The Recall Desk

Archive

April 2018 recalls

622 recalls were announced in April 2018.

What the numbers show

Critical
19
Severe
146
High
321
Moderate
110
Low
26

Of the 622 recalls this month scored against our rubric, 3% are Critical, 23% are Severe.

601–622 of 622

  • ModerateFDA (Devices)·Z-1224-2018·2018-04-04

    Zimmer Biomet Recalls Persona Knee System Components Due to Missing Parts

    Zimmer Biomet is recalling 3 units of the Persona Knee System because the set screw and taper plug were missing from the packaging.

    Product
    PERSONA¿ THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1210-2018·2018-04-04

    Johnson & Johnson Recalls ACUVUE ADVANCE Contact Lenses Due to Foreign Matter

    Johnson & Johnson Vision Care is recalling specific lots of ACUVUE ADVANCE contact lenses because foreign matter was found between the blister package and foil.

    Product
    ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1272-2018·2018-04-04

    SIE AG Recalls FEMTO LDV Z8 Femtosecond Surgical Lasers

    SIE AG is recalling 125 FEMTO LDV Z8 femtosecond surgical lasers worldwide due to usability and performance improvements identified after a cataract procedure complication.

    Product
    The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser is an ophthalmic surgical laser intended for use in the creation of corneal incisions indicated for use in patients undergoing LASIK surgery, tunnel creation for implantation of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0608-2018·2018-04-04

    Paddock Recalls Evamist Estradiol Spray Due to Vial Cracks

    Paddock Laboratories is recalling 52,596 bottles of Evamist (estradiol) transdermal spray because cracks in the vial neck may cause product evaporation, leaking, or dispensing failure.

    Product
    EVAMIST — EVAMIST (ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1206-2018·2018-04-04

    Johnson & Johnson Recalls First Aid Wraps Due to Latex Labeling Error

    Johnson & Johnson is voluntarily recalling select first aid wraps because the packaging incorrectly states they are not made with natural rubber latex.

    Product
    Johnson & Johnson BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wrap (size: 2in)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0980-2018·2018-04-04

    Dreyer's Vanilla Bean Ice Cream Recalled for Incorrect Butter Pecan Contents

    Nestle Dreyers is recalling 30 cases of Dreyer's Slow Churned Vanilla Bean Ice Cream in Colorado because the cartons contain Butter Pecan ice cream.

    Product
    Dreyer's Slow Churned Vanilla Bean Ice Cream; 1.5 qt, (48-fl oz.); Lid is for Dreyer's Slow Churned Butter Pecan Ice Cream UPC 41548 00386
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1191-2018·2018-04-04

    Zimmer Biomet Recalls Mismatched Hip Implant Packages

    Zimmer Biomet is recalling 12 hip implant packages labeled as size 7.5 that actually contained size 4 implants.

    Product
    Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 7.5 Extended Offset Reduced Neck Length; Part Number: 00-7711-007-40
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-1270-2018·2018-04-04

    Roche cobas e 411 Analyzer Recall for Questionable Results

    Roche Diagnostics is recalling cobas e 411 Immunoassay Analyzers because using 13 mm sample tubes without adapters may cause questionable results.

    Product
    cobas e 411 Immunoassay Analyzer (Discrete Photometric Analyzer for Clinical use), Catalog Numbers: 04775201001 (rack system), 04775279001 (disk system), 04775201973 (rack system) & 04775279973 (disk system).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1189-2018·2018-04-04

    Zimmer Dental Recalls Tapered Screw-Vent Implants Due to Labeling Error

    Zimmer Dental Inc is recalling Tapered Screw-Vent MTX dental implants because two lots were inadvertently commingled during manufacturing, potentially resulting in mislabeling.

    Product
    Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1198-2018·2018-04-04

    GE Healthcare Recalls 28 Datex-Ohmeda TEC 7 Anesthesia Vaporizers

    GE Healthcare is recalling 28 Datex-Ohmeda TEC 7 anesthesia vaporizers shipped from a service center without proper evaluation, potentially making them nonconforming.

    Product
    DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia.
    Category
    Medical Device
    Distribution
    5 states
  • LowFDA (Devices)·Z-1242-2018·2018-04-04

    Mindray Gas Module 3 monitoring spirometer recalled for regulatory changes

    Mindray DS USA is recalling 1,719 Gas Module 3 monitoring spirometers because the firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification.

