The Recall Desk

Archive

March 2023 recalls

1,013 recalls were announced in March 2023.

What the numbers show

Critical
68
Severe
432
High
400
Moderate
107
Low
6

Of the 1,013 recalls this month scored against our rubric, 7% are Critical, 43% are Severe.

Which agencies issued them

701–800 of 1013

  • HighFDA (Devices)·Z-1221-2023·2023-03-15

    CardioMEMS Hospital Electronics System RF Emissions May Interfere With Implanted Devices

    St. Jude Medical is recalling the CardioMEMS HF System (Model CM3000) due to excessive radiofrequency emissions that may interfere with pacemakers, defibrillators, and other implanted devices during use. The recall affects 1,905 units distributed worldwide.

    Product
    CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physician
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1228-2023·2023-03-15

    Tri-Staple 2.0 Surgical Stapler Reloads Recalled for Malfunction Risk

    Covidien is recalling certain Tri-Staple 2.0 surgical stapler reloads due to a mechanical defect that may cause the device to malfunction during surgery. Affected units may fail to form staples properly, potentially causing serious surgical complications.

    Product
    Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1216-2023·2023-03-15

    LATITUDE NXT Remote Patient Monitoring System Alerts Not Displaying

    Boston Scientific's LATITUDE NXT system failed to display cardiac alerts for 1,531 patient records during 2022. Contact Boston Scientific to determine if your patients were affected.

    Product
    LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1209-2023·2023-03-15

    COVID-19 Diagnostic Test Kits May Leak, Causing Invalid Results

    DiaSorin Molecular's Simplexa COVID-19 Direct test kits may leak, potentially causing contamination and invalid test results. The FDA has issued a Class II recall affecting approximately 90,142 units distributed nationwide.

    Product
    Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0419-2023·2023-03-15

    Daily Harvest French Lentil Crumbles Recalled for Gastrointestinal Illness

    Daily Harvest French Lentil + leek Crumbles (Item L02-VEGBN) are being recalled due to complaints of gastrointestinal illness. The recall affects 28,776 units distributed nationwide with lot codes from September through November 2022.

    Product
    Daily Harvest French Lentil + leek Crumbles, Item ID L02-VEGBN, Net Wt. 12 oz. (340g) Keep Frozen, Cook Thoroughly. Perishable. Store Frozen. Cook Thoroughly to internal temperature of 165F. Distr. by Daily Harvest Inc. New York, NY 10013.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1219-2023·2023-03-15

    CardioMEMS Heart Monitoring System Emissions May Interfere With Pacemakers

    FDA recalls CardioMEMS HF System patient monitor for radiofrequency signal emissions that can interfere with pacemakers, defibrillators, and other implanted medical devices. The emissions exceed radiofrequency limits.

    Product
    CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1229-2023·2023-03-15

    Cardiosave Hybrid Intra-Aortic Balloon Pump recalled for helium regulator failure

    Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump models due to helium regulator failures that may prevent proper device operation and replenishment.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-0800-33, 0998-UC-08
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1231-2023·2023-03-15

    Cardiosave intra-aortic balloon pump O-ring defects may interrupt therapy

    Damaged or worn O-rings on the Cardiosave pump console quick disconnect fitting can leak helium, potentially interrupting cardiac support therapy for affected patients.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31, D998-00-0800-32, D998-00-0800-33, D998-00-0800-35, D998-00-0800-36, D998-00-0800-45, D998-00-0800-52, D998-00-0800-53, D998-00-0800-55, D998-00-0800-65, D998-00-0800-83, D998-UC-0800-31, D998-UC-0800-33,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0445-2023·2023-03-15

    FDA Recalls Phenylephrine IV Solution for Manufacturing Practice Deviations

    Denver Solutions recalls 8,136 units of Phenylephrine HCl IV solution nationwide due to manufacturing practice deviations. The FDA classified this Class II recall as affecting prescription injectable solutions distributed to hospitals and government facilities.

    Product
    Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-148-94
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1233-2023·2023-03-15

    Monaco RTP System software may calculate radiation therapy doses inaccurately

    Elekta's Monaco RTP radiation therapy treatment planning software may display inaccurate radiation doses when re-optimizing plans after adding anatomical contours. The defect affects 2,020 units distributed nationwide and internationally.

    Product
    Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1213-2023·2023-03-15

    Baxter peritoneal dialysis cap incorrectly sealed, risks inadequate disinfection

    Baxter MiniCap Disconnect Cap pouches may have faulty seals allowing air exposure, risking inadequate disinfection of the sterile connector used in peritoneal dialysis.

    Product
    Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for peritoneal dialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0441-2023·2023-03-15

    Metformin Extended-Release Tablets Recalled for Excess NDMA Contamination

    Teva Pharmaceuticals is recalling Metformin hydrochloride Extended-Release Tablets (1000 mg) due to CGMP deviations that resulted in NDMA contamination exceeding the Acceptable Daily Intake Limit. The recall affects 12,044 bottles distributed in California.

