Recalls in Idaho (page 13)
3874 recalls.
- Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number:... recall (Instrumentation Laboratory)
Medical deviceClass IIReported August 5, 2026 · Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID. - Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3... recall (Instrumentation Laboratory)
Medical deviceClass IIReported August 5, 2026 · Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID. - GEM Premier 5000 with IQM2 Model/Catalog Number: 00024019255 and GEM Premier 7000... recall (Instrumentation Laboratory)
Medical deviceClass IIReported August 5, 2026 · Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID. - OsteoBallast recall (IsoTis OrthoBiologics, Inc.)
Medical deviceClass IIReported August 5, 2026 · Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were... - AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Port Tray - RX recall (Windstone Medical Packaging, Inc.)
Medical deviceClass IIReported August 5, 2026 · Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices... - AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Loop Recorder... recall (Windstone Medical Packaging, Inc.)
Medical deviceClass IIReported August 5, 2026 · Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices... - AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Block Tray - RX recall (Windstone Medical Packaging, Inc.)
Medical deviceClass IIReported August 5, 2026 · Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices... - AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cath Tray - RX recall (Windstone Medical Packaging, Inc.)
Medical deviceClass IIReported August 5, 2026 · Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices... - AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack - RX recall (Windstone Medical Packaging, Inc.)
Medical deviceClass IIReported August 5, 2026 · Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices... - AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Nerve Block... recall (Windstone Medical Packaging, Inc.)
Medical deviceClass IIReported August 5, 2026 · Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices... - AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Dr Fred Chiu... recall (Windstone Medical Packaging, Inc.)
Medical deviceClass IIReported August 5, 2026 · Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices... - AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT recall (Windstone Medical Packaging, Inc.)
Medical deviceClass IIReported August 5, 2026 · Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices... - EOPA 3D Arterial Cannula 22FR recall (Medtronic Perfusion Systems)
Medical deviceClass IIReported August 5, 2026 · Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel... - EOPA 3D Arterial Cannula DIL TIP 22FR recall (Medtronic Perfusion Systems)
Medical deviceClass IIReported August 5, 2026 · Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel... - EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR recall (Medtronic Perfusion Systems)
Medical deviceClass IIReported August 5, 2026 · Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel... - EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR recall (Medtronic Perfusion Systems)
Medical deviceClass IIReported August 5, 2026 · Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel... - EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR recall (Medtronic Perfusion Systems)
Medical deviceClass IIReported August 5, 2026 · Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel... - EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR recall (Medtronic Perfusion Systems)
Medical deviceClass IIReported August 5, 2026 · Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel... - AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Laminectomy Pack recall (Windstone Medical Packaging, Inc.)
Medical deviceClass IIReported August 5, 2026 · The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile... - AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Neuro Pack recall (Windstone Medical Packaging, Inc.)
Medical deviceClass IIReported August 5, 2026 · The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile... - AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack recall (Windstone Medical Packaging, Inc.)
Medical deviceClass IIReported August 5, 2026 · The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile... - AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack recall (Windstone Medical Packaging, Inc.)
Medical deviceClass IIReported August 5, 2026 · The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile... - Power Over Fiber Base Module recall (Terex Utilities)
Medical deviceClass IIReported August 5, 2026 · Device not certified - no laser product report was filed with CDRH prior to distribution. Product label incorrectly states device is "Class IV", although... - Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium ... recall (PHILIPS MEDICAL SYSTEMS)
Medical deviceClass IIReported August 5, 2026 · The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may... - IQon Spectral CT IQon Spectral CT Upgrades recall (PHILIPS MEDICAL SYSTEMS)
Medical deviceClass IIReported August 5, 2026 · The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may... - Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel ... recall (PHILIPS MEDICAL SYSTEMS)
