The Recall Desk

Archive

March 2023 recalls

1,013 recalls were announced in March 2023.

What the numbers show

Critical
68
Severe
446
High
386
Moderate
107
Low
6

Of the 1,013 recalls this month scored against our rubric, 7% are Critical, 44% are Severe.

Which agencies issued them

701–800 of 1013

  • 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-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 (Devices)·Z-1224-2023·2023-03-15

    CardioMEMS PA Sensor models affected by radio-frequency range at high elevations

    St. Jude Medical recalls CardioMEMS PA Sensors that may operate outside intended frequency range above 2,000 feet elevation, risking inaccurate readings in heart failure monitoring. Approximately 1,905 units affected.

    Product
    CardioMEMS HF System PA Sensor and Delivery System, 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 physicians…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1225-2023·2023-03-15

    CardioMEMS Heart Failure Sensor May Give Inaccurate Readings at High Elevations

    St. Jude Medical is recalling 317 CardioMEMS PA Sensors due to operation outside their intended frequency range at elevations above 2,000 feet, which may cause inaccurate pressure readings or signal acquisition problems.

    Product
    CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, 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-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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0436-2023·2023-03-15

    Verapamil Hydrochloride Tablets Recalled for Failed Dissolution Specification

    Amerisource Health Services LLC is recalling 422 cartons of Verapamil Hydrochloride Extended-Release Tablets, 120 mg due to failed dissolution testing. The tablets did not meet specifications for drug release.

    Product
    Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 Tablets per Carton (10 x 10), Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-493-01; NDC Unit Dose: 60687-493-11.
    Category
    Drug
    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 (Drugs)·D-0434-2023·2023-03-15

    Heparin Sodium in Dextrose Injection Recalled for Low Anticoagulant Potency

    B. Braun Medical Inc. is recalling Heparin Sodium in Dextrose Injection (Lot J2C017) due to subpotent anti-Factor IIa activity, which may reduce anticoagulant effectiveness.

    Product
    HEPARIN SODIUM IN DEXTROSE — HEPARIN SODIUM IN DEXTROSE (HEPARIN SODIUM AND DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0406-2023·2023-03-15

    Rao's Roasted Peppers with Portobello Mushrooms Recalled for Undeclared Pine Nuts

    Sunny Dell, Inc. recalls Rao's Homemade Roasted Peppers with Portobello Mushrooms (12 oz) for undeclared pine nuts. Product distributed to Northeast U.S. Consumers with pine nut allergies should be aware of this recall.

    Product
    Rao's Homemade Roasted Peppers with Portobello Mushrooms Net WT. 12OZ (340g) UPC:74749001106 Packaged in glass jars, 12 packages per cases
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0444-2023·2023-03-15

    FDA Drug Recall: Phenylephrine IV Bags Recalled for Manufacturing Deviations

    Denver Solutions recalls 1,212 units of Phenylephrine HCl IV bags nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The voluntary recall affects products distributed across the U.S. including government facilities.

    Product
    Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-150-82
    Category
    Drug
    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-1234-2023·2023-03-15

    TMJ Reconstruction Prosthesis Recalled for Lacking FDA Regulatory Approval

    A patient-fitted temporomandibular (TMJ) reconstruction prosthesis from Stryker Leibinger was recalled after being shipped without FDA regulatory approval. The single device distributed to a customer in Massachusetts has not been evaluated for safety and effectiveness.

    Product
    Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
    Category
    Medical Device
    Distribution
    1 state
  • 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1230-2023·2023-03-15

    Cardiosave Rescue IABP Helium Regulator Failures May Impair Function

    Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to helium regulator failures that may cause insufficient helium levels when the pump console is docked. The defect may affect device operation.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1223-2023·2023-03-15

    CardioMEMS PA Sensor Operates Outside Frequency Range at High Elevations

    Select CardioMEMS CM2000 PA sensors may operate outside their intended frequency range above 2,000 feet elevation, potentially causing inaccurate readings or signal acquisition problems in heart failure monitoring.

    Product
    CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, 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
  • 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-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 (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 (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…
    Category
    Food
    Distribution
    30 states
  • 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-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 (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-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-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 (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…
    Category
    Medical Device
    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
  • 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-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 (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-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 (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-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-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-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
  • 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·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
  • 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·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
  • 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
  • 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·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·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
  • 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
  • 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
  • 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
  • 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·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
  • 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
  • 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
  • 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
  • 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 (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
  • 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-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
  • 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
  • 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
  • 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
  • HighFDA (Drugs)·D-0360-2023·2023-03-08

    Phenylephrine injection lacks sterility assurance; FDA recalls vials

    Nephron Sterile Compounding Center has recalled phenylephrine HCl injection vials due to lack of assurance of sterility. Patients and healthcare providers should discontinue use of the affected lots.

