Recalls in South Dakota (page 10)
3823 recalls.
- Medline convenience kits labeled as: 1) MAJOR GYN PACK recall (Medline Industries, LP)
Medical deviceClass IIReported September 2, 2026 · Kits contain a potentially contaminated component which were recalled by the manufacturer - Medline convenience kits labeled as: LTP CDS-LF recall (Medline Industries, LP)
Medical deviceClass IIReported September 2, 2026 · Kits contain a potentially contaminated component which were recalled by the manufacturer - Medline convenience kits labeled as: 1) MAJOR PROCEDURE recall (Medline Industries, LP)
Medical deviceClass IIReported September 2, 2026 · Kits contain a potentially contaminated component which were recalled by the manufacturer - Medline convenience kits labeled as: MAJOR HEAD AND NECK PPS recall (Medline Industries, LP)
Medical deviceClass IIReported September 2, 2026 · Kits contain a potentially contaminated component which were recalled by the manufacturer - Medline convenience kits labeled as: 1) OPEN HEART PACK recall (Medline Industries, LP)
Medical deviceClass IIReported September 2, 2026 · Kits contain a potentially contaminated component which were recalled by the manufacturer - Medline convenience kits labeled as: 1) FEMORAL PACK recall (Medline Industries, LP)
Medical deviceClass IIReported September 2, 2026 · Kits contain a potentially contaminated component which were recalled by the manufacturer - CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B... recall (ConMed Corporation)
Medical deviceClass IIReported September 2, 2026 · Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability. - Fresenius Medical Care recall (Fresenius Medical Care Renal Therapies Group, LLC)
Medical deviceClass IIReported September 2, 2026 · Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T¿ ... - Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm recall (Henry Schein Inc.)
Medical deviceClass IIReported September 2, 2026 · Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device. - Structur 2 SC Temporary Resin Cartridge Refill 75Gm recall (Henry Schein Inc.)
Medical deviceClass IIReported September 2, 2026 · Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device. - Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital... recall (Canon Medical System, USA, INC.)
Medical deviceClass IIReported September 2, 2026 · Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose. - Midmark Digital ECG HD+12 recall (Midmark Corporation)
Medical deviceClass IIReported September 2, 2026 · A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation. - Midmark IQecg Digital ECG recall (Midmark Corporation)
Medical deviceClass IIReported September 2, 2026 · A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation. - Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 recall (AVID Medical, Inc.)
Medical deviceClass IIReported September 2, 2026 · Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. - Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 recall (AVID Medical, Inc.)
Medical deviceClass IIReported September 2, 2026 · Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. - Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 recall (AVID Medical, Inc.)
Medical deviceClass IIReported September 2, 2026 · Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. - Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 recall (AVID Medical, Inc.)
Medical deviceClass IIReported September 2, 2026 · Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. - Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 recall (AVID Medical, Inc.)
Medical deviceClass IIReported September 2, 2026 · Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. - Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 recall (AVID Medical, Inc.)
Medical deviceClass IIReported September 2, 2026 · Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. - Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY... recall (AVID Medical, Inc.)
Medical deviceClass IIReported September 2, 2026 · Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. - Merge PACS and Merge OrthoPACS recall (Merge Healthcare, Inc.)
Medical deviceClass IIReported September 2, 2026 · Software issue may cause measurements to be displayed inaccurately. - American Contract System Convenience Kit recall (American Contract Systems Inc)
Medical deviceClass IIReported September 2, 2026 · The Convenience Kits contain Medline's Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has... - American Contract System Convenience Kits recall (American Contract Systems Inc)
Medical deviceClass IIReported September 2, 2026 · The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has... - American Contract System Convenience Kit recall (American Contract Systems Inc)
Medical deviceClass IIReported September 2, 2026 · The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has... - American Contract System Convenience Kit recall (American Contract Systems Inc)
Medical deviceClass IIReported September 2, 2026 · The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has... - Medline medical convenience kit labeled as: TRACH TUBE KIT recall (Medline Industries, LP)
Medical deviceClass IIReported September 2, 2026 · Component labeling discrepancy - Onli 17cm Hydrophilic Urethral Intermittent Catheter recall (Hollister Ulc)
Medical deviceClass IIReported September 2, 2026 · Hollister has identified that select lots of the catheters identified in the above table may exhibit a protrusion caused by a manufacturing defect which might... - Medline medical convenience kits recall (Medline Industries, LP)
Medical deviceClass IIReported September 2, 2026 · Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential... - Medline medical convenience kits recall (Medline Industries, LP)
Medical deviceClass IIReported September 2, 2026 · Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential... - Medline medical convenience kits recall (Medline Industries, LP)
Medical deviceClass IIReported September 2, 2026 · Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential... - Medline medical convenience kits recall (Medline Industries, LP)
Medical deviceClass IIReported September 2, 2026 · Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential... - Medline breathing circuits labeled as: 1) MEDLINE HUDSON RCI recall (Medline Industries, LP)
Medical deviceClass IIReported September 2, 2026 · Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit... - Medline breathing circuits labeled as: 1) HUDSON RCI recall (Medline Industries, LP)
Medical deviceClass IIReported September 2, 2026 · Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit... - Medline Hudson RCI recall (Medline Industries, LP)
Medical deviceClass IIReported September 2, 2026 · Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit... - Philips Incisive CT with software V4.5&V5.0 recall (Philips Healthcare (Suzhou) Co., Ltd.)