    Product
    Gas Module 3 monitoring spirometer, Part Number: 115-030108-00 Product Usage: The Gas Module 3 is an accessory device designed to monitor airway gases during anesthesia and/or assisted respiration. Monitored gases includes O2, CO2, N2O and anesthetic agents Halothane…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1179-2018·2018-04-04

    Keystone Dental Recalls Mispackaged Plastic Abutment Sleeves

    Keystone Dental Inc is recalling 55 units of plastic abutment sleeves that were packed as non-locking but are actually locking.

    Product
    STAGE-1¿ RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Food)·F-0982-2018·2018-04-04

    PepsiCo Recalls Diet Pepsi Cans Due to Mislabeling

    PepsiCo is recalling 1,296 cases of Diet Pepsi 12-packs in Arizona due to mislabeling. No illnesses have been reported.

    Product
    diet Pepsi Classic Diet Pepsi Taste, 12oz cans, sold as a 12 pk, ambient storage.
    Category
    Food
    Distribution
    1 state
  • LowFDA (Drugs)·D-0613-2018·2018-04-04

    Akorn Recalls Subpotent Chlorhexidine Oral Rinse Kits

    Akorn, Inc. is recalling 24-HOUR Oral Care q4 Kits containing subpotent Chlorhexidine Gluconate Oral Rinse due to product crystallization.

    Product
    24-HOUR Oral Care q4 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cup (NDC 50383-720-15), Rx Only, Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701; Kit Manufactured by Halyard Health…
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0983-2018·2018-04-04

    PepsiCo Recalls Diet Pepsi Caffeine Free Due to Aspartame Labeling Error

    PepsiCo is recalling 194 cases of Diet Pepsi Caffeine Free because the outer packaging incorrectly states 'Aspartame Free' while the product contains aspartame.

    Product
    diet pepsi caffeine free Classic Diet Pepsi Taste, 12 FL OZ (355 mL), UPC: 0 12000 17230 4
    Category
    Food
    Distribution
    4 states
  • LowFDA (Drugs)·D-0605-2018·2018-04-04

    Renaissance Lakewood Recalls Flucanazole Injection Due to Stability Failures

    Renaissance Lakewood, LLC is recalling 1,277 bags of Flucanazole Injection due to superpotent and failed stability specifications.

    Product
    Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only, Manufactured for: Claris Lifesciences, Inc. North Brunswick, NJ 08902 By; Claris Injectables Ltd. Gujarat, India --- NDC 36000-006-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·029-2018·2018-04-03

    Good Foods Recalls Curry Chicken Salad Due to Undeclared Cashews

    Good Foods Group is recalling ready-to-eat curry chicken salad cups because they contain undeclared cashews. The mislabeled products were distributed to retail locations in seven states.

    Product
    Good Foods Group, LLC — Good Foods Group, LLC Recalls Ready-To-Eat Chicken Products Due to Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    7 states
  • SevereNHTSA·18V211000·2018-04-03

    Toyota Recalls 2017-2018 Models for Brake Booster Vacuum Pump Defect

    Toyota is recalling specific 2017-2018 Camry, Highlander, Sienna, Tacoma, and Lexus RX350 vehicles because a manufacturing defect in the brake booster vacuum pump may cause a sudden loss of brake assist.

    Product
    TOYOTA — TOYOTA, LEXUS SIENNA, TACOMA, RX350, HIGHLANDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18135·2018-04-03

    3M Recalls Scotch Thermal Laminators Due to Overheating Burn Hazard

    3M is recalling about 395,000 Scotch thermal laminators because the plastic enclosure can overheat, posing a burn hazard. No injuries have been reported.

    Product
    Scotch™ thermal laminators
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·18133·2018-04-02

    Polaris Recalls RZR XP 1000 Vehicles Due to Exhaust Fire Hazard

    Polaris is recalling about 107,000 RZR XP 1000 vehicles because a cracked exhaust silencer can cause a fire. No injuries have been reported.

    Product
    Model Year 2014-2018 Polaris RZR XP 1000
    Category
    Vehicle
    Distribution
    Distributed nationwide

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