    Product
    Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 00591-2720-60
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1218-2023·2023-03-15

    CardioMEMS Heart Failure Monitor Recalled for Radiofrequency Emissions

    St. Jude Medical is recalling certain CardioMEMS heart failure monitoring devices due to excessive radiofrequency emissions that could interfere with pacemakers, defibrillators, and other implanted medical devices when in close proximity.

    Product
    CardioMEMS HF System Patient Electronics System (PES), Model number CM1000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1220-2023·2023-03-15

    CardioMEMS Patient Electronics System Recalled for Excessive Radiofrequency Emissions

    CardioMEMS heart-failure monitoring devices are recalled due to radiofrequency emissions that can interfere with other medical devices like pacemakers when operating nearby.

    Product
    CardioMEMS HF System Patient Electronics System (PES), Model number CM1100, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0415-2023·2023-03-15

    Chili Pepper Powder Recalled for Undeclared Sesame Allergen

    Shirakiku brand Chili Pepper Powder (ICHIMI TOGARASHI) is being recalled nationwide and internationally because it contains sesame that is not declared on the ingredient label. Consumers with sesame allergies should not consume this product.

    Product
    Chili Pepper Powder (ICHIMI TOGARASHI) 300g UPC: 074410341169 Brand: Shirakiku Distributed by: Wismettac Asian Foods, Inc. Santa Fe Springs, CA 90670 Product of China
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1236-2023·2023-03-15

    Genesis Sterilization Containers Recalled for Shelf-Life Testing Failure

    Carefusion's CD5 Series Genesis surgical sterilization containers are being recalled due to failure to meet shelf-life testing requirements, resulting in a potential breach of sterility. The recall affects 5,952 devices distributed worldwide.

    Product
    CD5 Series of Genesis Reusable Rigid Sterilization Container Systems catalog number and product name: 1. CD5-3B, CONTAINER SHALLOW LG ENDO 3IN PERF; 2. CD5-3C, CONTAINER SHALLOW LG ENDO 3IN SOLID; 3. CD5-61B, GENESIS CONT LARGE ENDO PERF 28X11X6IN; 4. CD5-61C, GENESIS C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0440-2023·2023-03-15

    NaturalCare Children's Allergy Care Homeopathic Drops Recalled for CGMP Deviation

    Nutraceutical Corporation is recalling NaturalCare children's homeopathic allergy drops (Lot 222148) nationwide due to a manufacturing deviation in raw materials. No illnesses have been reported.

    Product
    NaturalCare, children's, Allergy Care, Homeopathic, 4 Months and Up, Liquid Drops, 0.1% Alcohol, 1 FL OZ( 30mL), Mfd. Nutraceutical Corp., Salt Lake City, UT, 84101 USA, UPC 3 71402 30101 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0443-2023·2023-03-15

    FDA Class II: Phenylephrine Injection Recalled for Manufacturing Deviations

    Denver Solutions is recalling 325,300 units of Phenylephrine HCl injection due to Current Good Manufacturing Practice deviations. The product was distributed nationwide, including to government facilities.

    Product
    Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0457-2023·2023-03-15

    Drug Recall: Purely Soothing MSM Nasal Spray due to manufacturing deviations

    Pharmedica USA is recalling Purely Soothing MSM Nasal Spray (15%, Lot #1808051) due to manufacturing practice violations. The recall affects 995 bottles distributed nationwide and internationally.

    Product
    Purely Soothing MSM Nasal Spray, 15%, packaged in 30ml, 1.014 fl. oz bottles, Manufactured by: Pharmedica USA, Phoenix, AZ, UPC 7 31034 91380 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0449-2023·2023-03-15

    Drug manufacturer recalls Soltice Quick-RUB nationwide due to manufacturing deviations

    Ecometics, Inc. recalled Soltice Quick-RUB nationwide due to Current Good Manufacturing Practice (CGMP) deviations. This was a voluntary recall initiated by the manufacturer in February 2023.

    Product
    Soltice Quick-RUB (Menthol 5.1%, Camphor 5.1%) packaged in a) 1.33 oz (37g) plastic jars and b) 3 Oz (85g) plastic jars
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0435-2023·2023-03-15

    Heparin Sodium Injection Recalled Due to Labeling Issue

    Sagent Pharmaceuticals is recalling 28,875 vials of Heparin Sodium Injection nationwide due to a labeling issue. Healthcare providers should verify patient medication before administration.

    Product
    HEPARIN SODIUM — HEPARIN SODIUM (HEPARIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0446-2023·2023-03-15

    Drug Recall: Alcolado Relampago Topical for Manufacturing Practice Deviations

    Ecometics recalls Alcolado Relampago topical product nationwide due to Current Good Manufacturing Practice deviations. About 18,000 bottles in 7 oz and 16 oz sizes were distributed in the U.S.

    Product
    Alcolado Relampago (menthol 1%, camphor 1.5%), packaged in a) 7 fluid oz. (207 ml) and b) 16 fluid oz. (472 ml) bottles, Distributed by: The Larkspur Group Inc. South Norwalk, CT 06854
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0442-2023·2023-03-15

    Phenylephrine HCl syringe recalled for manufacturing practice deviations

    Phenylephrine HCl syringe recalled for manufacturing practice deviations. 13,445 units distributed nationwide were recalled by Denver Solutions, LLC.