    Product
    Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL 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 69374-305-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1205-2023·2023-03-08

    Sit to Stand STS500 Patient Lift Recalled Due to Loose Boom Fasteners

    Med-Mizer is recalling 37 units of the Sit to Stand STS500 Patient Lift due to risk of boom pivot failure caused by a loose securing nut and unsecured bolt on the boom flange.

    Product
    Sit to Stand STS500 Patient Lift
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1182-2023·2023-03-08

    Custom Suture Packs recalled due to sterile barrier breach risk

    Covidien Custom Suture Packs (US1638 and US1756) are recalled due to a sterile barrier breach in the breather pouch, which may cause infection or vision loss during ophthalmic procedures.

    Product
    Custom Suture Pack Product Description: US1638 CUSTOM SUTURE PACK US1756 CUSTOM SUTURE PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1183-2023·2023-03-08

    Surgical Mesh Recalled Due to Incorrect Collagen Film Placement

    Covidien is recalling Parietex Composite Mesh because the collagen film was positioned on the wrong side, which may cause delays in treatment, adhesions, erosion, migration, pain, fistula, hernia recurrence, or implant failure.

    Product
    Parietex Composite Mesh Polyester with Absorbable Collagen Film, Horseshoe- Shaped, 9 x 8 cm (3.6" x 3.1"). Intended for the reinforcement of tissues during surgical repair Model Number: PCO2H3
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1169-2023·2023-03-08

    Orthopedic Bone Fixation Plates Recalled for Incorrect Product Packaging

    Wright Medical Technology recalls ORTHOLOC 3DSi CLAW II bone fixation plates due to incorrect products placed in packages. Healthcare providers should verify product identification matches packaging before use.

    Product
    ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0384-2023·2023-03-08

    Dofetilide antiarrhythmic prescription drug recalled for manufacturing deviations

    Accord Healthcare is recalling 113,571 bottles of dofetilide capsules distributed in the US, Puerto Rico, and Canada due to Current Good Manufacturing Practice (CGMP) deviations found during FDA inspection. No illnesses have been reported.

    Product
    DOFETILIDE — DOFETILIDE (DOFETILIDE)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1198-2023·2023-03-08

    CooperVision Biofinity XR Toric lenses recalled for manufacturing misalignment

    CooperVision is recalling Biofinity XR Toric contact lenses manufactured with misaligned axis, resulting in incorrect lens power and poor visual acuity.

    Product
    Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1196-2023·2023-03-08

    Vascular diagnostic device recalled for air line misconnection risk

    Unetixs Vascular is recalling the MultiLab Series II REVO vascular diagnostic device because faulty connectors may allow the air line to be misconnected to an IV line, potentially causing a dangerous air embolism.

    Product
    MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0402-2023·2023-03-08

    Phenylephrine Hydrochloride Injection Recalled for Manufacturing Practice Deviations

    Accord Healthcare is recalling 5,090 vials of Phenylephrine Hydrochloride Injection due to manufacturing deviations found during an FDA inspection. Affected batches include R2101570, R2101574, and R2101576, distributed in the United States, Puerto Rico, and Canada.

    Product
    Phenylephrine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), Rx Only, 5 mL Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA; Vial NDC 16729-465-31, UPC 3 16729 46531 1; Carton…
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-0396-2023·2023-03-08

    Drizzilicious Birthday Cake Popcorn Recalled for Undeclared Peanut Allergen

    Snack Innovations Inc. is recalling Drizzilicious Birthday Cake Popcorn 3.6oz bags due to undeclared peanut residue. Consumers with peanut allergies should not consume this product.

    Product
    Drizzilicious drizzled Birthday Cake Popcorn 3.6oz Bags UPC: 857900005525 Packaged in a plastic bags
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-1193-2023·2023-03-08

    Medical Device Recall: Vascular Diagnostic Device Air Embolism Risk

    Unetixs Vascular is recalling 1706 units of the MultiLab Series II 2CP & 2CP Express vascular diagnostic device due to luer fittings that could allow air lines to be misconnected to intravenous lines, potentially causing air embolism.

    Product
    MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0391-2023·2023-03-08

    Finasteride Tablets 1 mg Recalled for Manufacturing Quality Deviations

    Accord Healthcare recalled 1.4 million bottles of Finasteride 1 mg tablets due to manufacturing quality deviations discovered during FDA inspection. No illnesses have been reported.

    Product
    Finasteride Tablets USP 1 mg, 90-count bottle, Keeps, Rx Only, Manufactured for: Thirty Madison, Inc. New York, NY 10016 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 71713-096-90 UPC 3 71713 09690 2
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1187-2023·2023-03-08

    EMPOWR VVC Knee Tibial Insert Recalled for Reversed Box Labeling

    Encore Medical recalls EMPOWR VVC Knee Tibial Inserts due to reversed box labeling—large inserts marked as small and vice versa. Surgeons may implant the wrong size if the labeling discrepancy is not identified before surgery.

