The Recall Desk

Archive

April 2018 recalls

622 recalls were announced in April 2018.

What the numbers show

Critical
19
Severe
135
High
332
Moderate
110
Low
26

Of the 622 recalls this month scored against our rubric, 3% are Critical, 22% are Severe.

Which agencies issued them

601–622 of 622

  • ModerateFDA (Devices)·Z-1241-2018·2018-04-04

    Encore Medical Recalls AltiVate Reverse Humeral Socket Shell Trials

    Encore Medical is recalling AltiVate Reverse Humeral Socket Shell Trials due to broken or missing screws and retaining clips.

    Product
    AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Orthopedic surgical instrument. Product Usage: The humeral socket shell trial is used to replicate/trial the shell geometry of the AltiVate Reverse Standard Sh
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1273-2018·2018-04-04

    Mesa Laboratories Recalls ProSpore Biological Indicators Due to Concentration Defect

    Mesa Laboratories is recalling specific lots of ProSpore Biological Indicators because the concentration of bromocresol purple does not conform to specification.

    Product
    ProSpore Biological Indicator Part Numbers: PS-6-50, PS-5-50, PS-4-10, PS-4-50, 3471
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1203-2018·2018-04-04

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

    Johnson & Johnson is recalling select first aid wraps because they were labeled as latex-free but used natural latex in early manufacturing.

    Product
    Johnson & Johnson BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wrap (size: 2in)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0609-2018·2018-04-04

    Bracco Recalls E-Z-Paste Barium Sulfate Due to Preservative Failure

    Bracco Diagnostics is recalling E-Z-Paste Barium Sulfate Esophageal Cream because one lot failed stability testing for the preservative methylparaben.

    Product
    E-Z-PASTE — E-Z-PASTE (BARIUM SULFATE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0611-2018·2018-04-04

    Akorn Recalls Subpotent Chlorhexidine Gluconate Oral Rinse Unit Dose Cups

    Akorn, Inc. is recalling Chlorhexidine Gluconate Oral Rinse unit dose cups due to product crystallization and low assay results.

    Product
    Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-720-15) packaged in 100-count (10 x 10) cups per case pack (NDC 50383-720-18 or 50383-720-19), Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701.
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-1239-2018·2018-04-04

    Zimmer Biomet Recalls Coonrad/Morrey Elbow Implant Humeral Assemblies

    Zimmer Biomet is recalling nine Coonrad/Morrey Elbow Implant humeral assemblies because they are missing required humeral bushing components.

    Product
    Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 (UDI: (01)0088902427 4006(17)220731(10)63694912)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1261-2018·2018-04-04

    Siemens Syngo.via software recall due to data archiving configuration error

    Siemens is recalling 165 units of Syngo.via software because a software upgrade disabled a data cleanup function, causing incorrect archiving flags and reduced disk capacity.

    Product
    Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1209-2018·2018-04-04

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

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

    Product
    ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • 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, In
    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 (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 (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 (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
  • 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, Isoflur
    Category
    Medical Device
    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

Looking for a different month? Back to 2018.