The Recall Desk

Archive

July 2020 recalls

590 recalls were announced in July 2020.

What the numbers show

Critical
11
Severe
159
High
329
Moderate
75
Low
16

Of the 590 recalls this month scored against our rubric, 2% are Critical, 27% are Severe.

Which agencies issued them

301–400 of 590

  • ModerateFDA (Devices)·Z-2638-2020·2020-07-22

    Neocis Dental Chairside Splints Recalled for Potential Mislabeling

    Neocis Inc. is recalling 70 units of Gen 2 Posterior Chairside Splints due to potential mislabeling. The affected products are used in dental implantation surgery.

    Product
    DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1390-2020·2020-07-22

    Preferred Pharmaceuticals Recalls Lidothol Patches Due to Missing Batch Records

    Preferred Pharmaceuticals is recalling Lidothol Patches because the contract manufacturer misplaced or lost batch records and test results.

    Product
    Lidothol Patch, Lidocaine 4.5% & Menthol 5%, In each patch: lidocaine 4.5% topical anesthetic, menthol 5% topical analgesic, Pkg Size 15 patches per box, Insurance NDC: 53225-1025-01, Mfg: Terrain Pharmaceuticals; Reno, NV, Prod # (NDC): 68788-7405-01, Preferred Pharmaceuticals,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1021-2020·2020-07-22

    Abbott Recalls Water Bottles Labeled as Similac Pro-Advance Infant Formula

    Abbott Nutrition is recalling 111 cases of water-filled bottles incorrectly labeled as Similac Pro-Advance infant formula. The bottles were not intended for distribution.

    Product
    Similac Pro-Advance Infant Formula with Iron, Milk-Based, Ready to Feed, 32 FL OZ (1 QT)
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-1389-2020·2020-07-22

    Keryx Recalls Auryxia Tablets Due to Manufacturing Process Deviations

    Keryx Biopharmaceuticals is recalling 59,820 bottles of Auryxia (ferric citrate) tablets because they were not manufactured in conformance with the FDA-approved process.

    Product
    AURYXIA — AURYXIA (FERRIC CITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1388-2020·2020-07-22

    Akorn Recalls Proparacaine Hydrochloride Ophthalmic Solution Due to Chemical Contamination

    Akorn, Inc. is recalling Proparacaine Hydrochloride Ophthalmic Solution, 0.5%, due to chemical contamination from equipment cleaning residue.

    Product
    Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-263-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1387-2020·2020-07-22

    RemedyRepack Recalls Carbamazepine 200 mg Tablets Due to Dissolution Failure

    RemedyRepack Inc. is recalling Carbamazepine 200 mg tablets because routine stability testing revealed low dissolution results.

    Product
    Carbamazepine 200 mg Tablets, 100-unit dose tablets per box, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2489-00 for box; 70518-2489-01 per unit dose.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2591-2020·2020-07-22

    Shimadzu Recalls Three Trinias DAP Meters for Tolerance Issues

    Shimadzu Medical Systems is recalling three Trinias DAP Meters because they were found to be outside of tolerance. The devices are used in interventional procedures.

    Product
    Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Usage: It is intended to be used for interventional procedures, such as invasive cardiology, interventional radiology, and interventional neuroradiology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1045-2020·2020-07-22

    Lamb Weston Recalls WinCo Tater Bites Due to Foreign Material Contamination

    Lamb Weston is recalling WinCo Foods Tater Bites Shaped, Shredded Potatoes because the product may contain foreign material. The recall covers 558 cases distributed in California, Oregon, and Washington.

    Product
    WinCo Foods Tater Bites Shaped, Shredded Potatoes, frozen product. Retail 32 oz. poly bag has UPC 0 70552 30303 4. The master case contains 12/32 oz. bags (net wt. 24 lbs.), identified as WinCo Foods Tater Bites WN420, 1 00 70552 30303 1. The 32 oz. retail package label is
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2590-2020·2020-07-22

    DJO Nylatex Wraps Recalled for Missing Latex Warning Labels

    DJO, LLC is recalling Nylatex wraps used with Intelect and V-Sonic devices because they lack appropriate latex warning labels.

    Product
    This is an accessory to Intelect Advanced, Intelect Mobile, Intelect Neo, and V-Sonic devices. NYLATEX WRAP - Product Usage: are intended to be used based on the devices associated with them. Nylatex wraps are composed of nylon and natural rubber and are accessories used to secur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1028-2020·2020-07-22

    Golden Nutrition Recalls Anti-Viral Immune Enhance Dietary Supplement

    Golden Nutrition Inc. is recalling specific lots of Anti-Viral Immune Enhance dietary supplements because the product makes drug claims regarding COVID-19.

