Recalls in South Dakota (page 12)
3823 recalls.
- 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. - 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... - 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... - 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... - 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... - GE Healthcare Portrait Core Services SW V 1.2.0 recall (GE Medical Systems Information Technologies Inc)
Medical deviceClass IIReported August 12, 2026 · A software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient monitoring, missed... - 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... - GE Healthcare MAC VU360 recall (GE Medical Systems Information Technologies Inc)
Medical deviceClass IIReported August 12, 2026 · Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close... - Merge OrthoPACS recall (Merge Healthcare, Inc.)
Medical deviceClass IIReported August 12, 2026 · Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open. - Merge PACS recall (Merge Healthcare, Inc.)
Medical deviceClass IIReported August 12, 2026 · Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open. - STRYKER PKG. recall (Stryker Corporation)
Medical deviceClass IIReported August 12, 2026 · There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. - STRYKER PKG. recall (Stryker Corporation)
Medical deviceClass IIReported August 12, 2026 · There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. - STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING recall (Stryker Corporation)
Medical deviceClass IIReported August 12, 2026 · There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. - STRYKER AHTO TUBE SET WITH TIP PACKAGING recall (Stryker Corporation)
Medical deviceClass IIReported August 12, 2026 · There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. - STRYKER AHTO TUBE SET PACKAGING recall (Stryker Corporation)
Medical deviceClass IIReported August 12, 2026 · There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. - 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. - Brand Name: OXOS Medical recall (Oxos Medical Inc)
Medical deviceClass IIReported August 12, 2026 · Due to a defective circuit board that overheats - 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... - Brand Name: WASPLab Product Name: WASPLab Model/Catalog Number: W087 Software... recall (Copan WASP)
Medical deviceClass IIReported August 12, 2026 · Due to a software issue within the WebApp that potentially prevents the user to overwrite the results. - 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. - Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the... recall (INTEGRATED MEDCRAFT LLC)
Medical deviceClass IIReported August 12, 2026 · Devices could potentially contain an occluded or partially occluded Guedel Airway tip. - FORWARD Oral Airway Kit recall (INTEGRATED MEDCRAFT LLC)
Medical deviceClass IIReported August 12, 2026 · Devices could potentially contain an occluded or partially occluded Guedel Airway tip. - Charger for the Therabody Theragun recall (Therabody, Inc)
Medical deviceClass IIReported August 12, 2026 · Charging cradle for the device may overheat while charging the device's removable battery pack, presenting risk of thermal event (fire). Firm has received... - Halyard convenience kits containing recalled Medline Namic Angiographic Star Off... recall (AVID Medical, Inc.)
Medical deviceClass IReported August 12, 2026 · Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within... - Halyard convenience kits containing recalled Medline Namic Angiographic Star Off... recall (AVID Medical, Inc.)
Medical deviceClass IReported August 12, 2026 · Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within... - Halyard convenience kits containing recalled Medline Namic Angiographic Star Off... recall (AVID Medical, Inc.)
Medical deviceClass IReported August 12, 2026 · Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within... - Head Watersports Recalls Apeks Second Stage Scuba Regulators Recalled Due to Risk of Serious Injury or Death from Drowning Hazard
Consumer productReported August 7, 2026 · The recalled second stage regulators can restrict air flow to the user at depths exceeding 45 meters (approximately 147 feet), posing risk of serious injury or... - Fitueyes Recalls Laziza Dressers Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violate Mandatory Standard for Clothing Storage Units
Consumer productReported August 7, 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... - Wichard Groupe North America Recalls Courant Spliced Kalimba Climbing Ropes Due to Risk of Serious Injury or Death from Fall Hazard
Consumer productReported August 7, 2026 · The spliced termination ends on the recalled ropes can fail unexpectedly, posing a risk of serious injury or death from fall hazard. - Vanderhall North America Recalls Brawley GTS Electric Recreational Off Highway Vehicles (ROVs) Due to Risk of Serious Injury or Death from Crash Hazard
Consumer productReported August 7, 2026 · The recalled recreational off highway vehicle can maintain speed or accelerate when the accelerator pedal is released, posing a risk of serious injury or death... - KC Imports and Exports Recalls Mini Laser Pointer Keychains Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Consumer Products with Button Cell Batteries
Consumer productReported August 7, 2026 · The Mini Laser Pointer Keychains violate the mandatory safety standard for consumer products with button cell and coin batteries because the button batteries... - Syera Projecting Finger Light Toys Recalled Due to Risk of Serious Injury from Battery Ingestion; Violate Mandatory Standard for Toys; Sold on TEMU by Senyu
Consumer productReported August 7, 2026 · The recalled LED finger lights violate the mandatory safety standard for toys because they contain button cell batteries that can be easily accessed by... - Little Rawr Pull String Teething Toys Recalled Due to Risk of Serious Injury or Death from Choking; Violate Mandatory Standard for Toys; Sold on Amazon by Okabesini-us
