The Recall Desk

Archive

October 2019 recalls

807 recalls were announced in October 2019.

What the numbers show

Critical
64
Severe
328
High
307
Moderate
88
Low
20

Of the 807 recalls this month scored against our rubric, 8% are Critical, 41% are Severe.

201–300 of 807

  • HighNHTSA·19V743000·2019-10-18

    Subaru Recalls Impreza and Crosstrek for Electrical Software Defect

    Subaru is recalling 2017-2019 Impreza and 2018-2019 Crosstrek vehicles because a software defect may cause the engine to stall while driving, increasing crash risk.

    Product
    SUBARU — SUBARU IMPREZA, CROSSTREK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V749000·2019-10-18

    Collins Recalls 2018-2019 School Buses Lacking Rear Backup Cameras

    Collins Bus Corporation is recalling 2018-2019 TL400, TL408, TH400, and TH408 school buses that may lack rear backup cameras, increasing crash risk.

    Product
    COLLINS — COLLINS TL408, TH400, TH408, TL400
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V751000·2019-10-18

    Vac-Tron Recalls 2015-2019 LP 873 SD Trailers Due to Sway Risk

    Vac-Tron is recalling 2015-2019 LP 873 SD heavy trailers because they may sway while being towed, increasing the risk of a crash.

    Product
    VAC-TRON — VAC-TRON LP 873 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V740000·2019-10-17

    Yetti Trailers Recalled for Missing Spindle Nut Retainer Clips

    Voyager Industries is recalling 2018-2020 Yetti trailers because missing retainer clips may allow spindle nuts to loosen, potentially causing the wheel to come off the axle.

    Product
    YETTI — YETTI TRAXX, GRAND ESCAPE, ANGLER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V741000·2019-10-17

    Toyota Recalls Vehicles Due to Airbag Inflator Explosion Risk

    Toyota is recalling approximately 928,220 vehicles because previously replaced airbag inflators may explode due to propellant degradation, posing a risk of serious injury or death.

    Product
    LEXUS — LEXUS, TOYOTA, SCION IS 350C, IS 250C, SEQUOIA, TUNDRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·098-2019·2019-10-17

    Global Zakii Enterprises Recalls Canned Meat and Poultry Products

    Global Zakii Enterprises is recalling 174 pounds of canned meat and poultry products imported from Jordan without required inspection.

    Product
    Global Zakii Enterprises, LLC Recalls Canned Meat and Canned Poultry Products Produced without Benefit of Import Inspection
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·19E071000·2019-10-17

    Honda Recalls Rear Carriers for 2019-2020 Monkey Motorcycles

    Honda is recalling Genuine Accessory Rear Carriers for 2019-2020 Monkey motorcycles because they may fail under load, posing a crash risk.

    Product
    EQUIPMENT:MECHANICAL:CARRIER/RACK recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V744000·2019-10-17

    Subaru Recalls Impreza and Crosstrek Vehicles for PCV Valve Defect

    Subaru is recalling 2017-2018 Impreza and 2018 Crosstrek vehicles because the PCV valve may break apart, potentially causing a loss of power while driving.

    Product
    SUBARU — SUBARU IMPREZA, CROSSTREK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V745000·2019-10-17

    Subaru Recalls 2017 Impreza Vehicles Due to PCV Valve Defect

    Subaru is recalling 2017 Impreza vehicles because a defective PCV valve may break apart and enter the engine, causing a loss of power while driving.

    Product
    SUBARU — SUBARU IMPREZA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0044-2020·2019-10-16

    Lipari Foods Recalls Fresh Grab Turkey Sandwiches Due to Listeria

    Lipari Foods is recalling Fresh Grab Turkey No Cheese sandwiches after FDA testing detected Listeria monocytogenes. Consumers should discard or return the product.

    Product
    Fresh Grab brand Turkey No Cheese, refrigerated 5 oz. wheat bread wedge cut sandwich, with UPC 612510002100
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Food)·F-0047-2020·2019-10-16

    Lipari Foods Recalls Tuna Salad Sandwiches Due to Listeria Risk

    Lipari Foods is recalling Premo and Fresh Grab Tuna Salad sandwiches after FDA environmental sampling detected Listeria monocytogenes.

    Product
    Premo and Fresh Grab brands Tuna Salad, refrigerated 5 oz. wheat bread wedge cut sandwich, with UPC 612510002049
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Food)·F-0040-2020·2019-10-16

    Sara Lee Frozen Bakery Recalls Whole Grain Banana Muffins for Tree Nut Contamination

    Sara Lee Frozen Bakery is recalling Chef Pierre Small Whole Grain Banana Muffins after a consumer reported finding tree nut foreign material in the product.