    Product
    EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 7, 22MM, REF: 346-22-707; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 8, 22MM, REF: 346-22-708; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 9, 22MM, REF: 346-22-709; EMPOWR VVC KNEE TIBIAL INSERT…
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1171-2023·2023-03-08

    Summit Medical Nasal Septal Button Recall: Unsealed Sterile Pouches

    Summit Medical is recalling 30 Nasal Septal Buttons due to unsealed sterile pouches that compromise product sterility. Patients face potential infection risk from non-sterile device exposure.

    Product
    Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.
    Category
    Medical Device
    Distribution
    6 states
  • 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 (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-0425-2023·2023-03-08

    Ropinirole tablets recalled due to FDA manufacturing compliance deviations

    Accord Healthcare recalls 139,332 bottles of ropinirole 0.25 mg tablets distributed in the US, Puerto Rico, and Canada due to manufacturing compliance deviations identified during FDA inspection.

    Product
    ROPINIROLE — ROPINIROLE (ROPINIROLE)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0356-2023·2023-03-08

    Norepinephrine Injection Recalled for Lack of Sterility Assurance

    Nephron Sterile Compounding Center is recalling 443,483 bottles of Norepinephrine Bitartrate injection nationwide due to lack of sterility assurance in the product.

    Product
    Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL (32 mcg/mL*), 250 mL Single-Dose Container, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-316-25.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0374-2023·2023-03-08

    Atorvastatin Calcium 80 mg tablets recalled for manufacturing quality deviations

    Accord Healthcare recalls Atorvastatin Calcium 80 mg tablets due to manufacturing process deviations identified during FDA inspection. 72,376 bottles were distributed in the US, Puerto Rico, and Canada.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1177-2023·2023-03-08

    Surgidac Uncoated Braided Polyester sutures recalled due to sterile barrier breach

    Covidien is recalling Surgidac Uncoated Braided Polyester sutures (5-0, 45cm) due to a sterile barrier breach in the breather pouch. This breach may cause infection or vision loss in ophthalmic patients undergoing direct surgical contact.

    Product
    Surgidac Uncoated Braided Polyester suture Product Description D-1764K SURGIDAC* 5-0 WHI 45CM SS24DA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0399-2023·2023-03-08

    Glycopyrrolate Injection Recalled Due to Manufacturing Quality Deviations

    Accord Healthcare is recalling Glycopyrrolate Injection (4 mg/20 mL) from two batches due to CGMP deviations identified during FDA inspection. No illnesses have been reported.

    Product
    GLYCOPYRROLATE — GLYCOPYRROLATE (GLYCOPYRROLATE)
    Category
    Drug
    Distribution
    1 state
  • 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…
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1191-2023·2023-03-08

    Stryker Hoffmann LRF Transport Strut Locking Mechanism Recall

    Stryker is recalling Hoffmann LRF Transport Strut devices due to oversized thread pitch that prevents the distal ring fixation from locking, affecting 488 units nationwide.

    Product
    stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended to keep bone fragments/segments in a correct anatomical position until reliable bone consolidation is achieved
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (Devices)·Z-1185-2023·2023-03-08

    Medivac Guardian blood loss estimation device inserts may provide inaccurate readings

    Stryker's Medivac Guardian 3L scanning labels may cause inaccurate blood loss estimates, potentially delaying treatment for postpartum hemorrhage. The recall affects 541 units distributed nationwide.

    Product
    Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L Catalog Number: FG 12022. Intended adjunct in the estimation of blood loss.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-0369-2023·2023-03-08

    Aripiprazole 20 mg Tablets Recalled for Manufacturing Quality Deviations

    Accord Healthcare is recalling 170,448 bottles of Aripiprazole 20 mg tablets distributed in the United States, Puerto Rico, and Canada due to manufacturing quality control (CGMP) deviations identified during FDA inspection.

    Product
    ARIPIPRAZOLE — ARIPIPRAZOLE (ARIPIPRAZOLE)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-0392-2023·2023-03-08

    Drizzilicious Mini Rice Cake Bites Recalled for Undeclared Peanut Residue

    Snack Innovations Inc. is recalling Drizzilicious Mini Rice Cake bites for undeclared peanut residue. The recall affects approximately 6,701 cases distributed across multiple states; consumers with peanut allergies should not consume the product.

    Product
    Drizzilicious Mini Rice Cake bites Net Wt. 4oz and .74oz Bags Birthday Cake UPC: 857900005402 and 857900005419 Packaged in a plastic bags Product also packed in the Drizzilicious mini rice cakes 32-ct Variety box
    Category
    Food
    Distribution
    10 states
  • HighFDA (Drugs)·D-0416-2023·2023-03-08

    Tadalafil tablets recalled for manufacturing quality control deviations

    Accord Healthcare is recalling Tadalafil 10 mg tablets in the United States, Puerto Rico, and Canada due to manufacturing quality control deviations discovered during an FDA inspection.

    Product
    TADALAFIL — TADALAFIL (TADALAFIL)
    Category
    Drug
    Distribution
    1 state

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