Medical deviceClass IIReported September 2, 2026 · Potential of failing to trigger clinical scan during Bolus Tracking. - Montessori Baby Toy Sets Recalled Due to Risk of Serious Injury or Death from Choking; Violate Mandatory Standard for Toys; Sold on Amazon by Chillife Official
Consumer productReported August 27, 2026 · The recalled baby toy sets contain a pull string teething toy that violates the mandatory standard for toys because the silicone strings are smaller and longer... - Walmart Reannounces Recall of Mainstays Nine-Drawer Fabric Dressers Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Walmart Distributed Recalled Dressers Post-Recall; Sold to Consumers Through Liquidators
Consumer productReported August 27, 2026 · The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risk of serious injuries or... - Pressure Washers Recalled Due to Serious Risk of Injury or Death from Shock and Electrocution Hazards; Sold on Amazon by YERYORK
Consumer productReported August 27, 2026 · The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI) and an adequate-length power cord, posing serious risks of injury or... - Little Loves & Co. Recalls Youth Clothing with Drawstrings Due to Risk of Serious Injury or Death from Entrapment Hazard
Consumer productReported August 27, 2026 · The drawstrings in the recalled clothing can get caught on objects and cause death or serious injury to children due to an entrapment hazard. - Steelite Pressure Washers Recalled Due to Risk of Serious Injury or Death from Shock and Electrocution Hazards; Sold on Amazon by Longer 3D
Consumer productReported August 27, 2026 · The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI) and an adequate-length power cord, posing a risk of serious injury or... - Excel Industries Recalls Accessory LED Light Kits Due to Risk of Serious Injury from Fire Hazard
Consumer productReported August 27, 2026 · The light bars can overheat or produce flames, posing a risk of serious injury from a fire hazard. - Kmaier Recalls Infant Walkers Due to Risk of Serious Injury or Death from Fall Hazard; Violate Mandatory Standard for Infant Walkers
Consumer productReported August 27, 2026 · The recalled walkers violate the mandatory standard for infant walkers because they can fit through a standard doorway and fail to stop at the edge of a step... - AudioLineOut Recalls Studio Six Headphone Amplifiers Due to Risk of Serious Injury or Death from Electrocution Hazard
Consumer productReported August 27, 2026 · When the amplifiers are used with aftermarket metal base tubes, the bare metal can become electrified, posing a risk of serious injury or death from... - HABA USA Recalls Rainbow Rattle Grasping and Teething Toys Due to Risk of Serious Injury or Death from Choking and Ingestion Hazards
Consumer productReported August 27, 2026 · The glued knot on the elastic cord can become untied on the recalled product, allowing young children access to the small wooden and plastic pieces, posing a... - Diamond Wipes International Recalls MD Wipe Outz Numbing Tattoo Wipes Due to Risk of Serious Injury or Death from Child Poisoning; Violate Mandatory Standard for Child-Resistant Packaging
Consumer productReported August 27, 2026 · The recalled numbing wipes contain lidocaine, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The packaging of... - Conair Expands Recall of Cuisinart Grill Brushes Due to Ingestion Hazard; Over 3.6 Million Brushes Now Recalled
Consumer productReported August 27, 2026 · Small metal wire bristles can detach from the brushes and stick to the grill or food, posing an ingestion hazard and risk of serious internal injuries that... - Dentsply Sirona Capsule Mixer Model No. 5546068 recall (SDI Limited)
Medical deviceClass IIReported August 26, 2026 · Potential for electrical discharge from unit when unplugged. - Jalapeno Pepper packaged in bulk generic Coast Tropical cardboard packaging. Packaged... recall (Coast Citrus Distributors)
FoodClass IReported August 26, 2026 · Potential Salmonella Javiana contamination - niCARdipine Hydrochloride Injection recall (American Regent, Inc.)