    Product
    Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0413-2023·2023-03-15

    Gem City Fine Foods Vegan Chocolate Cake Recalled for Incorrect Ingredient Labeling

    Gem City Fine Foods is recalling its GF Vegan Chocolate Cake (25 oz) due to an incorrect ingredients label that lists dairy, eggs, and soy as contents when the product does not contain them.

    Product
    Gem City Fine Foods GF Vegan Chocolate Cake, 25 oz, in recyclable plastic circular container with black base and clear lid, Gem City Fine Foods, LLC, 3403 S 1400 W, Ste C., West Valley City, UT 84119. UPC 855026-00142-1
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0451-2023·2023-03-15

    Sodium fluoride oral rinse recalled for manufacturing deviations

    Activator Concentrate, a sodium fluoride oral rinse manufactured by Ecometics, Inc., was voluntarily recalled due to manufacturing practice deviations. The recall affected 34,320 bottles distributed nationwide.

    Product
    Activator Concentrate (sodium fluoride 0.96% in Activator) 1 fl. Oz, liquid oral rinse plastic bottles, Manufactured for: All USA Direct LLC, Broadview, IL 60155
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0437-2023·2023-03-15

    FDA Recalls NaturalCare bioAllers Nasal Spray Due to Manufacturing Defects

    Nutraceutical Corporation recalls NaturalCare bioAllers Allergy Nasal Spray nationwide due to manufacturing quality deviations in raw materials. The recalled lots show discoloration and do not meet FDA Good Manufacturing Practice standards.

    Product
    NaturalCare bioAllers, Allergy Nasal Spray, Homeopathic, All Region Formula, 0.8 fl oz( 24mL), Mfd. Nutraceutical Corp., NaturalCare Park City, UT, 84098 USA, UPC 3 71400 70801 9
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0448-2023·2023-03-15

    FDA Recalls Unguentine Original Ointment for Manufacturing Practice Deviations

    Ecometics, Inc. has voluntarily recalled Unguentine Original Ointment for Burns due to manufacturing practice deviations. The recall affects 20,746 units distributed nationwide.

    Product
    Unguentine Original Ointment for Burns (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%) packaged in 1 oz. (28g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0454-2023·2023-03-15

    OTC Hemorrhoidal Ointment Recalled for Missing Lot and Expiration Date

    Akron Pharma is recalling Dibucaine 1% Hemorrhoidal Ointment due to incorrect or missing lot and expiration date information on the label. This labeling error affects 4,416 tubes distributed nationwide.

    Product
    DIBUCAINE — DIBUCAINE (DIBUCAINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0414-2023·2023-03-15

    Organic Brussel Sprouts Recalled Due to Chlorpyrifos Pesticide Contamination

    4 Earth Farms is recalling organic brussel sprouts sold under multiple retail brands because the product tested positive for the pesticide Chlorpyrifos. The affected products were distributed to consumers across the United States and Canada.

    Product
    Brussel Sprouts 98.5% of product was packaged for retail and 110 cases were bulk Brands: 4 Earth Farms, Trader Joe s, Wegman s, O Organics, STO Kroger. Unit size: 2lbs (plastic bag), 1lbs (mesh bag and plastic bag), 14 oz (plastic bag), 12 oz (plastic bag), 10 oz (plastic bag),
    Category
    Food
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-1227-2023·2023-03-15

    BIOPHEN Protein C 5 Kit Labeling Update for Reproductive Hazard

    The BIOPHEN Protein C 5 reagent kit from Aniara Diagnostica contains Cesium Chloride in Reagent 2, suspected of damaging fertility. The manufacturer is issuing updated product labeling with warnings about this regulatory classification change.

    Product
    BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human citrated plasma. Protein C is a glycoprotein, vitamin K dependent, which inhibits coagulation. Protein C in plasma is measured following a specific activation with Protac (Agkistrodo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1215-2023·2023-03-15

    epoc Host 2 Diagnostic Analyzers Recalled for Oxygen Measurement Inaccuracy

    Siemens Healthcare Diagnostics is recalling 4,369 epoc Host 2 blood gas analyzers due to elevated oxygen measurements in quality control testing when adjusted for barometric pressure. No illnesses reported.

    Product
    epoc Host 2 as follows: Product SMN epoc NXS Host, US 11413475 epoc NXS Host, EU 11413497 epoc NXS Host, Japan 11413498 epoc NXS Host, Canada 11413506 epoc NXS Host, ROW 11413518 epoc NXS Host, China-Korea 11413583
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0452-2023·2023-03-15

    Unguentine Original Pain Relief Ointment Recalled for Manufacturing Process Deviations

    Unguentine Original Pain Relief Ointment is being recalled due to manufacturing process deviations. The FDA-led voluntary recall affects nationwide distribution.

