The Recall Desk

Archive

February 2024 recalls

677 recalls were announced in February 2024.

What the numbers show

Critical
21
Severe
160
High
457
Moderate
38
Low
1

Of the 677 recalls this month scored against our rubric, 3% are Critical, 24% are Severe.

601–677 of 677

  • HighFDA (Devices)·Z-0898-2024·2024-02-07

    Knee Replacement Implant Component Recalled Due to Material Oxidation Risk

    The FDA is recalling SCORPIO U-DOME PATELLA knee replacement components because manufacturing used raw material over 5 years old that may have elevated oxidation levels affecting the implant's material properties.

    Product
    SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3910
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0845-2024·2024-02-07

    Surgical sutures recalled due to substandard gamma sterilization doses

    Covidien is recalling multiple surgical suture products because certain lots were sterilized with gamma doses exceeding approved levels. The excess radiation may reduce suture strength over time, potentially causing wound failure and bleeding.

    Product
    Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 SOFSILK* 4-0 BLK 75CM V20 X36 S-176 SOFSILK* 0 BLK 12X45CM PCT X24 S-182 SOFSILK* 5-0 BLK 12X45CM PCT X36 S-184 SOFSILK* 3-0 BLK 12X45CM PCT X36 S-185 SOFSILK* 2-0 BLK 12X45CM PCT X36 S-245 SOFSILK* 2-0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0908-2024·2024-02-07

    Knee Replacement Inserts Recalled Due to Material Oxidation Risk

    Howmedica Osteonics is recalling knee replacement inserts manufactured with UHMWPE material over 5 years old, which may develop elevated oxidation levels that could affect joint stability.

    Product
    LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-231
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0911-2024·2024-02-07

    Knee replacement implant recalled due to material oxidation risk

    Howmedica is recalling knee replacement implants manufactured with UHMWPE material over 5 years old due to potential oxidation that could affect material properties.

    Product
    RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-831
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0953-2024·2024-02-07

    MRI Scanner Quadrature Coil Seal Failure Poses Patient Contact Risk

    Philips is recalling the Intera 1.5T Achieva Nova-Dual MRI scanner due to potential failure of the Quadrature Body Coil seal adhesive. If the seal fails, sharp edges may contact patients, risking skin injuries.

    Product
    Intera 1.5T Achieva Nova-Dual. Model (REF) Number 781173.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0876-2024·2024-02-07

    Knee Implant Inserts Recalled Due to Potential Material Degradation

    Howmedica Osteonics is recalling SCORPIO TS TIB knee implant inserts (Part Number 72-4-0510) manufactured with UHMWPE material over 5 years old. The material may have elevated oxidation levels that could affect implant performance.

    Product
    SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0510
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0873-2024·2024-02-07

    Series II Tibial Bear Insert Recalled for Potential Material Degradation

    Howmedica Osteonics Corp. is recalling the Series II Tibial Bear Insert for knee replacement because UHMWPE material over 5 years old may develop elevated oxidation that can affect the component's material properties.

    Product
    SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0515
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0899-2024·2024-02-07

    Knee Replacement Component Recalled Due to Material Oxidation Risk

    Howmedica Osteonics is recalling Scorpio NRG Tibial Brg Insert Assembly knee replacement components due to potential oxidation of raw materials over 5 years of age, which could affect material properties.

    Product
    Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0908
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0902-2024·2024-02-07

    Knee Replacement Component Recalled for Potential Material Oxidation and Degradation

    Howmedica Osteonics is recalling TRIDENT 0 deg knee implant components manufactured with aged raw material that may have elevated oxidation levels, potentially affecting material properties.

    Product
    HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-32J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0895-2024·2024-02-07

    FDA Recalls SCORPIO U-DOME Knee Implants for Potential Material Oxidation

    Howmedica is recalling SCORPIO U-DOME PATELLA knee replacement implants manufactured with UHMWPE material over 5 years old due to potential elevated oxidation levels that could affect material properties.

    Product
    SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3508
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0884-2024·2024-02-07

    Knee replacement bearing insert recalled due to material degradation risk

    Howmedica Osteonics Corp. is recalling Scorpio-Flex knee bearing inserts made with material over 5 years old that may develop oxidation affecting performance. Affected patients should contact their physician if they experience knee problems.