    Product
    Chef Pierre ¿ SMALL WHOLE GRAIN BANANA MUFFINS NET WT 12 LB (5.44kg) 4 TRAYS/24/2 oz WHOLE GRAIN BANANA MUFFINS KEEP FROZEN CONTAINS WHEAT, EGGS DISTRIBUTED BY TYSON FOOD SERVICE SPRINGDALE, AR 72765-2020 UPC (01) 1 00 32100 08896 8
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-0046-2020·2019-10-16

    Lipari Foods Recalls Egg Salad Sandwiches Due to Listeria Test Results

    Lipari Foods is recalling Premo and Fresh Grab Egg Salad sandwiches after FDA environmental sampling detected Listeria monocytogenes.

    Product
    Premo and Fresh Grab brands Egg Salad, refrigerated 5 oz. wheat bread wedge cut sandwich, with UPC 612510002025
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Food)·F-0045-2020·2019-10-16

    Lipari Foods Recalls Chicken Salad Sandwiches Due to Listeria Risk

    Lipari Foods is recalling Premo and Fresh Grab chicken salad sandwiches after FDA environmental sampling detected Listeria monocytogenes.

    Product
    Premo and Fresh Grab brands Chicken Salad, refrigerated 5 oz. wheat bread wedge cut sandwich, with UPC 612510002032
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Food)·F-0039-2020·2019-10-16

    Consider Bardwell Farm Cow Cheese Recalled for Listeria Risk

    Consider Bardwell Farm is recalling Experience Handmade Cow Cheese due to potential Listeria monocytogenes contamination. The product was distributed in six states.

    Product
    Consider Bardwell Farm brand Experience Handmade Cow Cheese - Ingredients Pasteurized Cow Milk, Cultures, Sea Salt - 0.75 lb Square - Consider Bardwell Farm, LLC 133 RTE. 153 W.Pawlet, Vermont 05775
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0024-2020·2019-10-16

    Lion Foods Recalls Crispy Fried Onions Due to Potential Metal Contamination

    Lion Foods is recalling specific lots of Greenland and Chirag brand crispy fried onions due to potential metal contamination. The products were distributed in the US, Europe, and Canada.

    Product
    Greenland All Natural Gourmet Crispy Fried Onions NET WT 400g UPC 5415685068 packaged in foil bag then carton; Chirag Gourmet Crispy Fried Onion Net Weight 400 Grams/14 oz. UPC 6421832035 packaged in foil bag then carton
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0130-2020·2019-10-16

    Morton Grove Recalls Prednisolone Sodium Phosphate Oral Solution Due to Impurity Failure

    Morton Grove Pharmaceuticals is recalling Prednisolone Sodium Phosphate Oral Solution because it failed impurity specifications for Prednisolone Impurity 14.

    Product
    Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in a 8 fl oz (237 mL) bottle, Rx only, Manufactured By Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053. NDC 60432-212-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0042-2020·2019-10-16

    Lipari Foods Recalls Premo Bologna & Cheese Wedges Due to Listeria

    Lipari Foods is recalling Premo brand Bologna & Cheese Wedges because FDA environmental testing detected Listeria monocytogenes.

    Product
    Premo brand Bologna & Cheese Wedge, refrigerated 5 oz. wedge cut sandwich, UPC 612510093306.
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Devices)·Z-0118-2020·2019-10-16

    TriMed Dorsal Wrist Hook Plate Recalled for Structural Integrity Issues

    TriMed Inc. is recalling 5 Dorsal Wrist Hook Plates due to unqualified design modifications that may compromise structural integrity.

    Product
    TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert, or poly package containing varying amounts, Nonsterile, Single Use Only, Rx. The firm name on the label is TriMed, Santa Clarita, CA.
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Devices)·Z-0074-2020·2019-10-16

    BD FACSLyric Flow Cytometers Recalled for Potential False High Counts

    Becton, Dickinson and Company is recalling 22 BD FACSLyric Flow Cytometers because they may produce falsely high absolute counts when used with BD Trucount Tubes.

    Product
    BD FACSLyric Flow Cytometer, 3-Laser 12 Color Instrument, REF: 663029, when using BD Trucount Tubes
    Category
    Medical Device
    Distribution
    26 states
  • SevereFDA (Drugs)·D-0133-2020·2019-10-16

    DrKids Himasal Nasal Saline Recalled for Potential B. cepacia Contamination

    Unipharma is recalling DrKids Himasal Natural Nasal Saline Solution vials due to a precautionary measure regarding potential contamination with B. cepacia bacteria.