    Product
    Anti-Viral Immune Enhance "Corona Virus (COVID-19) " "Influenza (H1N1)" "Bronchitis" "Common Cold" 60 Capsules, Dietary Supplement, Manufactured by: Golden Nutrition
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2639-2020·2020-07-22

    Neocis Gen 2 Anterior Chairside Splint Recalled for Mislabeled Packaging

    Neocis Inc. is recalling 50 units of Gen 2 Anterior Chairside Splints due to potential mislabeling. The affected products are distributed nationwide.

    Product
    DRW-0742-01: Gen 2 Anterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2550-2020·2020-07-22

    Access Scientific Recalls Mislabeled Powerwand XL Maximum Barrier Kits

    Access Scientific LLC is recalling 1,710 Powerwand XL kits due to incorrect catheter length labels. The error may cause treatment delays or user annoyance.

    Product
    POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Catheter made of ChronoFlex C with BioGUARD Technology), Catalog No. 94108, Device UDI 00859821006773/Pacakge UDI 10859821006770 - Product Usage: Introducer with Extended Dwell Catheter is used to gain ac
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1391-2020·2020-07-22

    Fresenius Kabi Recalls Fosaprepitant Injection Due to Labeling Error

    Fresenius Kabi USA, LLC is recalling 63,067 vials of Fosaprepitant for Injection because carton labels and product inserts incorrectly state the amount of the excipient edetate disodium (EDTA).

    Product
    FOSAPREPITANT — FOSAPREPITANT (FOSAPREPITANT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·20V421000·2020-07-21

    Newmar Recalls Motorhomes with Damaged Rear Power Distribution Modules

    Newmar is recalling specific 2016-2020 motorhomes because a damaged rear Power Distribution Module may cause exterior lights to stop working, increasing crash risk.

    Product
    NEWMAR — NEWMAR NEW AIRE, LONDON AIRE, ESSEX, VENTANA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V419000·2020-07-20

    2021 Thor Motor Coach motorhomes recalled for battery cable fire risk

    Thor Motor Coach is recalling 2021 motorhomes because an improperly secured battery cable may contact the exhaust manifold and pose a fire risk. Owners should contact Thor Motor Coach for a free inspection and repair.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH DAYBREAK, FOUR WINDS, QUANTUM, CHATEAU
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V420000·2020-07-20

    Altec Recalls 1995-1998 Aerial Devices Due to Hydraulic Cylinder Defect

    Altec Industries is recalling 1995-1998 A0442 aerial devices because a hydraulic cylinder end gland may fail, causing uncontrolled boom movement and increasing injury risk.

    Product
    ALTEC — ALTEC AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V415000·2020-07-17

    Ford Recalls 2020 Escape and Transit Vehicles for Air Bag Defect

    Ford is recalling 2020 Escape and Transit vehicles because a defective air bag component may prevent proper inflation during a crash, increasing injury risk.

    Product
    FORD — FORD ESCAPE, TRANSIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V414000·2020-07-17

    Ford Recalls Lincoln MKX and Nautilus for Air Bag Wire Damage Risk

    Ford is recalling 2016-2020 Lincoln vehicles because seat tilt functions may damage air bag wiring, causing unintended deployment or failure to deploy.

    Product
    LINCOLN — LINCOLN MKX, NAUTILUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·015-2020 ·2020-07-17

    Hafiz Foods Recalls Chicken Samosas Lacking Federal Inspection

    Hafiz Foods is recalling approximately 675 pounds of frozen chicken samosas because the poultry was produced without federal inspection. No adverse reactions have been reported.

    Product
    Tempura Foods & Spices LLC — Hafiz Foods, Inc. Recalls Samosas Containing Chicken Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    5 states
  • HighNHTSA·20E049000·2020-07-17

    Allison Transmission Drive Units Recalled for Pressure Switch Failure

    Allison Transmission is recalling specific drive units because pressure switches may fail, potentially causing a loss of drive and increasing crash risk.

    Product
    POWER TRAIN:AUTOMATIC TRANSMISSION recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V416000·2020-07-17

    Mercedes-Benz Recalls 2019 A 220 Vehicles for Electrical Water Ingress Risk

    Mercedes-Benz is recalling 2019 A 220 vehicles because a poorly installed air conditioning drain hose may allow water to enter electrical components, potentially causing system malfunctions.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ A 220
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V413000·2020-07-17

    Ford recalls 2021 F-650 and F-750 trucks for missing heat shields

    Ford is recalling certain 2021 F-650 and F-750 trucks because heat-protection components were not installed during assembly. Without these shields, the cabin floor and seat attachments may become too hot and cause burns.

