The Recall Desk

Archive

July 2024 recalls

547 recalls were announced in July 2024.

What the numbers show

Critical
9
Severe
88
High
398
Moderate
49
Low
3

Of the 547 recalls this month scored against our rubric, 2% are Critical, 16% are Severe.

Which agencies issued them

1–100 of 547

  • SevereFDA (Devices)·Z-2409-2024·2024-07-31

    NIM Vital Nerve Monitoring Systems Recalled for False Negative Risk

    Medtronic Xomed is recalling NIM Vital Nerve Monitoring systems because they may fail to detect nerve damage or dysfunction. Approximately 7,804 units were distributed worldwide.

    Product
    NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1, v1.3.2, v1.4.3. NIM Vital Nerve Integrity Monitor with below product descriptions. 1. CONSOLE NIM4CM01 NIM 4.0, Model Number: NIM4CM01. 2. CONSOLE NIM4CM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V568000·2024-07-31

    Jayco Recalls 2025 Entegra Cornerstone Motorhomes Due to Fire Risk

    Jayco is recalling 2025 Entegra Cornerstone motorhomes because inadequate fuse protection on chassis batteries increases the risk of a fire.

    Product
    ENTEGRA — ENTEGRA CORNERSTONE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2415-2024·2024-07-31

    Electrosurgical Generators Olympus ESG-410 May Fail to Power On

    Olympus is recalling 86 ESG-410 Electrosurgical Generators because they may fail to power on during use, potentially delaying treatment or prolonging surgery.

    Product
    ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation of tissue in open, laparoscopic , and endoscopic surgeries Model/Catalog Number: WA91307C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2445-2024·2024-07-31

    LINK SymphoKnee Patella Sizing Template recalled due to incorrect markings

    LINK BIO CORP is recalling the LINK SymphoKnee Patella Sizing Template (Item Number 881-509/00, Lot C225066) because markings on two arms of the instrument were mixed up during manufacturing.

    Product
    LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2423-2024·2024-07-31

    Medtronic TourniKwik Tourniquet Set Recalled for Incorrect Component

    Medtronic is recalling 636 units of TourniKwik Tourniquet Sets due to incorrect components placed in four manufactured lots. Distribution includes the US states of Minnesota, Massachusetts, Utah, California, Florida, Japan, and Slovenia.

    Product
    TourniKwik Tourniquet Set (CFN 79012)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1490-2024·2024-07-31

    Organic Aussie Bites recalled for undeclared gluten content

    Best Express Foods is recalling Universal Bakery Organic Aussie Bites due to undeclared gluten. Products labeled as gluten-free were found to contain gluten above regulatory limits.

    Product
    Universal Bakery Organic Aussie Bites, 30 oz clamshell container USDA Organic Certified Gluten Free Rolled Oats, Dried Apricots, Flax Seeds, Sunflower Seeds, Honey, Coconut, Quinoa, Chia Seeds + More! INGREDIENTS: Organic Rolled Oats, Organic Oat Flour, Organic Invert Cane Sugar
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-2431-2024·2024-07-31

    Abbott Infinity 7 Pulse Generator May Have Shorter-Than-Labeled Service Date

    The Abbott Infinity 7 implantable pulse generator's replacement indicator and end-of-service date may be shorter than the product labeling states, potentially leading to loss of therapy for patients.

    Product
    Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1613-2024·2024-07-31

    Bakery Cookie Recalled for Undeclared Peanut Allergen

    Shweetz Bakery-To-Go cookies are being recalled due to undeclared peanuts. The recall affects 11,070 cookies distributed across Pennsylvania, Maryland, Ohio, Virginia, and West Virginia.

    Product
    Shweetz Bakery-To-Go brand Peanut Butter Brownie Cheezecake Mashup Cookie Net Wt. 3 oz (85g) UPC: 759465005029. Individually packaged in a clear film wrap. 45 units per case. Frozen storage, thawed for retail sale.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-2436-2024·2024-07-31

    Perfusor Space infusion pump syringe incompatibility may cause dosing error

    B Braun is recalling Perfusor Space infusion pump kits because Cardinal Health Monoject syringes have manufacturing changes that make them incompatible, potentially causing overdose, underdose, or delayed therapy.

    Product
    Brand Name: Perfusor Space Product Name: PERFUSOR SPACE ACM-KIT Model/Catalog Number: 8713040U Product Description: Perfusor Space, Infusion Pump Kit, 1 each Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2418-2024·2024-07-31

    Wireless Nurse Call Station Recalled for Potential Alarm Communication Failure

    Arial Call Station wireless nurse call systems (models CSK200-1069 and CSK200-1069MR) are recalled due to risk of alarm communication failure and premature battery depletion. 77 units affected across multiple U.S. states.

    Product
    Arial Call Station, Model Numbers CSK200-1069 and CSK200-1069MR, is a wireless nurse call station.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-2427-2024·2024-07-31

    Medtronic A610 Clinician Programmer pocket adaptors limited to head-only MRI

    Medtronic recalled A610 Clinician Programmer software and pocket adaptors (Models 64001, 64002) due to MRI safety restrictions. Patients with these implants are limited to head-only MRI procedures.

    Product
    A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584, 2.0.4594, 2.0.4605, 2.0.4630, and 2.0.4648), Version 3.0.x (3.0.1057, 3.0.1062, 3.0.1081, and 3.0.1098), Version 4.0.x (4.0.1052). Includes the below product descripti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1494-2024·2024-07-31

    Signature Blue Canned Crab Recalled for Improper Temperature Control

    Pacific Shellfish, Inc. is recalling Signature Blue Swimming Crab Claw and Lump canned crab (lots #78821 and #788454) from California due to storage at temperatures above 40°F without ice as of July 1, 2024.