Consumer productReported August 7, 2026 · The recalled teething toys violate the mandatory standard for toys because the silicone strings are smaller and longer than permitted. The strings can reach... - A2batt Recalls EEMB Lithium Coin Battery Chargers Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Consumer Products with Coin Batteries
Consumer productReported August 7, 2026 · The recalled battery chargers violate the mandatory standard for consumer products containing button cell or coin batteries, because the charger has lithium... - Play Yard and Crib Mattresses Recalled Due to Risk of Serious Injury or Death from Entrapment and Fire Hazards; Violate Mandatory Standards for Mattresses; Sold on Amazon by Voomf
Consumer productReported August 7, 2026 · The recalled mattresses violate the mandatory safety standard for crib mattresses because the mattresses may not adequately fit certain play yards, posing a... - Liuqibax Adult Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violate Mandatory Standard for Adult Portable Bed Rails; Sold on Amazon by Luqiba
Consumer productReported August 7, 2026 · The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail or between the bed... - Magnetic Fidget Sliders Recalled Due to Risk of Serious Injury or Death from Magnet Ingestion; Violate Mandatory Standard for Toys; Sold on Amazon by PIXLABBY
Consumer productReported August 7, 2026 · The magnetic fidget sliders violate the mandatory standard for toys because they can liberate loose high-powered magnets posing an ingestion hazard to... - Wnttmt Baby Walkers Recalled Due to Risk of Serious Injury or Death from Fall and Entrapment Hazards; Violate Mandatory Standard for Infant Walkers; Sold on Amazon by WURUI.BABY
Consumer productReported August 7, 2026 · The recalled infant 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... - Magnetic Fidget Sliders Recalled Due to Risk of Serious Injury or Death from Magnet Ingestion; Violate Mandatory Standard for Toys: Sold on Amazon by BUSOHA
Consumer productReported August 7, 2026 · The magnetic fidget sliders violate the mandatory standard for toys because they can liberate loose magnets posing an ingestion hazard to children. When... - Winston Porter and Seeday 3-Drawer, 4-Drawer, and 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
Consumer productReported August 7, 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... - OKK Trading Recalls Easter LED Headbands Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Toys
Consumer productReported August 7, 2026 · The recalled headbands violate the mandatory safety standard for toys with button cell and coin batteries because the lithium coin batteries can be accessed... - Louisville Ladder Recalls Over One Million Attic Stairway Ladders Due to Risk of Serious Injury or Death from Fall Hazard
Consumer productReported August 7, 2026 · The bolts on the attic stairway ladders can break while in use, posing a risk of serious injury or death from fall hazard. - DR Power Equipment Recalls Lawn Mowers Due to Risk of Serious Injury or Death from Laceration Hazard; Violate Mandatory Standard for Lawn Mowers
Consumer productReported August 7, 2026 · The recalled mowers violate the mandatory safety standard for walk-behind power lawn mowers because the blades can operate without the blade control system... - Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides... recall (ResMed Ltd.)
Medical deviceClass IReported August 5, 2026 · Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of... - Mellish Island Super Skin recall (Mellish Island Corp)
FoodClass IIReported August 5, 2026 · Firm's finished product label does not declare the source of marine collagen which was determined to be fish. - Dabigatran Etexilate Capsules recall (Ascend Laboratories, LLC)
DrugClass IIIReported August 5, 2026 · Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for... - Dabigatran Etexilate Capsules recall (Ascend Laboratories, LLC)
DrugClass IIIReported August 5, 2026 · Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for... - Dabigatran Etexilate Capsules recall (Ascend Laboratories, LLC)
DrugClass IIIReported August 5, 2026 · Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for... - Mycophenolate Mofetil for Injection USP recall (MYLAN PHARMACEUTICALS INC)
DrugClass IIReported August 5, 2026 · Presence of precipitate - Azelaic Acid Gel recall (Glenmark Pharmaceuticals Inc., USA)
DrugClass IIReported August 5, 2026 · CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received. - Dorzolamide HCl and Timolol Maleate Ophthalmic Solution recall (MICRO LABS USA INC)
DrugClass IIReported August 5, 2026 · Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops. - Stryker Hoffmann II Connecting Rod Micro 3 x 150mm. Catalog Number: 50796150. recall (Stryker GmbH)
Medical deviceClass IIReported August 5, 2026 · Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. - Stryker Hoffmann II Connecting Rod Micro 3 x 120mm. Catalog Number: 50796120. recall (Stryker GmbH)
Medical deviceClass IIReported August 5, 2026 · Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. - Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090. recall (Stryker GmbH)
Medical deviceClass IIReported August 5, 2026 · Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. - Stryker Hoffmann II Connecting Rod Micro 3 x 60mm. Catalog Number: 50796060. recall (Stryker GmbH)
Medical deviceClass IIReported August 5, 2026 · Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. - Stryker Hoffmann II Connecting Rod Micro 3 x 50mm. Catalog Number: 50796050. recall (Stryker GmbH)
Medical deviceClass IIReported August 5, 2026 · Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. - Stryker Hoffmann II Connecting Rod Micro 3 x 40mm. Catalog Number: 50796040. recall (Stryker GmbH)
Medical deviceClass IIReported August 5, 2026 · Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. - Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030. recall (Stryker GmbH)
Medical deviceClass IIReported August 5, 2026 · Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. - 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 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 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 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...