Medical deviceClass IIReported August 5, 2026 · The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may... - OCOOPA Direct Recalls 1.5 Million Rechargeable Hand Warmers Due to Risk of Serious Injury or Death from Fire and Burn Hazards; One Death Reported; Imported by Shenzhen Street Cat Technology
Consumer productReported July 31, 2026 · The lithium-ion battery in the recalled hand warmers can overheat and ignite, posing a risk of serious injury or death from fire and burn hazards. - Woodure Toddler Kitchen Step Stools Recalled Due to Risk of Serious Injury and Death from Entrapment and Fall Hazards; Imported by Shenzhen Muqiqu Creative Development
Consumer productReported July 31, 2026 · The recalled tower stools can collapse or tip over while in use, and a child's torso can fit through the openings on the front and back sides, posing a risk of... - Recall of Cpzzkq Baby Loungers Expanded Due to Risk Serious Injury or Death from Suffocation Hazard; Violate Mandatory Standard for Infant Support Cushions; Sold on Amazon by CetoPMax
Consumer productReported July 31, 2026 · The recalled baby loungers violate the mandatory safety standard for infant support cushions because the padding can obstruct an infant's breathing, posing a... - Mommy's Baby Lovely Deluxe Baby Doll Playsets Recalled Due to Risk of Serious Injury or Death from Choking Hazard; Violate Small Parts Ban; Sold on Temu by TOYHW
Consumer productReported July 31, 2026 · The recalled doll playsets violate the small parts ban because the toys are for children under three years old and some of the accessories are small parts... - Mangohood Direct Kids Kitchen Standing Towers Recalled Due to Risk of Serious Injury and Death from Entrapment and Fall Hazards; Imported by Hangzhou Xinyanchuangxin
Consumer productReported July 31, 2026 · The recalled tower stools can collapse or tip over while in use, and a child's torso can fit through the openings on the front and back sides, posing a risk of... - Joyin Expands Recall of Sloosh Dive Sticks Due to Risk of Serious Injury from Impalement; Violate Federal Dive Sticks Ban
Consumer productReported July 31, 2026 · The recalled dive sticks violate the federal dive sticks ban because they exceeded the compress limit, posing an impalement hazard. In shallow water, children... - Jake's Fireworks Recalls World Class Fireworks "Skull Strobe" Rockets Due to Risk of Serious Injury from Explosion and Burn Hazards
Consumer productReported July 31, 2026 · The recalled fireworks rockets can explode prematurely before reaching their intended height, posing explosion and burn hazards. - Heated Sherpa Throws and Blankets Recalled Due to Risk of Serious Injury or Death from Fire and Burn Hazards; Sold on Amazon by OCTROT
Consumer productReported July 31, 2026 · The electrical cord on the recalled throws and blankets can detach and ignite, posing a risk of serious injury or death from fire, burn and shock hazards. - HARPPA Recalls Nordi Toddler Tower Stools Due to Risk of Serious Injury and Death from Entrapment and Fall Hazards
Consumer productReported July 31, 2026 · The recalled tower stools can collapse or tip over while in use, and a child's torso can fit through the openings on the front and back sides, posing a risk of... - Golden Link Recalls Fantastic Four Cups and Captain America Popcorn Helmet Containers with LED Lights Due to Risk of Serious Injury or Death from Battery Ingestion Hazard; Violate Mandatory Standard for Consumer Products with Button Cell Batteries
Consumer productReported July 31, 2026 · The cups and containers violate the mandatory standard for consumer products with button cell and coin batteries because they contain button cell batteries... - Galanz Americas Recalls Retro Refrigerators Due to Risk of Serious Injury or Death from Fire and Burn Hazards; One Death Reported
Consumer productReported July 31, 2026 · The recalled refrigerators' internal electrical components can short circuit and ignite, posing a risk of serious injury or death from fire and burn hazards. - BenQ America Recalls GV31 Portable Projectors Due to Risk of Serious Injury or Death from Fire and Burn Hazards
Consumer productReported July 31, 2026 · The recalled projectors' lithium-ion battery can overheat, posing a risk of serious injury or death from fire and burn hazards. - 5-Drawer Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violate Mandatory Standard for Clothing Storage Units; Sold on Amazon by KAIFAM
Consumer productReported July 31, 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... - 15-Drawer Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violate Mandatory Standard for Clothing Storage Units; Sold on Amazon by Enhomee-Direct
Consumer productReported July 31, 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... - Trsmima Zipline Kits and Zipline Spring Brakes Recalled Due to Fall and Collision Hazards; Manufactured by Trsmima
Consumer productReported July 31, 2026 · The zipline kit's steel cable, turnbuckle and seat can detach or break during use, posing a fall hazard. The zipline spring brakes are not stiff enough to... - MiniMed Go App recall (Medtronic MiniMed, Inc.)
Medical deviceClass IIReported July 29, 2026 · For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the... - Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Flow is... recall (Emano Metrics, Inc.)
Medical deviceClass IIReported July 29, 2026 · Problem description/Reason for recall: During the period March 22, 2026, to May 29, 2026, recorded urination audio was captured at 48,000 Hz while the model... - Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT recall (Penumbra, Inc.)