    Product
    Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0908
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0286-2024·2024-02-07

    OralProCare Medicated Lip Treatment Recalled for Manufacturing Specification Deviations

    Den-Mat Holdings recalls OralProCare medicated lip treatment due to manufacturing quality control deviations that may affect product conformance to labeled specifications. No illnesses reported.

    Product
    OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcohol 6.0% Antibacterial, Manufactured by: Den-Mat Holdings, LLC, Lompoc, CA, 93436, USA, NDC 59883-500-01, UPC: 3 59883 00000 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0914-2024·2024-02-07

    Knee Replacement Inserts Recalled Due to Potential Material Degradation

    Howmedica Osteonics is recalling PRIMARY REV.TIB.INSERT-DURACON knee replacement inserts manufactured with aging UHMWPE material that has potential for oxidation affecting material properties. Affected lots: 36273601 and 36609701.

    Product
    PRIMARY REV.TIB.INSERT-DURACON Intended for knee replacement. Product Number: 6637-4-031
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0844-2024·2024-02-07

    Surgilon Braided Nylon Sutures Recalled for Excessive Gamma Sterilization

    Covidien LP recalls specific lots of Surgilon Braided Nylon sutures sterilized with excessive gamma radiation, which may weaken the sutures and cause wound complications.

    Product
    Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-71 SURGILON* 1 BLK 7X75CM PCT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0923-2024·2024-02-07

    Knee Replacement Component Recalled for Potential Material Oxidation

    Howmedica Osteonics is recalling PS Lipped Tibial Insert Assy knee replacement components manufactured with UHMWPE material older than 5 years due to potential oxidation affecting performance.

    Product
    PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-411
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0886-2024·2024-02-07

    Knee Replacement Component Recalled Due to Raw Material Oxidation Risk

    Howmedica Osteonics Corp. is recalling a SCORPIO TOTAL KNEE prosthesis component because UHMWPE raw material over 5 years old may have elevated oxidation levels affecting material properties and implant performance. Consumers with this implant should contact their physician for guidance.

    Product
    SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-0110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0952-2024·2024-02-07

    Philips MRI Scanner Quadrature Coil Seal Adhesive May Fail and Create Sharp Edges

    Philips Intera 1.5T Achieva Nova MRI machines (Model 781172) may develop seal adhesive failure in the Quadrature Body Coil, creating sharp edges that could injure patients during scanning.

    Product
    Intera 1.5T Achieva Nova. Model (REF) Numbers 781172.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0910-2024·2024-02-07

    Knee Replacement Implant Components Recalled for Material Degradation Risk

    Howmedica Osteonics Corp. is recalling specific lots of knee replacement implant components manufactured with aged raw material. The UHMWPE material may experience oxidation that could affect its structural properties.

    Product
    LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-631
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0943-2024·2024-02-07

    Olympus EZDilate Balloon Dilators Recalled for Device Malfunction and Retained Foreign Bodies

    Olympus recalled EZDilate Wire Guided Balloon endoscopic dilators due to reports of bursting, leaking, and retained foreign bodies during patient procedures. The Class II recall affects 4,182 units used to treat esophageal strictures.

    Product
    EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1855
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0967-2024·2024-02-07

    Medline Blood Culture Kits Recalled: Expired Component Not Disclosed on Insert

    Medline Industries is recalling certain blood culture kits due to a Bactec component with an expiration date not reflected on the kit insert. Users may unknowingly use an expired component if they do not check the Bactec itself.

    Product
    MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1723
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0897-2024·2024-02-07

    Knee replacement component recalled due to potential material oxidation

    Howmedica Osteonics recalls SCORPIO U-DOME PATELLA knee components. Older UHMWPE raw material may have elevated oxidation, potentially affecting material properties.

    Product
    SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3710
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0927-2024·2024-02-07

    Cryo Module Tank Hose Assemblies Recalled for Material and Design Defects

    AtriCure recalls certain tank hose assemblies for Cryo Module equipment due to manufacturing defects. The units have incorrect inner tube material and missing required perforations on the outer sheathing.

    Product
    Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0865-2024·2024-02-07

    GE Voluson IC9-RS Ultrasound Probes Recalled for Double Image Artifacts

    GE HealthCare is recalling certain IC9-RS intracavitary ultrasound probes due to a double image artifact that creates ghost images. This unrecognized artifact can lead to diagnostic errors.

