed without FDA clearance.

    Product
    TTDEYE (brand) Devil Red, B16112201 - Product Usage: Colored contact lenses
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2728-2020·2020-08-05

    Teleflex Medical Recalls Rusch Greenlite Laryngoscopes Due to Welded Joint Breakage

    Teleflex Medical Inc. is recalling 7,401 Rusch Greenlite laryngoscopes because the welded joint may break during use.

    Product
    Rusch Greenlite Product Code: 004550004 GTIN: 14026704663085 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2731-2020·2020-08-05

    Teleflex Rusch Greenlite Laryngoscopes Recalled for Welded Joint Breakage

    Teleflex Medical is recalling Rusch Greenlite laryngoscopes because the welded joints may break. The devices are used for tracheal intubation.

    Product
    Rusch Greenlite Product Code: 004551004 GTIN: 24026704553796 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2727-2020·2020-08-05

    Teleflex Recalls Rusch Greenlite Laryngoscopes Due to Welded Joint Breakage

    Teleflex Medical Inc is recalling Rusch Greenlite laryngoscopes because the welded joint may break. The recall covers 27,341 units distributed nationwide.

    Product
    Rusch Greenlite Product Code: 0004550003 GTIN: 14026704663078 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1043-2020·2020-08-05

    Giant Eagle Dried Island Fruit Mix Recalled for Undeclared Allergens

    Giant Eagle is recalling Dried Island Fruit Mix because it may contain undeclared peanut, almond, milk, and soy allergens.

    Product
    Giant Eagle Dried Island Fruit Mix , Net Wt. 10 oz. , 6 units per case. Packaging is a gusseted plastic resealable bag. Expiration date 01/15/2021
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2730-2020·2020-08-05

    Teleflex Recalls Rusch Greenlite Laryngoscopes Due to Welded Joint Breakage

    Teleflex Medical Inc is recalling Rusch Greenlite laryngoscopes because the welded joint may break. The devices are used for tracheal intubation.

    Product
    Rusch Greenlite Product Code: 004551003 GTIN: 14026704663122 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1044-2020·2020-08-05

    Kasugai Matcha Ame Candy Recalled for Undeclared Soybean Allergen

    J F C International Inc is recalling Kasugai brand Matcha Ame candy because the label fails to declare soybean, a major food allergen, present in the mold lubricant.

    Product
    Kasugai brand Matcha Ame (Green tea candy); 4.58 oz. plastic bag; 2 x 12 individual items per case Product of Japan Ingredients: glucose syrup, sugar, green tea powder, palm oil, artificial flavor. The label should include "mold lubricant oil (palm, rapseed, soybeans)
    Category
    Food
    Distribution
    25 states
  • HighFDA (Food)·F-1047-2020·2020-08-05

    Stick-E Fingers Barbecue Rub Recalled for Undeclared Milk Allergen

    Stick E Fingers BBQ LLC is recalling 181 jars of All Purpose Rub because the label declares butter but fails to list milk or buttermilk.

    Product
    Stick-E Fingers Barbecue All Purpose Rub is a dry rub, packaged in 13.2 oz plastic jar, UPC 8 60003 24004 5. No company's address listed on the label. The product label is read in parts: "***STICK-E FINGERS BARBECUE***All Purpose Rub *** INGREDIENTS: SALT, ONION, BUTTER FLAVO
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1033-2020·2020-08-05

    Happy Colon Chocolate Chip Cookies Recalled for Undeclared Milk

    Happy Colon Foods is recalling specific chocolate chip cookies because they contain butter but do not list milk as an ingredient.

    Product
    Happy Colon MMMM Chocolate Chip Cookie 0.98oz UPC 56817 00703
    Category
    Food
    Distribution
    10 states
  • HighCPSC·20160·2020-08-05

    WD-40 Recalls X-14 Mildew Stain Remover Due to Skin Irritation Risk

    WD-40 Company is recalling specific 16 and 32-ounce bottles of X-14 Mildew Stain Remover because pressure buildup may cause leaks and skin irritation.