    Product
    DrKids Himasal Natural Nasal Saline Solution, packaged in Pre-measured Singe-Use Vials a) 0.5 mL Each (20 count) UPC 37030244608; b) 1.5 mL Each (20 count) UPC 370302446098, Manufactured in USA by: UNIPHARMA, LLC Tamarac, FL 33321
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0038-2020·2019-10-16

    Consider Bardwell Farm Dorset Handmade Cow Cheese Recalled for Listeria Risk

    Consider Bardwell Farm is recalling Dorset Handmade Cow Cheese because the product may be contaminated with Listeria monocytogenes.

    Product
    Consider Bardwell Farm brand Dorset Handmade Cow Cheese - Ingredients Raw Cow Milk, Cultures, Salt, Microbial Rennet - 2.5 lb Wheel - Consider Bardwell Farm, LLC 133 RTE. 153 W.Pawlet, Vermont 05775
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0126-2020·2019-10-16

    Major Infants' Gas Relief Drops Recalled for Microbial Contamination

    GCP Laboratories is recalling Major Infants' Gas Relief Drops due to microbial contamination of the non-sterile product.

    Product
    Major Infants' Gas Relief Drops, Simethicone Oral Suspension USP, 1 FL OZ (30 mL) bottle, Distributed by: Major Pharmaceuticals 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 USA. NDC 0904-5894-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0128-2020·2019-10-16

    Sandoz Recalls Ranitidine Capsules Due to NDMA Impurity Detection

    Sandoz is recalling 13,130 bottles of Ranitidine Hydrochloride Capsules 150mg because a trace amount of the impurity NDMA was detected.

    Product
    Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2855-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0127-2020·2019-10-16

    Sandoz Recalls Ranitidine Capsules Due to NDMA Impurity

    Sandoz is recalling specific lots of Ranitidine Hydrochloride Capsules 150mg because a trace amount of the impurity NDMA was detected.

    Product
    Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ Product of India NDC 0781-2855-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0037-2020·2019-10-16

    Consider Bardwell Farm Goat Cheese Recalled for Listeria Risk

    Consider Bardwell Farm is recalling Slyboro Handmade Goat Cheese because it may be contaminated with Listeria monocytogenes.

    Product
    Consider Bardwell Farm brand Slyboro Handmade Goat Cheese - Ingredients Raw Goat Milk, Cultures, Salt, Microbial Rennet - 2 lb Wheel - Consider Bardwell Farm, LLC 133 RTE. 153 W.Pawlet, Vermont 05775
    Category
    Food
    Distribution
    6 states
  • SevereNHTSA·19V735000·2019-10-16

    Porsche Recalls Cayenne and Panamera for Brake Warning Defect

    Porsche is recalling 2017-2020 Cayenne and Panamera vehicles because the instrument cluster may fail to warn drivers when brake pads are worn out.

    Product
    PORSCHE — PORSCHE CAYENNE, PANAMERA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V734000·2019-10-16

    Airstream Atlas Motorhomes Recalled for Electrical Wiring Fire Risk

    Airstream is recalling 2019-2020 Atlas motorhomes because incorrect wiring may cause overheating and fire. Dealers will correct the wiring free of charge.

    Product
    AIRSTREAM — AIRSTREAM ATLAS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V738000·2019-10-16

    BMW Recalls 2020 X3 and X4 Models for Steering Rack Defect

    BMW is recalling 2020 X3 M40i and X4 M40i vehicles because the steering rack pinion teeth may break, causing a loss of steering control.

    Product
    BMW — BMW X3, X4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0129-2020·2019-10-16

    Sandoz Recalls Ranitidine Capsules Due to NDMA Impurity Detection

    Sandoz is recalling Ranitidine Hydrochloride Capsules 300mg because a trace amount of the impurity NDMA was detected.

    Product
    Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2865-31
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0049-2020·2019-10-16

    Becton Dickinson Recalls CareFusion MaxPlus Clear Needleless Connectors

    Becton Dickinson is recalling 115,200 CareFusion MaxPlus Clear Needleless Connectors because the valve may fail to close, posing risks of blood loss and air embolism.

    Product
    CareFusion MaxPlus Clear Needleless Connector. Intended for Positive Displacement Connector for needleless access to the IV line and/or IV catheter during IV therapy Cat. No. MP1000-C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0020-2020·2019-10-16

    Trail's End Chocolatey Carmel Crunch Recalled for Undeclared Nuts

    Weaver Fundraising is recalling Trail's End Chocolatey Carmel Crunch tins due to undeclared almonds, cashews, and pecans.