    Product
    GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0891-2024·2024-02-07

    Knee Replacement Implant Component Recalled for Material Degradation Risk

    Howmedica Osteonics Corp. is recalling SCORPIO Total Knee Concentric Dome Patella components due to potential oxidation in raw materials over 5 years old. No illnesses have been reported.

    Product
    SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-2710
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0893-2024·2024-02-07

    Knee Replacement Component Recalled for Potential Material Degradation

    Howmedica Osteonics Corp. recalls SCORPIO U-DOME PATELLA knee replacement components due to potential oxidation in raw materials over 5 years old, which could affect material properties.

    Product
    SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0818-2024·2024-02-07

    Cardiac surgical kits recalled due to improper sterilization exposure

    American Contract Systems is recalling 12,291 cardiac procedure kits nationwide. Components were exposed to sterilization without documented assessment of suitability, potentially causing loss of functionality or efficacy.

    Product
    Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IMPLANT PACK, kit number AGBI64J; b) LAB DEVICE IMPLANT, kit number AGDI40J; c) LAB DEVICE IMPLANT, kit number AGDI40K; d) MINOR VASCULAR, kit number AGMV26O; e) OPEN HEART ACCESSORY, kit number
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0846-2024·2024-02-07

    Cortera Spinal Fixation System screws recalled for incorrect dimensions

    XTANT Medical is recalling Cortera Spinal Fixation System screws that were manufactured with incorrect dimensions. Screws labeled 8.5 mm by 50 mm are actually 5.5 mm by 45 mm, potentially preventing proper screw engagement.

    Product
    Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0965-2024·2024-02-07

    Medline Blood Culture Collection Kit Recalled for Expired Bactec Component

    Medline Industries recalls specific lots of blood culture collection kits because the Bactec component expiration date was not documented on the kit insert. Users who fail to check the component's expiration date inside the kit risk using an expired diagnostic component.

    Product
    MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1714A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0956-2024·2024-02-07

    Philips MRI coil seal adhesive may fail, creating sharp edges and injury risk

    A Philips MRI coil component's adhesive may fail and create sharp edges that could injure patients during scanning. The defect affects 286 units worldwide.

    Product
    SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0819-2024·2024-02-07

    Cardiac central line insertion kits lack documented sterilization validation

    American Contract Systems is recalling 290 cardiac procedural kits nationwide because components were subjected to sterilization without documented assessment of temperature suitability, potentially causing loss of functionality or efficacy.

    Product
    Custom procedural convenience kits and trays, cardiac, labeled as: a) CENTRAL LINE INSERTION PACK, kit number LLCE52; b) Adult Central Line Insertion Supply Kit, kit number UICL44N; c) Pediatric Central Line Insertion, kit number UIPL77K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0860-2024·2024-02-07

    Philips Azurion 7 M20 FlexArm system recalled for software connectivity loss

    Philips Medical Systems recalls the Azurion 7 M20 FlexArm system due to a software issue causing loss of connectivity between the FlexArm and Maquet Magnus Table. The recall affects 28 systems worldwide.

    Product
    Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0871-2024·2024-02-07

    Knee Replacement Implant Recalled Due to Potential Material Degradation

    Howmedica Osteonics is recalling SCORPIO RECESSED PATELLA knee replacement implants manufactured with UHMWPE material over 5 years old. The aged material may develop elevated oxidation levels that could affect the implant's performance.

    Product
    SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0030
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0919-2024·2024-02-07

    Knee Replacement Implants Recalled for Potential Material Oxidation

    Howmedica Osteonics Corp. is recalling knee replacement implants manufactured with UHMWPE material over 5 years old. The aged material has potential for elevated oxidation levels, which could affect the implant's material properties.

    Product
    DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-609
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0903-2024·2024-02-07

    Howmedica Osteonics Trident Knee Insert Recalled for Oxidation Risk

    Howmedica Osteonics Trident knee replacement inserts manufactured with raw material over 5 years old may have elevated oxidation levels affecting material properties. This FDA Class II recall applies to Lot Number 29518001.

