Archive
524 recalls were announced in January 2024.
Of the 524 recalls this month scored against our rubric, 2% are Critical, 25% are Severe.
Which agencies issued them
All lots of Peanut Butter Fudge sold in Iowa are recalled due to undeclared egg allergen. The manufacturer initiated the voluntary recall.
Olympus is updating instructions for the VISERA Cysto-Nephro Videoscope (Model CYF-V2) nationwide, removing reusable brushes from manual cleaning procedures. Single-use brushes remain compatible.
Bard is recalling Mission Disposable Core Biopsy Instrument Kits due to dimensional issues that may prevent the biopsy needle from fitting properly into the cannula, potentially causing tissue injury and prolonging procedures.
The SPRYSTEP VECTOR KAFO custom ankle-foot orthosis is being recalled by Townsend Design due to air pockets that could cause complete structural failure.
The XScribe CP Cardiac Stress Testing System (version 6) is being recalled because it may produce distorted electrocardiogram readings when the Source Consistency Filter is enabled, which could affect the accuracy of cardiac test results.
Ambu is recalling the aView 2 A Monitor due to fire and burn hazards if mounting screws longer than 16mm are used. Improper installation can penetrate the lithium-ion battery, causing fires, severe burns, and smoke inhalation.
Two Olympus ENDOEYE HD II Rigid Videoscope catalog numbers (WA50040A, WA50042A) have been recalled due to reports of pink or green image discoloration during use. The issue could require device exchange during surgery and potentially result in visual impacts or bleeding.
Heartland is recalling 2024 Corterra fifth wheels because certification labels may have missing or incorrect tire size information, potentially leading to the installation of wrong tires.
Medline is recalling 2,100 Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 surgical gowns because they were manufactured with the wrong sleeve. The affected gowns were distributed to healthcare facilities in Maryland, Ohio, Tennessee, Texas, and Wisconsin.
Medtronic is recalling 4,235 percutaneous surgical pins that may have a manufacturing defect preventing proper fit into or removal from the tap cap. The pins were distributed nationwide and internationally.
Philips is recalling BrightView Gamma Camera Systems because a gap can form between patient support and detector during quality assurance scans, creating an extremity entrapment hazard that may cause fractures or crush injuries.
Bard Peripheral Vascular is recalling BD Recanalization Systems due to a manufacturing defect that may allow continuous operation without required safety warnings, increasing risk of device overheating or breaking during patient treatment.
Philips is recalling Incisive CT scanners due to nine software defects including image artifacts, incorrect orientation labels, display failures, and positioning errors that could lead to misdiagnosis or need for rescans. No illnesses have been reported.
Icotec is recalling VADER pedicle system torque wrenches because the torque limiting function can malfunction, potentially leaving screw fasteners insufficiently tightened during implant surgery.
Ingomar Packing Co is recalling diced tomatoes in juice due to possible plastic contamination. Affected product was distributed to California, Washington, and Japan.
BD Biosciences is recalling CD11b APC diagnostic reagent vials that may produce dim fluorescence signals, potentially causing false negative results and misdiagnosis of blood cancers.
BioFire FILMARRAY GI Panel diagnostic test kits may return false negative results due to a manufacturing event, potentially leading to missed diagnoses and inappropriate treatment. The affected kits were distributed to locations in 16 U.S. states.
Olympus Corporation recalls 1,403 ENDOEYE Flex endoscopic videoscopes due to deviations in reprocessing instructions. Affected devices may not be reprocessed properly for safe reuse in surgical procedures.
Medtronic is recalling NIM TriVantage EMG Endotracheal Tubes worldwide for noise, lead-off issues, high impedance, and loss of or intermittent nerve monitoring. The 80,569 affected units may fail to provide reliable nerve monitoring function.
Baxter Healthcare Corporation is recalling 2,985 units of the XScribe Cardiac Stress Testing System, version 6, due to potential distortion in electrocardiogram readings when the Source Consistency Filter is enabled. No injuries have been reported.
Abiomed Introducer Kits may have holes in outer pouches that compromise sterility, exposing patients to bacterial contamination and risk of infection, bacteremia, or sepsis.
Abiomed Axillary Insertion Introducer Kits have holes in the outer pouch that may compromise sterility, potentially exposing patients to serious infections including bacteremia and sepsis.
Lupin Pharmaceuticals is recalling Desloratadine 5mg tablets distributed nationwide because N-Nitroso impurity levels exceeded acceptable limits. Affected lots expire in January 2024.
Abbott ARCHITECT c4000 Processing Module laboratory analyzers are recalled due to unlabeled dry natural rubber (latex) subcomponents. Individuals with latex allergies may experience allergic reactions if exposed to the undisclosed component.
Philips Ingenia Ambition X and S MRI systems may experience uncontrolled shutdown of the sealed magnet if cryo-cooling is lost due to power outages. This could disrupt patient scans and operations.
Abiomed is recalling Introducer Kits (part 0052-3021) with holes in the outer pouch that compromise the sterile barrier, potentially exposing patients to infection. The kits were distributed nationwide and internationally.
Dr. Reddy's Laboratories is recalling Tizanidine 4mg tablets due to the presence of 2mg tablets in bottles. About 38,952 bottles were distributed nationwide.
Abiomed is recalling 84 introducer kits that may have holes in the outer pouch, compromising the sterile barrier. This exposes patients to microbial contamination and risk of serious infections including bacteremia and sepsis.
Olympus has updated cleaning instructions for the Model CYF-VH Cysto-Nephro Videoscope. Reusable cleaning brushes are no longer recommended for manual cleaning; single-use brushes remain compatible.
Boston Scientific is recalling pacemaker programmer software that displays certain diagnostic dates incorrectly, with dates showing years in the 1990s. Affected diagnostic information may impact clinical monitoring.
Philips BrightView X gamma cameras may create a gap between patient support and detector during quality assurance scans, potentially trapping a patient's extremity.
Medtronic is recalling 4,224 REF 9733236 percutaneous pins due to a manufacturing defect that may prevent proper fitting or cause difficult removal. Affected devices were distributed worldwide.
Icotec Ag is recalling VADER pedicle system torque wrenches (Catalog Number 42-702) because the torque limiting function may malfunction, potentially leaving nut screws insufficiently tightened during implant surgery. No injuries have been reported.
Ingomar Packing Co is recalling 3/4" diced tomatoes in juice sold in 55-gallon drums due to potential plastic contamination. Affected products were distributed to California, Washington, and Japan.
Rising Pharma Holdings is recalling 47,976 bottles of Bupropion Hydrochloride 150mg tablets nationwide due to foreign tablets or capsules found in some bottles. Consumers should stop use and contact their pharmacist immediately.
BioFire Diagnostics recalls 57 kits of the BIOFIRE Respiratory Panel 2.1 due to a manufacturing defect that may produce false negative results, potentially causing treatment delays or missing infections.
Abbott Laboratories is recalling 1,325 Alinity i Processing Module systems due to unlabeled dry natural rubber (latex) subcomponents. Users with latex allergies may be at risk of exposure.
Abiomed is recalling its Oscor Introducer Kit due to holes in the outer pouch that may compromise the sterile barrier. Non-sterile introducers could expose patients to infection, bacteremia, or sepsis.
Abbott Laboratories is recalling 1,127 Alinity c Processing Module chemistry analyzers because unlabeled latex subcomponents are present. Users with latex allergies may experience serious allergic reactions upon contact.
Baxter Healthcare is recalling marketing materials for its Vascu-Guard Peripheral Vascular Patch because a cardiovascular surgery brochure contains inaccurate content conflicting with official Instructions for Use and Prescribing Information.
The Scoot Control R-net wheelchair attendant controller's throttle lever may stick and fail to return to neutral, potentially causing unwanted chair movement. A total of 129 units were distributed in Tennessee and Texas.
Immunostics is recalling H. Pylori diagnostic test kits due to mislabeled expiration dates. Using the product after expiration may produce false positive, false negative, or invalid results.
Baxter Healthcare has recalled a marketing brochure for its Preveleak Surgical Sealant due to inaccurate content that does not align with the product's Instructions for Use. Healthcare providers and consumers should consult the accurate product Instructions for Use and Prescribing Information.
Townsend Design is recalling 248 units of CUSTOM SPRYSTEP ankle-foot orthotics for potential air pockets that could cause complete structural failure and loss of ankle support.
Abiomed is recalling Oscor Intro Introducer Kits due to holes in the outer pouch that may compromise the sterile barrier, potentially exposing patients to harmful bacteria and infections including bacteremia and sepsis.
Abiomed is recalling introducer kits due to holes in the outer pouch that compromise the sterile barrier. Non-sterile product could allow microbial contamination, leading to infection such as bacteremia or sepsis.
Olympus Corporation is recalling 271 ENDOEYE Flex Deflectable Videoscopes due to deviations in reprocessing instructions. Proper sterilization procedures are critical for safe endoscopic use.
Philips BrightView XCT gamma cameras may pose an extremity entrapment hazard during certain scanning operations. A gap can form between the patient support and detector, risking fractures, lacerations, and crush injuries.
The Q-Stress Cardiac Stress Testing System version 6 may distort electrocardiogram (ECG) readings when the Source Consistency Filter is enabled. Healthcare facilities should verify ECG readings and consult product documentation.
Abiomed Oscor Introducer Kits may have holes in the outer pouch that compromise sterility. This could allow bacteria to enter the patient's bloodstream during catheter insertion.
Dr. Reddy's Laboratories is recalling 8,280 bottles of Tacrolimus 1 mg capsules after a 0.5 mg capsule was found in a bottle. The wrong-strength capsule could cause dosage confusion.
Townsend Design is recalling the SPRYSTEP VECTOR custom ankle-foot orthosis due to potential air pockets between material layers that could cause complete structural failure. Users should stop using the device and contact the manufacturer.
Siemens is recalling 331 units of the Sensis Vibe Hemo medical device due to a potential software crash in its documentation functionality application. Units affected are distributed in California, Connecticut, and Florida.
SoClean, Inc is voluntarily recalling 40,075 units of the SoClean 3 sleep equipment cleaner due to potential ozone gas exposure. The manufacturer is providing an updated user manual with safety instructions and a protective hose and mask adapter.
Abiomed introducer kits may have holes in the outer pouch, compromising sterility and exposing patients to potential microbial contamination. This could lead to serious infections including bacteremia or sepsis.
Abiomed is recalling Introducer Kits because holes in the outer pouch may compromise the sterile barrier, risking bacterial infection. The kits are distributed nationwide and internationally.
Newmar is recalling certain 2016–2023 motorhomes because seat pedestal mounting plates may be improperly welded, risking seat loosening or detachment and increasing injury risk.
Baxter Healthcare is recalling marketing materials for the Flo-Thru Intraluminal Shunt due to inaccurate content that does not match the product's official instructions for use or prescribing information.
Baxter Healthcare is recalling Flo-Rester internal vessel occluders because marketing materials contain inaccurate information that doesn't match the product's Instructions for Use and Prescribing Information.
Baxter Healthcare Corporation is recalling PERI-GUARD SUPPLE surgical devices because the marketing brochure contains inaccurate content that does not align with the products' actual Instructions for Use.
Cordis US Corp is recalling MYNXGRIP 5F vascular closure devices due to incorrect labeling on carton boxes. The carton labels between two lots were swapped; however, the individual device labels remain correct.
Blue Belt Technologies is recalling 1,859 CORI REAL INTELLIGENCE Robotic Drills (models ROB10013 and ROB10013S) because users cannot resolve drill disconnection error messages. No illnesses or injuries have been reported.
Olympus has updated cleaning instructions for the EVIS EXERA III Bronchovideoscope. Reusable brushes are no longer approved for manual cleaning; only single-use brushes should be used.
Olympus updated cleaning instructions for the Model CYF-VHR Cysto-Nephro Videoscope. Reusable brushes have been removed from manual cleaning procedures; single-use brushes remain compatible.
Shirakawa Olympus Co., Ltd. is updating cleaning instructions for the Model CYF-5R Cystonephrofiberscope. Reusable cleaning brushes have been removed from manual cleaning procedures; single-use brushes remain approved.
Baxter Healthcare is recalling marketing materials for the Ostene Hemostasis Material due to inaccuracies that do not align with the product's official Instructions for Use and Prescribing Information.
Shirakawa Olympus updated cleaning instructions for VISERA Cysto-Nephro Videoscopes, recommending removal of reusable brushes from manual cleaning procedures. Single-use brushes remain compatible.
Ortho-Clinical Diagnostics is recalling QMS Tacrolimus Calibrators Lot 74859619 due to improper storage that degrades product quality, potentially causing erroneous test results and testing delays.
Shirakawa Olympus has updated cleaning instructions for the Model CYF-5 cystonephrofiberscope, removing reusable cleaning brushes from the manual cleaning protocol while single-use brushes remain compatible.
SoClean is recalling its SoClean 2 hose and mask maintenance system to reduce potential ozone gas exposure risks. An updated user manual and replacement adapter will be provided by the manufacturer.
Baxter Healthcare Corporation is recalling Coseal Premix Surgical Sealant due to inaccurate information in a marketing brochure that conflicts with the product's Instructions for Use and Prescribing Information.
Baxter is recalling marketing materials for Vascu-Guard Peripheral Vascular Patch because a brochure contains inaccurate information that conflicts with the product's official instructions and prescribing information.
Baxter Healthcare is recalling a cardiovascular surgery marketing brochure for Baxter Floseal Hemostatic Matrix Fast Prep because it contains inaccurate content that does not match the official product instructions and prescribing information.
Cordis recalled 70 units of MYNXGRIP vascular closure devices due to carton label errors affecting two lots. Carton boxes were labeled incorrectly, though individual device labels are correct.
Shiloh Farms recalled 534 cases of Bread for Life Organic 7 Grain due to labeling error: cholesterol and sodium daily values listed in grams instead of milligrams. Product content is accurate.
Baxter Healthcare recalls a marketing brochure for Peri-Guard Repair Patch because it contains inaccurate information that does not match the product's Instructions for Use.
Shirakawa Olympus is recalling instructions for the Model ENF-XP Rhino-Laryngofiberscope. Reusable cleaning brushes have been removed from the manual cleaning procedure; single-use brushes remain compatible.
Baxter Healthcare is recalling its Vascular Probe due to inaccurate marketing materials that do not align with the product's official Instructions for Use. Providers should reference only the official IFU and PI.
Vita 360, LLC is recalling SUPREX Plant Based Nutrition Carb & Sugar Block supplements (Lot #2633) because FDA testing found chromium content at only 16% of the declared amount.
A Baxter marketing brochure for FloSeal Hemostatic Matrix contains inaccurate content that does not match the product's official Instructions for Use and Prescribing Information.
Baxter Healthcare Corporation is recalling Baxter FloSeal Hemostatic Matrix RECOTHROM products because the marketing brochure contains inaccurate information that does not align with the product's official Instructions for Use and Prescribing Information.
Shirakawa Olympus has updated cleaning instructions for the EVIS EXERA III bronchovideoscope. Reusable brushes are no longer approved for manual cleaning; single-use brushes remain compatible.
Baxter Healthcare recalls Peri-Guard Repair Patch due to cardiovascular surgery marketing brochure containing inaccurate content that does not align with the product's Instructions for Use.
Garden Spot Foods recalls Shiloh Farms Organic Salt Free 7 Grain Bread due to incorrect units on the nutrition label. Daily cholesterol and sodium values are listed in grams instead of milligrams, though the product content itself is accurate.
Shiloh Farms Organic 7 Grain Bread mistakenly displays cholesterol and sodium values in grams instead of milligrams on its nutrition label. The actual product content is accurate and safe.
PACCAR is recalling certain 2022-2024 Peterbilt and Kenworth trucks because the glass lock ring on the cab mirror assembly may not be fully seated, allowing the mirror glass to detach and reduce driver visibility.
E-One is recalling 280 fire apparatus vehicles because an incorrectly machined steering assist bracket may reduce hydraulic force, increasing steering effort and crash risk.
General Motors is recalling 2022 BrightDrop EV600 vehicles because the front-drive unit may leak oil, creating a risk of engine compartment fire.
Daikin Comfort Technologies Manufacturing is expanding its recall of evaporator coil drain pans that can overheat, melt, and deform, creating a fire hazard. The expansion includes about 3,600 additional units manufactured between January 2019 and February 2020 that were incorrectly marked with a 2018 serial number.
SVI Trucks is recalling Command Light Towers and Traffic Flowboards with specific Weldon nodes because a wiring failure could cause an electrical fire.
Villa International is recalling seat pedestals with part number 400029 because improper welding may cause the seat assembly to loosen or detach.
Altec is recalling certain 2004-2023 AT Series aerial devices because cables in the engine compartment may contact the hood, damaging the cables and causing a short circuit that increases fire risk. Free repair available through Altec.
Plastic New Age furniture tip restraint kits can break or become brittle, allowing anchored clothing storage units to detach and tip over, creating a hazard to children. Consumers should check manufacture dates and contact Alliance4Safety for free replacements.
Retrospec is recalling Scout model kid's bike helmets due to inadequate impact protection that violates the federal safety regulation for bicycle helmets. About 72,000 units sold between February 2019 and March 2023 are affected.
Boot Royalty is recalling about 3,200 Justin Boots Keaven WP Met Guard Work Boots (Model SE4570) because the metatarsal guard may be missing, creating a crush hazard to the wearer's feet. One injury has been reported.
Busse Hospital Disposables is recalling tracheostomy care kits due to failed sterility assurance. The affected product cannot guarantee required sterility levels and poses risks of infection and sepsis.
ROi CPS LLC is recalling Regard Dressing change kits (Item 800026006) due to a defective irrigation solution component. Approximately 1,830 units distributed in Louisiana are affected.
Busse Hospital Disposables is recalling tracheostomy care kits containing Nurse Assist Sterile Normal Saline because the required sterility assurance level cannot be guaranteed. Contaminated products could cause serious infections including bloodstream, respiratory, and urinary tract infections, or sepsis.
Samsung Bean Sprout is recalling Sung Soy Bean Sprouts (1lb packages) distributed to Virginia due to Listeria monocytogenes contamination. Products have a sell-by date of 12/14/23.
The Omnipod 5 app bolus calculator may fail to record a decimal point if entered first when adjusting a dose, potentially causing insulin over-delivery. Users should verify dose values on both the calculator and confirmation screens before administering insulin.
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