    Product
    FORD — FORD F-650 SD, F-750 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20764·2020-07-16

    Polaris Recalls 2015-2020 AXYS Snowmobiles Due to Fire Hazard

    Polaris is recalling approximately 41,200 AXYS snowmobiles because improperly secured fuel hoses may pose a fire hazard. No fires or injuries have been reported.

    Product
    Model Year 2015-2020 AXYS Trail Performance and Crossover snowmobiles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·20150·2020-07-16

    Rocky Mountain Recalls Alloy Instinct and Pipeline Bicycles Due to Frame Cracking

    Rocky Mountain is recalling about 1,530 non-electric alloy frame Instinct and Pipeline bicycles because the front frame triangle can crack, posing fall and injury hazards.

    Product
    Rocky Mountain non-electric alloy frame Instinct, Instinct BC and Pipeline bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2504-2020·2020-07-15

    CTL Medical Recalls CEZANNE II TLIF Bullet-Tip Cages Due to Fracturing

    CTL Medical Corporation is recalling 46 units of CEZANNE II TLIF Bullet-Tip Cages because reports indicate the devices fractured during insertion.

    Product
    CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H8mm, Part #018.1908.
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Devices)·Z-2489-2020·2020-07-15

    Prodimed Combicath Catheters Recalled for Sterility Assurance Concerns

    Prodimed Plastimed Division is recalling 300 Combicath catheters nationwide due to a lack of assurance of sterility.

    Product
    Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH 90 cm x 1.9 mm Product Code: 58229 19US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V409000·2020-07-15

    Blue Bird Recalls School Buses Due to Seat Belt Anchor Defect

    Blue Bird is recalling 2018-2021 All-American and 2019-2021 Vision school buses because seat belt anchorages may lack reinforcing washers, increasing injury risk in crashes.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN, ALL AMERICAN SCHOOL BUS, VISION SCHOOL BUS, VISION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2503-2020·2020-07-15

    CTL Medical Recalls CEZANNE II TLIF Bullet-Tip Cage Due to Fracturing

    CTL Medical Corporation is recalling 45 units of CEZANNE II TLIF Bullet-Tip Cages because reports indicate the devices fractured during insertion.

    Product
    CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308.
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Devices)·Z-2501-2020·2020-07-15

    CTL Medical Recalls CEZANNE II TLIF Bullet-Tip Cage Due to Fracturing

    CTL Medical Corporation is recalling 39 units of CEZANNE II TLIF Bullet-Tip Cage because reports indicate the device fractured during insertion.

    Product
    CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H7mm, Part #018.1307.
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Drugs)·D-1379-2020·2020-07-15

    EMD Serono Recalls Cetrotide Vials Due to Missing Rubber Stoppers

    EMD Serono is recalling 30,756 vials of Cetrotide because missing rubber stoppers could compromise sterility assurance.

    Product
    CETROTIDE — CETROTIDE (CETRORELIX ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2502-2020·2020-07-15

    CTL Medical Recalls CEZANNE II TLIF Bullet-Tip Cage Due to Fracture Reports

    CTL Medical Corporation is recalling 39 units of CEZANNE II TLIF Bullet-Tip Cages because reports indicate the devices fractured during insertion.

    Product
    CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H7mm, Part #018.1907.
    Category
    Medical Device
    Distribution
    9 states
  • SevereNHTSA·20V407000·2020-07-15

    Blue Bird Transit Bus Recall for Missing Seat Belt Hardware

    Blue Bird is recalling 2019-2021 Vision and All-American buses because seat belt anchorages may lack reinforcing washers, increasing injury risk in crashes.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN TRANSIT BUS, ALL AMERICAN, VISION, VISION TRANSIT BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2491-2020·2020-07-15

    Prodimed Combicath Paediatric Catheters Recalled Due to Sterility Assurance Issues

    Prodimed Plastimed Division is recalling 180 units of Combicath Paediatric catheters nationwide because the company cannot assure the sterility of the devices.

    Product
    Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling- COMBICATH 35 cm x 1.9 mm Product Code: 58 223 19US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2534-2020·2020-07-15

    Dufner De Bakey Slim Needleholder Recalled for Potential Tissue Injury

    Dufner Instrumente GmbH is recalling De Bakey Slim Needleholders because the tungsten carbide plate can break under pressure, potentially causing patient tissue injury.

    Product
    DUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold a suturing needle for closing wounds during suturing and surgical procedures Reference Number: 18044-23
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2492-2020·2020-07-15

    Prodimed Combicath Paediatric Catheters Recalled for Sterility Assurance Issues

    Prodimed is recalling Combicath Paediatric catheters due to a lack of assurance of sterility. The recall covers 2,580 units distributed nationwide.

