Recalls in Tennessee (page 12)
3981 recalls.
- Diovan recall (Novartis Pharmaceuticals Corporation)
DrugClass IIReported August 19, 2026 · Failed Dissolution Specifications - Cardinal Health Presource Kits: 1) BASIC PACK recall (Cardinal Health 200, LLC)
Medical deviceClass IIReported August 19, 2026 · Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. - Cardinal Health Presource Kits: 1) KIT recall (Cardinal Health 200, LLC)
Medical deviceClass IIReported August 19, 2026 · Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. - Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 recall (Cardinal Health 200, LLC)
Medical deviceClass IIReported August 19, 2026 · Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. - Cardinal Health Presource Kits: 1) SEPTO RHINO PACK recall (Cardinal Health 200, LLC)
Medical deviceClass IIReported August 19, 2026 · Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. - Cardinal Health Presource Kits: 1) ENT TRAY recall (Cardinal Health 200, LLC)
Medical deviceClass IIReported August 19, 2026 · Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. - Cardinal Health Presource Kits: 1) NEWNAN SMR PACK recall (Cardinal Health 200, LLC)
Medical deviceClass IIReported August 19, 2026 · Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. - Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK recall (Cardinal Health 200, LLC)
Medical deviceClass IIReported August 19, 2026 · Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. - Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT recall (Cardinal Health 200, LLC)
Medical deviceClass IIReported August 19, 2026 · Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. - BIOFIRE Respiratory Panel 2.1 recall (BioFire Diagnostics, LLC)
Medical deviceClass IIReported August 19, 2026 · Due to increase in false negative results - Straumann Bone Level Tapered recall (Straumann USA LLC)
Medical deviceClass IIReported August 19, 2026 · Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the... - GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. ... recall (Terumo Medical Corporation)
Medical deviceClass IIReported August 19, 2026 · Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire. - Allura Xper FD. Model Numbers: 722026 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported August 19, 2026 · Firmware issue potentially leading to loss of geometry movements. - Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL recall (Remel Europe Ltd.)
Medical deviceClass IIReported August 19, 2026 · Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds. - Medline Micro-Kill Bleach Germicidal Bleach Wipes recall (Medline Industries, LP)
Medical deviceClass IIReported August 19, 2026 · Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled... - Medline Micro-Kill Bleach Germicidal Bleach Wipes recall (Medline Industries, LP)
Medical deviceClass IIReported August 19, 2026 · Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled... - Medline Micro-Kill Bleach Germicidal Bleach Wipes recall (Medline Industries, LP)
Medical deviceClass IIReported August 19, 2026 · Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled... - Medline Micro-Kill Bleach Germicidal Bleach Wipes recall (Medline Industries, LP)
Medical deviceClass IIReported August 19, 2026 · Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled... - Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX recall (Covidien, LP)
Medical deviceClass IIReported August 19, 2026 · Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to... - Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623 recall (Covidien, LP)
Medical deviceClass IIReported August 19, 2026 · Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to... - Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31... recall (Covidien, LP)
Medical deviceClass IIReported August 19, 2026 · Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to... - V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING ... recall (Covidien, LP)
Medical deviceClass IIReported August 19, 2026 · Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to... - V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 ... recall (Covidien, LP)
Medical deviceClass IIReported August 19, 2026 · Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to... - Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP recall (Galt Medical Corporation)
Medical deviceClass IIReported August 19, 2026 · Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits. - GORE VIABIL Short Wire Biliary Endoprosthesis recall (W L Gore & Associates, Inc.)
Medical deviceClass IIReported August 19, 2026 · 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes... - GORE VIABIL Short Wire Biliary Endoprosthesis recall (W L Gore & Associates, Inc.)
Medical deviceClass IIReported August 19, 2026 · 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes... - Baxter Duo-Vent Solution Set and Male Luer Lock Adapter recall (Baxter Healthcare Corporation)
Medical deviceClass IReported August 19, 2026 · Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open... - Hampton Bay Halwin 52-Inch Ceiling Fans Recalled Due to Impact and Injury Hazards; Manufactured by Youngo Limited
Consumer productReported August 14, 2026 · The fan blades can separate from the fan motor flywheel, posing impact and injury hazards to consumers. - Sunnyside Corporation Recalls 1-K Kerosene Heater and Appliance Fuel Containers Due to Risk of Serious Injury or Death from Flash Fire and Burn Hazard; Violates Mandatory Standards for Portable Fuel Containers
Consumer productReported August 14, 2026 · The pre-filled fuel containers violate the mandatory safety standards of the Portable Fuel Container Safety Act because they lack flame mitigation devices... - Fastbuy Recalls Zimtown Portable Gas and Fuel Cans Due to Risk of Serious Injury or Death from Burn Hazard and Child Poisoning; Violate Mandatory Standard for Portable Fuel Containers
Consumer productReported August 14, 2026 · The fuel containers violate the requirement for closures under the Children's Gasoline Burn Prevention Act because the closure is not child-resistant, posing a... - SUGIFT Recalls SUGIFT Pressure Washers Due to Serious Risk of Injury or Death from Shock and Electrocution Hazards
Consumer productReported August 14, 2026 · The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI) and, because the power cord is short, it may encourage use of an... - CuberShop Magnetic Speed Cubes Recalled Due to Risk of Serious Injury or Death from Magnet Ingestion; Violate Mandatory Standard for Toys; Imported by SKY CUBE HK
Consumer productReported August 14, 2026 · The recalled magnetic cubes violate the mandatory standard for toys because the cubes were packaged with loose high-powered magnets, posing an ingestion hazard... - Shengsen Prank Sound Makers Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Consumer Products with Coin Batteries; Imported by Shengsen Toys
Consumer productReported August 14, 2026 · The recalled sound maker violates the mandatory safety standard for consumer products with button cell and coin batteries because the lithium coin batteries... - Ritchey Design Recalls Carbon Bicycle Forks Due to Risk of Serious Injury or Death from Fall and Crash Hazards
Consumer productReported August 14, 2026 · The alloy insert located in the front crown hole of the carbon fork can come loose, causing an accessory to fall off and land on the bike's front wheel, posing... - Mattresses Recalled Due to Risk of Serious Injury or Death from Fire Hazard; Violate Mandatory Standard for Mattress Flammability; Sold on Amazon by Qabefy
Consumer productReported August 14, 2026 · The recalled mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire. - GigaCloud Technology USA Recalls Merax Murphy Beds Due to Risk of Serious Injury or Death from Impact and Crush Hazards
Consumer productReported August 14, 2026 · During assembly or disassembly, the frame of the wall bed can fall onto consumers, posing deadly impact, crush and laceration hazards. - Yamazuki Recalls Youth All-Terrain Vehicles (ATVs) Due to Risk of Serious Injury or Death from Crash Hazard; Violates Mandatory Standard for ATVs
Consumer productReported August 14, 2026 · The recalled youth ATVs violate the mandatory safety standard for ATVs because the parking brakes fail to hold and the ATV's speed limiting device is not set... - COMMOWNER Pressure Washers Recalled Due to Serious Risk of Injury or Death from Shock and Electrocution Hazards; Imported by AZ Home Concept
Consumer productReported August 14, 2026 · The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI) and, because the power cord is short, it may encourage use of an... - Deli Jerry Fuel Containers Recalled Due to Risk of Serious Injury or Death from Burn Hazard and Child Poisoning; Violate Mandatory Standard for Portable Fuel Containers; Sold on Walmart.com by Deli OfficeSupplies
Consumer productReported August 14, 2026 · The recalled fuel containers violate the requirement for closures under the Children's Gasoline Burn Prevention Act. The closure is not child-resistant, posing... - DUMOS Nine-Drawer Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violate Mandatory Standard for Clothing Storage Units
Consumer productReported August 14, 2026 · The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or... - TooyBing Wooden Bead Stacking Toys Recalled Due to Risk of Serious Injury or Death from Choking; Violate Small Parts Ban
Consumer productReported August 14, 2026 · The recalled toys violate the small parts ban because they are intended for children under three years old and the wooden beads pose a deadly choking hazard to... - Taleco Gear Recalls Baby Jumpers, Baby Swings and 2-in-1 Baby Jumper & Swings Due to Risk of Serious Injury or Death from Fall and Strangulation Hazards
Consumer productReported August 14, 2026 · The baby jumper, baby swing and 2-in-1 baby jumper & swing can become unstable, posing fall and impact hazards. Additionally, the hanging restraint straps and... - Southern Telecom Recalls Brookstone-Branded Tabletop Fire Pits Due to Risk of Serious Burn Injury or Death from Flame Jetting and Fire Hazards
Consumer productReported August 14, 2026 · Use of the fire pits can result in uncontrolled pool fires where flames burn across the surface of pooled or spilled alcohol, as well as flame jetting from... - Goody King Magnetic Building Cubes and Blocks Recalled Due to Risk of Serious Injury or Death from Magnetic Ingestion Hazard; Imported by Yi Suen Commerce
Consumer productReported August 14, 2026 · The recalled magnetic building cubes contain magnets that can become loose if the cubes break or open, posing a magnet ingestion hazard to children. When... - Cooluli Recalls 10-Liter and 15-Liter Minifridges Due to Fire and Burn Hazards
Consumer productReported August 14, 2026 · The recalled minifridges' electrical switch can short circuit, posing fire and burn hazards. - Pumpkin Tree Peter Rabbit Organics Banana & Strawberry fruit puree recall (PT Organics Limited)
FoodClass IIReported August 12, 2026 · Possible foreign object (thin, soft plastic strands). - Spicy Breakfast Burrito sold under the following brand names: FRESH & READY FOODS... recall (M.G. Foods, Inc.)
FoodClass IReported August 12, 2026 · Undeclared Soy. The firm received complaints of sausage in the burritos. Upon review the firm discovered the sausage contains soy which is not listed on the... - 5-PLASMA Bivalirudin Control recall (Aniara Diagnostica LLC)
Medical deviceClass IIReported August 12, 2026 · Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of... - 5-PLASMA Bivalirudin Calibrator recall (Aniara Diagnostica LLC)
Medical deviceClass IIReported August 12, 2026 · Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of... - 5-PLASMA Bivalirudin AMR Verification Kit recall (Aniara Diagnostica LLC)
Medical deviceClass IIReported August 12, 2026 · Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of... - REF # D23354 recall (Beckman Coulter Inc.)
Medical deviceClass IIReported August 12, 2026 · Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications." - REF # D23352 recall (Beckman Coulter Inc.)
Medical deviceClass IIReported August 12, 2026 · Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications." - HardyDisk AST Cefiderocol 30¿g recall (Hardy Diagnostics)
Medical deviceClass IIReported August 12, 2026 · Due to incorrect cartridges include in affected products that there is the potential for false-susceptible or false-resistant susceptibility results and may... - FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: recall (Biofire Defense)
Medical deviceClass IIReported August 12, 2026 · Firm has identified mismatches between the outbreak strain and the reference strain used in the development of its qualitative, multiplexed, nucleic acid-based... - Brand Name: Quantum Rehab Product Name: Quantum Rival Model/Catalog Number: Quantum... recall (Pride Mobility Products Corp.)
Medical deviceClass IIReported August 12, 2026 · If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while... - Brand Name: Quantum Rehab Product Name: 4Front Model/Catalog Number: 4Front ... recall (Pride Mobility Products Corp.)
Medical deviceClass IIReported August 12, 2026 · If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while... - Brand Name: Quantum Rehab Product Name: Quantum 4Front 2HD Model/Catalog Number:... recall (Pride Mobility Products Corp.)
Medical deviceClass IIReported August 12, 2026 · If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while... - Brand Name: Quantum Rehab Product Name: Q6 Edge 4 Model/Catalog Number: Q6 Edge 4 ... recall (Pride Mobility Products Corp.)
Medical deviceClass IIReported August 12, 2026 · If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while... - Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Model/Catalog Number: Q6 Edge 3 ... recall (Pride Mobility Products Corp.)
Medical deviceClass IIReported August 12, 2026 · If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while... - Brand Name: Quantum Rehab Product Name: Q6 Edge 2.0 recall (Pride Mobility Products Corp.)
Medical deviceClass IIReported August 12, 2026 · If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while... - Brand Name: Quantum Rehab Product Name: Quantum 1450 Model/Catalog Number: Quantum... recall (Pride Mobility Products Corp.)
Medical deviceClass IIReported August 12, 2026 · If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while... - Brand Name: Quantum rehab Product Name: Q6 Edge 2.0 Model/Catalog Number: Q6 Edge... recall (Pride Mobility Products Corp.)
Medical deviceClass IIReported August 12, 2026 · If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while... - Brand Name: Quantum Rehab Product Name: Q6 Edge HD Model/Catalog Number: Q6 Edge HD ... recall (Pride Mobility Products Corp.)
Medical deviceClass IIReported August 12, 2026 · If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while... - Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK ... recall (Pride Mobility Products Corp.)
Medical deviceClass IIReported August 12, 2026 · If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while... - Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Stretto Model/Catalog Number: Q6... recall (Pride Mobility Products Corp.)
Medical deviceClass IIReported August 12, 2026 · If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while... - Brand Name: Quantum Rehab Product Name: Quantum Outback Model/Catalog Number:... recall (Pride Mobility Products Corp.)
Medical deviceClass IIReported August 12, 2026 · If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while... - Brand Name: Quantum Rehab Product Name: Quantum 4Front 2 Model/Catalog Number:... recall (Pride Mobility Products Corp.)