    Product
    Signature Blue Swimming Crab Claw and Lump 1lb can Tin Can, Lot # 78821 Expiration June 09th 2026, Lot # 788454 Expiration June 09th 2026
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2432-2024·2024-07-31

    Abbott Infinity 7 Implantable Pulse Generators Recalled for Potentially Shortened Service Life

    Abbott is recalling 1198 Infinity 7 Implantable Pulse Generators due to potentially incorrect service life indicators and end-of-service dates in product labeling, which could result in loss of therapy.

    Product
    Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2429-2024·2024-07-31

    Abbott Infinity 5 Pulse Generator May Have Inaccurate Battery-Life Labels

    Abbott Infinity 5 implantable pulse generators have inaccurate end-of-service dates in labeling, which may result in loss of therapy. Approximately 5,900 units are affected and distributed worldwide.

    Product
    Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2434-2024·2024-07-31

    Perfusor Space Syringe Pump Recalled Due to Monoject Syringe Incompatibility

    B Braun Medical's Perfusor Space Syringe Pump may not properly recognize Cardinal Health Monoject syringes due to manufacturing changes, risking medication overdose, underdose, or therapy delays.

    Product
    Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wireless Model/Catalog Number: 8713031U Software Version: 8713031U Product Description: Perfusor Space Syringe Pump, Infusion Pump, 1 each Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2426-2024·2024-07-31

    ABL800 FLEX Blood Gas Analyzers May Report Inaccurate pH Results

    Radiometer Medical ABL800 FLEX blood gas analyzers (models 393-800, 393-801) may report inaccurate pH results due to bacterial growth in calibration solution bottles. Approximately 27,127 units distributed worldwide are affected.

    Product
    ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglob
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2414-2024·2024-07-31

    Dxl 9000 Immunoassay Analyzer Recalled for Corrosion of USB Cable Contacts

    Beckman Coulter is recalling 143 Dxl 9000 Immunoassay Analyzers due to nonconforming USB cables with brass instead of gold contacts. Brass may corrode, potentially disabling internal communication and delaying patient test results.

    Product
    Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2441-2024·2024-07-31

    Sensis Vibe medical diagnostic system software crashes during documentation events

    A software issue in certain Siemens Sensis Vibe diagnostic systems may cause the application to crash when documentation features are used during clinical reporting events.

    Product
    Sensis Vibe systems with software version VD15B-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology as well as surgical studies. Equipped by modules,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1491-2024·2024-07-31

    Universal Bakery Organic Sunrise Energy Bars recalled for undeclared gluten

    Universal Bakery Organic Sunrise Energy Bars labeled as gluten-free but found to contain gluten above FDA limits. The product poses a risk to consumers with celiac disease or gluten sensitivity.

    Product
    Universal Bakery Organic Sunrise Energy Bars 32 oz. and 10 oz. Gluten Free USDA Organic Made With: Rolled Oats, Dried Fruits, Flax Seeds, Quinoa, Coconut, Pumpkin Seeds, Chia Seeds + More Ingredients: Organic Rolled Oats, Organic Sunflower Oil, Organic Evaporated Cane Juice, Or
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-2438-2024·2024-07-31

    Sensis Vibe diagnostic systems software crash during event documentation

    Siemens Sensis Vibe diagnostic systems may crash when using documentation features during once-per-study event reporting. Three systems are affected; no injuries reported.

    Product
    Sensis Vibe systems with software version VD15B in combination with Sensis High End Server -Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology as wel
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2428-2024·2024-07-31

    Beckman Coulter Clinical Reagent Recalled Due to Incorrect Lipemia Check Settings

    Beckman Coulter has recalled 13,565 units of IGM clinical reagent due to incorrect lipemia check settings that may produce false low results or report high results as normal. Affected units were distributed worldwide.

    Product
    Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2430-2024·2024-07-31

    Abbott Infinity 5 Pulse Generator May Fail Prematurely

    Abbott is recalling 5,900 Infinity 5 implantable pulse generators because the replacement indicator and end-of-service date may be shorter than labeled, potentially causing premature device failure. Patients should contact their doctor about device status.

    Product
    Abbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0617-2024·2024-07-31

    Venlafaxine Hydrochloride extended-release capsules recalled for failed dissolution specifications

    Zydus Pharmaceuticals (USA) Inc. is recalling Venlafaxine Hydrochloride Extended-Release Capsules USP 37.5mg due to failed dissolution specifications in lots M213175 and M213176. The recall affects 13,128 and 252 bottles distributed nationwide.

    Product
    VENLAFAXINE HYDROCHLORIDE — VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2417-2024·2024-07-31

    Call station devices may fail to transmit emergency alarms to staff

    Securitas Healthcare's Arial Call Station (models CSK200 and CSK200MR) may fail to transmit alarms and experience premature battery depletion. The FDA recall affects 1,268 units distributed in the U.S. and Canada.

    Product
    Arial Call Station, Model Numbers CSK200 and CSK200MR, is a wireless, battery-operated call device installed inside resident living areas to allow immediate staff response.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Food)·F-1516-2024·2024-07-31

    Indigenous Collection Signature Plates recalled for potential lead contamination

    Canadian Art Prints is recalling Indigenous Collection Signature Plates sets due to potential leachable lead exceeding FDA guidance levels. The affected sets were distributed across 18 US states.