    Product
    Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling-" COMBICATH PE 35 cm Product Code: 58 223 19
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2514-2020·2020-07-15

    Kentec Medical Recalls ENFit Feeding Tubes Due to Cap Fracture Risk

    Kentec Medical is recalling 480 ENFit feeding tubes because the plastic tethered closure cap may fracture or break, potentially delaying patient care.

    Product
    Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-40P-50 (4 fr. 50 cm ENFit Enteral Feeding Tube).
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2520-2020·2020-07-15

    Kentec Medical Recalls ENFit Enteral Feeding Tubes Due to Cap Fracture Risk

    Kentec Medical is recalling 170 ENFit enteral feeding tubes because the plastic tethered closure cap may fracture or break, potentially delaying patient care.

    Product
    Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-Y60P-80 (6 fr. 80 cm ENFit Enteral Feeding Tube with Y-Port).
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2544-2020·2020-07-15

    Cardinal Health NPWT Canisters Recalled Due to Oversized O-Ring Defect

    Cardinal Health is recalling 1,960 NPWT Occlusion Detection Canisters because an oversized O-ring may prevent proper installation into the device connector.

    Product
    Cardinal Health NPWT Occlusion Detection Canister 300cc, Prescription Only - Product Usage: The systems are intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2528-2020·2020-07-15

    TeDan Phantom CS Quick Start Distraction Screw Recall for Seal Defect

    TeDan Surgical Innovations LLC is recalling 730 sterile Phantom CS Quick Start Distraction Screws due to a lack of pouch seal.

    Product
    PHANTOM CS QUICK START DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2521-2020·2020-07-15

    United Imaging Recalls uDR 596i Digital Medical X-Ray Imaging Systems

    Shanghai United Imaging Healthcare is recalling six uDR 596i digital medical X-ray systems due to software errors that may cause incorrect anatomical positioning or loss of image tags, leading to additional radiation exposure.

    Product
    uDR 596i Digital Medical X-Ray Imaging System - Product Usage: intended to use by a qualified/ trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2541-2020·2020-07-15

    Abbott Recalls TactiCath Quartz Contact Force Ablation Catheters Due to Data Loss

    Abbott is recalling TactiCath Quartz Contact Force Ablation Catheters because they may lose contact force information during use.

    Product
    TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN 07640157990033) and PN-004 075 (GTIN 07640157990040) - Product Usage: is a multi-electrode irrigated catheter with a deflectable tip designed to allow electrophysiological mapping of the heart and,
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2526-2020·2020-07-15

    TeDan Phantom CS Distraction Screw Recall for Lack of Pouch Seal

    TeDan Surgical Innovations LLC is recalling 1,965 Phantom CS Distraction Screws because the packaging lacks a pouch seal, compromising the sterile labeling.

    Product
    PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2487-2020·2020-07-15

    Prodimed Combicath Catheters Recalled for Sterility Assurance Concerns

    Prodimed Plastimed Division is recalling 7,220 Combicath catheters for mini bronchoalveolar lavage due to a lack of assurance of sterility.

    Product
    Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 60 cm x 2.7 mm Product Code: 58216 27US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2524-2020·2020-07-15

    TeDan 3COR Distraction Screw Recall Due to Sterility Seal Failure

    TeDan Surgical Innovations LLC is recalling 3COR Distraction Screws because the pouch seal is lacking, compromising the sterile labeling.

    Product
    3COR DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2545-2020·2020-07-15

    Centurion Difficult IV Kit Recalled for False Carboxyhemoglobin Results

    Centurion Medical Products is recalling 140 Difficult IV Kits containing BD Vacutainer tubes that may cause false carboxyhemoglobin results.

    Product
    Centurion DIFFICULT IV KIT containing BD's Vacutainer Plastic Lithium Heparin Tubes (BD Vacutainer-BD Codes 367884 & 367960; Centurion code 45177 (VACUTAINER GREEN TOP) and 84815 (VACUTAINER 3ML LT. GREEN). Centurion Kit Code: IV8860
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2531-2020·2020-07-15

    Philips M3015A Microstream CO2 Extension Recall for Incompatibility

    Philips is recalling M3015A Microstream CO2 Extensions because they are incompatible with IntelliVue X3 and MMX monitors, which may cause a loss of monitoring.

    Product
    Philips M3015A Microstream CO2 Extension Model No. 862393 -used with an lntelliVue X3 Patient Monitor (Model No. 867030) or a lntelliVue MMX Multi-Measurement Module (Model No. 867036)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2515-2020·2020-07-15

    Kentec Medical Recalls ENFit Feeding Tubes Due to Cap Fracture Risk

    Kentec Medical is recalling 2,850 ENFit feeding tubes because the plastic tethered closure cap may fracture or break, potentially delaying patient care.

    Product
    Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-50P-50 (5 fr. 50 cm ENFit Enteral Feeding Tube).
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2522-2020·2020-07-15

    United Imaging uCT 760 CT System Recalled for Image Artifacts

    Shanghai United Imaging Healthcare is recalling five uCT 760 CT systems due to intermittent image artifacts and scanning interruptions that may require patient rescans.

    Product
    uCT 760 System, Computed Tomography X-ray System
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2518-2020·2020-07-15

    Kentec Medical Recalls ENFit Polyurethane and Silicone Feeding Tubes

    Kentec Medical is recalling ENFit feeding tubes because the plastic tethered closure cap may fracture or break, potentially delaying enteral feeding and medication administration.

    Product
    Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-Y60P-50 (6 fr. 50 cm ENFit Enteral Feeding Tube with Y-Port).
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2523-2020·2020-07-15

    Philips EasyDiagnost Eleva DRF X-ray System Recalled for Power Supply Defect

    Philips is recalling 52 EasyDiagnost Eleva DRF X-ray systems because incorrectly installed thermo switches in the main power supply may cause malfunction.

    Product
    EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic, general-purpose.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2542-2020·2020-07-15

    KCI ACTIV.A.C Therapy System Recalled for Unexpected Power Off

    KCI USA is recalling ACTIV.A.C Therapy Systems because they may power off without warning, stopping negative pressure wound therapy.

    Product
    ACTIV.A.C Therapy System; Model Numbers; US: 340000 ACTIV.A.C., NORTH AMERICAN UDI (01)00878237008188 - Product Usage: is an integrated wound management system for use in the acute, extended, and home care settings. When used on open wounds, it is intended to create an environm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2494-2020·2020-07-15

    Radiometer ABL800 FLEX Blood Gas Analyzer Software Recall

    Radiometer Medical ApS is recalling ABL800 FLEX blood gas analyzers due to a software issue that may cause patient mix-ups.

    Product
    Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-801; UDI (01)05700693938011. Model 393-801 is available as ABL837. The FlexQ module is optional and can be added to all models and configurations.
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2537-2020·2020-07-15

    Vitalconnect VistaSolution Software Recall for Missing SpO2 Notifications

    Vitalconnect Inc. is recalling VistaSolution software due to a defect that prevented low SpO2 alerts, potentially exposing patients to short-term hypoxia.

    Product
    VistaSolution, physiological signal transmitter. A software graphical user interface for use by healthcare professionals to display physiological data collected by the wireless remote monitoring system in healthcare settings. This is a secondary, adjunct patient monitor and is
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·20148·2020-07-15

    Simplers Botanicals Wintergreen Essential Oil Recalled for Packaging Defect

    Nutraceutical is recalling Simplers Botanicals Wintergreen Essential Oil because the packaging is not child-resistant, posing a poisoning risk.

    Product
    Simplers Botanicals Organic Wintergreen (Gaultheria Fragrantissiam) Essential Oil
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·20V410000·2020-07-15

    Toyota Recalls 2018-2020 Tundra for Dim Turn Signals

    Toyota is recalling 2018-2020 Tundra trucks with LED headlights because a wiring error causes front turn signals to flash too dimly, potentially increasing crash risk.

    Product
    TOYOTA — TOYOTA TUNDRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2476-2020·2020-07-15

    Verathon Recalls GlideScope Core OneTouch Smart Cables Due to Connection Defect

    Verathon is recalling 437 GlideScope Core OneTouch Smart Cables because twisting during connection may damage the internal circuit board, causing video loss during critical intubation procedures.

    Product
    GlideScope Core OneTouch Smart Cable, REF: 0800 0601, an accessory to the GlideScope Video Laryngoscope System Per PLRA: The Core OneTouch Cables (Reusable Device) is ancillary equipment used with the Core 10 and Core 15 monitors. The monitor and workstation are intended to w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2517-2020·2020-07-15

    Kentec Medical Recalls ENFit Polyurethane and Silicone Feeding Tubes

    Kentec Medical is recalling 2,130 ENFit feeding tubes because the plastic tethered closure cap may fracture or break, potentially delaying patient care.

    Product
    Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-80P-50 (8 fr. 50 cm ENFit Enteral Feeding Tube).
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·F-1016-2020·2020-07-15

    Blanxart Dark Chocolate Bar Recalled Due to Foreign Object

    Power Selles Imports is recalling Blanxart 85% Nicaragua Organic Dark Chocolate Bars because a consumer found a foreign object in the product.