    Product
    Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%), packaged in 1 oz. (28.3g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0447-2023·2023-03-15

    Medicated Balm Recalled for Manufacturing Process Deviations

    Ecometics, Inc. is voluntarily recalling Vencedor medicated balm (capsaicin 0.028%) nationwide due to manufacturing process deviations. The recall affects Lot #2E021A with expiration date January 2025.

    Product
    Vencedor medicated balm (capsaicin 0.028%) 1.5 oz. (43g) tubes, Distributed by: The Larkspur Group Inc. Norwalk, CT 06854
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0450-2023·2023-03-15

    FDA Recalls Nose Better Gel Due to Manufacturing Process Deviations

    Ecometics, Inc. is recalling Nose Better Gel nationwide due to manufacturing process deviations (CGMP violations). The firm-initiated voluntary recall affects 37,968 units with lot number 1E253A.

    Product
    Nose Better Gel (0.75% Camphor, 0.50% Menthol, 0.50% Allantoin), packaged in 0.46 oz. (13g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1226-2023·2023-03-15

    Dental anaerobic glue recalled for incorrect expiration date labeling

    Preat Corp is recalling 652 units of PREAT NOBIL GRIP dental adhesive due to incorrect expiration dates on product labels. Consumers should verify lot numbers and contact the manufacturer.

    Product
    PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental anaerobic glue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V166000·2023-03-14

    2023 REV Recreation Motorhomes Recalled for Defective Entry Door Latches

    REV Recreation is recalling 2023 motorhomes due to a faulty entry door latch that may fail, preventing occupants from entering or exiting during an emergency. About 479 units are affected.

    Product
    FLEETWOOD — FLEETWOOD, HOLIDAY RAMBLER, AMERICAN COACH DISCOVERY, DISCOVERY LXE, BOUNDER, FLAIR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23C003000·2023-03-14

    Dorel Recalls Maxi-Cosi Coral XP Infant Seats Due to Restraint Defect

    Dorel Juvenile Group is recalling Maxi-Cosi Coral XP rear-facing infant seats because the inner carrier does not sufficiently restrain a child without the outer carrier.

    Product
    CHILD SEAT recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V164000·2023-03-10

    2022 Ford F-53 and F-59 brake caliper bolts may loosen

    Ford is recalling certain 2022 F-53 and F-59 vehicles because improperly tightened rear brake caliper bolts could loosen and damage brake lines or wheels, increasing crash risk. Dealers will inspect and repair at no cost.

    Product
    FORD — FORD F-59, F-53
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V165000·2023-03-10

    2021-2022 Ford Bronco rearview camera image stays on after reversing

    Certain 2021-2022 Ford Broncos may display the rearview camera image after reversing, potentially distracting the driver. Ford is issuing a free software update to fix the issue.

    Product
    FORD — FORD BRONCO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-03102023-01·2023-03-10

    Trader Joe's Chicken Salad Alerted for Undeclared Cashews

    USDA FSIS issued a public health alert for Trader Joe's chicken salad containing undeclared cashews. Consumers should not eat the product.

    Product
    Taylor Farms Northwest LLC — FSIS Issues Public Health Alert for Trader Joe’s Chicken Salad Due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    3 states
  • HighNHTSA·23V162000·2023-03-10

    Ford Recalls 2013-2018 Fusion and Lincoln MKZ for Brake Hose Rupture

    Ford is recalling 2013-2018 Fusion and Lincoln MKZ vehicles because front brake hoses may rupture and leak fluid, increasing stopping distance and crash risk.

    Product
    FORD — FORD, LINCOLN FUSION, MKZ
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V160000·2023-03-10

    2023 Ford Maverick missing electrical circuit affects trailer taillights

    A missing electrical circuit in certain 2023 Ford Maverick vehicles prevents trailer taillights from illuminating properly. This creates a crash risk and violates vehicle safety standards.

    Product
    FORD — FORD MAVERICK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalCPSC·23150·2023-03-09

    Calico Critters Animal Figures Recalled Due to Choking Hazard; Two Deaths Reported

    Epoch Everlasting Play is recalling more than 3.2 million Calico Critters animal figures and sets sold with bottle and pacifier accessories due to choking hazard. Two fatal incidents have been reported.

    Product
    Calico Critters® Animal Figures and Sets sold with Bottle and Pacifier Accessories
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·23735·2023-03-09

    Bedsure Electric Heating Blankets and Pads Recalled for Fire and Burn Hazards

    Bedsure electric heating blankets and pads are recalled because their controllers can malfunction, causing fires and thermal burns. Consumers should stop using them immediately and contact Bedsure for a refund.

    Product
    Bedsure Electric Heating Blankets and Pads
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23736·2023-03-09

    Monoprice Pure Outdoor Cooking System Fire Hazard Recall

    Monoprice is recalling about 3,780 Pure Outdoor Cooking Systems because the insulation coating on the stove can ignite during use. Consumers should stop using the product immediately and contact Monoprice for a refund.

    Product
    Pure Outdoor Cooking Systems
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23151·2023-03-09

    Vaunn Medical Adult Bed Rails Recalled for Entrapment and Asphyxia Risk

    BeyondMedShop is recalling approximately 102,000 Vaunn Medical Bed Assist Rail bed rails due to risk of user entrapment and asphyxiation. Users can become trapped within the rail or between the rail and mattress.

