Recalls in California (page 12)
4209 recalls.
- Honeyville YELLOW COLOR 1 GALLON NFI: WATER recall (FlavorsandColor.Com)
FoodClass IIIReported August 19, 2026 · Undeclared Red #40. - 60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 ... recall (BD SWITZERLAND SARL)
Medical deviceClass IIReported August 19, 2026 · Products may not have received adequate sterilization processing. - ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000 recall (Erbe USA Inc)
Medical deviceClass IIReported August 19, 2026 · A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the connector resulting in... - OBP Medical recall (OBP Medical Corporation)
Medical deviceClass IIReported August 19, 2026 · There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact regions for both... - GM Helix Implant recall (Straumann USA LLC)
Medical deviceClass IIReported August 19, 2026 · There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect... - Brand Name: Xhibit Product Name: Xhibit Central Station Model/Catalog Number: 96102 ... recall (Spacelabs Healthcare, Inc.)
Medical deviceClass IIReported August 19, 2026 · Due to off-the-shelf display port component that has audio/video failures - navify Digital Pathology recall (Ventana Medical Systems, Inc.)
Medical deviceClass IIReported August 19, 2026 · Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window - BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL ... recall (MICROVENTION INC.)
Medical deviceClass IIReported August 19, 2026 · Due to an increase rate of balloon pinhole defects. - Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection recall (Spectra Medical Devices, Llc)
Medical deviceClass IReported August 19, 2026 · Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be... - Cefazolin in Dextrose recall (Baxter Healthcare Corporation)
DrugClass IReported August 19, 2026 · Presence of Particulate Matter - Optiray Imaging Bulk Package-350 recall (Liebel-Flarsheim Company LLC)
DrugClass IReported August 19, 2026 · Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass. - Glutathione recall (Victory Medical Center Pharmacy)
DrugClass IReported August 19, 2026 · Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin. - CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION recall (Heritage Pharmaceuticals Inc)
DrugClass IIReported August 19, 2026 · Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles. - CLEAR EYES Maximum Itchy Eye Relief recall (Prestige Brands Holdings)
DrugClass IIReported August 19, 2026 · Lack of assurance of sterility. The recall is due to potential contamination - SILDENAFIL CITRATE USP recall (Shoolin Pharma Chem LLP)
DrugClass IIReported August 19, 2026 · CGMP Deviations:Noted during FDA inspection - TADALAFIL USP recall (Shoolin Pharma Chem LLP)
DrugClass IIReported August 19, 2026 · CGMP Deviations:Noted during FDA inspection - TADALAFIL USP recall (Shoolin Pharma Chem LLP)
DrugClass IIReported August 19, 2026 · CGMP Deviations:Noted during FDA inspection - TADALAFIL USP recall (Shoolin Pharma Chem LLP)
DrugClass IIReported August 19, 2026 · CGMP Deviations:Noted during FDA inspection - SILDENAFIL CITRATE USP recall (Shoolin Pharma Chem LLP)
DrugClass IIReported August 19, 2026 · CGMP Deviations:Noted during FDA inspection - SEMAGLUTIDE 20mg recall (Apollo Care, LLC)
DrugClass IIReported August 19, 2026 · Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material - SEMAGLUTIDE 10mg recall (Apollo Care, LLC)
DrugClass IIReported August 19, 2026 · Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material - SEMAGLUTIDE 7.5mg recall (Apollo Care, LLC)
DrugClass IIReported August 19, 2026 · Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material - SEMAGLUTIDE 5mg recall (Apollo Care, LLC)
DrugClass IIReported August 19, 2026 · Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material - SEMAGLUTIDE 2.5mg recall (Apollo Care, LLC)
DrugClass IIReported August 19, 2026 · Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material - SEMAGLUTIDE 0.9mg recall (Apollo Care, LLC)
DrugClass IIReported August 19, 2026 · Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material - SEMAGLUTIDE 9mg recall (Apollo Care, LLC)
DrugClass IIReported August 19, 2026 · Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material - SEMAGLUTIDE 4.5mg recall (Apollo Care, LLC)
DrugClass IIReported August 19, 2026 · Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material - SEMAGLUTIDE 6.75mg recall (Apollo Care, LLC)
DrugClass IIReported August 19, 2026 · Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material - SEMAGLUTIDE 2.25MG recall (Apollo Care, LLC)
DrugClass IIReported August 19, 2026 · Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material - SEMAGLUTIDE 12.5MG recall (Apollo Care, LLC)
DrugClass IIReported August 19, 2026 · Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material - 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). - FLOUNDER SASHIMI WITH SAUCE recall (Eunha Fisheries Co., LTD)
FoodClass IIReported August 12, 2026 · Foreign Manufacturer label contains Undeclared allergen ingredients Wheat, Soy, Sesame, Yellow #5 and Blue #1 in Frozen Flounder Products. - Sliced Korean Halibut with Soy sauce recall (Eunha Fisheries Co., LTD)
FoodClass IIReported August 12, 2026 · Foreign Manufacturer label contains Undeclared allergen ingredients Wheat, Soy, Sesame, Yellow #5 and Blue #1 in Frozen Flounder Products. - "***Hondashi 0.25oz***" seasoning packed in silver plastic/metallic pouch recall (Pack'n Fresh LLC)
FoodClass IIReported August 12, 2026 · Allergen missing from contains statement: fish - 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... - 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... - 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... - 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... - 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... - Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 ... recall (Maquet Critical Care AB)
Medical deviceClass IIReported August 12, 2026 · Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failure to deliver the anesthetic agent may result in the patient... - Anti-Torque recall (Innovasis, Inc)
Medical deviceClass IIReported August 12, 2026 · Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion may have anti-torque... - Brand Name: Medical Action Industries Product Name: Dialysis Change Tray Clear... recall (Medical Action Industries, Inc. 306)
Medical deviceClass IIReported August 12, 2026 · Convenience kits contain needle free access device that has an improper seal which may result in doming or tearing of the silicone seal. - munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control... recall (MUNEVO GMBH)
Medical deviceClass IIReported August 12, 2026 · A software issue may cause the wheelchair's driving mechanism to fall out of calibration. When this occurs, the device may experience unexpected steering drift...