Medical deviceClass IIReported August 12, 2026 · If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while... - Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial... recall (Boston Scientific Corporation)
Medical deviceClass IIReported August 12, 2026 · Potential for breach in sterile barrier of device packaging. - Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: ... recall (Boston Scientific Corporation)
Medical deviceClass IIReported August 12, 2026 · Potential for breach in sterile barrier of device packaging. - Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN:... recall (Boston Scientific Corporation)
Medical deviceClass IIReported August 12, 2026 · Potential for breach in sterile barrier of device packaging. - Ashfiat Alharamain Energy Support 250ml/8fl. oz. recall (AKKARCO LLC)
FoodClass IReported August 12, 2026 · Undeclared tadalafil - Mirabegron Extended-Release Tablets recall (Zydus Pharmaceuticals (USA) Inc)
DrugClass IIReported August 12, 2026 · CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity. - Cyclophosphamide for Injection recall (Sunny Pharmtech Inc.)
DrugClass IReported August 12, 2026 · Presence of Particulate Matter; identified as stainless steel - Cyclophosphamide for Injection recall (Sunny Pharmtech Inc.)
DrugClass IReported August 12, 2026 · Presence of Particulate Matter; identified as stainless steel - Dicyclomine Hydrochloride Capsules recall (Aurobindo Pharma USA Inc)
DrugClass IIReported August 12, 2026 · shortfill; reports of empty capsules. - Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated... recall (Contego Medical, Inc)
Medical deviceClass IIReported August 12, 2026 · Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter, that due to a wire-to-filter-bond issue, may... - Blom-Singer Classic Indwelling Voice Prosthesis recall (Freudenberg Medical, LLC)
Medical deviceClass IIReported August 12, 2026 · Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large... - Blom-Singer Classic Indwelling Voice Prosthesis recall (Freudenberg Medical, LLC)
Medical deviceClass IIReported August 12, 2026 · Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large... - Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number:... recall (TISSIUM SA)
Medical deviceClass IIReported August 12, 2026 · Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use... - Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number:... recall (TISSIUM SA)
Medical deviceClass IIReported August 12, 2026 · Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use... - Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number:... recall (TISSIUM SA)
Medical deviceClass IIReported August 12, 2026 · Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use... - Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number:... recall (TISSIUM SA)
Medical deviceClass IIReported August 12, 2026 · Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use... - Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number:... recall (TISSIUM SA)
Medical deviceClass IIReported August 12, 2026 · Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use... - Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number:... recall (TISSIUM SA)
Medical deviceClass IIReported August 12, 2026 · Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use... - Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number:... recall (TISSIUM SA)
Medical deviceClass IIReported August 12, 2026 · Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use... - Brand Name: COAPTIUM Connect Product Name: COAPTIUM Connect Model/Catalog Number:... recall (TISSIUM SA)
Medical deviceClass IIReported August 12, 2026 · Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use... - GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 ... recall (Instrumentation Laboratory)
Medical deviceClass IIReported August 12, 2026 · The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing specifications. The... - GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 ... recall (Instrumentation Laboratory)
Medical deviceClass IIReported August 12, 2026 · The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 PAK lots did not meet established manufacturing... - Brand Name: U2 Total Knee System Product Name: Femoral offset bushing recall (United Orthopedic Corp.)
Medical deviceClass IIReported August 12, 2026 · Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant. - Brand Name: U2 Total Knee System Product Name: Femoral offset bushing recall (United Orthopedic Corp.)
Medical deviceClass IIReported August 12, 2026 · Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant. - Philips Allura recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported August 12, 2026 · Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives. - Philips Azurion under the following System Descriptions and corresponding model... recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported August 12, 2026 · Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives. - Philips Allura under the following System Descriptions and corresponding model... recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported August 12, 2026 · Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives. - Atellica CH Urine Albumin REF: 11537225 recall (Siemens Healthcare Diagnostics, Inc.)
Medical deviceClass IIReported August 12, 2026 · Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely... - Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor recall (United Orthopedic Corp.)
Medical deviceClass IIReported August 12, 2026 · Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. - Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor recall (United Orthopedic Corp.)
Medical deviceClass IIReported August 12, 2026 · Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. - Brand Name: USTAR II Knee System Product Name: Hinge Box Trial recall (United Orthopedic Corp.)
Medical deviceClass IIReported August 12, 2026 · Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. - Brand Name: U2 Total Knee System Product Name: PSA Box Trial recall (United Orthopedic Corp.)
Medical deviceClass IIReported August 12, 2026 · Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. - Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 ... recall (Siemens Healthcare Diagnostics, Inc.)
Medical deviceClass IIIReported August 12, 2026 · out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not... - Syva Emit Disopyramide Assay Enzyme Immunoassay recall (Siemens Healthcare Diagnostics, Inc.)
Medical deviceClass IIIReported August 12, 2026 · Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the...