Archive
567 recalls were announced in December 2019.
Of the 567 recalls this month scored against our rubric, 8% are Critical, 28% are Severe.
Which agencies issued them
CornFusion Gourmet Popcorn is recalling 11 packages of Maple Bacon flavored popcorn because the label declares butter but fails to declare milk.
Meijer Inc. is recalling Fresh From Meijer Cauliflower Florets due to a Listeria monocytogenes hazard. The product was sold in Meijer stores in six states.
Nectar Foods is recalling Honey Mama's Truffle Bar sold at Trader Joe's because the product contains milk, which is not listed on the label.
Elekta Inc is recalling Monaco Radiation Treatment Planning System software due to incorrect energy usage during dose calculation.
CornFusion Gourmet Popcorn is recalling 12 packages of 7-oz caramel popcorn in Washington because the label declares butter but omits milk.
Cain Food Industries is recalling 1,000 pounds of OXIBAKE YF due to possible Salmonella contamination. The product was distributed in seven states.
Cook Inc. is recalling 43 CrossCath Support Catheters because a manufacturing error may cause radiopaque marker bands to be too loose or too tight.
AC Culinary Group LLC is recalling Chef Pineiro's Ajo con Cilantro in 8 oz and 32 oz sizes due to the presence of metal filaments.
CP Medical Inc is recalling 2,124 coated PGA sutures because they failed to meet USP minimum average value for knot pull strength.
Smiths Medical is recalling 626 Medfusion 4000 Syringe Pumps due to a firmware anomaly that may disable battery alarms and interrupt therapy.
Forest River is recalling 2018-2020 Dynamax Isata motorhomes because slide-out mechanisms may activate unexpectedly, increasing the risk of injury or a crash.
Integra LifeSciences is recalling 820 C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray does not meet the 30-minute drying criteria stated in the manual.
Abbott Medical is recalling 8,940 radiofrequency grounding pads nationwide because an incorrectly oriented release liner may leave film on the pad, interfering with skin contact and causing uneven heating.
Ford is recalling 2006-2010 Fusion, Milan, MKZ, and Zephyr vehicles because ABS valves may fail to close, increasing stopping distance and crash risk.
Skidmore Sales & Distributing Co Inc is recalling CBI BG 2280/45025 because the product contains undeclared soy lecithin.
Viewray is recalling 24 MRIdian Linac Radiation Therapy Systems because the operator's manual and software lack adequate instructions for transferring treatment plans between systems.
AC Culinary Group LLC is recalling Chef Pineiro's Sofrito con Cilantro in 12 oz and 32 oz sizes due to a customer complaint about a metal filament.
Integra LifeSciences is recalling 820 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray does not meet the required drying time criteria.
AC Culinary Group LLC is recalling Chef Pineiro's Sofrito con Albahaca in 12 oz and 32 oz sizes because a metal filament was found in the product and its raw materials.
Meijer Inc. is recalling Fresh From Meijer vegetable trays and dip due to Listeria monocytogenes contamination. The affected products were sold in six states.
Whole Foods Market is recalling Raspberry Cheesecake Italian Gelato because it contains undeclared egg. The product was distributed nationwide.
Getinge is recalling 3,633 units of Quadrox-iD Pediatric Diffusion Membrane Oxygenators because the sterile barrier system may be compromised.
Encore Medical is recalling 410 EMPOWR Locking Femoral Impactors because the tips may break off during surgery. This defect can cause off-axis loading, device failure, and potential long-term complications.
Meijer Inc. is recalling Fresh From Meijer Broccoli Florets in six states due to a potential Listeria monocytogenes contamination.
House Foods America Corporation is recalling Chinese Mabo Tofu Sauce due to weak pouch seals that may leak and allow microorganism growth.
Ford is recalling 2020 F-150 trucks because the 17-inch spare tire may be damaged, increasing crash risk. Dealers will replace the tire free of charge.
Boston Scientific is recalling 139 Habib EUS RFA electrode tips because capacitive coupling may cause thermal injury to tissue outside the target area.
Werner Gourmet Meat Snacks is recalling Jolly Rancher hard candies due to undeclared soy lecithin. The product was distributed nationwide and in Canada.
Conformis, Inc. is recalling the iTotal CR Knee Replacement System because the polyethylene inserts did not securely fit into the cobalt chrome tray implant.
Cruise Car is recalling 2019 Moke vehicles because they may have windshields with incorrect glass quality ratings, which could affect driver visibility and increase crash risk.
Cain Food Industries is recalling 600 pounds of CDC-2010 packaged in 50 lb. bags due to possible Salmonella contamination. The product was distributed in seven states.
Kraft Heinz is recalling Breakstones 4% Milkfat Large Curd Cottage Cheese due to the potential presence of red plastic and metal pieces introduced during production.
Airstream is recalling 2018-2019 Interstate motorhomes because incorrect occupant and cargo capacity labels may lead to vehicle overloading and increased crash risk.