    Product
    Blanxart 85% Nicaragua Organic Dark Chocolate Bar, packaged in paper packaging with internal foil wrapper. Net weight 4.4 oz (125 g). UPC 8 32924 00058 9. Product's label is read in parts: "***BLANXART 85% NICARAGUA ORGANIC DARK CHOCOLATE***Organic dark chocolate, Cocoa 85% m
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-2488-2020·2020-07-15

    Prodimed Combicath Catheters Recalled Due to Sterility Assurance Concerns

    Prodimed Plastimed Division is recalling Combicath catheters for mini bronchoalveolar lavage because of a lack of assurance of sterility.

    Product
    Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 85 cm x 4.0 mm 58124 40US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2529-2020·2020-07-15

    TeDan Phantom CS Distraction Screw Recalled for Sterility Seal Defect

    TeDan Surgical Innovations LLC is recalling 495 Phantom CS Quick Start Distraction Screws because the pouch seal is lacking, compromising the sterile labeling.

    Product
    PHANTOM CS QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1017-2020·2020-07-15

    Fresh Express Southwest Chopped Kit Recalled for Undeclared Allergens

    Fresh Express is recalling Southwest Chopped Kits because incorrect condiment packets were included, resulting in undeclared wheat, soy, cashews, and coconut.

    Product
    Fresh Express Chopped Kit SOUTHWEST TOTAL NET WT. 11.5 oz (326g) plastic bag. FRESH EXPRESS INCORPORATED P.O. BOX 80599, SALINAS, CA 93912 UPC 0 71279 30602 5
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-2493-2020·2020-07-15

    Radiometer ABL800 FLEX Blood Gas Analyzers Recalled for Software Issues

    Radiometer Medical ApS is recalling ABL800 FLEX blood gas analyzers due to a software issue that creates a potential risk of patient mix-up.

    Product
    Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI (01)05700693938004. Model 393-800 is available in the following configurations: ABL835, ABL830, ABL827, ABL825, ABL825, ABL820, ABL817, ABL815, ABL810, ABL805 and ABL810 BG only and ABL800Bas
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2527-2020·2020-07-15

    TeDan Phantom CS Distraction Screw Recalled for Lack of Pouch Seal

    TeDan Surgical Innovations is recalling 1,965 sterile Phantom CS Distraction Screws because the packaging lacks a pouch seal, compromising the sterile claim.

    Product
    PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2519-2020·2020-07-15

    Kentec Medical Recalls ENFit Feeding Tubes Due to Cap Fracture Risk

    Kentec Medical is recalling 70 ENFit feeding tubes because the plastic tethered closure cap may fracture, potentially delaying care or causing unnecessary radiation exposure.

    Product
    Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-Y50P-80 (5 fr. 80 cm ENFit Enteral Feeding Tube with Y-Port).
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2530-2020·2020-07-15

    TeDan Phantom CS Quick Start Distraction Screw Recall for Seal Defect

    TeDan Surgical Innovations LLC is recalling 340 sterile Phantom CS Quick Start Distraction Screws due to a lack of pouch seal.

    Product
    PHANTOM CS QUICK START DISTRACTION SCREW, 16 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2490-2020·2020-07-15

    Prodimed Combicath catheters recalled due to sterility assurance concerns

    Prodimed is recalling 1,460 Combicath catheters nationwide because the company cannot assure the products are sterile.

    Product
    Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH PE 90 cm Product Code: 58229 19
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2532-2020·2020-07-15

    Bound Tree Medical Recalls Ambu King LTS-D Supraglottic Airway Kits

    Bound Tree Medical is recalling 167 Ambu King LTS-D Supraglottic Airway Kits because they contain an incompatible catheter-tip syringe that may prevent the airway balloon from inflating properly.

    Product
    Curaplex Ambu King LTS-D Supraglottic Airway Kit with ET Tube Part Number: KLTSD404K Curaplex Ambu¿ King LTS-D" Supraglottic Airway Kit with ET Tube (hereafter the Kit which contains all of the components necessary to successfully obtain an open patient airway with an Ambu¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2497-2020·2020-07-15

    Ra Medical Systems Recalls DABRA Laser Due to Software Issue

    Ra Medical Systems is recalling 79 DABRA Laser units because a software issue could cause unintended laser light release, potentially injuring users or patients.