    Product
    UPC 772665860106. PLT010. Indigenous Collection Signature Plates set - Dancing Bears & Three Bears on box and back of plate. Art by Dawn Oman. Brand Indigenous Collection by CAP on box and back of plate. The Dancing Bears is a scene with three dancing polar bears with a night s
    Category
    Consumer Product
    Distribution
    18 states
  • HighFDA (Devices)·Z-2440-2024·2024-07-31

    Sensis Vibe Cardiac Imaging System Software May Crash During Documentation

    Siemens' Sensis Vibe cardiac imaging system software may crash when documentation functionality is used during diagnostic event recording. Two affected systems have been recalled nationwide.

    Product
    Sensis Vibe systems with software version VD15B in combination with AXIOM Sensis Post Processing Workstation-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as intervention
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2435-2024·2024-07-31

    Perfusor Space syringe pump recalled for Cardinal Health syringe incompatibility

    B Braun is recalling Perfusor Space syringe pumps because manufacturing changes to Cardinal Health Monoject syringes may cause incompatibility, resulting in dosing errors or delayed treatment.

    Product
    Brand Name: Perfusor Space Product Name: Perfusor PCA Syringe Pump Model/Catalog Number: 8713080U Product Description: Perfusor¿ Space Syringe Pump, Infusion Pump, 1 each Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2424-2024·2024-07-31

    BD Nano 2nd Gen Pen Needles recalled for post-expiration distribution

    Embecta Corp. is recalling BD Nano 2nd Gen Pen Needles that were distributed at or after their February 29, 2024 expiration date. Using expired needles cannot guarantee sterility and integrity.

    Product
    BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Counseling Sample Toolbox -Catalog 6484755/Lot Number: 3750144)-Sterile, single use devices designed for the parenteral administration of a drug from a cartridge contained in a drug pen injector Model/C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1515-2024·2024-07-31

    Glazed ceramic plates recalled for exceeding lead guidance levels

    Canadian Art Prints is recalling Indigenous Collection Signature Plates sets because the glazed ceramic plates may exceed FDA guidance levels for leachable lead. Consumers should stop using these plates immediately.

    Product
    UPC Code 772665860083, Stock code PLT008, Indigenous Collection Signature Plates set - Not Forgotten & Ancient Messages. Artist Maxine Noel on box and back of plates. Brand Indigenous Collection by CAP on box and back of plates. Not Forgotten is an image of a woman with indigeno
    Category
    Consumer Product
    Distribution
    18 states
  • HighFDA (Devices)·Z-2433-2024·2024-07-31

    Infusion Pump Syringe Compatibility Issue May Cause Overdose or Underdose

    B Braun is recalling Perfusor Space infusion pumps due to syringe compatibility issues with Cardinal Health Monoject syringes. The incompatibility may cause overdose, underdose, therapy delays, and alarm failures.

    Product
    Brand Name: Perfusor Space Product Name: Perfusor Space Infusion Pump System Model/Catalog Number: 8713030U Product Description: Perfusor Space Infusion Pump System, Infusion Pump, 1 each Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2437-2024·2024-07-31

    Perfusor Space Syringe Pump Recalled for Monoject Syringe Incompatibility Risk

    B Braun's Perfusor Space infusion pump may be incompatible with Cardinal Health Monoject syringes affected by manufacturing changes, creating risks of overdose, underdose, and delayed therapy.

    Product
    Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Non-Wireless Model/Catalog Number: 8713032U Product Description: Perfusor Space Syringe Pump, Non-Wireless, Infusion Pump, 1 each Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0615-2024·2024-07-31

    Hemp Bombs CBD Pain Freeze Recalled Due to Subpotent Menthol Content

    Global Widget LLC is recalling Hemp Bombs CBD Pain Freeze (4% menthol) because the menthol concentration is below the labeled claim. Approximately 11,130 bottles were distributed nationwide.

    Product
    Hemp Bombs CBD Pain Freeze (menthol 4%), 400mg, 4 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634; UPC code: 8-40078-56497-0
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1492-2024·2024-07-31

    Dried Plums Recalled for Undeclared Cyclamate Content

    Sweet Preserved Dried Plums from Farmer's Grange contain undeclared cyclamate sweetener. The product was distributed in select U.S. states and should not be consumed.

    Product
    Sweet Preserved Dried Plums; Farmer's Grange; Series Food; 88g; Plastic synthetic (flexible) package; INGREDIENTS: Plum, Salt, Sugar, ADDITIVES: Clove, Cinnamon, Liquorice, Citric acid, Red #40.; Product contains sulfite; PRODUCT OF CHINA (T.F.C).
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0614-2024·2024-07-31

    Nature's Script CBD Pain Relief Roll-On Recalled for Subpotent Menthol

    FDA Class III recall of Nature's Script CBD Cryotherapy Pain Relief Roll-on (200mg, 1 oz bottles) due to subpotent menthol content less than the labeled 4%. The product did not contain the claimed amount of active ingredient.

    Product
    Nature's Script CBD Cryotherapy Pain Relief Roll on (menthol 4%) 200mg, 1 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634, UPC code: 8-40078-56731-5
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2439-2024·2024-07-31

    Medical device diagnostic software vulnerability causes potential application crashes

    Siemens Sensis Vibe diagnostic systems may crash when documentation functionality is used during certain reporting events. Seven units were distributed to facilities nationwide.