    Product
    Vaunn Medical Bed Assist Rail adult bed rails
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23737·2023-03-09

    Baby Crib Bumpers Recalled for Suffocation Hazard and Federal Ban Violation

    About 125 padded baby crib bumpers sold online from November 2022 through January 2023 are recalled due to suffocation risk. Infants can suffocate if they roll into the bumper and obstruct their breathing; padded crib bumpers are banned under federal law.

    Product
    Baby Crib Bumpers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23E019000·2023-03-09

    Chrysler Recalls Mopar Hydraulic Control Unit Modules for Brake Safety

    Chrysler is recalling Mopar Hydraulic Control Unit modules that may falsely read brake pressure, allowing vehicles to start without the brake pedal applied.

    Product
    SERVICE BRAKES, HYDRAULIC:ANTILOCK/TRACTION CONTROL/ELECTRONIC LIMITED SLIP:CONTROL UNIT/MODULE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23149·2023-03-09

    Kindred Bravely Bamboo Nursing Hoodies Recalled for Choking Hazard

    Akerson Enterprises is recalling about 7,500 Kindred Bravely Bamboo Nursing Hoodies because small plastic caps on the drawcords can be swallowed by nursing babies, creating a choking hazard. No injuries have been reported.

    Product
    Kindred Bravely Bamboo Nursing Hoodies
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V158000·2023-03-09

    Honda Recalls 448,613 Vehicles for Front Seat Belt Buckle Defect

    Honda is recalling 448,613 vehicles because a manufacturing issue may prevent front seat belt buckles from latching, increasing injury risk in a crash.

    Product
    ACURA — ACURA, HONDA RDX, CR-V, ODYSSEY, ACCORD HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V159000·2023-03-09

    Rivian R1S vehicles recalled for improperly secured side curtain air bags

    Rivian is recalling certain 2022-2023 R1S vehicles because fasteners securing the side curtain air bags may be improperly secured, potentially preventing proper deployment in a crash.

    Product
    RIVIAN — RIVIAN R1S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23147·2023-03-09

    Anker 535 Power Banks Recalled Due to Fire Hazard from Battery Overheating

    Fantasia Trading is recalling about 42,000 Anker 535 Power Banks (PowerCore 20k, model A1366) because their lithium-ion batteries can overheat and pose a fire hazard. The firm has received 10 reports of overheating incidents, including one report of minor injuries.

    Product
    Anker 535 Power Banks (PowerCore 20k)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23145·2023-03-09

    YETI Soft Coolers and Gear Cases Recalled for Magnet Detachment Risk

    YETI is recalling about 1.9 million soft coolers and gear cases because the magnet-lined closures can fail and detach magnets that pose a risk of serious injury or death if ingested.

    Product
    YETI soft coolers and gear cases
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23148·2023-03-09

    Vornado Air Recalls SRTH Small Room Tower Heaters Due to Fire Hazard

    Vornado Air is recalling about 1,450 SRTH Small Room Tower Heaters due to a manufacturing wiring error that can cause the heater to overheat and pose a fire hazard. No injuries have been reported.

    Product
    SRTH Small Room Tower Heaters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1142-2023·2023-03-08

    Life2000 Ventilator poses oxygen desaturation risk with oxygen concentrators

    The FDA recalls Baxter's Life2000 Ventilator due to potential patient desaturation when connected to an oxygen concentrator. Affects 71 units nationwide.

    Product
    Life2000 Ventilator , REF MS-01-0118, ventilatory support for the care of individuals
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1139-2023·2023-03-08

    Life2000 Ventilator System Recall: Risk of Patient Desaturation

    Baxter Healthcare is recalling 4,279 Life2000 Ventilator Systems due to potential patient desaturation when connected to oxygen concentrators.

    Product
    Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individuals
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V152000·2023-03-08

    Bentley Recalls Continental GT Cabrio for Air Bag Defect

    Bentley is recalling 2020-2021 Continental GT Cabrio vehicles because a sharp edge on the air bag deflector bracket may cause seat air bags to tear during deployment.

    Product
    BENTLEY — BENTLEY CONTINENTAL GT CABRIO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0384-2023·2023-03-08

    Matsunaga Mini Shiruko Sand Biscuits Recalled Due to Undeclared Soy Allergen

    Matsunaga Mini Shiruko Sand Biscuits are being recalled because they contain soy allergen that is not listed on the ingredient label. Consumers with soy allergies should not consume this product.

    Product
    Matsunaga Mini Shiruko Sand Biscuits 100 g packages, containing 4 individually wrapped servings of 4 (25mg per unit) SKU number 4902773016966 Manufactured in Japan.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0453-2023·2023-03-08

    PrimeZEN Black 6000 Capsule Recalled for Undeclared Pharmaceutical Ingredients

    The FDA is recalling PrimeZEN Black 6000 capsules distributed nationwide because they contain undeclared sildenafil and tadalafil. The product is unapproved and was marketed without FDA authorization.