    Product
    DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer laser ultraviolet light source and delivery system, collectively the DABRA Laser System". The system is designed to deliver the energy to the surgical site to ablate unwanted material. The optica
    Category
    Medical Device
    Distribution
    22 states
  • HighFDA (Devices)·Z-2546-2020·2020-07-15

    Cook Zenith Alpha Abdominal Endovascular Graft Recall for Damaged Bushing

    Cook Inc. is recalling 571 units of Zenith Alpha Abdominal Endovascular Grafts due to a potential damaged bushing that may prevent full deployment.

    Product
    Zenith Alpha Abdominal Endovascular Graft, Catalog Prefix ZIMB - Product Usage: is indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms having morphology suitable for endovascular repair.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2500-2020·2020-07-15

    XTANT Medical Recalls Irix-C Forceps Inserter Due to Fracture Risk

    XTANT Medical is recalling four Irix-C Forceps Inserters because the strike plate may fracture off due to unsatisfactory welds.

    Product
    Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2516-2020·2020-07-15

    Kentec Medical Recalls ENFit Polyurethane and Silicone Feeding Tubes

    Kentec Medical is recalling 710 ENFit feeding tubes because the plastic tethered closure cap may fracture or break, potentially delaying care or increasing radiation exposure.

    Product
    Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-60P-50 (6 fr. 50 cm ENFit Enteral Feeding Tube).
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2538-2020·2020-07-15

    OrthoPediatrics Recalls ShieldLoc ACL Implant Components Due to Labeling Errors

    OrthoPediatrics Corp is recalling 9 units of ShieldLoc 6mm implant components because some packages contain the wrong size.

    Product
    OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2498-2020·2020-07-15

    CooperSurgical Recalls Mislabeled Os Finder Cervical Dilators

    CooperSurgical is recalling 2,250 Os Finder Cervical Dilators due to mislabeled blister trays. The product inside is correct, but the packaging label is incorrect.

    Product
    COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2511-2020·2020-07-15

    Medtronic Percepta CRT-P MRI Recall for Temporary Feature Suspension

    Medtronic is recalling 37,360 Percepta CRT-P MRI devices due to a rare communication issue that may temporarily suspend certain device features.

    Product
    Percepta CRT-P MRI, Model Numbers: a) W1TR01, b) W1TR04, c) W4TR01, d) W4TR04
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2525-2020·2020-07-15

    TeDan 3COR Distraction Screw Recall Due to Pouch Seal Defect

    TeDan Surgical Innovations is recalling 3COR Distraction Screws because the sterile pouch seal is defective, potentially compromising sterility.

    Product
    3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2508-2020·2020-07-15

    Medtronic Azure S DR MRI Recall for Temporary Feature Suspension

    Medtronic is recalling 49,513 Azure S DR MRI devices because a rare communication issue may temporarily suspend certain device features.

    Product
    Azure S DR MRI, Model Number W3DR01
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2506-2020·2020-07-15

    Medtronic Patient Connector Recall for Temporary Feature Suspension

    Medtronic is recalling 1,025 Patient Connectors because a rare communication error may temporarily suspend device features. The issue is unlikely to cause clinical impact and features restore automatically.

    Product
    Patient Connector, Model Number 24967
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2543-2020·2020-07-15

    Cardinal Health NPWT Canisters Recalled for Oversized O-Ring Defect

    Cardinal Health is recalling 3,000 NPWT Canisters with Gel 300cc because they may contain an oversized O-ring that cannot be installed.

    Product
    Cardinal Health NPWT Canister with Gel 300cc, Prescription Only - Product Usage: The systems are intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The Car
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2513-2020·2020-07-15

    Medtronic Solara CRT-P MRI Recall for Temporary Feature Suspension

    Medtronic is recalling 16,667 Solara CRT-P MRI devices worldwide due to a rare communication issue that may temporarily suspend certain device features.

    Product
    Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2496-2020·2020-07-15

    Tomtec ARENA TTA2 Software Recalled for Potential Data Storage Error

    Tomtec Imaging Systems is recalling ARENA TTA2 software versions 2.20 and lower because measurements from one study might be stored to another.

    Product
    TOMTEC-ARENA TTA2;software version no. 2.20 and lower; Picture archiving and communications system. Software Versions and applicable UDI: TTA 1.2 release prior to UDI requirement TTA2.00.01 release prior to UDI requirement TTA2.11.01 release prior to UDI requirement T
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-2505-2020·2020-07-15

    Medtronic Recalls CareLink SmartSync Device Manager Due to Feature Suspension

    Medtronic is recalling 2,773 CareLink SmartSync Device Manager units worldwide because a rare communication error may temporarily suspend certain device features.

    Product
    CareLink SmartSync Device Manager, Model Number 24970A
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2533-2020·2020-07-15

    Teleflex Recalls RUSCH LASERTUBE Devices Due to Laser Guard Foil Separation

    Teleflex is voluntarily recalling 6,014 RUSCH LASERTUBE devices because the laser guard foil may partially separate or detach at the edges when exposed to moisture.