    Product
    Sensis Vibe systems with software version VD15B in combination with VM VIRTUAL SERVER Model: 10765502-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2425-2024·2024-07-31

    Cystatin C Diagnostic Reagent Marketed Without FDA 510(k) Clearance

    Randox Laboratories is recalling 115 kits of RX Series CYSC Cystatin C Reagent because it was marketed without required FDA 510(k) clearance. Healthcare facilities should discontinue use and contact the manufacturer.

    Product
    RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers. Catalogue Number: CYS4004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2422-2024·2024-07-31

    MIC-KEY Gastric-Jejunal Feeding Tube Kits Recalled for Incomplete Safety Information

    Avanos Medical is recalling MIC-KEY Gastric-Jejunal Feeding Tube Kits because the Instructions for Use were missing required risk information about potential complications. No illnesses have been reported.

    Product
    MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx (Non-ENFIT); and MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Extension Sets with ENFit Connectors, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 8270xx, ste
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0616-2024·2024-07-31

    Hemp Bombs CBD Pain Freeze Recalled for Subpotent Menthol Content

    Hemp Bombs CBD Pain Freeze is being recalled because the menthol content is weaker than the labeled 4% claim. The recall affects 2,082 bottles distributed nationwide.

    Product
    Hemp Bombs CBD Pain Freeze (menthol 4%), 1000mg, 4 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634; UPC Code: 8-40078-56612-7
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0613-2024·2024-07-31

    Hemp Bombs CBD Pain Freeze Recalled Due to Subpotent Menthol Content

    Hemp Bombs CBD Pain Freeze is being recalled because the menthol potency is less than the labeled 4%. Consumers should stop using the affected product and return it to the retailer.

    Product
    Hemp Bombs CBD Pain Freeze (menthol 4%), 100mg, 1 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634, NDC 73423-003-01; UPC Code: 8-40078-56493-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0618-2024·2024-07-31

    Homeopathic Kit Recalled for Label Mix-up Between Products

    Washington Homeopathic Products is recalling 11 Complete 30C/200C Homeopathic Kits nationwide due to a labeling error. Some bottles labeled as Ferrum Metallicum 200C actually contain Ferrum Phosphoricum 200C.

    Product
    Complete 30C/200C Homeopathic Kit, Contains: One hundred 1/2 dram vials of homeopathic medicines, Washington Homeopathic Products, Inc., Berkley Springs, WV 25411, UPC 7 40640 64300 6.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·023-2024-EXP·2024-07-30

    Boar's Head Expands Recall of Deli Meats Due to Listeria

    Boar's Head is recalling 7 million pounds of ready-to-eat meat and poultry products due to possible Listeria contamination linked to a multistate outbreak.

    Product
    Boar's Head Provisions Co., Inc. — Boar's Head Provisions Co. Expands Recall for Ready-To-Eat Meat and Poultry Products Due to Possible Listeria Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V566000·2024-07-30

    Tiffin motorhome chassis controller can blow a fuse shutting down engine

    Tiffin is recalling certain 2022-2025 Phaeton, Allegro Bus and Zephyr motorhomes because the PowerGlide chassis controller may have insufficient circuit protection, which can blow a fuse and shut down the engine.

    Product
    TIFFIN — TIFFIN PHAETON, ZEPHYR, ALLEGRO BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24E063000·2024-07-30

    Mevotech Recalls Aftermarket Front Lower Control Arms Due to Design Flaw

    Mevotech is recalling specific aftermarket front lower control arms because a design flaw may cause the ball joint to separate, increasing crash risk.

    Product
    SUSPENSION:FRONT:CONTROL ARM:LOWER ARM recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V567000·2024-07-30

    Mack truck seat and belt anchorage bolts may be improperly tightened

    Mack is recalling certain 2024-2025 Anthem, Granite and Pinnacle vehicles with RollTek driver's seats because the seat pedestal and seat belt attachment may have been improperly tightened.

    Product
    MACK — MACK PINNACLE (PI/PN), ANTHEM (AN), PIONEER PR (4), GRANITE (GR)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·023-2024·2024-07-26

    Boar's Head Recalls Deli Meats Due to Listeria Contamination

    Boar's Head Provisions is recalling liverwurst and other deli meats nationwide due to possible Listeria monocytogenes contamination linked to a multistate outbreak.

    Product
    Boar's Head Provisions Co., Inc. — Boar's Head Provisions Co. Recalls Ready-To-Eat Liverwurst And Other Deli Meat Products Due to Possible Listeria Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·24E062000·2024-07-26

    Meritor Recalls Replacement Tie Rods Due to Heat-Treatment Defect

    Meritor is recalling replacement tie rods with specific USK ball studs that may break due to incorrect heat treatment, risking loss of steering control.

    Product
    STEERING:LINKAGES:TIE ROD ASSEMBLY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V564000·2024-07-26

    Nova Bus window glazing may reduce the driver's visibility

    Nova Bus is recalling certain 2019-2023 LFS and LFS Artic buses because the glazing used on the glass windows may reduce the driver's visibility, failing FMVSS 205.

    Product
    NOVA BUS — NOVA BUS LFS, LFS ARTIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V563000·2024-07-26

    Forest River Cherokee Travel Trailer Recall for Microwave Fire Risk

    Forest River is recalling 2025 Cherokee CKT20-0G travel trailers because an incorrect screw in the microwave compartment can cause electrical arcing and fire.