    Product
    Trail's End Chocolatey Carmel Crunch, in 15oz fundraiser tin, distributed in six count wholesale cases marked as ACP Caramel Corn w/almonds.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0135-2020·2019-10-16

    Epic Pharma Recalls Estradiol Tablets Due to Foreign Tablet Presence

    Epic Pharma is recalling Estradiol 0.5 mg tablets because 1 mg tablets were found in the bottles. Patients should stop using the product and contact their healthcare provider.

    Product
    ESTRADIOL — ESTRADIOL (ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0101-2020·2019-10-16

    Centurion Medical Recalls VANTEX CVC Bundles Due to Connector Defect

    Centurion Medical Products is recalling VANTEX 7FR, 16CM, 3L CVC Bundles because the included BD MaxZeroNeedleess Connector may leak fluid droplets after disconnection.

    Product
    VANTEX 7FR, 16CM, 3L CVC BUNDLE ECVC6670
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0084-2020·2019-10-16

    Centurion Infusa Port Kit Recalled for Fluid Droplet Risk

    Centurion Medical Products is recalling Infusa Port Kits containing a recalled BD connector due to the potential for fluid droplets to separate from the sealed surface.

    Product
    INFUSA PORT KIT DYNDC1840E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0066-2020·2019-10-16

    BD FACSLyric Flow Cytometer Recalled for Potential False High Counts

    Becton, Dickinson and Company is recalling 12 BD FACSLyric Flow Cytometers because they may produce falsely high absolute counts when used with specific tubes, potentially affecting clinical decisions.

    Product
    BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 662875, when using BD Trucount Tubes
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Food)·F-0033-2020·2019-10-16

    Vinh Sanh Trading Corp Recalls Tep Say Crispy Tiny Shrimp Snack

    Vinh Sanh Trading Corp is recalling Tep Say Crispy Tiny Shrimp Snack due to undeclared sulfites. The product was distributed to 19 U.S. states.

    Product
    Tep Say Crispy Tiny Shrimp Snack, Net Wt. 7 oz. in plastic jar UPC 7 37483 77926 9 Distributed By: First World Trading Corp. Fremont, California Tel: (510) 683-8778
    Category
    Food
    Distribution
    17 states
  • HighFDA (Devices)·Z-0041-2020·2019-10-16

    Giraffe Omnibed Infant Incubator Recalled for Inadequate Cleaning Instructions

    Ohmeda Medical is recalling Giraffe Omnibed infant incubators because cleaning guidelines failed to prevent debris buildup, creating a potential infection risk.

    Product
    Giraffe Omnibed - Product Usage: The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same tim
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19V736000·2019-10-16

    Forest River Recalls 2020 RVs for Seatbelt Warning Light Defect

    Forest River is recalling 2020 Sunseeker, Freelander, and Leprechaun vehicles because the seatbelt warning light may not illuminate, increasing crash injury risk.

    Product
    FOREST RIVER — FOREST RIVER LEPRECHAUN, SUNSEEKER, FREELANDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0031-2020·2019-10-16

    Chef's Companion Chocolate Mousse Mix Recalled for Undeclared Soy

    Diamond Crystal Brands is recalling Chef's Companion Instant Chocolate Mousse Mix because it contains soy lecithin that is not declared on the label.

    Product
    Chef's Companion Instant Chocolate Mousse Mix Net Wt. 1 lb 14 oz (851 g), Dist by Diamond Crystal Brands, Inc. Savannah, GA packaged 8 boxes per case.
    Category
    Food
    Distribution
    18 states
  • HighFDA (Devices)·Z-0055-2020·2019-10-16

    BD Microtainer Tubes Recalled for Damaged Reservoirs and Erroneous Test Results

    Becton Dickinson is recalling specific lots of BD Microtainer Tubes with Lithium Heparin because damaged reservoirs may cause insufficient sample volumes and erroneous test results.

    Product
    BD Microtainer Tubes with LH (Lithium Heparin) Part/Catalog No.365965
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0083-2020·2019-10-16

    Centurion Medical Products Recalls CAP CHANGE KIT DYNDC1496B

    Centurion Medical Products is recalling CAP CHANGE KIT DYNDC1496B because the included BD MaxZeroNeedleess Connector may release fluid droplets after disconnection.