    Product
    HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-32J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0938-2024·2024-02-07

    EZDilate Fixed Wire Balloon Medical Device Recalled Due to Device Failures

    Olympus is recalling 8,294 EZDilate Fixed Wire Balloon devices due to reports of device failures including bursting, leaking, and foreign body retention in patients undergoing esophageal dilation.

    Product
    EZDilate Fixed Wire Balloon 18-19-20. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-2080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0945-2024·2024-02-07

    Philips Achieva MRI Scanner Recall: Loose Coil Seals May Cause Skin Injury

    Philips is recalling Achieva 1.5T MRI scanners due to a seal adhesive defect on the body coil that may fail during scanning, creating sharp edges that risk skin injury including abrasions and lacerations.

    Product
    Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0969-2024·2024-02-07

    Medline Blood Culture Tray Adult recalled for incomplete component labeling

    Medline recalls Adult Blood Culture Trays due to incomplete documentation of Bactec component expiration dates on kit inserts. Users should verify the component expiration date before use.

    Product
    MEDLINE BLOOD CULTURE TRAY ADULT, Reorder Number DYNDH1194A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0964-2024·2024-02-07

    Blood Culture Bottle Kit Recalled for Expired Component Documentation Issue

    Medline is recalling blood culture bottle kits with mismatched component expiration date documentation, creating risk of using expired components if not verified by users.

    Product
    MEDLINE BLOOD CULTURE BOTTLE KIT, Reorder Number DYNDH1738A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0803-2024·2024-02-07

    Solgar Glucosamine Chondroitin Recalled Due to Wrong Product Packaging Error

    Nestle Health Science recalled Solgar Glucosamine Chondroitin (120-tablet bottles) distributed in six states due to a packaging error where Megasorb B-Complex was filled into mislabeled bottles.

    Product
    Solgar, Triple Strength, Shellfish -Free, Glucosamine Chondroitin MSM, 120 Tablets per bottle. Glass Bottle, 12 per Case, Store at room temperature . Product Number -1319
    Category
    Drug
    Distribution
    6 states
  • ModerateFDA (Food)·F-0802-2024·2024-02-07

    Milk N Cookies Keto Brick recalled for undeclared MCT oil and acacia fiber

    Savage Sports LLC is recalling Milk N Cookies Keto Brick due to undeclared MCT oil and acacia fiber in the formulation. Approximately 7,461 units distributed via the company's website are affected.

    Product
    Milk N Cookies Keto Brick / 1 Brick, 145g 5.1 oz
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0966-2024·2024-02-07

    Medline Blood Culture Collection Kit Recalled for Undocumented Component Expiration

    Medline is recalling blood culture collection kits because the Bactec component expiration date is not documented on the kit insert. Users who do not check the component directly risk using an expired element.

    Product
    MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1626B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0866-2024·2024-02-07

    Surgical needle holders distributed with incorrect product labels

    Aesculap Inc is recalling 53 JACOBSON DUROGRIP TC micro needle holders that were shipped with incorrect product labels, which may cause delays during surgical procedures.

    Product
    MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 220MM";
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0868-2024·2024-02-07

    TERUMO HydroPearl embolization microspheres recalled for manufacturing process deviation

    MICROVENTION is recalling TERUMO HydroPearl Compressible Microspheres because manufacturing and quality processes were not followed during production. The recall affects 22 units distributed in seven U.S. states.

    Product
    TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0968-2024·2024-02-07

    Medline Blood Culture Kits recalled for inaccurate expiration dating

    Medline recalls Blood Culture Kits because kit inserts fail to reflect the expiration date of included Bactec components. Users could unknowingly use expired components if they don't independently check the Bactec label.

    Product
    MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1622C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0287-2024·2024-02-07

    Hydrogen Peroxide Oral Rinse Recalled for Manufacturing Deviations

    Den-Mat Holdings recalls Hydrogen Peroxide Oral Rinse products nationwide due to manufacturing deviations that may result in products not conforming to labeled specifications.

    Product
    Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint Flavor, Alcohol Free, a)16 fl. oz. (473 mL) bottle, NDC 59883-202-16, UPC 3 59883 00009 7); b) 64 fl. oz. (1.89 L) bottle, NDC 59883-202-64; c) 128 fl. oz. (1 gal) 3.78L bottle, NDC 59883-202-28, UPC 3 59883
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0837-2024·2024-02-07

    FDA Recalls Terragene Bionova PCD Device Due to Instructions Discrepancy

    Terragene S.A. is recalling Terragene Bionova PCD (Model PCD222-C) medical devices nationwide due to a discrepancy between FDA-cleared instructions for use and the actual instructions distributed with the products.