Boston Scientific is recalling 179 Habib EUS RFA electrode tips because capacitive coupling may cause unintended thermal injury to tissue outside the treatment area.
Anazao Health is recalling Morphine Sulfate and Bupivacaine HCL combination products due to the presence of Talaromyces rotundus fungi.
Anazao Health is recalling compounded fentanyl and bupivacaine medications due to the presence of Talaromyces rotundus fungi detected during environmental sampling.
Anazao Health is recalling specific lots of Morphine Sulfate, Bupivacaine HCL, and Clonidine HCL because environmental sampling detected Talaromyces rotundus, a fungus.
Anazao Health is recalling Clonidine HCL/Hydromorphone HCL products because environmental sampling detected Talaromyces rotundus, a fungus, indicating a lack of processing controls.
Integra LifeSciences is recalling 820 C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray does not meet the required 30-minute drying time.
Integra LifeSciences is recalling the C7000 CUSA Clarity system because the operator manual lists an incorrect minimum drying time for the 36 kHz Sterilization Tray.
Integra LifeSciences is recalling the C7000 CUSA Clarity System because the 36 kHz Sterilization Tray does not meet the required 30-minute drying time.
Anazao Health is recalling Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL due to environmental sampling revealing a fungus.
Anazao Health is recalling Glutamine/Arginine/Carnitine vials because environmental sampling detected Talaromyces rotundus, a fungus, indicating a lack of processing controls.
Coast Quality Pharmacy is recalling Bupivacaine, Clonidine, and Hydromorphone injections due to fungal contamination found during environmental sampling.
Medtronic Navigation is recalling Biopsy Needle FPU Kits because the depth stop may not tighten securely, potentially causing surgery delays.
Edney and Sellers, Ltd. is recalling Lalamilo Farms Tropical Dreams Hawaiian Ice Cream - Strawberry Cheesecake due to reports of plastic pieces found in the product.
Coast Quality Pharmacy is recalling Morphine Sulfate and Bupivacaine HCL because environmental sampling detected Talaromyces rotundus, a fungus.
Integra LifeSciences is recalling 820 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray requires 40 minutes to dry, not the 30 minutes stated in the manual.
Integra LifeSciences is recalling CUSA Clarity 36 kHz Sterilization Trays because the manual lists a 30-minute drying time, but 40 minutes are required for complete drying.
Integra LifeSciences is recalling 820 C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray does not meet the required drying time criteria.
Coast Quality Pharmacy is recalling Hydromorphone HCL and Bupivacaine HCL products due to the detection of Talaromyces rotundus fungi during environmental sampling.
Anazao Health is recalling hydromorphone and bupivacaine combination injections due to the presence of Talaromyces rotundus fungi detected during environmental sampling.
Anazao Health is recalling Clonidine HCL and Baclofen products because environmental sampling detected Talaromyces rotundus, a fungus.
Integra LifeSciences is recalling 820 C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems because the operator manual lists an incorrect minimum drying time for sterilization trays.
Anazao Health is recalling compounded bupivacaine, clonidine, hydromorphone, and fentanyl medications due to the detection of Talaromyces rotundus fungi.
Integra LifeSciences is recalling the C7000 CUSA Clarity System because the 36 kHz Sterilization Tray does not meet the 30-minute drying criteria stated in the manual.
Integra LifeSciences is recalling 820 C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray does not meet the required 30-minute drying time criteria.
OraLabs is recalling specific lots of petroleum jelly tubes distributed by Rite Aid due to cross-contamination with phenol and camphor.
Integra LifeSciences is recalling the C7000 CUSA Clarity Ultrasonic Tissue Ablation System because the 36 kHz Sterilization Tray fails to meet the required 30-minute drying time.
Integra LifeSciences is recalling 820 C7000 CUSA Clarity systems because the 36 kHz Sterilization Tray fails to meet the 30-minute drying time criteria stated in the manual.
Bellus Medical is recalling SKINFUSE Rescue Calming Complex Kits because they were packaged with a mislabeled medical product.
Integra LifeSciences is recalling 820 CUSA Clarity Ultrasonic Tissue Ablation Systems because the sterilization tray does not meet the required drying time criteria.
Leica Microsystems is recalling 558 BOND Polymer Refine Detection Kits because they were stored improperly, which may result in suboptimal staining.
Integra LifeSciences is recalling 820 C7000 CUSA Clarity systems because the 36 kHz Sterilization Tray does not meet the 30-minute drying time criteria stated in the manual.
Anazao Health is recalling Baclofen and Morphine Sulfate because environmental sampling detected Talaromyces rotundus, a fungus, indicating a lack of processing controls.
Medtronic Navigation is recalling Biopsy Needle FPU Kits because the depth stop may not tighten securely, potentially delaying surgery.
Coast Quality Pharmacy is recalling Hydromorphone HCL because environmental sampling detected Talaromyces rotundus, a fungus.
DePuy Mitek is recalling 299 Healix Knotless ADV BR 4.75 Suture Anchors because they were manufactured with BIOCRYL material instead of BIOCRYL RAPIDE.