    Product
    CAP CHANGE KIT DYNDC1496B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19V739000·2019-10-16

    Hyundai Translead Recalls 2018-2019 Dry Van Trailers for Air Hose Defect

    Hyundai Translead is recalling 2018-2019 Dry Van Trailers because a beam clip may detach, allowing air hoses to drag on the ground and potentially leak air.

    Product
    HYUNDAI TRANSLEAD — HYUNDAI TRANSLEAD DRY VAN TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0136-2020·2019-10-16

    Pfizer Recalls LMD in Dextrose Bags Due to Sterility Concerns

    Pfizer is recalling 17,832 bags of LMD in Dextrose Injection due to a potential leak that compromises sterility.

    Product
    LMD IN DEXTROSE — LMD IN DEXTROSE (DEXTRAN 40)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0032-2020·2019-10-16

    Gridestone Cafe Swiss Style Cocoa Mix Recalled for Undeclared Soy

    Diamond Crystal Brands is recalling Gridestone Cafe Swiss Style Cocoa Mix because the product contains soy lecithin, which is not declared on the label.

    Product
    Gridestone Cafe Swiss Style Cocoa Mix, Net Wt. 32 OZ (2 lb) 907 g, Distributed by Performance Food Group, Richmond, VA packaged 12 boxes per case.
    Category
    Food
    Distribution
    18 states
  • HighFDA (Food)·F-0025-2020·2019-10-16

    MOWI Farmed Fresh Atlantic Salmon Recalled for Listeria Risk

    MOWI USA, LLC is recalling farmed fresh Atlantic Salmon due to potential Listeria monocytogenes contamination. The product was distributed to consignees in California and Illinois.

    Product
    MOWI brand. Whole, head-on gutted farmed, fresh Atlantic Salmon packed with ice inside Styrofoam coolers. Each cooler weighs approximately 47 lbs.
    Category
    Food
    Distribution
    2 states
  • HighUSDA FSIS·pha-101619-01·2019-10-16

    USDA Issues Public Health Alert for Raw Beef Products Due to E. coli O157:H7

    USDA FSIS issued a public health alert for raw non-intact beef products in ten states due to possible E. coli O157:H7 contamination from imported Canadian beef.

    Product
    FSIS Issues Public Health Alert for Beef Products due to Possible E. coli O157:H7 Contamination
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-0105-2020·2019-10-16

    Centurion Medical Invasive Procedure Tray Recall for Connector Defect

    Centurion Medical Products is recalling Invasive Procedure Trays because they include a recalled connector that may release fluid droplets.

    Product
    INVASIVE PROCEDURE TRAY MNS9510
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0040-2020·2019-10-16

    AZIYO BIOLOGICS Recalls CanGaroo Envelopes Due to Suture Brittleness

    AZIYO BIOLOGICS is recalling CanGaroo Envelopes because sutures may become brittle or break before expiration. The devices are used to secure cardiac and neurostimulator implants.

    Product
    CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single pack); 2. CanGaroo Envelope (Medium) (single pack); 3. CanGaroo Envelope (Extra Large) (single pack); 4. CanGaroo Envelope (Extra Extra Large) (single pack); 5. CanGaroo Env
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0107-2020·2019-10-16

    Centurion Medical UVC Tray Recall Due to Fluid Droplet Risk

    Centurion Medical Products is recalling UVC Trays containing BD MaxZeroNeedleess Connectors due to a risk of fluid droplets separating from the connector surface.

    Product
    UVC TRAY UVT875
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0079-2020·2019-10-16

    Centurion Medical CVC Bundle Recall Due to Fluid Droplet Risk

    Centurion Medical is recalling CVC bundles containing a recalled BD connector due to potential fluid droplet separation.

    Product
    CVC BUNDLE WITHOUT CATH CVI4600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0094-2020·2019-10-16

    Centurion Medical CVC Bundle Recall Due to Fluid Droplet Risk

    Centurion Medical is recalling CVC Bundle VanTex kits because the included BD MaxZeroNeedleess Connector may release fluid droplets after disconnection.

    Product
    CVC BUNDLE VANTEX 7F, 3L, 20CM ECVC6065
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0103-2020·2019-10-16

    Centurion IV Securement Kit Recall Due to Fluid Droplet Risk

    Centurion Medical Products is recalling IV Securement Kits containing a recalled BD connector due to the potential for fluid droplets to separate from the sealed surface.