    Product
    FOREST RIVER — FOREST RIVER CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V561000·2024-07-26

    Hyundai Santa Fe floor wiring may chafe against the second row seat

    Hyundai is recalling certain 2024 Santa Fe and Santa Fe Hybrid vehicles because the main floor wiring harness may chafe and become damaged, affecting airbag deployment.

    Product
    HYUNDAI — HYUNDAI SANTA FE HYBRID, SANTA FE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V557000·2024-07-26

    BMW R 1300 GS starter motor relays may overheat

    BMW is recalling certain 2024 R 1300 GS motorcycles because the starter motor relay housing may have been manufactured incorrectly, resulting in a damaged relay that can overheat.

    Product
    BMW — BMW R 1300 GS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V556000·2024-07-25

    Second Navistar recall covers incorrectly heat treated tie rod ball studs

    A second Navistar recall covers certain 2025 International HV, HX, LT, MV and RH vehicles whose tie rod ball studs may have been incorrectly heat-treated. 573 units affected.

    Product
    INTERNATIONAL — INTERNATIONAL HX, LT, RH, HV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V559000·2024-07-25

    Nova Bus Recalls 2019-2021 LFS Models Due to Brake Chamber Defect

    Nova Bus is recalling 166 LFS and LFS Artic buses because a defective brake chamber may leak air, causing unexpected braking, overheating, or fire.

    Product
    NOVA BUS — NOVA BUS LFS, LFS ARTIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V558000·2024-07-25

    Nova Bus Recalls 2016-2019 LFS Models Due to Brake Chamber Defect

    Nova Bus is recalling 2016-2019 LFS and LFS Artic buses because a defective brake chamber may leak air, causing unexpected braking, overheating, or fire.

    Product
    NOVA BUS — NOVA BUS LFS ARTIC, LFS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·24315·2024-07-25

    Ophanie Large Pink Area Rugs Recalled for Fire Hazard

    Ophanie large pink area rugs sold on Amazon violate federal flammability regulations and pose a fire hazard. About 5,200 units sold from April through June 2024 are being recalled.

    Product
    Ophanie Large Pink Area Rugs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·24321·2024-07-25

    Hover-1 Dynamo E-Scooters Recalled Due to Brake Failure Risk

    DGL Group is recalling about 4,200 Hover-1 Dynamo e-scooters sold on Walmart.com from November 2021 through July 2022 because the brakes can fail, creating a serious injury and crash hazard. The company has received 22 reports of brake failure resulting in seven injuries.

    Product
    Hover-1 Dynamo E-scooters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24311·2024-07-25

    Lancaster Table & Seating Plastic Restaurant High Chairs Recalled for Fall Hazard

    Clark Associates is recalling about 27,140 Lancaster Table & Seating Standard Height Plastic Restaurant High Chairs because the T-bar at the front can become loose, fall, or break off during use, posing a fall hazard to children.

    Product
    Lancaster Table & Seating Standard Height Plastic Restaurant High Chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·24V560000·2024-07-25

    Nissan Ariya inverter software may shut down the EV system

    Nissan is recalling certain 2023 Ariya vehicles because the inverter software may misdiagnose an error and shut down the EV system, resulting in a loss of drive power.

    Product
    NISSAN — NISSAN ARIYA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24318·2024-07-25

    Victor Electric Folding Soft Bullet Toy Guns Recalled for Eye Injury Hazard

    Victor Electric Folding Soft Bullet Toy Guns sold on Temu.com lack required blaze orange tips and have projectiles that fail to meet federal safety standards for toy weapons. The recalled toy guns pose an eye injury hazard to children.

    Product
    Victor Electric Folding Soft Bullet Toy Guns
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24310·2024-07-25

    ProForm 50 LB Adjustable Dumbbells Recalled for Weight Plate Dislodgement

    iFIT Inc. is recalling ProForm Rapid Strike 50 LB Adjustable Dumbbell Sets because weight plates can dislodge during use, causing impact injuries. The firm has received eight reports of dislodgement, including three resulting in contusions and abrasions.

    Product
    ProForm Rapid Strike 50 LB Adjustable Dumbbell Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24317·2024-07-25

    2024 Arctic Cat Mountain 600 Snowmobiles Recalled Due to Crash Hazard

    Textron Specialized Vehicles is recalling about 600 of the 2024 Arctic Cat Mountain 600 Snowmobiles because a pin on the steering knuckle u-joint may not be properly installed, allowing it to come loose and cause loss of steering control.

    Product
    2024 Arctic Cat Mountain 600 Snowmobiles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24312·2024-07-25

    2024 Kawasaki Mule PRO 1000 Utility Vehicles Recalled for Fire Hazard

    Kawasaki is recalling approximately 19,100 units of the 2024 Mule PRO 1000 utility vehicles due to improper combustion during engine start that can pose a fire hazard. Three fires have been reported with no injuries.

    Product
    2024 Kawasaki Mule PRO 1000 Off-Highway Utility Vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24313·2024-07-25

    Razor Icon Electric Scooters Recalled Due to Fall Hazard

    Razor is recalling about 7,300 Icon electric scooters because the downtube can separate from the floorboard during use, causing falls. The company has received 34 reports of downtube separation with two reported injuries.

    Product
    Razor Icon electric scooters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24316·2024-07-25

    Besrey Twins Strollers Recalled for Entrapment, Fall, and Choking Hazards

    Stiger Inc. is recalling about 3,045 Besrey Twins Strollers sold on Amazon due to entrapment, fall, and choking hazards that violate federal stroller safety regulations. Consumers should stop using the product immediately.

    Product
    Besrey Twins Strollers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·24322·2024-07-25

    Essential Values Golf Grip Solvent Recalled for Deceptive Labeling and Poisoning Risk

    Torquay eTrading is recalling Essential Values Golf Grip Solvent and Golf Grip Kits because they are falsely labeled as "Safe and Non-Toxic" and lack required warnings for petroleum distillates, creating a poisoning risk.

    Product
    Essential Values Golf Grip Solvent and Golf Grip Kits
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·24314·2024-07-25

    Grand Rapids Chair Company Recalls Wood Dining Chairs Due to Fall Hazard

    Grand Rapids Chair Company is recalling approximately 5,670 wood dining chairs that can shift, break, or collapse, posing a fall hazard. The company has received three reports of the chair breaking, though no injuries have been reported.

    Product
    Wood dining chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1483-2024·2024-07-24

    Deluxe Roasted Salted Mixed Nuts recalled for undeclared peanut allergen

    DSD Merchandisers recalls Deluxe Roasted Salted Mixed Nuts (Item 99651) for undeclared peanut allergen, with distribution in six western states and a sell-by date of October 9, 2024. Consumers with peanut allergies should not consume this product.

    Product
    Deluxe Roasted Salted Mixed Nuts ITEM NUMBER 99651 UPC: 6-51433-99651-6 SELL BY: 10/09/2024
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Devices)·Z-2319-2024·2024-07-24

    Abiomed Impella CP with SmartAssist heart pump units recalled for failed inspection

    Abiomed is recalling 9 Impella CP with SmartAssist heart pump units that failed inspection and were inadvertently released. The devices were distributed in Florida, Massachusetts, Ohio, and Texas.

    Product
    Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-2322-2024·2024-07-24

    Volara System Blue Ventilator Adapter Module Handset Plug Disconnection

    Baxter Healthcare is recalling 350 units of the Volara System Blue Ventilator Adapter Module because the handset plug may disconnect from the nebulizer port, disrupting ventilator gas flow. Affected units were distributed nationwide and internationally.

    Product
    Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing device component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2321-2024·2024-07-24

    Ventilation Device Handset Plug May Disconnect from Nebulizer Adapter

    Baxter's Volara System SPU circuit kits may have a faulty handset plug that disconnects from the nebulizer adapter, preventing proper ventilator gas flow.

    Product
    Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent positive pressure breathing device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0604-2024·2024-07-24

    Potassium Chloride Extended-Release Capsules Recalled for Failed Dissolution Specifications

    Glenmark Pharmaceuticals is recalling potassium chloride extended-release capsules (750 mg) nationwide due to failed dissolution specifications. Affected patients should contact their healthcare provider before making any changes to their medication.

    Product
    POTASSIUM CHLORIDE — POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0609-2024·2024-07-24

    StellaLife VEGA Oral Care Spray Recalled for Bacillus Contamination

    StellaLife VEGA Oral Care spray bottles have been recalled due to contamination with multiple Bacillus species organisms. The FDA Class I recall affects 31,811 bottles distributed nationwide to physician offices.

    Product
    STELLALIFE VEGA ORAL CARE — STELLALIFE VEGA ORAL CARE (ARNICA, CALENDULA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, HEPAR SULPH CALC, HYPERICUM, LGNATIA, RUTA, STAPHYSAGRIA)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1477-2024·2024-07-24

    Organic Spring Mix Recalled for Possible Listeria Contamination

    Solata Food LLC is recalling organic spring mix products for potential Listeria monocytogenes contamination. The recall affects products distributed in NY, NJ, and NH with expiration dates 6/20/24 and 6/24/24.

    Product
    1. Greens Gaia Organic Spring Mix; 6x1.7 clamshell; UPC: 850039434075 / 2. Greens Gaia Organic Spring Mix; 6x1.7 clamshell; UPC: 850039434082 / 3. Greens Full Circle Organic Spring Mix; 6x10 clamshell; UPC: 036800490529 / 4. Greens Solata Spring Mix; 6x10 clamshell; UPC: 85002149
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1480-2024·2024-07-24

    Greens Farmer Direct Organic Chopped Kale Spinach recalled for Listeria contamination

    Solata Food LLC is recalling Greens Farmer Direct Organic Chopped Kale Spinach due to potential Listeria monocytogenes contamination. The product may pose a serious health risk.

    Product
    1. Greens Farmer Direct Organic Chopped Kale Spinach; 6x9 bag; UPC: 854311007377 /
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1476-2024·2024-07-24

    Multiple Spinach Products Recalled for Potential Listeria Contamination

    Multiple spinach products from various brands are being recalled due to potential Listeria monocytogenes contamination. The recall affects products distributed in New York, New Jersey, and New Hampshire.

    Product
    1. Greens Solata Spinach; 10x9 bag; UPC: 854311007391 / 2. Greens Full Circle Organic Baby Spinach; 6x10 Clamshell; UPC: 036800490512 / 3. Greens Solata Baby Spinach 6x10 clamshell; UPC: 85002149475 / 4. Greens Gaia Organic Baby Spinach 6x10 clamshell; UPC: 850021494837 / 5. Gre
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1485-2024·2024-07-24

    Terrafina raw macadamia nuts recalled for salmonella contamination

    Terrafina macadamia nuts are being recalled because they tested positive for salmonella. The product was distributed in New Jersey and New York.