    Product
    PrimeZEN Black 6000 capsule, 2000mg, Male Sexual Performance Enhancement, 1-count blister card, Distributed by: Prime Premier Group, Los Angeles, CA 90006, UPC 7 28175 52189 1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1140-2023·2023-03-08

    Life2000 Hospital Ventilator Recalled for Potential Patient Desaturation Risk

    Baxter Healthcare is recalling 135 Life2000 ventilators nationwide due to potential patient desaturation when connected to an oxygen concentrator.

    Product
    Life2000 Ventilator PKG, Hospital, a) REF BT20007, b) REF BT-20-0007, ventilatory support for the care of individuals
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V150000·2023-03-08

    Terex Advance Mixer Recall: Steering Shaft May Come Loose

    Terex Advance is recalling 2022-2023 Front Discharge Mixers because the steering shaft may come loose, risking loss of steering control.

    Product
    TEREX ADVANCE — TEREX ADVANCE FRONT DISCHARGE MIXER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1141-2023·2023-03-08

    Life2000 Hospital Ventilator Recalled for Patient Desaturation Risk

    Baxter Healthcare is recalling 8 Life2000 Hospital Ventilator systems due to potential patient desaturation events when the device is connected to an oxygen concentrator.

    Product
    Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the care of individuals
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V154000·2023-03-08

    2023-2024 International trucks recalled for loose battery box bolts

    Navistar is recalling certain 2023 and 2024 International trucks because battery box mounting bolts may be loose or missing. Loose bolts could allow the battery box to detach, creating a road hazard and increasing crash risk.

    Product
    INTERNATIONAL — INTERNATIONAL MV, HV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V155000·2023-03-08

    Ford Recalls 2022-2023 Bronco for Steering Gear Lock-Up Defect

    Ford recalls 2022-2023 Broncos for steering gear damage that can lock up the steering wheel and cause loss of steering control, increasing crash risk.

    Product
    FORD — FORD BRONCO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1180-2023·2023-03-08

    Surgipro II Surgical Sutures recalled for sterile barrier breach

    Covidien is recalling Surgipro II Monofilament Polypropylene Sutures due to a sterile barrier breach in the breather pouch that may cause infection or vision loss in ophthalmic procedures with direct patient contact.

    Product
    Surgipro II Monofilament Polypropylene Sutures Product Description Model Number VP-421X SURGIPRO*II 4-0 90CM V20 DA7P VP421X VP-435-X SURGIPRO II 4-0 90CM KV5 DA7P VP435X VP-541X SURGIPRO*II 4-0 BLU 120CM V20DA VP541X VP-542-X SURGIPRO II 3-0 BLU 120CM V20DA VP542X VP-735-X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0388-2023·2023-03-08

    Doxazosin tablets recalled due to manufacturing quality control deviations

    Accord Healthcare is recalling 75,190 bottles of Doxazosin 4 mg tablets due to manufacturing quality control deviations discovered during an FDA inspection. No illnesses have been reported.

    Product
    DOXAZOSIN — DOXAZOSIN (DOXAZOSIN)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0365-2023·2023-03-08

    Aripiprazole tablets recalled due to manufacturing process deviations

    Accord Healthcare is recalling 747,464 bottles of Aripiprazole 2mg tablets due to manufacturing process deviations discovered during an FDA inspection. The affected medication was distributed in the United States, Puerto Rico, and Canada.

    Product
    ARIPIPRAZOLE — ARIPIPRAZOLE (ARIPIPRAZOLE)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-0386-2023·2023-03-08

    Lobster Ball Product Recalled for Incomplete Shellfish Allergen Labeling

    Lobster Ball frozen seafood is recalled for inadequate shellfish allergen labeling. The product contains shellfish but is labeled as 'may contain shellfish,' failing to properly warn consumers with shellfish allergies.

    Product
    Lobster Ball***Ingredients: Surimi; Nemipterus Spp. (contain Egg), Palm Shortening, Water, Acetylated Tapioca Starch (E1420), Cellulose (E460(i)), Soy Protein, Flying Fish Roe, Permitted Flavour Enhancer***Salt, Sugar, Milk Powder, Emulsifiers, Flavouring***
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0372-2023·2023-03-08

    Atorvastatin Calcium tablets recalled due to manufacturing practice deviations

    Accord Healthcare is recalling Atorvastatin Calcium 20 mg tablets due to manufacturing practice deviations found during an FDA inspection. The affected products were distributed in the United States, Puerto Rico, and Canada.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1195-2023·2023-03-08

    Vascular Diagnostic Device Recalled for Risk of Air Line Misconnection

    Unetixs Vascular recalls MultiLab Series II ROODRA vascular diagnostic devices due to luer fittings that may allow air line misconnection to intravenous lines, potentially causing air embolism.

    Product
    MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1197-2023·2023-03-08

    Contact Lenses Recalled for Misaligned Axis Causing Poor Vision

    CooperVision is recalling Biofinity XR Toric contact lenses due to misaligned axis in manufacturing that results in incorrect lens power. Users may experience poor visual acuity.