    Product
    IV SECUREMENT KIT IVS3405
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0085-2020·2019-10-16

    Centurion Medical Recalls Infusa Port Kits Due to Fluid Droplet Risk

    Centurion Medical Products Corporation is recalling Infusa Port Kits containing a specific connector due to the potential for fluid droplets to separate from the sealed surface.

    Product
    INFUSA PORT KIT DYNDC1840F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0098-2020·2019-10-16

    Centurion Medical Central Line Bundle Recalled for Fluid Droplet Risk

    Centurion Medical is recalling central line bundles containing a BD MaxZeroNeedleess Connector due to the potential for fluid droplets to separate from the sealed surface after disconnection.

    Product
    CENTRAL LINE BUNDLE 16CM MULTIMED ECVC6545
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0120-2020·2019-10-16

    Centurion Circlamp Recalled for Angle Mismatch Defect

    Centurion Medical Products is recalling 1,530 Circlamps due to a design mismatch that may cause the device to remove foreskin without a scalpel.

    Product
    Centurion CIRCLAMP W/1.1CM BELL - single-use, disposable instrument used to compress the foreskin of the penis during circumcision of a male infant. ReOrder: 310CR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0086-2020·2019-10-16

    Centurion Medical Products Recalls Sterile Cap Change Kits

    Centurion Medical Products is recalling sterile cap change kits because they include a connector that may leak fluid droplets after disconnection.

    Product
    STERILE CAP CHANGE KIT DYNDC1946B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0070-2020·2019-10-16

    BD FACSLyric Flow Cytometers Recalled for Potential False High Absolute Counts

    Becton, Dickinson and Company is recalling 21 BD FACSLyric Flow Cytometers because they may produce falsely high absolute counts when used with specific tubes, potentially affecting clinical decisions.

    Product
    BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 651164, when using BD Trucount Tubes
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-0102-2020·2019-10-16

    Centurion IV Start Kits Recalled Due to Fluid Droplet Risk

    Centurion Medical Products is recalling IV Start Kits containing a recalled BD connector due to potential fluid droplet separation.

    Product
    IV START KIT IV8440
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0073-2020·2019-10-16

    BD FACSLyric Flow Cytometer Recall for Potential False High Absolute Counts

    Becton, Dickinson and Company is recalling 236 BD FACSLyric Flow Cytometers because they may produce falsely high absolute counts when used with BD Trucount Tubes.

    Product
    BD FACSLyric Flow Cytometer,3-Laser 10 Color Instrument, REF: 659180 and 65918001, when using BD Trucount Tubes
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-0043-2020·2019-10-16

    Roche Online TDM Vancomycin Gen.3 Recalled for Inaccurate Low Sample Results

    Roche Diagnostics is recalling Online TDM Vancomycin Gen.3 kits because they may produce inaccurately low sample results.

    Product
    Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Analyzer/Module: cobas c 311 and cobas c 501/502
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-0088-2020·2019-10-16

    Centurion Triple Lumen Bundle Kit Recalled for Fluid Droplet Risk

    Centurion Medical Products is recalling Triple Lumen Bundle Kits because the included BD MaxZeroNeedleess Connector may release fluid droplets after disconnection.

    Product
    TRIPLE LUMEN BUNDLE KIT ECVC1540
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0042-2020·2019-10-16

    Roche Vancomycin Test Recall Due to Inaccurate Low Results

    Roche Diagnostics is recalling Online TDM Vancomycin Gen.3 tests because they may produce inaccurately low sample results.

    Product
    Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Food)·F-0030-2020·2019-10-16

    Madrona Market Hot Cocoa Mix Recalled for Undeclared Soy

    Diamond Crystal Brands is recalling Madrona Market Hot Cocoa Mix because it contains soy lecithin that is not declared on the label.

    Product
    Madrona Market Delicatessen Hot Cocoa Mix, Net Wt. 2 lb (907 g), Distributed by Food Services of America, Inc. Scottsdale, AZ packaged 6 boxes per case.
    Category
    Food
    Distribution
    18 states
  • HighFDA (Devices)·Z-0106-2020·2019-10-16

    Centurion Medical Products Recalls Triple Lumen CVC Kits Due to Connector Defect

    Centurion Medical Products is recalling Triple Lumen CVC kits because the included BD MaxZeroNeedleess Connector may allow fluid droplets to separate from the sealed surface after disconnection.

    Product
    TRIPLE LUMEN CVC 20CM BUNDLE STCVC2040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0080-2020·2019-10-16

    Centurion Medical Recalls Port and IO Access Dressing Kits

    Centurion Medical Products Corporation is recalling Port and IO Access Dressing Kits because they include a connector recalled for potential fluid droplet separation.