    Product
    Terrafina, Macadamia in the Raw , Net Wt. 6oz , (170 g)
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1493-2024·2024-07-24

    Aahu Barah Apricot Roll recalled for undeclared elevated sulfites

    Aahu Barah Apricot Roll (14 oz, UPC 882475000279) is being recalled because it contains elevated levels of undeclared sulfites. Consumers with sulfite sensitivity should not consume this product.

    Product
    Aahu Barah Apricot Roll; 14 oz; sold in clear plastic bags (6 inch x 8 inch) packing with the Aaha Barah label on the front and back; the product is labeled "Apricot Roll" on both the front and back; UPC 882475000279; label states "May Contain Sulfites As preservatives"
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-1481-2024·2024-07-24

    Spring Mix Herb Products Recalled for Potential Listeria monocytogenes Contamination

    Solata Food LLC is recalling three brands of spring mix herb products sold in NY, NJ, and NH due to potential contamination with Listeria monocytogenes, a bacterium that can cause serious illness.

    Product
    1. Greens Gaia Organic Spring Mix Herb; 8x45 clamshell; UPC: 850021494896 / 2. Greens Solata Spring Mix Herb; 8x5 clamshell; UPC: 854311007063 / 3. Greens Uncle Vinny's Spring Mix Herb; 8x5 clamshell; UPC: 804879459965
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1479-2024·2024-07-24

    Greens products recalled for potential Listeria monocytogenes contamination

    Solata Food LLC is recalling multiple brands of greens products distributed in NY, NJ, and NH due to potential Listeria monocytogenes contamination. Affected products, totaling 4,382 lbs with expiration dates of June 20–24, 2024, should not be consumed.

    Product
    1. Greens Solata 5050; 6x10 clamshell; UPC: 850021494766 / 2. Greens Gaia Organic 5050; 6x10 clamshell; UPC: 850021494827 / 3. Greens Gaia Organic 50/50 blend; 8x45 clamshell; UPC: 850021494919 / 4. Greens Gaia Organic 50/50; 8x45 clamshell; UPC: 850021494957 / 5. Greens Full Ci
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1478-2024·2024-07-24

    Power Greens Products Recalled Due to Listeria monocytogenes Contamination Risk

    Solata Food LLC is recalling multiple Power Greens products due to potential Listeria monocytogenes contamination. Affected products were distributed in NY, NJ, and NH with expiration dates of 6/20/24 and 6/24/24.

    Product
    1. Greens Full Circle Organic Power Greens; 6x10 Clamshell; UPC: 036800490550 / 2. Greens Gaia Organic Power Greens; 8x45 clamshell; UPC: 850021494889 / 3. Greens Full Circle Organic Power Greens; 8x5 clamshell; UPC: 036800388758 / 4. Greens Solata Power Greens; 8x5 Clamshell; U
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-0602-2024·2024-07-24

    Cardura XL Tablets Recalled for Failed Impurities and Degradation Specifications

    Viatris Inc is recalling Cardura XL (doxazosin) 4mg tablets due to failed impurities and degradation specifications. The recall affects 12,691 bottles distributed nationwide.

    Product
    Cardura XL (doxazosin) extended release tablets 4mg, 30-count bottles, Rx Only, Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2040-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2393-2024·2024-07-24

    IV Infusion Pump Set Backcheck Valve Malfunction Recall

    B. Braun Medical recalls Infusomat UNIV. 15 DROP PUMP SET due to backcheck valve malfunction that could cause medication backflow and loss of medication, resulting in adverse drug reactions.

    Product
    Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363433
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1501-2024·2024-07-24

    Canned black coffee and maple syrup beverage recalled for potential under-processing

    Snapchill, LLC is recalling Mud LLC Maple Mud canned black coffee with maple syrup beverages (12 oz, UPC 854555007058) nationwide and in Canada due to potential under-processing. Affected products have expiration dates from June 16, 2024 to April 16, 2025.

    Product
    Black Coffee + Maple Syrup Canned Beverage packaged under the following brands and sizes: 1. Mud LLC Maple Mud, 12 oz. UPC 8 54555-00705 8.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2386-2024·2024-07-24

    Infusion Pump Set Recalled for Potential Backcheck Valve Malfunction and Medication Backflow

    B. Braun's Infusomat UNIV. 15 IV infusion pump set is being recalled due to a potential backcheck valve malfunction that could cause medication to backflow from secondary into primary IV containers, potentially resulting in patient injury.

    Product
    Infusomat UNIV. 15 DROP PUMP SET W/3 SAFELINE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363030
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0600-2024·2024-07-24

    Cyanocobalamin Injection Vials Recalled for Glass Particulate Contamination

    Zydus Pharmaceuticals recalls 432,250 vials of Cyanocobalamin Injection USP due to glass particulate matter. Affected vials are distributed in Tennessee.

    Product
    Cyanocobalamin Injection, USP, 1,000mcg/mL, 1 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN, 38141, Mfd. in India, NDC 16714-165-01.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0597-2024·2024-07-24

    FDA Recalls Nitrofurantoin Capsules Due to Failed Dissolution Specifications

    Sun Pharmaceutical recalls Nitrofurantoin Capsules (100 mg) due to failed dissolution, affecting medication effectiveness. The recall involves 5,752 bottles nationwide in lots 231067 and 231069.