DrugClass IIReported August 26, 2026 · Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde - Tralement recall (American Regent, Inc.)
DrugClass IIReported August 26, 2026 · Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde - Papaverine HCl Injection recall (American Regent, Inc.)
DrugClass IReported August 26, 2026 · Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde - Multrys recall (American Regent, Inc.)
DrugClass IIReported August 26, 2026 · Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde - Selenious Acid Injection recall (American Regent, Inc.)
DrugClass IIReported August 26, 2026 · Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde - ACETYLCYSTEINE SOLUTION recall (American Regent, Inc.)
DrugClass IIReported August 26, 2026 · Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde - ACETYLCYSTEINE SOLUTION recall (American Regent, Inc.)
DrugClass IIReported August 26, 2026 · Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde - Atropine Sulfate injection recall (American Regent, Inc.)
DrugClass IIReported August 26, 2026 · Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde - AMINAOCAPROIC ACID INJECTION recall (American Regent, Inc.)
DrugClass IIReported August 26, 2026 · Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde - Cyanocobalamin injection USP recall (American Regent, Inc.)
DrugClass IIReported August 26, 2026 · Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde - Cyanocobalamin injection USP recall (American Regent, Inc.)
DrugClass IIReported August 26, 2026 · Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde - Nitroglycerin injection recall (American Regent, Inc.)
DrugClass IIReported August 26, 2026 · Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde - Morphine Sulfate Injection recall (Fresenius Kabi USA, LLC)
DrugClass IReported August 26, 2026 · Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL. - Acamprosate Calcium recall (Mylan Pharmaceuticals Inc)
DrugClass IIReported August 26, 2026 · Failed Dissolution Specifications - Carbamazepine Tablets recall (Golden State Medical Supply Inc.)
DrugClass IIReported August 26, 2026 · CGMP deviations: tablets with black specks. - Carbamazepine Tablets recall (SUN PHARMACEUTICAL INDUSTRIES INC)
DrugClass IIReported August 26, 2026 · CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing - Libtayo recall (Regeneron Pharmaceuticals Inc)
DrugClass IIReported August 26, 2026 · Lack of Assurance of Sterility - PEMRYDI RTU recall (Shilpa Medicare Limited)
DrugClass IIReported August 26, 2026 · Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials - PEMRYDI RTU recall (Shilpa Medicare Limited)
DrugClass IIReported August 26, 2026 · Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials - Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard... recall (restor3d Inc.)
Medical deviceClass IIReported August 26, 2026 · Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws. - Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703 recall (ConvaTec, Inc)
Medical deviceClass IIReported August 26, 2026 · Urostomy Pouches may leak from cap during use. - Fort Defiance Industries recall (Fort Defiance Industries, LLC)
Medical deviceClass IIReported August 26, 2026 · The Automated Field Steam Sterilizer's water recovery system 120V Amphenol connector may experience an intermittent loss of ground continuity, which could... - Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus recall (Boston Scientific Corporation)
Medical deviceClass IReported August 26, 2026 · Potential for arterial sheath tip separation or partial tip separation during use. - Boston Scientific ENROUTE Transcarotid Neuroprotection System recall (Boston Scientific Corporation)
Medical deviceClass IReported August 26, 2026 · Potential for arterial sheath tip separation or partial tip separation during use. - Beckman Coulter recall (Siemens Healthcare Diagnostics, Inc.)
Medical deviceClass IIReported August 26, 2026 · Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine... - Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL recall (Siemens Healthcare Diagnostics, Inc.)
Medical deviceClass IIReported August 26, 2026 · Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine... - Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or... recall (Beckman Coulter Inc.)
Medical deviceClass IIReported August 26, 2026 · a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by... - Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or... recall (Beckman Coulter Inc.)
Medical deviceClass IIReported August 26, 2026 · a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by... - Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A recall (Paragon 28, Inc.)