    Product
    Terragene Bionova PCD (PCD222-C)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V072000·2024-02-06

    Mitsubishi Fuso Rizon Trucks Recalled for Unexpected Drive Power Loss

    Mitsubishi Fuso is recalling 2024 Rizon FEC7K and FEC9K trucks because a control unit error may cause the vehicle to shut down unexpectedly, increasing crash risk.

    Product
    MITSUBISHI FUSO — MITSUBISHI FUSO RIZON FEC7K (E16), RIZON FEC9K (E18)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24E007000·2024-02-05

    Worldwide Recalls INGUSA/LP ASME Remote Fill Tanks Due to Leak Risk

    Worldwide Distribution is recalling INGUSA/LP ASME Remote fill tanks because the liquid level remote fill gauge may leak in the open position, increasing fire risk.

    Product
    EQUIPMENT:RECREATIONAL VEHICLE/TRAILER:LPG SYSTEMS:TANK VALVE/GAUGE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·005-2024·2024-02-03

    Hormel Recalls Spiced Deli Ham for Undeclared Milk Allergen

    Hormel Foods is recalling approximately 945 pounds of ready-to-eat spiced deli ham products due to misbranding and an undeclared milk allergen. The products were distributed to retail locations in Pennsylvania.

    Product
    Hormel Foods Corporation — Hormel Foods Recalls Ready-To-Eat Spiced Deli Ham Products Due to Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    1 state
  • SevereUSDA FSIS·004-2024·2024-02-02

    Macgregors Recalls Frozen Ready-to-Eat Pork Products for Import Violation

    Macgregors Meat and Seafood Ltd is recalling approximately 2,745 pounds of frozen, ready-to-eat pork products that were imported into the U.S. without required reinspection.

    Product
    Macgregors Meat and Seafood Ltd Recalls Frozen Ready-To-Eat Pork Products Imported Without Benefit of Import Reinspection
    Category
    Food
    Distribution
    6 states
  • HighNHTSA·24V066000·2024-02-02

    Forest River Salem and Wildwood travel trailers incorrect tire size

    Forest River is recalling 2023-2024 Salem and Wildwood fifth wheel travel trailers due to incorrect tire size information on their federal placards. This could lead to wrong tire installation and increased crash risk.

    Product
    FOREST RIVER — FOREST RIVER SALEM, WILDWOOD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V069000·2024-02-02

    Indian Challenger and FTR Motorcycles Recalled for Unintended Brake Light Illumination

    Indian Motorcycle Company is recalling certain 2019-2022 Challenger, FTR 1200, and Pursuit motorcycles due to brake lights that may illuminate unexpectedly without rider input, potentially confusing following drivers and increasing crash risk.

    Product
    INDIAN — INDIAN PURSUIT DARK HORSE, FTR 1200 S, FTR1200, CHALLENGER LIMITED
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V070000·2024-02-02

    2019-2022 Mercedes-Benz GLC models recalled for incorrect headlight adjustment and glare

    Mercedes-Benz is recalling 2019-2022 GLC 300, 2020 GLC 350e, and 2020-2022 AMG GLC 43 vehicles for headlights that may be incorrectly adjusted, creating glare for oncoming traffic. Dealers will correct the adjustment free of charge.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG GLC43, GLC 300, GLC 350 E
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V068000·2024-02-02

    Blue Bird Recalls 2021-2024 Vision School Buses for Stop Arm Defect

    Blue Bird is recalling 2021-2024 Vision school buses because a software defect may cause warning lights to turn off and the stop arm to retract unexpectedly.

    Product
    BLUE BIRD — BLUE BIRD VISION SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V067000·2024-02-02

    Gulf Stream Trail Boss Trailers Recalled for Incorrect Tire Labeling

    Gulf Stream is recalling 2024 Trail Boss 160FK trailers because the federal certification label lists incorrect tire size and pressure, which could lead to improper tire installation.

