Medical device recalls (page 7)
2545 recalls.
- Medline convenience kits labeled as: 1) LAMI FUSION recall (Medline Industries, LP)
Medical deviceClass IIReported September 2, 2026 · Kits contain a potentially contaminated component which were recalled by the manufacturer - Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF recall (Medline Industries, LP)
Medical deviceClass IIReported September 2, 2026 · Kits contain a potentially contaminated component which were recalled by the manufacturer - Medline convenience kits labeled as: 1) LAVH recall (Medline Industries, LP)
Medical deviceClass IIReported September 2, 2026 · Kits contain a potentially contaminated component which were recalled by the manufacturer - Medline convenience kits labeled as: 1) C-SECTION recall (Medline Industries, LP)
Medical deviceClass IIReported September 2, 2026 · Kits contain a potentially contaminated component which were recalled by the manufacturer - Medline convenience kits labeled as: 1) GYN ROBOTIC CDS recall (Medline Industries, LP)
Medical deviceClass IIReported September 2, 2026 · Kits contain a potentially contaminated component which were recalled by the manufacturer - Medline convenience kits labeled as: 1) MAJOR GYN PACK recall (Medline Industries, LP)
Medical deviceClass IIReported September 2, 2026 · Kits contain a potentially contaminated component which were recalled by the manufacturer - Medline convenience kits labeled as: LTP CDS-LF recall (Medline Industries, LP)
Medical deviceClass IIReported September 2, 2026 · Kits contain a potentially contaminated component which were recalled by the manufacturer - Medline convenience kits labeled as: 1) MAJOR PROCEDURE recall (Medline Industries, LP)
Medical deviceClass IIReported September 2, 2026 · Kits contain a potentially contaminated component which were recalled by the manufacturer - Medline convenience kits labeled as: MAJOR HEAD AND NECK PPS recall (Medline Industries, LP)
Medical deviceClass IIReported September 2, 2026 · Kits contain a potentially contaminated component which were recalled by the manufacturer - Medline convenience kits labeled as: 1) OPEN HEART PACK recall (Medline Industries, LP)
Medical deviceClass IIReported September 2, 2026 · Kits contain a potentially contaminated component which were recalled by the manufacturer - Medline convenience kits labeled as: 1) FEMORAL PACK recall (Medline Industries, LP)
Medical deviceClass IIReported September 2, 2026 · Kits contain a potentially contaminated component which were recalled by the manufacturer - CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B... recall (ConMed Corporation)
Medical deviceClass IIReported September 2, 2026 · Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability. - Fresenius Medical Care recall (Fresenius Medical Care Renal Therapies Group, LLC)
Medical deviceClass IIReported September 2, 2026 · Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T¿ ... - Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm recall (Henry Schein Inc.)
Medical deviceClass IIReported September 2, 2026 · Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device. - Structur 2 SC Temporary Resin Cartridge Refill 75Gm recall (Henry Schein Inc.)
Medical deviceClass IIReported September 2, 2026 · Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device. - Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital... recall (Canon Medical System, USA, INC.)
Medical deviceClass IIReported September 2, 2026 · Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose. - Midmark Digital ECG HD+12 recall (Midmark Corporation)
Medical deviceClass IIReported September 2, 2026 · A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation. - Midmark IQecg Digital ECG recall (Midmark Corporation)
Medical deviceClass IIReported September 2, 2026 · A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation. - Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 recall (AVID Medical, Inc.)
Medical deviceClass IIReported September 2, 2026 · Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. - Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 recall (AVID Medical, Inc.)
Medical deviceClass IIReported September 2, 2026 · Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. - Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 recall (AVID Medical, Inc.)
Medical deviceClass IIReported September 2, 2026 · Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. - Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 recall (AVID Medical, Inc.)
Medical deviceClass IIReported September 2, 2026 · Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. - Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 recall (AVID Medical, Inc.)
Medical deviceClass IIReported September 2, 2026 · Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. - Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 recall (AVID Medical, Inc.)
Medical deviceClass IIReported September 2, 2026 · Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. - Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY... recall (AVID Medical, Inc.)
Medical deviceClass IIReported September 2, 2026 · Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. - Merge PACS and Merge OrthoPACS recall (Merge Healthcare, Inc.)
Medical deviceClass IIReported September 2, 2026 · Software issue may cause measurements to be displayed inaccurately. - American Contract System Convenience Kit recall (American Contract Systems Inc)
Medical deviceClass IIReported September 2, 2026 · The Convenience Kits contain Medline's Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has... - American Contract System Convenience Kits recall (American Contract Systems Inc)
Medical deviceClass IIReported September 2, 2026 · The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has... - American Contract System Convenience Kit recall (American Contract Systems Inc)
Medical deviceClass IIReported September 2, 2026 · The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has... - American Contract System Convenience Kit recall (American Contract Systems Inc)
Medical deviceClass IIReported September 2, 2026 · The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has... - Medline medical convenience kit labeled as: TRACH TUBE KIT recall (Medline Industries, LP)
Medical deviceClass IIReported September 2, 2026 · Component labeling discrepancy - Onli 17cm Hydrophilic Urethral Intermittent Catheter recall (Hollister Ulc)
Medical deviceClass IIReported September 2, 2026 · Hollister has identified that select lots of the catheters identified in the above table may exhibit a protrusion caused by a manufacturing defect which might... - Medline medical convenience kits recall (Medline Industries, LP)
Medical deviceClass IIReported September 2, 2026 · Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential... - Medline medical convenience kits recall (Medline Industries, LP)
Medical deviceClass IIReported September 2, 2026 · Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential... - Medline medical convenience kits recall (Medline Industries, LP)
Medical deviceClass IIReported September 2, 2026 · Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential... - Medline medical convenience kits recall (Medline Industries, LP)
Medical deviceClass IIReported September 2, 2026 · Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential... - Medline breathing circuits labeled as: 1) MEDLINE HUDSON RCI recall (Medline Industries, LP)
Medical deviceClass IIReported September 2, 2026 · Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit... - Medline breathing circuits labeled as: 1) HUDSON RCI recall (Medline Industries, LP)
Medical deviceClass IIReported September 2, 2026 · Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit... - Medline Hudson RCI recall (Medline Industries, LP)
Medical deviceClass IIReported September 2, 2026 · Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit... - Philips Incisive CT with software V4.5&V5.0 recall (Philips Healthcare (Suzhou) Co., Ltd.)