Medical deviceClass IIReported July 29, 2026 · Due to manufacturing issues, reperfusion catheters may fractures - Power F2 Powered Fastening System recall (Ferno-Washington Inc)
Medical deviceClass IIReported July 29, 2026 · Product may experience accelerated roller wear and potential deformation due to interference between the roller assembly and rail. In the worst-case condition... - 1. TNVitamins 100% Organic Moringa Capsules 1 recall (Total Nutrition Inc)
FoodClass IReported July 29, 2026 · Contaminated with Salmonella - Modern Warrior Ready recall (Modern Warrior Life, LLC)
FoodClass IReported July 29, 2026 · FDA analysis revealed the presence of unapproved ingredients including tianeptine, 1,4 DMAA, and aniracetam. - Trokendi XR recall (Supernus Pharmaceuticals, Inc.)
DrugClass IIIReported July 29, 2026 · Failed Dissolution Specifications - Divalproex Sodium Delayed-Release Tablets recall (Bionpharma Inc.)
DrugClass IIReported July 29, 2026 · Presence of Foreign Tablets/Capsules - Glycopyrrolate Oral Solution recall (Precision Dose Inc.)
DrugClass IIReported July 29, 2026 · Failed Impurities/Degradation Specifications - Dabigatran etexilate Capsules recall (Ascend Laboratories, LLC)
DrugClass IIIReported July 29, 2026 · Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and... - Dabigatran etexilate Capsules recall (Ascend Laboratories, LLC)
DrugClass IIIReported July 29, 2026 · Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and... - Cetirizine Hydrochloride Tablets USP 5 mg recall (JB Chemicals and Pharmaceuticals Ltd)
DrugClass IReported July 29, 2026 · Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets... - Xylocaine recall (Fresenius Kabi USA, LLC)
DrugClass IIReported July 29, 2026 · Presence of Particulate Matter: Hair was found in products - Xylocaine recall (Fresenius Kabi USA, LLC)
DrugClass IIReported July 29, 2026 · Presence of Particulate Matter: Hair was found in products - Naropin recall (Fresenius Kabi USA, LLC)
DrugClass IIReported July 29, 2026 · Presence of Particulate Matter: Hair was found in products - Lidocaine HCl Injection recall (Fresenius Kabi USA, LLC)
DrugClass IIReported July 29, 2026 · Presence of Particulate Matter: Hair was found in products - Glycopyrrolate Injection recall (Fresenius Kabi USA, LLC)
DrugClass IIReported July 29, 2026 · Presence of Particulate Matter: Hair was found in product - Rising recall (Rising Pharma Holding, Inc.)
DrugClass IIReported July 29, 2026 · Presence of Precipitate: medication was crystallizing and particles floating in the bottle - Rohto Cooling Eye Drops Cool Relief recall (Rohto-Mentholatum (Vietnam) Co., Ltd.)
DrugClass IIReported July 29, 2026 · Lack of Assurance of Sterility - Rohto Cooling Eye Drops Dry Aid recall (Rohto-Mentholatum (Vietnam) Co., Ltd.)
DrugClass IIReported July 29, 2026 · Lack of Assurance of Sterility - Rohto Cooling Eye Drops Dry Aid recall (Rohto-Mentholatum (Vietnam) Co., Ltd.)
DrugClass IIReported July 29, 2026 · Lack of Assurance of Sterility - Rohto Cooling Eye Drops Digi Eye recall (Rohto-Mentholatum (Vietnam) Co., Ltd.)
DrugClass IIReported July 29, 2026 · Lack of Assurance of Sterility - Rohto Cooling Eye Drops Optic Glow recall (Rohto-Mentholatum (Vietnam) Co., Ltd.)
DrugClass IIReported July 29, 2026 · Lack of Assurance of Sterility - Rohto Cooling Eye Drops Max Strength recall (Rohto-Mentholatum (Vietnam) Co., Ltd.)
DrugClass IIReported July 29, 2026 · Lack of Assurance of Sterility - Rohto Cooling Eye Drops Max Strength recall (Rohto-Mentholatum (Vietnam) Co., Ltd.)
DrugClass IIReported July 29, 2026 · Lack of Assurance of Sterility - Rohto Cooling Eye Drops ALL-IN-ONE recall (Rohto-Mentholatum (Vietnam) Co., Ltd.)
DrugClass IIReported July 29, 2026 · Lack of Assurance of Sterility - Amlodipine and Olmesartan Medoxomil Tablets recall (Ascend Laboratories, LLC)
DrugClass IIReported July 29, 2026 · Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications - Levothyroxine Sodium Tablets recall (Major Pharmaceuticals)
DrugClass IIReported July 29, 2026 · Subpotent Drug - Levothyroxine Sodium Tablets recall (Major Pharmaceuticals)
DrugClass IIReported July 29, 2026 · Subpotent Drug - Levothyroxine Sodium Tablets recall (Major Pharmaceuticals)
DrugClass IIReported July 29, 2026 · Subpotent Drug - Levothyroxine Sodium Tablets recall (Major Pharmaceuticals)
DrugClass IIReported July 29, 2026 · Subpotent Drug - Levothyroxine Sodium Tablets recall (Major Pharmaceuticals)
DrugClass IIReported July 29, 2026 · Subpotent Drug - Levothyroxine Sodium Tablets recall (Major Pharmaceuticals)
DrugClass IIReported July 29, 2026 · Subpotent Drug - Levothyroxine Sodium Tablets recall (Major Pharmaceuticals)
DrugClass IIReported July 29, 2026 · Subpotent Drug - Levothyroxine Sodium Tablets recall (Major Pharmaceuticals)
DrugClass IIReported July 29, 2026 · Subpotent Drug - Levothyroxine Sodium Tablets recall (Major Pharmaceuticals)
DrugClass IIReported July 29, 2026 · Subpotent Drug - Levothyroxine Sodium Tablets recall (Major Pharmaceuticals)
DrugClass IIReported July 29, 2026 · Subpotent Drug - Levothyroxine Sodium Tablets recall (Major Pharmaceuticals)
DrugClass IIReported July 29, 2026 · Subpotent Drug - Levothyroxine Sodium Tablets recall (Major Pharmaceuticals)
DrugClass IIReported July 29, 2026 · Subpotent Drug - Flexible Hystero-Fiberscope Kits REF: 11264BBU1 recall (Karl Storz Endoscopy)
Medical deviceClass IIReported July 29, 2026 · Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for... - SafeOp Patient Interface recall (Alphatec Spine, Inc.)
Medical deviceClass IIReported July 29, 2026 · Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during... - Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters recall (Medline Industries, LP)
Medical deviceClass IIReported July 29, 2026 · Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the... - Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters recall (Medline Industries, LP)
Medical deviceClass IIReported July 29, 2026 · Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the... - Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters recall (Medline Industries, LP)
Medical deviceClass IIReported July 29, 2026 · Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the... - Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters recall (Medline Industries, LP)
Medical deviceClass IIReported July 29, 2026 · Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the... - Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters recall (Medline Industries, LP)
Medical deviceClass IIReported July 29, 2026 · Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the... - Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters recall (Medline Industries, LP)
Medical deviceClass IIReported July 29, 2026 · Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the... - Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters recall (Medline Industries, LP)
Medical deviceClass IIReported July 29, 2026 · Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the... - Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters recall (Medline Industries, LP)
Medical deviceClass IIReported July 29, 2026 · Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the... - Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters recall (Medline Industries, LP)
Medical deviceClass IIReported July 29, 2026 · Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the... - Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4 recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported July 29, 2026 · Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases. - SnapshotGLO Wound Imaging Device recall (KENT IMAGING, INC.)
Medical deviceClass IIReported July 29, 2026 · The software controlling the wound imaging device's battery charging circuit was not designed to recognize and recover a battery that has fully discharged into... - Pipeline Flex Embolization Device with Shield Technology recall (Micro Therapeutics, Inc.)
Medical deviceClass IIReported July 29, 2026 · Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20... - Pipeline Flex Embolization Device with Shield Technology recall (Micro Therapeutics, Inc.)
Medical deviceClass IIReported July 29, 2026 · Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20... - Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. ... recall (AVID Medical, Inc.)
Medical deviceClass IIReported July 29, 2026 · Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage. - Boston Scientific TheraSphere 360 Y-90 Management Platform recall (Boston Scientific Corporation)
Medical deviceClass IIReported July 29, 2026 · Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a... - Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog... recall (Prismatik Dentalcraft, Inc.)
Medical deviceClass IIReported July 29, 2026 · Due to device not having FDA Clearance - Ventriculostomy Kit recall (Medtronic Neurosurgery)
Medical deviceClass IIReported July 29, 2026 · Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that exceed the... - 3mensio Workstation recall (PIE Medical Imaging B.V.)
Medical deviceClass IIReported July 29, 2026 · User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than...