    Product
    Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0424-2023·2023-03-08

    Pravastatin Sodium 80 mg tablets recalled for manufacturing deviations

    Accord Healthcare is recalling Pravastatin Sodium 80 mg tablets due to manufacturing process deviations discovered during an FDA inspection. The recall affects approximately 1,970 bottles distributed in the United States, Puerto Rico, and Canada.

    Product
    PRAVASTATIN SODIUM — PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1178-2023·2023-03-08

    Surgilon Braided Nylon sutures recalled due to sterile barrier defect

    Covidien is recalling Surgilon Braided Nylon sutures due to a sterile barrier breach in the breather pouch that could allow bacterial contamination, potentially causing infection or vision loss in ophthalmic procedures.

    Product
    Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM C16 88861915-71 SURGILON* 1 BLK 75CM GS11 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-61 SURGILON* 0 B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1201-2023·2023-03-08

    Medical Device Middleware: MYLA Software Fails to Apply AST Filter Rules

    Biomerieux MYLA laboratory middleware may fail to apply activated antibiotic susceptibility test (AST) filter rules when sending results to clinicians. The defect affects VITEK MS users with versions 4.8.x and 4.9.

    Product
    MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments for ID/AST and blood culture activities and the laboratory information system (LIS).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V153000·2023-03-08

    2023 International MV and HV Vehicles Recalled for Driveshaft Separation Risk

    Navistar is recalling certain 2023 International HV and 2023-2024 International MV vehicles due to incorrectly installed rear axle wedge shims that can cause driveshaft separation and loss of drive power. This increases the risk of a crash.

    Product
    INTERNATIONAL — INTERNATIONAL MV, HV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1192-2023·2023-03-08

    Alaris PC Unit 8015 wireless network connectivity failure affecting infusion pump management

    Certain Alaris PC Unit 8015 infusion pump computers with specific wireless network cards may lose network connectivity, preventing remote infusion programming and data transfer. Manual programming of infusions may be required.

    Product
    Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-1170-2023·2023-03-08

    Bone fixation plates recalled due to product packaging mix-up

    Wright Medical Technology is recalling ORTHOLOC 3DSi CLAW II bone fixation plates due to packaging mix-up in specific lots. Packages contained incorrect product codes.

    Product
    ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0432-2023·2023-03-08

    Carbidopa and Levodopa Tablets Recalled for Inadequate Blister Packaging Seal

    The Harvard Drug Group is recalling Carbidopa and Levodopa Tablets due to inadequate sealing of the blister packaging. The recall affects Lot M04145 distributed nationwide.

    Product
    Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Only, Manufactured in Czech Republic by: Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, Packaged and Distributed by: M
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0393-2023·2023-03-08

    Accord Healthcare recalls Glimepiride tablets due to manufacturing practice deviations

    Accord Healthcare is recalling Glimepiride 1 mg tablets distributed in the US, Puerto Rico, and Canada due to Current Good Manufacturing Practice deviations discovered during an FDA inspection. The recall affects 469,944 bottles.

    Product
    GLIMEPIRIDE — GLIMEPIRIDE (GLIMEPIRIDE)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0397-2023·2023-03-08

    Prescription Glycopyrrolate Injection Recalled Due to Manufacturing Process Deviations

    Accord Healthcare is recalling Glycopyrrolate Injection due to manufacturing process deviations found during FDA inspection. The recall involves 5,273 vials distributed across the United States, Puerto Rico, and Canada.

    Product
    GLYCOPYRROLATE — GLYCOPYRROLATE (GLYCOPYRROLATE)
    Category
    Drug
    Distribution
    1 state
  • HighNHTSA·23E018000·2023-03-08

    AROW Recalls Emergency Exit Windows Due to Latch Failure Risk

    AROW Global Corp is recalling MV204 and MV207 emergency exit windows because the latch may fail during a crash, potentially allowing the window to open and increasing injury risk.

    Product
    STRUCTURE:EMERGENCY:ESCAPE/EGRESS/EXIT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0391-2023·2023-03-08

    Tuna Flakes Recalled for Dried Fish Bones Found in Product

    Arroyabe Bonito Flakes White Meat Tuna is being recalled because dried fish bones were discovered in the cans, presenting a choking hazard. The affected product includes Lot Code L1104-1 and was distributed in Washington and Utah.

    Product
    Arroyabe Bonito Flakes White Meat Tuna Flakes in Oil From the Basque region of Spain. Product is packaged in metal can, Net wt: 32oz (900g), Drained Weight: 21oz (590g). Ingredients: White Tuna, Sunflower Oil and Salt. Imported By: Culinary Collective Lynnwood, WA. UPC on metal
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0390-2023·2023-03-08

    Peanut Butter Hot Chocolate and Cappuccino Recall for Undeclared Peanut Allergen

    Corim Industries recalls Peanut Butter Hot Chocolate and Peanut Butter Cappuccino in multiple formats due to undeclared peanut allergen. Consumers with peanut allergies should not consume these products.