Medical deviceClass IIIReported August 26, 2026 · Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility. - Custom Made Device Implant 6123 Navicular Cage Small Right Rev A recall (Paragon 28, Inc.)
Medical deviceClass IIIReported August 26, 2026 · Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility. - Blanketrol III recall (Gentherm Medical, LLC)
Medical deviceClass IIReported August 26, 2026 · Overheating of the 115V CPU board may cause the device to shut down. - Innercool Coolblue Console recall (Gentherm Medical, LLC)
Medical deviceClass IIReported August 26, 2026 · Overheating of the 115V CPU board may cause the device to shut down. - Blanketrol II Model 222S recall (Gentherm Medical, LLC)
Medical deviceClass IIReported August 26, 2026 · Overheating of the 115V CPU board may cause the device to shut down. - Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF#... recall (Paragonix Technologies Inc.)
Medical deviceClass IIReported August 26, 2026 · Due to a firmware defect, the portable organ transfer device datalogger may lose its configuration, resulting in a blank screen and loss of displayed... - Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF recall (Siemens Healthcare Diagnostics Products Ltd.)
Medical deviceClass IIReported August 26, 2026 · Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive. - Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2 recall (Siemens Healthcare Diagnostics Products Ltd.)
Medical deviceClass IIReported August 26, 2026 · Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive. - Halyard LAVH PACK recall (AVID Medical, Inc.)
Medical deviceClass IIReported August 26, 2026 · The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit. - GETINGE Y SENSOR Module recall (Maquet Critical Care AB)
Medical deviceClass IIReported August 26, 2026 · The module did not undergo electrical safety tests and functional tests during production. - Suture Cinch Long 1pk. Endoscopic tissue approximation device. recall (Boston Scientific Corporation)
Medical deviceClass IIReported August 26, 2026 · Device may fail to deploy the cinch implant and/or fail to cut the suture as intended. - OverStitch Suture Cinch recall (Boston Scientific Corporation)
Medical deviceClass IIReported August 26, 2026 · Device may fail to deploy the cinch implant and/or fail to cut the suture as intended. - TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799 recall (Tobii Dynavox Llc)
Medical deviceClass IIReported August 26, 2026 · Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an... - TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798 recall (Tobii Dynavox Llc)
Medical deviceClass IIReported August 26, 2026 · Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an... - Arrow-LOK Implant recall (Arrowhead DE LLC)
Medical deviceClass IIReported August 26, 2026 · Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection. - Cardiac Workstation 7000. Product Number: 860441. recall (Philips North America Llc)
Medical deviceClass IIReported August 26, 2026 · Device will intermittently provide inaccurate data related to native heart rate. - Cardiac Workstation 5000. Product Number: 860439. recall (Philips North America Llc)
Medical deviceClass IIReported August 26, 2026 · Device will intermittently provide inaccurate data related to native heart rate. - One-Piece Guedel Airway recall (Intersurgical Inc)
Medical deviceClass IIReported August 26, 2026 · Devices could potentially be occluded or partially occluded. - One-Piece Guedel Airway recall (Intersurgical Inc)
Medical deviceClass IIReported August 26, 2026 · Devices could potentially be occluded or partially occluded. - Hamilton Microlab STAR Liquid Handler recall (Foundation Medicine, Inc.)
Medical deviceClass IIReported August 26, 2026 · Software issue that can cause an increase in spontaneous software closures. - EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 ... recall (Covidien, LLC)
Medical deviceClass IIReported August 26, 2026 · The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures. - CCM Hockey U.S. Recalls FMHVR Hybrid Visors and ACCHVR Replacement Visor Accessories Due to Risk of Injury from Laceration or Impact Hazards
Consumer productReported August 20, 2026 · The recalled hockey visors and replacement visor accessories can crack upon impact, posing a risk of injury due to laceration or impact hazards. - Workbless Pressure Washers Recalled Due to Risk of Serious Injury or Death from Shock and Electrocution Hazards
Consumer productReported August 20, 2026 · The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI) and an adequate-length power cord, posing serious risks of injury or... - Koorlian Mattresses Recalled Due to Risk of Serious Injury or Death from Fire Hazard; Violate Mandatory Standard for Mattress Flammability; Sold on Amazon by Dream Bedding Technology
Consumer productReported August 20, 2026 · The recalled mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire.