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All product recalls affecting South Dakota.
Includes nationwide recalls (tagged “Nationwide”) and recalls with South Dakota in the distribution area.
This recall involves Leatherman Charge Plus and Charge Plus TTi multi-tools. The Charge Plus multi-tools come in black and stainless-steel colors and with a black MOLLE or black nylon sheath. The Charge Plus TTi multi-tools were sold in a stainless-steel color with a black nylon sheath. The name "Leatherman" is etched on the product.
This recall involves four different styles of Baby Loren Morning children's 100% cotton loungewear dresses. The loungewear was sold in floral tulips, princess and castle and unicorn and butterfly prints and in sizes 2T, 3T, 4T, 5Y and 6Y. The Baby Loren logo, the size, "October 2022" or "October 2023" and a batch number ending in 3465, 3585, 3599 or 3569 are printed on sewn-in neck labels.
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
The potential of the elastic bands included in the kit detaching or fracturing during surgical procedures. As a result, these failures may pose a risk of retained foreign bodies in the surgical cavity and potentially leading to surgical site infections.
Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
Storyteller Overland, LLC (Storyteller) is recalling certain 2023 Mode LT recreational vehicles. The exterior shore power inlet may have been improperly tightened.
Due to a classification error in the inventory management system, specific medical devices were shipped to customers that did not have the requisite license to purchase such devices.
Premier Trailer Solutions LLC (Premier Trailer) is recalling certain 2024 Reel and Pole trailers. The oil seals may have been improperly installed, allowing oil to leak onto the brake system.
Dental implants were imported under temperature and storage conditions that do not comply with the instructions for use and product labeling so there may be packaging damage, which could compromise product quality and performance.
Brinkley RV (Brinkley) is recalling certain 2025 Model Z trailers. The electrical wiring may not be secured properly, which can result in damaged wiring and a short circuit.
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Units may have been packaged with an incorrect pouch label, which lists the reference number and unique device identifier of the 4F version of the device, rather than the packaged 6F version.
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Mack Trucks, Inc. (Mack) is recalling certain 2026 Mack GR trucks. The brake drum and steer axle combination are incompatible, which may cause a loss of brake function. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard (FMVSS) number 121, "Air Brake Systems."
Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.
VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lots from coating 0130 and above with Condition Code TH4-63J during calibration, causing the delay of lac test results and potentially impact patient management. The issue was identified by QuidelOrtho through an increase in customer complaints compared to the historical baseline with average failure rate of 1% for coating 0130 in 2025 while average of failure rate for other coating was 0.06% in 2025 and average of failure rate for all coatings is 0.03% for 2024.
Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.