    Product
    NITROFURANTION — NITROFURANTION (NITROFURANTION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2372-2024·2024-07-24

    UNITRAX Hip Endoprosthesis Head Components Mislabeled with Incorrect Package Sizes

    Howmedica Osteonics Corp. is recalling UNITRAX Endoprosthesis Head Components because the package label size may not match the actual device inside. Mislabeling could result in the wrong implant size being used during hip surgery.

    Product
    UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-038
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2380-2024·2024-07-24

    Infusomat IV Pump Set Recalled for Backcheck Valve Malfunction

    The Infusomat 60DROP METRISET PUMP SET may experience backcheck valve malfunction, causing medication to flow backward between IV containers and loss of medication. This could result in adverse drug reactions or inability to administer medication properly.

    Product
    Infusomat 60DROP METRISET PUMP SET, 3 SAFELINE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362034
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1507-2024·2024-07-24

    Canned Coffee Beverage Recalled Due to Potential Under-Processing

    Snapchill, LLC is recalling approximately 549,146 cans of Perkatory Coffee Roasters Three Witches Blend due to potential under-processing. Affected cans have expiration dates between June 16, 2024 and April 16, 2025.

    Product
    Coffee + Non-Dairy Creamer + Sugar + Pumpkin Spice Syrup Canned Beverage packaged under the following brands and sizes: 1. Perkatory Coffee Roasters Three Witches Blend, 12 oz. UPC 8 50044-13023 8.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2374-2024·2024-07-24

    BD Pyxis Automated Dispensing Cabinets Software Error Prevents Medication Access

    BD Pyxis automated dispensing cabinets with ES 1.7.x software may display errors preventing medication access when Component Manager is in 'installed mode' and patch KB 5033688 is applied.

    Product
    BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: 327; CII Safe ES, REF: 1116-00; CII Safe ES, Desktop PC, Wired Scanner, REF: 107-254-01; CII Safe ES, Desktop PC, Wireless Scanner, REF: 107-255-01; CII Safe ES, Desktop PC,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2390-2024·2024-07-24

    Infusion Pump Set Recalled Due to Valve Malfunction Risk

    B. Braun's Infusomat UNIV. 60 infusion pump sets are recalled due to backcheck valve malfunction that may cause medication backflow from secondary to primary IV bags, risking adverse drug reactions or medication loss.

    Product
    Infusomat UNIV. 60 DROP PUMP SET, 2 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363423
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0611-2024·2024-07-24

    Potassium Chloride Extended Release Capsules Recalled for Dissolution Defect

    RemedyRepack Inc. is recalling Potassium Chloride Micro 10mEq K Extended Release Capsules because they fail to meet dissolution specifications, which could affect medication effectiveness.

    Product
    Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count blister card, Rx only, MFG: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1203-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2371-2024·2024-07-24

    Hip Prosthesis Component Mislabeled; Package Size May Not Match Device

    Howmedica Osteonics is recalling 18 units of UNITRAX Endoprosthesis Head Components due to mislabeled package sizes. The label may not match the actual device size inside.

    Product
    UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-042
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2396-2024·2024-07-24

    Infusomat SPACE IV infusion sets recalled for backcheck valve malfunction

    Infusomat SPACE IV infusion sets are recalled due to a backcheck valve defect that may cause medication to flow backward into primary IV bags, potentially resulting in medication loss or adverse drug reactions.

    Product
    Infusomat SPACE PUMP IV SET 15D, 90 IN. Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number 480263
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1504-2024·2024-07-24

    Canned Coffee Beverages Recalled for Potential Under-Processing Risk

    Snapchill is recalling 549,146 cans of Heine Brothers Coffee Toasted Coconut for potential under-processing. Products were distributed nationwide and in Canada with expiration dates from June 2024 through April 2025.

    Product
    Coffee + Non-Dairy Creamer + Sugar + Coconut Syrup Canned Beverage packaged under the following brands and sizes: 1. Heine Brothers Coffee Toasted Coconut, 8 oz. UPC 8 10149-37052 6. 2. Heine Brothers Coffee Toasted Coconut, 7.5 oz. UPC 8 10149-37093 9.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2349-2024·2024-07-24

    Cascade IOMAX Cortical Module recalled for defective circuit board

    Cascade IOMAX Cortical Module devices are recalled due to a defective printed circuit board that may cause unintended electrical stimulation. Affected units were distributed in the U.S. and internationally.

    Product
    Cascade IOMAX Cortical Module, REF: 190296-200
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2394-2024·2024-07-24

    Infusomat SPACE Pump IV Sets Recalled for Backcheck Valve Malfunction

    B. Braun's Infusomat SPACE Pump IV sets are recalled due to a potential backcheck valve malfunction that could cause medication backflow and inability to prime. The defect affects approximately 109,464 units distributed in the US and Canada.

    Product
    Infusomat SPACE PUMP IV SET 15D, 110 IN. -Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 480254
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2355-2024·2024-07-24

    Knee walker recalled for tiller separation that may cause falls

    Medical Depot is recalling the Nitro Glide Knee Walker (model 791RD) because the tiller can separate from the base assembly, potentially causing users to fall. The recall affects 667 units distributed nationwide and in Canada.

    Product
    Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain mobile and glide through their daily activities. Model: 791RD (Red)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2408-2024·2024-07-24

    High Flow Insufflation Tubing Recalled for Incomplete Seals

    Canadian Hospital Specialties is recalling HIGH FLOW INSUFFLATION TUBING with incomplete seals that may result in non-sterile product. The defect affects 6,300 units and poses patient safety concerns.

    Product
    Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator
    Category
    Medical Device
    Distribution
    Distributed nationwide

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