    Product
    GULF STREAM — GULF STREAM TRAIL BOSS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V071000·2024-02-02

    Nissan LEAF rearview camera harness damage reduces rear visibility

    Nissan is recalling approximately 57,914 LEAF vehicles (2018-2022) where the rearview camera harness may become damaged, causing image distortion or loss and reducing rear visibility.

    Product
    NISSAN — NISSAN LEAF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalCPSC·24096·2024-02-01

    Fishing Games Recalled for High-Powered Magnet Ingestion Hazard

    Huihuang Trading is recalling Fishing Games sold on Amazon.com from June through July 2023 because they contain magnets that exceed federal safety limits. Swallowed magnets can become lodged in the digestive system and cause serious injury or death.

    Product
    Fishing Games
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalCPSC·24097·2024-02-01

    DailySale Magnetic DIY Balls Magic Cube Recalled for Ingestion Hazard

    DailySale Inc. is recalling its 216-piece 5mm Magnetic DIY Balls Magic Cube because the high-powered magnets violate federal toy safety regulations. When swallowed, the magnets can lodge in the digestive system and cause serious injury or death.

    Product
    Magnetic DIY Balls Magic Cube, 5mm
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·003-2024·2024-02-01

    Vanee Foods Recalls Chicken Flavored Base for Undeclared Allergens

    Vanee Foods is recalling chicken flavored base products that may contain undeclared soy and wheat. The recall covers 9,564 pounds shipped to distributors in three states.

    Product
    Vanee Foods Company — Vanee Foods Recalls Chicken Flavored Base Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    3 states
  • SevereCPSC·24107·2024-02-01

    BISSELL Multi Reach Hand and Floor Vacuum Cleaners Recalled for Fire Hazard

    BISSELL is recalling about 142,000 Multi Reach Hand and Floor Vacuum Cleaners because the battery pack can overheat and smoke, creating a fire risk. Six reports included the battery catching fire, causing minor property damage and burn injuries in some cases.

    Product
    BISSELL® brand Multi Reach Hand and Floor Vacuum Cleaners
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V063000·2024-02-01

    Braun Ambulances Recall 2020-2024 Models Due to Electrical Fire Risk

    Braun Ambulances is recalling 628 emergency vehicles from 2020-2024 because a wiring defect could cause electrical circuits to overheat and start a fire.

    Product
    BRAUN AMBULANCES — BRAUN AMBULANCES CHIEF XL TYPE I, LIBERTY TYPE I, SIGNATURE SERIES TYPE III, SUPER CHIEF TYPE I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V060000·2024-02-01

    General Motors Recalls Pickup Trucks with Defective Power Tailgate Latches

    General Motors is recalling certain 2020-2024 Chevrolet Silverado and GMC Sierra pickup trucks due to faulty electronic tailgate switches that may inadvertently unlatch while the vehicle is parked. The defect can allow the tailgate to open while driving, potentially causing cargo loss and creating a road hazard.

    Product
    GMC — GMC, CHEVROLET SIERRA 3500, SILVERADO 2500, SILVERADO 3500, SIERRA 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24102·2024-02-01

    iFIT NordicTrack 50-Pound Adjustable Dumbbells Recalled for Impact Hazard

    iFIT is recalling NordicTrack 50-pound iSelect voice-controlled adjustable dumbbells because weight plates can dislodge during use, posing an impact hazard. Eight injuries including contusions and abrasions have been reported.

    Product
    NordicTrack 50 LB iSelect Voice-Controlled Adjustable Dumbbells
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·24V065000·2024-02-01

    2023 Hyundai IONIQ 5 and IONIQ 6 driveshaft replacement recall

    Hyundai is recalling 2023 IONIQ 5, IONIQ 6, and Genesis GV60 vehicles for rear driveshafts that may break under load due to improper heat treatment, causing loss of drive power. Dealers will replace the driveshaft free of charge.

    Product
    HYUNDAI — HYUNDAI, GENESIS IONIQ 6, IONIQ 5, GV60
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24098·2024-02-01

    Lovevery Slide & Seek Ball Runs Recalled for Choking Hazard

    Lovevery is recalling about 47,000 Slide & Seek Ball Runs with wooden knobs because the wooden knob can detach during or after shipping, posing a choking hazard to children. The product was sold online as part of the Babbler Play Kit from June 2023 through November 2023.

    Product
    Slide & Seek Ball Runs with Wooden Knobs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24095·2024-02-01

    Snap Recalls Lithium-Ion Battery for Pixy Flying Cameras Due to Fire Hazard

    Snap is recalling about 71,000 rechargeable lithium-ion batteries sold with Pixy Flying Cameras because the battery can overheat and pose a fire hazard. The company has received four reports of battery overheating and bulging, including one minor battery fire and one minor injury.

    Product
    Lithium-ion battery sold for Pixy Flying Cameras
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24103·2024-02-01

    SRAM 12-Speed Shift Brake Levers Recalled Due to Crash Hazard

    SRAM is recalling about 61,300 12-speed shift brake levers because the clamp bolt can come loose, preventing proper braking and posing a crash hazard to riders. No injuries have been reported.

    Product
    Shift Brake Levers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24100·2024-02-01

    Ekouaer Girl's Nightgowns Recalled for Fire and Burn Hazard

    Ekouaer girl's nightgowns fail to meet federal flammability standards for children's sleepwear, posing a risk of burn injuries. About 16,800 units sold on Amazon from May 2020 through July 2023 are affected.

    Product
    Ekouaer Girl's Nightgowns
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24101·2024-02-01

    Children's Nightgowns Recalled Due to Fire and Burn Hazard

    Stripe and Stare children's nightgowns violate federal flammability regulations for sleepwear, posing a risk of burn injuries. About 250 units sold online from February 2021 through January 2023.

    Product
    Children's nightgowns
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24104·2024-02-01

    NextGen Children's Bicycles Recalled for Safety Standard Violations

    Flat River Group is recalling about 22,700 NextGen children's bicycles because they do not meet federal safety standards. The bicycles lack required foot brakes, chain guards, or pedal reflectors, posing crash and injury hazards to children.

    Product
    NextGen Children's Bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·24V062000·2024-02-01

    Tiffin Allegro Bay motorhomes recalled for battery fire risk

    Tiffin is recalling certain 2022–2024 Allegro Bay motorhomes because batteries may shift during travel, causing electrical arcing and fire risk. Dealers will install new hold-down hardware at no charge.

    Product
    TIFFIN — TIFFIN ALLEGRO BAY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V061000·2024-02-01

    Motorhome Seat Pedestal Weld Defect Causes Unsafe Seat Separation Risk

    Jayco is recalling certain 2020-2023 Entegra motorhomes because passenger seats may have improperly welded pedestals that can separate and cause the seat to loosen or detach.

    Product
    ENTEGRA — ENTEGRA REATTA XL, CORNERSTONE, ANTHEM, ASPIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V064000·2024-02-01

    Multiple Honda and Acura models recalled for defective airbag sensor

    Honda and Acura are recalling 750,114 vehicles from 2020-2022 model years. A defective front passenger seat weight sensor may fail to suppress the airbag, increasing the risk of injury in a crash.

    Product
    HONDA — HONDA, ACURA ACCORD, INSIGHT, CR-V, CIVIC TYPE R
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateCPSC·24099·2024-02-01

    Meijer December Home Light Bulbs Recalled for Burst Hazard

    Meijer is recalling December Home branded candelabra-style light bulbs because some packages contain 3V bulbs instead of the labeled 120V versions. When a 3V bulb is used in a 120V fixture, it can burst, creating a laceration hazard.

    Product
    DECEMBER HOME® Replacement Light Bulbs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·24105·2024-02-01

    Box Components Recalls BMX Race Bicycle Stems Due to Fall Hazard

    Box Components is recalling about 160 BMX Race Box One Oversized 31.8 Delta bicycle stems because the faceplate can crack and break, loosening handlebars and causing loss of control and crash injury risk. No injuries have been reported to date.

    Product
    BMX Race Box One Bicycle Stems
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·24106·2024-02-01

    Glass Little Wanderer Snow Globes Recalled for Laceration Hazard

    The Museum of Modern Art is recalling about 1,915 glass Little Wanderer snow globes sold at MoMA Design Stores because they can crack or fracture, posing a laceration hazard. No injuries have been reported.

    Product
    Snow globes (Little Wanderer)
    Category
    Consumer Product
    Distribution
    Distributed nationwide

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