    Product
    Colonial Coffee, 12 ct single serve coffee pods (4.44 oz. carton)
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0383-2023·2023-03-08

    Chocolate holiday treats recalled due to plastic contamination

    Alpenland International recalled Heilemann Confiserie chocolate treats after receiving a complaint of plastic in the product. The affected 3.5 oz boxes were distributed across 30 U.S. states.

    Product
    HEILEMANN CONFISERIE WEHNACHTSFIGUREN AUS EDELVOLLMILCH-SCHOKOLADE Solid Chocolate Holiday Treats 3.5 oz box UPC 4006574007199
    Category
    Food
    Distribution
    30 states
  • HighFDA (Drugs)·D-0429-2023·2023-03-08

    FDA Recalls Ropinirole 3mg Tablets due to CGMP Deviations

    Accord Healthcare's Ropinirole 3mg tablets are being recalled due to manufacturing compliance deviations identified during an FDA inspection. The recall affects 14,928 bottles distributed in the United States, Puerto Rico, and Canada.

    Product
    ROPINIROLE — ROPINIROLE (ROPINIROLE)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0359-2023·2023-03-08

    Nephron Phenylephrine HCl Injection Recalled for Sterility Assurance

    Nephron Sterile Compounding Center LLC is recalling Phenylephrine HCl Injection due to lack of assurance of sterility. The recall affects 546,450 vials distributed nationwide.

    Product
    Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1202-2023·2023-03-08

    Phoenix mKDR Mobile Diagnostic X-ray System Recalled for Erratic Movements

    SEDECAL SA is recalling 53 units of the Phoenix mKDR mobile diagnostic x-ray system following 3 incidents of erratic movements. Facilities using the affected equipment should discontinue use and contact the manufacturer.

    Product
    Phoenix mKDR, digital mobile diagnostic x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1188-2023·2023-03-08

    Maquet CARDIOHELP System extracorporeal support device components recalled for sterility

    Maquet is recalling CARDIOHELP System components due to insufficient evidence of packaging sterility. Non-sterile medical devices could expose patients to infection, sepsis, or ischemia.

    Product
    BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code 70106.9078. Part of the CARDIOHELP System, a pre-connected set used for extracorporeal respiratory and/or cardiovascular support.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0417-2023·2023-03-08

    Tadalafil Tablets Recalled Due to Manufacturing Practice Deviations

    Accord Healthcare recalls Tadalafil 20 mg tablets due to CGMP deviations identified during FDA inspection. Approximately 613,553 bottles distributed in the US, Puerto Rico, and Canada are affected.

    Product
    TADALAFIL — TADALAFIL (TADALAFIL)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0357-2023·2023-03-08

    FDA Recalls Norepinephrine Injection Due to Sterility Concerns

    Nephron Sterile Compounding Center is recalling Norepinephrine Bitartrate injection nationwide due to lack of sterility assurance. The recall affects 305,895 bottles across 13 lots.

    Product
    Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL (16 mcg/mL*), 250 mL Single-Dose Container bottle, packaged in 15 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-319-25.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1174-2023·2023-03-08

    Monosof nylon sutures recalled for sterile barrier breach

    Covidien is recalling Monosof nylon sutures due to sterile barrier breach in the breather pouch, which may cause infection or vision loss in ophthalmic procedures. The recall affects 54,288 units distributed nationwide and globally.

    Product
    Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1 BLK 100CM GS25 X36 CN-791 MONOSOF* 2-0 BLK 100CM GCC90X36 CN-791-12 MONOSOF* 2-0 BLK 100CM GCC90 CN-793 MONOSOF* 1 BLK 100CM GCC90 X36 CN-793-12 MONOSO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0423-2023·2023-03-08

    FDA Recalls Pravastatin Sodium Tablets Due to Manufacturing Deviations

    Accord Healthcare is recalling Pravastatin Sodium Tablets USP 40 mg due to manufacturing compliance deviations identified during an FDA inspection. The recall affects 120 bottles distributed in the United States, Puerto Rico, and Canada.

    Product
    PRAVASTATIN SODIUM — PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0427-2023·2023-03-08

    Ropinirole tablets recalled due to manufacturing practice deviations

    Accord Healthcare is recalling Ropinirole 1 mg tablets due to manufacturing deviations identified during FDA inspection. No illnesses have been reported.

    Product
    ROPINIROLE — ROPINIROLE (ROPINIROLE)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0362-2023·2023-03-08

    Phenylephrine injection recalled due to lack of sterility assurance

    Nephron Sterile Compounding Center is recalling Phenylephrine HCl injection nationwide due to lack of assurance of sterility. Lot PS2008A with expiration 03/07/2023 is affected.

    Product
    Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/mL), 250 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-321-25.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0398-2023·2023-03-08

    Safe + Fair Popcorn Recalled for Undeclared Peanut Residue

    Safe + Fair Food Company's Key Lime Pie Drizzled Popcorn is being recalled due to the potential presence of undeclared peanut residue. Consumers with peanut allergies should not consume this product.

    Product
    The Safe + Fair Food Company Key Lime Pie Drizzled Popcorn Kettle Popped Net Wt. 7.5 oz (212g) Packaged in a plastic bags
    Category
    Food
    Distribution
    10 states

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