Integra LifeSciences is recalling the C7000 CUSA Clarity System because the Polish OPS Manual incorrectly states the minimum drying time for the 36 kHz Sterilization Tray.
Integra LifeSciences is recalling 820 C7000 CUSA Clarity systems because the German OPS Manual incorrectly states the minimum dry time for the 36 kHz Sterilization Tray.
Natural Grocers is recalling two lots of 2 lb. organic soybeans because they have the potential to contain mold.
The Binding Site Group is recalling 10 Optilite C-Reactive Protein Kits because the reagent has deteriorated. The kits were distributed in California and Georgia.
LivaNova is recalling 643 VNS Therapy Program tablets due to a software error that causes incorrect diagnostic tests on specific devices.
Integra LifeSciences is recalling 820 C7000 CUSA Clarity systems because the 36 kHz sterilization tray requires 40 minutes to dry, not the 30 minutes stated in the manual.
Integra LifeSciences is recalling the C7000 CUSA Clarity 36 kHz Sterilization Tray because the manual lists a 30-minute drying time, but 40 minutes are required for complete drying.
Integra LifeSciences is recalling the C7000 CUSA Clarity System because the 36 kHz Sterilization Tray does not meet the 30-minute drying time criteria stated in the manual.
Integra LifeSciences is recalling C7000 CUSA Clarity systems because the operator manual lists a 30-minute drying time, but 40 minutes are required for complete drying.
Integra LifeSciences is recalling 820 C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray does not meet the required drying time criteria.
Medtronic is recalling 10,448 Passive Biopsy Needle Kits because a manufacturing issue may cause depth stops to fail, potentially delaying surgery.
Integra LifeSciences is recalling 820 CUSA Clarity systems because the 36 kHz sterilization tray does not meet the 30-minute drying time criteria stated in the manual.
Integra LifeSciences is recalling 820 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray requires 40 minutes to dry, not the 30 minutes stated in the manual.
Integra LifeSciences is recalling the C7000 CUSA Clarity system because the 36 kHz Sterilization Tray fails to meet the 30-minute drying time criteria stated in the manual.
Integra LifeSciences is recalling 820 C7000 CUSA Clarity systems because the operator manual underestimates the required drying time for sterilization trays.
Integra LifeSciences is recalling 820 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray fails to meet the required 30-minute drying time.
Integra LifeSciences is recalling 820 C7000 CUSA Clarity systems because the 36 kHz Sterilization Tray requires 40 minutes to dry, not the 30 minutes stated in the manual.
Anazao Health is recalling Morphine Sulfate products because environmental sampling detected Talaromyces rotundus, a type of fungus.
Integra LifeSciences is recalling the C7000 CUSA Clarity Ultrasonic Tissue Ablation System because the operator manual lists an incorrect minimum drying time for the 36 kHz Sterilization Tray.
Volcano Corporation is recalling FFR software due to interoperability issues when connected to specific Hemodynamic Systems.
AuroMedics Pharma LLC is recalling Mirtazapine 15 mg tablets because some 500-count bottles are incorrectly labeled as 7.5 mg tablets.
Klein Foods is recalling 60 pounds of Cookie Dough Fudge because it may contain food-grade rubber pieces. The product was distributed in Minnesota and sold in the company's retail store.
Coast Quality Pharmacy, LLC dba Anazao Health is recalling Hydromorphone HCL and Clonidine HCL products because environmental sampling detected Talaromyces rotundus, a fungus.
Kraft Foods Global Inc. is recalling specific boxes of Cheese Nips due to the presence of small food-grade yellow plastic pieces from a dough scraper.
Anazao Health is recalling Bupivacaine HCl and Hydromorphone HCl products because environmental sampling detected Talaromyces rotundus, a fungus.
Integra LifeSciences is recalling the C7000 CUSA Clarity System because the 36 kHz Sterilization Tray requires 40 minutes to dry, not the 30 minutes stated in the manual.
Integra LifeSciences is recalling the C7000 CUSA Clarity Ultrasonic Tissue Ablation System because the 36 kHz Sterilization Tray does not meet the required dry time criteria.
Young Dental Manufacturing Co, LLC is recalling Oral-B 5% Sodium Fluoride Varnish because the product shelf life may be shorter than indicated on the label.
Roche Diagnostics is recalling 712 units of the Elecsys Anti-HAV IgM assay because a software error caused incorrect test settings to be downloaded.
Integra LifeSciences is recalling 820 CUSA Clarity Ultrasonic Tissue Ablation Systems because the sterilization tray does not meet the required drying time criteria.
Integra LifeSciences is recalling the C7000 CUSA Clarity Ultrasonic Tissue Ablation System because the 36 kHz Sterilization Tray does not meet the required drying time criteria.
DePuy Mitek is recalling 599 Healix Knotless Suture Anchors because they were manufactured with BIOCRYL material instead of BIOCRYL RAPIDE.
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