    Product
    RUSCH LASERTUBE (Rubber), RES 102004, Sizes: a) I.D. mm 4,0, Product Code 102004-000040 b) I.D. mm 5,0, Product Code 102004-000050 c) I.D. mm 6,0, Product Code 102004-000060 d) I.D. mm 7,0, Product Code 102004-000070 e) I.D. mm 8,0, Product Code 102004-000080 Product Usage:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2540-2020·2020-07-15

    FHC Guideline 4000 5.0 Main Processing Unit Recalled for Electrical Defect

    FHC, Inc. is recalling six Guideline 4000 5.0 Main Processing Units because an electrical sub-circuit was not properly connected, potentially affecting performance during ESD events.

    Product
    FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and stimulate electrophysiological activity, as well as aid in the accurate placement of electrodes and other instruments. Catalogue Number: C0215 UDI: 00873263006740
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2536-2020·2020-07-15

    Capso Vision Recalls CapsoCam Plus Capsules Due to Data Recording Failure

    Capso Vision is recalling 82 CapsoCam Plus capsules because they fail to record data when ingested, potentially delaying diagnosis.

    Product
    The CapsoCam Plus (SV-3); Device Common Name: System, Imaging, Gastrointestinal, Wireless, Capsule; Catalog Number 2795 - Product Usage: intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2509-2020·2020-07-15

    Medtronic Azure XT SR MRI Recall for Temporary Feature Suspension

    Medtronic is recalling 31,736 Azure XT SR MRI devices due to a rare communication issue that temporarily suspends certain device features.

    Product
    Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2539-2020·2020-07-15

    OrthoPediatrics Recalls ShieldLoc ACL Implant Components Due to Labeling Errors

    OrthoPediatrics Corp is recalling 11 units of ShieldLoc 7mm implant components because some packages contain the wrong size product.

    Product
    OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2535-2020·2020-07-15

    Laborie Pump Tube Sets Recalled for Damaged Packaging Seals

    Laborie Medical Technologies is recalling 480 Pump Tube Sets due to damaged packaging seals that may compromise product integrity.

    Product
    Pump Tube Set for MMS Libra and Solar Systems - Product Usage: Intended for use during water perfusion urodynamic procedures to study the function of the bladder and urethra during filling and voiding, by monitoring pressure and pressure changes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2507-2020·2020-07-15

    Medtronic Azure XT DR MRI Recall for Temporary Feature Suspension

    Medtronic is recalling 266,252 Azure XT DR MRI devices worldwide due to a rare communication issue that may temporarily suspend certain device features.

    Product
    Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2510-2020·2020-07-15

    Medtronic Azure S SR MRI Recall for Temporary Feature Suspension

    Medtronic is recalling 11,953 Azure S SR MRI devices worldwide due to a rare communication issue that may temporarily suspend certain device features.

    Product
    Azure S SR MRI, Model Number W3SR01
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2512-2020·2020-07-15

    Medtronic Serena CRT-P MRI Recall for Temporary Feature Suspension

    Medtronic is recalling 17,750 Serena CRT-P MRI devices worldwide due to a rare communication issue that may temporarily suspend certain device features.

    Product
    Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-1381-2020·2020-07-15

    Biogen Recalls Tecfidera Capsules Due to Quality Control Deviations

    Biogen MA Inc. is recalling 3,922 bottles of Tecfidera (dimethyl fumarate) 240 mg capsules because a rejected lot was distributed to US markets.

    Product
    TECFIDERA — TECFIDERA (DIMETHYL FUMARATE)
    Category
    Drug
    Distribution
    3 states
  • LowFDA (Drugs)·D-1378-2020·2020-07-15

    VistaPharm Recalls Nystatin Oral Suspension Due to Impurity Exceeding Specifications

    VistaPharm is recalling Nystatin Oral Suspension because an impurity peak exceeded approved specifications. The affected product is distributed in the United States and Puerto Rico.

    Product
    Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before Using, Rx Only, Manufactured by: VistaPharm, Inc., Largo, FL 33771, NDC 66689-008-16.
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-1375-2020·2020-07-15

    Somerset Therapeutics Recalls Brimonidine Tartrate Ophthalmic Solution

    Somerset Therapeutics is recalling Brimonidine Tartrate Ophthalmic Solution 0.2% due to a slow leaching process from the product label that may impact the product over its shelf life.

    Product
    BRIMONIDINE TARTRATE — BRIMONIDINE TARTRATE (BRIMONIDINE TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide

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