    Product
    X-14® Mildew Stain Remover
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2703-2020·2020-08-05

    United Imaging uCT 760 CT Systems Recalled for Sharp Metal Edges

    Shanghai United Imaging Healthcare is recalling five uCT 760 CT systems because uneven metal edges on the mylar strip may create sharp edges.

    Product
    Computed Tomography X-ray System; Model uCT 760; Rx; UDI: (01) GTIN: 06971576831043 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2732-2020·2020-08-05

    Teleflex Medical Recalls Rusch Greenlite Laryngoscopes Due to Welded Joint Breakage

    Teleflex Medical Inc. is recalling 29,740 Rusch Greenlite laryngoscopes because the welded joint may break. The devices are used for tracheal intubation.

    Product
    Rusch Greenlite Product Code: 004551035 GTIN:7290102156443 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2707-2020·2020-08-05

    Medtronic StealthStation S7 System Recalled for Navigation Inaccuracy

    Medtronic is recalling two StealthStation S7 Systems with Polaris Spectra Cameras due to a manufacturing issue that may cause 6mm navigation inaccuracy when using specific trackers.

    Product
    StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2701-2020·2020-08-05

    Abbott Alinity ci System Control Module Recalled for Quality Control Failures

    Abbott is recalling Alinity ci System Control Modules because quality control results were not properly evaluated for failures.

    Product
    Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series software versions, 3.1.1 and below
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2733-2020·2020-08-05

    Arthrex Recalls Sterile Low Profile Titanium Bone Screws Due to Length Error

    Arthrex, Inc. is recalling 28 units of sterile low profile titanium bone screws because the screws are 5mm shorter than intended.

    Product
    Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product Usage: is intended to be used as a stand-alone bone screw, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2713-2020·2020-08-05

    TTDEYE Radial Pink Colored Contact Lenses Recalled for Lack of FDA Clearance

    Chengdu Ai Qin E-commerce Co., Ltd is recalling TTDEYE Radial Pink colored contact lenses because they were distributed without FDA clearance.

    Product
    TTDEYE (brand) Radial Pink, B16112110 - Product Usage: Colored contact lenses
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2708-2020·2020-08-05

    TTDEYE Black Starshine Colored Contact Lenses Recalled for Lack of FDA Clearance

    Chengdu Ai Qin E-commerce Co., Ltd is recalling TTDEYE Black Starshine colored contact lenses because they were distributed without FDA clearance.

    Product
    TTDEYE (brand) Black Starshine, B16112100 - Product Usage: Colored contact lenses
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2710-2020·2020-08-05

    TTDEYE Flower Brown Colored Contact Lenses Recalled for Lack of FDA Clearance

    Chengdu Ai Qin E-commerce Co., Ltd is recalling TTDEYE Flower Brown colored contact lenses because they were distributed without FDA clearance.

    Product
    TTDEYE (brand) Flower Brown, B16112210 - Product Usage: Colored contact lenses
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1434-2020·2020-08-05

    MasterPharm Recalls Progesterone Capsules Due to Processing Control Deficiencies

    MasterPharm LLC is recalling Progesterone Modified Release 200 mg Capsules because the company lacks processing controls to ensure the product meets specifications.

    Product
    Progesterone Modified Release 200 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1437-2020·2020-08-05

    MasterPharm Recalls Tadalafil 18 mg Capsules Due to Processing Control Deficiencies

    MasterPharm LLC is recalling Tadalafil 18 mg capsules nationwide due to a lack of processing controls that ensures conformity to specifications.

    Product
    Tadalafil 18 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1436-2020·2020-08-05

    MasterPharm Recalls Tadalafil 12 mg Capsules Due to Processing Control Deficiencies

    MasterPharm LLC is recalling Tadalafil 12 mg capsules nationwide due to a lack of processing controls that ensures conformity to specifications.

    Product
    Tadalafil 12 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2699-2020·2020-08-05

    Resource Optimization Recalls Regard Migrating Indicator Strips for Malfunction

    Resource Optimization & Innovation LLC is recalling Regard Migrating Indicator Strips because they malfunction and fail to reach the accept window during use.

