The Recall Desk

Archive

July 2017 recalls

930 recalls were announced in July 2017.

What the numbers show

Critical
40
Severe
116
High
613
Moderate
135
Low
26

Of the 930 recalls this month scored against our rubric, 4% are Critical, 12% are Severe.

901–930 of 930

  • ModerateFDA (Devices)·Z-2638-2017·2017-07-05

    Beckman Coulter Access System-GI Monitor Recalled for Biotin Interference

    Beckman Coulter is recalling Access System-GI Monitor (CA19-9) kits because they are susceptible to biotin interference, which may affect test results.

    Product
    Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2647-2017·2017-07-05

    Onkos Surgical Recalls Mislabelled Limb Salvage System Segmental Stems

    Onkos Surgical is recalling four units of the Eleos Limb Salvage System Segmental Stem due to incorrect collar size labeling.

    Product
    ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP20E
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2636-2017·2017-07-05

    Beckman Coulter Access Thyroglobulin Recalled for Biotin Interference

    Beckman Coulter is recalling Access Thyroglobulin immunoassays because they are susceptible to biotin interference, which may affect test results.

    Product
    Access Thyroglobulin, A34085G, Catalog No. 33860
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0927-2017·2017-07-05

    Doxycycline Hyclate API Recalled for Misbranding Under FDA Import Alert

    American Pharmaceutical Ingredients LLC is recalling Doxycycline Hyclate USP active pharmaceutical ingredient due to misbranding. The product is subject to FDA Import Alert 66-66.

    Product
    Doxycycline Hyclate USP, active pharmaceutical ingredient, a) 25 g packaged in a 500 cc container (NDC: 58597-8082-4), b) 100 g packaged in 16 oz container (NDC: 58597-8082-6), c) 500 g packaged in a 2500 cc container (NDC: 58597-8082-7) and a 1,000 g packaged in 1 gallon contai
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2644-2017·2017-07-05

    Exactech Novation Calcar Planer Guide Tip Recalled for Labeling Clarification

    Exactech is recalling 477 Novation Calcar Planer Guide Tips to update labeling with a caution about instrument breakage.

    Product
    Exactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for trans
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0924-2017·2017-07-05

    Apothecary by Design Recalls Progesterone Injection Vials Due to Closure Defect

    Apothecary by Design is recalling 25 vials of Progesterone Injection in Olive Oil due to a manufacturing defect where metal closures may adhere to rubber stoppers, potentially compromising container integrity.

    Product
    Progesterone Injection in Olive Oil With Benzyl Alcohol 10%, 50mg/mL, 10mL Multi-Dose Vial, Rx only, Apothecary by Design, 141 Preble Street, Portland, ME.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2408-2017·2017-07-05

    ProSupps Recalls Dr. Jekyll V2 Orange Burst for Undeclared Ingredient

    ProSupps USA LLC is recalling 698 units of Dr. Jekyll V2 Orange Burst because the product is potentially mislabeled and contains the non-dietary ingredient Picamilon.

    Product
    Dr. Jekyll V2 Orange Burst domestic
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2643-2017·2017-07-05

    Merge Healthcare Recalls MasimoSET SpO2 Sensors for Display Issues

    Merge Healthcare is recalling 65 MasimoSET LNOP DCI adult SpO2 reusable sensors because cables may stop displaying patient SpO2, causing slight delays in care.

    Product
    MasimoSET LNOP DCI adult SpO2 reusable sensor, adult finger clip (Merge Part Number: HW-HEMO-00075), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2652-2017·2017-07-05

    AGFA Healthcare Recalls IMPAX Cardiovascular Software Due to Incorrect Findings

    AGFA Healthcare Corp. is recalling 10 units of IMPAX Cardiovascular software because it displayed incorrect aneurysm findings in NIV reports.

    Product
    IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with representation in printed or electronic formats
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2632-2017·2017-07-05

    3M Ranger Pressure Infusor Recalled for Pressure Specification Deviation

    3M is recalling one Ranger Pressure Infusor, Model 145, because it produced pressure slightly below manufacturing specifications.

    Product
    3M Ranger(TM) Pressure Infusor, Model 145, SKU 70200792979 The 3M Ranger Pressure Infusor is a hardware device intended to provide pressure to I.V. solution bags when rapid infusion of liquids is required.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-2405-2017·2017-07-05

    ProSupps Recalls Dr. Jekyll V2 Watermelon Supplement for Mislabeling

    ProSupps USA LLC is recalling 6,348 units of Dr. Jekyll V2 Watermelon domestic because the product is potentially mislabeled and contains the non-dietary ingredient Picamilon.

    Product
    Dr. Jekyll V2 Watermelon domestic
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2648-2017·2017-07-05

    Onkos Surgical Recalls Mislabelled Limb Salvage System Segmental Stem

    Onkos Surgical, Inc. is recalling four units of the Eleos Limb Salvage System Segmental Stem due to incorrect collar size labeling.

    Product
    ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP22E
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2641-2017·2017-07-05

    Merge Healthcare Recalls Masimo SPO2 Sensors for Display Failure

    Merge Healthcare is recalling Masimo SPO2 ear clip sensors because cables may stop displaying SpO2 readings, causing slight delays in patient care.