    Product
    PORT AND IO ACCESS DRESSING KIT DT15780A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0038-2020·2019-10-16

    Vital Scientific V-Twin Automated Chemistry Analyzer Recall for Cooling Defect

    Vital Scientific N.V. is recalling 192 V-Twin automated chemistry analyzers because an improperly installed cooling indicator board may prevent warning signals if reagent cooling fails.

    Product
    V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0059-2020·2019-10-16

    BD Microtainer PSTTubes with Lithium Heparin Recalled for Damaged Reservoirs

    Becton Dickinson & Company is recalling BD Microtainer PSTTubes with Lithium Heparin because damaged reservoirs may cause insufficient sample volumes and erroneous test results.

    Product
    BD Microtainer PSTTubes with LH (Lithium Heparin) Part/Catalog Number:365985
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0039-2020·2019-10-16

    Aziyo BioEnvelope Surgical Mesh Recalled for Possible Suture Brittleness

    Aziyo Biologics is recalling BioEnvelope surgical mesh envelopes due to possible suture brittleness or breakage along the seam before the expiration date.

    Product
    BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single pack); 2. BioEnvelope (Large) (single pack); 3. BioEnvelope (Extra Large) (single pack); 4. BioEnvelope (Extra Extra Large) (single pack); 5. BioEnvelope (Larg
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0121-2020·2019-10-16

    Centurion CIRCLAMP Recall Due to Angle Mismatch Defect

    Centurion Medical Products is recalling 204 units of the CIRCLAMP W/1.3 CM BELL because a design mismatch may cause the clamp to remove foreskin without a scalpel.

    Product
    Centurion CIRCLAMP W/1.3 CM BELL-single-use, disposable instrument used to compress the foreskin of the penis during circumcision of a male infant. ReOrder: 330CR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0071-2020·2019-10-16

    BD FACSLyric Flow Cytometer Recall for Potential Inaccurate Cell Counts

    BD Biosciences is recalling 36 BD FACSLyric Flow Cytometers because they may produce falsely high absolute cell counts when used with BD Trucount Tubes, potentially affecting clinical decisions.

    Product
    BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 651165, when using BD Trucount Tubes
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-0089-2020·2019-10-16

    Centurion Medical Recalls Central Venous Access Device Bundles

    Centurion Medical Products Corporation is recalling Central Venous Access Device Bundles because they include a connector recalled for potential fluid droplet separation.

    Product
    CENTRAL VENOUS ACCESS DEVICE BUNDLE ECVC2840
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0119-2020·2019-10-16

    Horiba ABX Pentra Lipase CP Analyzer Recall for Interference

    Horiba Instruments is recalling ABX Pentra Lipase CP analyzers because triglyceride and cholesterol interference may cause false abnormal lipase results.

    Product
    Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A11A01631, Model/Part # 1220001631, UDI # 03610230004944
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-0064-2020·2019-10-16

    Conformis Recalls iTotal Hip Replacement Stems Due to Packaging Error

    Conformis, Inc. is recalling two iTotal Hip Replacement femoral stems because sizes 13 and 15 were packed in each other's packaging.

    Product
    iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0092-2020·2019-10-16

    Centurion CVC Bundle Recall Due to Fluid Droplet Risk

    Centurion Medical Products is recalling CVC bundles containing BD MaxZeroNeedleess Connectors due to a risk of fluid droplets separating from the connector surface.

    Product
    CVC BUNDLE, 20CM, 3L, PI ECVC5120A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0100-2020·2019-10-16

    Centurion Medical Products Recalls OR VANTEX Kits Due to Connector Defect

    Centurion Medical Products is recalling OR VANTEX kits because the included BD MaxZeroNeedleess Connector may allow fluid droplets to separate after disconnection.

    Product
    OR VANTEX 7FR 3L 16CM CVC ECVC6665
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0057-2020·2019-10-16

    BD Microtainer Tubes Recalled for Damaged Reservoirs Causing Test Errors

    Becton Dickinson is recalling BD Microtainer Tubes with K2E because damaged reservoirs may cause insufficient sample volume and erroneous test results.

    Product
    BD MicrotainerTubes with K2E (K2EDTA) Catalog Number: 365974
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0021-2020·2019-10-16

    Ritter Sport KAFFEESPLITTER Chocolate Recalled for Undeclared Milk

    STARK INC. is recalling Ritter Sport KAFFEESPLITTER chocolate bars because they contain undeclared milk, a major food allergen.