    Product
    regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage: The integrating indicator is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1409-2020·2020-08-05

    Allergan Recalls Subpotent Skin Medica Acne Treatment Lotion

    Allergan is recalling specific lots of Skin Medica Acne Treatment Lotion because the products failed potency tests at 12 and 24 months.

    Product
    Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 Oz bottle, Distributed in the U.S.A. by Allergan, Irvine, CA 92612, NDC 0023-4965-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1429-2020·2020-08-05

    MasterPharm Recalls Progesterone Troches Due to Lack of Processing Controls

    MasterPharm LLC is recalling Progesterone 300 mg Troches because the product lacks assurance of conformity to specifications.

    Product
    Progesterone 300 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1430-2020·2020-08-05

    MasterPharm Recalls Progesterone Tablets Due to Processing Control Deficiencies

    MasterPharm LLC is recalling specific lots of Progesterone 150 mg tablets because they lack assurance of conformity to specifications.

    Product
    Progesterone (Rapid-Dissolve) 150 mg Tablet, 30 tablets per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1442-2020·2020-08-05

    MasterPharm Recalls Vardenafil Troches Due to Lack of Processing Controls

    MasterPharm LLC is recalling Vardenafil 20 mg Troches nationwide due to a lack of processing controls that ensures conformity to specifications.

    Product
    Vardenafil 20 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1042-2020·2020-08-05

    Built Brands Recalls Toffee Almond Chocolate Protein Bars Due to Mold Risk

    Built Brands LLC is recalling Toffee Almond Chocolate covered protein bars because they may be moldy before the expiration date.

    Product
    Toffee Almond Chocolate covered protein bars, packaged in metalized polypropylene wrappers, packed in 6 count to 18 count boxes, net wt. ranges from 53 to 58 grams.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2702-2020·2020-08-05

    Smith & Nephew T-F1X0 RCG Drill Pac Recalled for Missing Sleeve

    Smith & Nephew is recalling T-F1X0 RCG Drill Pacs because some sterile packages contain only one sleeve instead of two, preventing the device from performing as intended for the second bone tunnel.

    Product
    Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated for use in surgical arthroscopic rotator cuff repair procedures. REF/ Catalog Number : 014771
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1425-2020·2020-08-05

    MasterPharm Recalls Minoxidil/Biotin Capsules Due to Processing Control Deficiencies

    MasterPharm LLC is recalling Minoxidil/Biotin 1.25mg/5mg capsules nationwide due to a lack of processing controls that ensures conformity to specifications.

    Product
    Minoxidil/Biotin 1.25mg/5mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1441-2020·2020-08-05

    MasterPharm Recalls Testosterone/Anastrozole Pellets Due to Processing Control Deficiencies

    MasterPharm LLC is recalling Testosterone/Anastrozole Pellets 100/6 mg due to a lack of processing controls that ensures conformity to specifications.

    Product
    Testosterone/Anastrozole Pellet 100/6 mg, 100 pellets per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419 (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1438-2020·2020-08-05

    MasterPharm Recalls Tadalafil 26 mg Capsules Due to Processing Controls

    MasterPharm LLC is recalling Tadalafil 26 mg capsules nationwide due to a lack of processing controls that ensures conformity to specifications.

    Product
    Tadalafil 26 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1034-2020·2020-08-05

    Built Brands Recalls Banana Nut Bread Chocolate Covered Protein Bars

    Built Brands LLC is recalling 333,420 Banana Nut Bread Chocolate covered protein bars because they may be moldy prior to the end of the stated shelf life.

    Product
    Banana Nut Bread Chocolate covered protein bars, packaged in metalized polypropylene wrappers, packed in 6 count to 18 count boxes, net wt. ranges from 53 to 58 grams.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2706-2020·2020-08-05

    Richard Wolf Recalls Tube Set for Transanal Endoscopic Microsurgery

    Richard Wolf GmbH is recalling 338 Tube Sets for TEM because smaller diameter tube material was used. The affected units were distributed internationally.

    Product
    Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the instrument set for the TEM procedure are designed to provide access to the rectal cavity and accessible part of the lower sigmoid colon using a stereo and/or monocular endoscope u
    Category
    Medical Device
    Distribution
    0 states

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