    Product
    Masimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0926-2017·2017-07-05

    Gaviscon Chewable Tablets Recalled for High Magnesium Levels

    Sanofi-Aventis is recalling Gaviscon chewable tablets due to high out-of-specification magnesium levels. The recall covers 2,980 bottles distributed in the US, Puerto Rico, and the UK.

    Product
    Gaviscon (Alumina & Magnesium Trisilicate) Regular Strength Original Flavor Chewable Tablets, 80 mg & 14.2 mg, 100-count bottles, Distributed by: GlaxoSmithKline Consumer Healthcare, L.P., Moon Twp, PA 15108, UPC 3 0088-1175-47 8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2649-2017·2017-07-05

    Medtest Holdings Recalls CK-MB Control Kits Due to Labeling Error

    Medtest Holdings is recalling five CK-MB Isoenzyme Control Kits because the product labeling contains an incorrect control range.

    Product
    The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-2623-2017·2017-07-05

    CryoLife BioGlue Surgical Adhesive Recalled for Incorrect Lot Labeling

    CryoLife, Inc. is recalling 705 boxes of BioGlue Surgical Adhesive because 9 boxes had incorrect lot numbers on their courtesy labels.

    Product
    BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-0925-2017·2017-07-05

    L. Perrigo Recalls Walgreens Cold and Flu Combo Packs Due to Label Error

    L. Perrigo is recalling 1,998 Walgreens Daytime and Nighttime Cold & Flu combo packs in Illinois because the packaging sleeve incorrectly identifies the contents as Day-Night Cold and Flu instead of Day-Night Cough Liquid.

    Product
    Walgreens Daytime and Nighttime Cold & Flu, packaged in combo pack of two plastic 12FL OZ (355 mL) bottles connected by one paper sleeve, TOTAL 24 FL OZ (1.5 pt)(710 mL), OTC, Distributed by: Walgreen CO., 200 Wilmot Rd., Deerfield, IL 60015
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Devices)·Z-2627-2017·2017-07-05

    Euro Diagnostica Recalls DIASTAT ANA Kits Due to Incorrect Expiration Date

    Euro Diagnostica AB is recalling 501 units of DIASTAT ANA kits because the packaging displayed the original expiration date instead of the shortened one.

    Product
    DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), S
    Category
    Medical Device
    Distribution
    4 states
  • LowFDA (Devices)·Z-2631-2017·2017-07-05

    Medtest CRP Calibrator and Standard Sets Recalled for Unit Mislabeling

    Medtest Holdings is recalling Pointe Scientific CRP calibrator and standard sets because vial labels incorrectly list units as mg/dl instead of mg/L.

    Product
    Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS) Wide Range Standard Set 5 Levels of 1 x 2 ml ready to use calibrator or standard The Pointe Scientific CRP (HS) Wide Range Multi-Calibrator Set is intended to be used for the calibration of the manuf
    Category
    Medical Device
    Distribution
    9 states
  • LowFDA (Devices)·Z-2650-2017·2017-07-05

    Medtest Liquid Creatine Kinase Reagent Set Recalled for Labeling Mismatch

    Medtest Holdings is recalling Pointe Scientific Liquid Creatine Kinase Reagent Sets because the product insert does not match the approved premarket notification.

    Product
    Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use: For the kinetic quantitative determination of creatine kinase activity in serum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0928-2017·2017-07-05

    BuPROPion HCL Tablets Recalled for Moisture Content Failures

    Mckesson Packaging Services is recalling BuPROPion HCL Tablets, 75 mg, due to out-of-specification moisture content.

    Product
    BuPROPion HCL Tablets, USP, 75 mg, packaged as UD 100 tablets (10x10), Rx Only, Mfg by: Sandoz Inc., 508 Carnegie Center, Suite 400, Princeton, NJ 08805, NDC: 63739-706-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·17V425000·2017-07-03

    Toyota Recalls Tacoma and 4Runner Vehicles with Detaching Hood Scoops

    Southeast Toyota Distributors is recalling 2011-2016 Toyota Tacoma and 4Runner vehicles because accessory hood scoops may detach, creating a road hazard.

    Product
    TOYOTA — TOYOTA TACOMA, 4RUNNER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V426000·2017-07-03

    Triumph Recalls 2017-2018 Street Cup Motorcycles for Wiring Defect

    Triumph is recalling 2017-2018 Street Cup motorcycles because the hazard light wiring harness may strain during steering, potentially causing the lights to fail and increasing crash risk.

    Product
    TRIUMPH — TRIUMPH STREET CUP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·080-2017·2017-07-01

    Willow Tree Poultry Farm Recalls Chicken Salad Due To Undeclared Tuna

    Willow Tree Poultry Farm is recalling buffalo style chicken salad products because they contain undeclared tuna and are mislabeled.

    Product
    WILLOW TREE POULTRY FARM, INC. — Willow Tree Poultry Farm Recalls Chicken Salad Products Due To Misbranding And Undeclared Allergens
    Category
    Food
    Distribution
    3 states

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