    Product
    Ritter Sport KAFFEESPLITTER Chocolate with caramelized coffee beans; Net Weight: 3.5oz / 100g; Ingredients: sugar, cocoa mass, caramelized pieces of coffee beans (sugar, coffee (roasted) (4%), sunflower oil), cocoa butter, butter pure fat, emulsifier: lecithin (soy) May contain t
    Category
    Food
    Distribution
    28 states
  • HighFDA (Devices)·Z-0075-2020·2019-10-16

    Centurion PICC Line Accessory Kit Recalled for Fluid Droplet Risk

    Centurion Medical Products is recalling PICC Line Accessory Kits containing a BD connector that may release fluid droplets upon disconnection.

    Product
    PICC Line Accessory Kit CVI4285
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0091-2020·2019-10-16

    Centurion Medical CVC Bundle Recall Due to Fluid Droplet Risk

    Centurion Medical Products is recalling CVC bundles containing a recalled BD connector due to potential fluid droplet separation.

    Product
    CVC BUNDLE, 20CM, 3L, PI ECVC5120
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0095-2020·2019-10-16

    Centurion Medical CVC Safety Bundle Recalled for Connector Fluid Leakage

    Centurion Medical Products is recalling CVC Triple Lumen Safety Bundles because the included BD MaxZeroNeedleess Connector may leak fluid droplets after disconnection.

    Product
    CVC TRIPLE LUMEN SAFETY BUNDLE ECVC6070
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0044-2020·2019-10-16

    Roche AssayTip/AssayCup Tray Recall for Abnormal Internal Structure

    Roche Diagnostics is recalling AssayTip/AssayCup Trays used on the cobas e 801 module due to abnormal internal structure that may lead to incorrect patient results.

    Product
    AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determination of analytes in human body fluids) Catalog Number: 5694302001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0062-2020·2019-10-16

    GE Healthcare Recalls AIR Technology Anterior Array MRI Coils

    GE Healthcare is recalling 22 AIR Technology Anterior Array MRI coils because the outer seam may separate, exposing porous internal material that cannot be disinfected.

    Product
    AIR Technology Anterior Array, Catalogue Numbers: (a) 5746694, (b) 5746695, (c) 5746696, a receive-only RF coil designed for use with GE 3.0T MRI systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0078-2020·2019-10-16

    Centurion Neonatal Procedure Tray Recall Due to Connector Fluid Droplet Risk

    Centurion Medical Products is recalling Neonatal Procedure Tray PICC Catheters because the included BD MaxZeroNeedleess Connector may release fluid droplets when disconnected.

    Product
    NEONATAL PROCEDURE TRAY PICC CATHETERS CVI4535
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0090-2020·2019-10-16

    Centurion Medical CVC Bundle Recall Due to Fluid Droplet Risk

    Centurion Medical Products is recalling CVC Bundles because the included BD MaxZeroNeedleess Connector may release fluid droplets after disconnection.

    Product
    CVC BUNDLE, 20CM, 4L, PI ECVC5095
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0069-2020·2019-10-16

    BD FACSLyric Flow Cytometer Recall for Potential False High Counts

    Becton, Dickinson and Company is recalling 78 BD FACSLyric Flow Cytometers because they may produce falsely high absolute counts when used with specific tubes, potentially affecting clinical decisions.

    Product
    BD FACSLyric Flow Cytometer, 3-Laser 10 Color Instrument, REF: 662878, and 66287808 when using BD Trucount Tubes
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-0096-2020·2019-10-16

    Centurion CVC Insertion Bundle Recalled for Fluid Droplet Risk

    Centurion Medical Products is recalling CVC Insertion Bundles because the included BD MaxZeroNeedleess Connector may release fluid droplets after disconnection.

    Product
    CVC INSERTION BUNDLE 8.5FR 4L 16CM ECVC6355
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0082-2020·2019-10-16

    Centurion Medical Recalls Neonatal Cap Change Kits Due to Fluid Droplet Risk

    Centurion Medical Products Corporation is recalling Neonatal Cap Change Kits because the included BD MaxZeroNeedleess Connector may release fluid droplets after disconnection.

    Product
    Neonatal Cap Change Kit DT20315
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0068-2020·2019-10-16

    BD FACSLyric Flow Cytometers Recalled for Potential False High Absolute Counts

    Becton, Dickinson and Company is recalling eight BD FACSLyric Flow Cytometers because they may produce falsely high absolute counts when used with BD Trucount Tubes.

    Product
    BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 662877, when using BD Trucount Tubes
    Category
    Medical Device
    Distribution
    26 states

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