Medical deviceClass IIReported September 2, 2026 · Potential of failing to trigger clinical scan during Bolus Tracking. - American Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR... recall (American Contract Systems Inc)
Medical deviceClass IIReported August 26, 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... - American Contract Systems medical procedure kits and trays labeled as: 1) CRANI... recall (American Contract Systems Inc)
Medical deviceClass IIReported August 26, 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... - Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard... recall (restor3d Inc.)
Medical deviceClass IIReported August 26, 2026 · Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws. - Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703 recall (ConvaTec, Inc)
Medical deviceClass IIReported August 26, 2026 · Urostomy Pouches may leak from cap during use. - Fort Defiance Industries recall (Fort Defiance Industries, LLC)
Medical deviceClass IIReported August 26, 2026 · The Automated Field Steam Sterilizer's water recovery system 120V Amphenol connector may experience an intermittent loss of ground continuity, which could... - MiniMed 780G Insulin Pump recall (Medtronic MiniMed, Inc.)
Medical deviceClass IIReported August 26, 2026 · Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result... - MiniMed 670G Insulin Pump recall (Medtronic MiniMed, Inc.)
Medical deviceClass IIReported August 26, 2026 · Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result... - MiniMed 640G Insulin Pump recall (Medtronic MiniMed, Inc.)
Medical deviceClass IIReported August 26, 2026 · Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result... - BMC/REACTHEALTH Luna G3 APAP REF LG 3600 recall (BMC Medical Co., Ltd.)
Medical deviceClass IReported August 26, 2026 · Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse - Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus recall (Boston Scientific Corporation)
Medical deviceClass IReported August 26, 2026 · Potential for arterial sheath tip separation or partial tip separation during use. - Boston Scientific ENROUTE Transcarotid Neuroprotection System recall (Boston Scientific Corporation)
Medical deviceClass IReported August 26, 2026 · Potential for arterial sheath tip separation or partial tip separation during use. - Beckman Coulter recall (Siemens Healthcare Diagnostics, Inc.)
Medical deviceClass IIReported August 26, 2026 · Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine... - Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL recall (Siemens Healthcare Diagnostics, Inc.)
Medical deviceClass IIReported August 26, 2026 · Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine... - Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or... recall (Beckman Coulter Inc.)
Medical deviceClass IIReported August 26, 2026 · a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by... - Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or... recall (Beckman Coulter Inc.)
Medical deviceClass IIReported August 26, 2026 · a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by... - Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A recall (Paragon 28, Inc.)
Medical deviceClass IIIReported August 26, 2026 · Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility. - Custom Made Device Implant 6123 Navicular Cage Small Right Rev A recall (Paragon 28, Inc.)
Medical deviceClass IIIReported August 26, 2026 · Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility. - Blanketrol III recall (Gentherm Medical, LLC)
Medical deviceClass IIReported August 26, 2026 · Overheating of the 115V CPU board may cause the device to shut down. - Innercool Coolblue Console recall (Gentherm Medical, LLC)
Medical deviceClass IIReported August 26, 2026 · Overheating of the 115V CPU board may cause the device to shut down. - Blanketrol II Model 222S recall (Gentherm Medical, LLC)
Medical deviceClass IIReported August 26, 2026 · Overheating of the 115V CPU board may cause the device to shut down. - Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF#... recall (Paragonix Technologies Inc.)
Medical deviceClass IIReported August 26, 2026 · Due to a firmware defect, the portable organ transfer device datalogger may lose its configuration, resulting in a blank screen and loss of displayed... - Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF recall (Siemens Healthcare Diagnostics Products Ltd.)
Medical deviceClass IIReported August 26, 2026 · Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive. - Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2 recall (Siemens Healthcare Diagnostics Products Ltd.)
Medical deviceClass IIReported August 26, 2026 · Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive. - Halyard LAVH PACK recall (AVID Medical, Inc.)
Medical deviceClass IIReported August 26, 2026 · The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit. - GETINGE Y SENSOR Module recall (Maquet Critical Care AB)
Medical deviceClass IIReported August 26, 2026 · The module did not undergo electrical safety tests and functional tests during production. - Suture Cinch Long 1pk. Endoscopic tissue approximation device. recall (Boston Scientific Corporation)
Medical deviceClass IIReported August 26, 2026 · Device may fail to deploy the cinch implant and/or fail to cut the suture as intended. - OverStitch Suture Cinch recall (Boston Scientific Corporation)
Medical deviceClass IIReported August 26, 2026 · Device may fail to deploy the cinch implant and/or fail to cut the suture as intended. - TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799 recall (Tobii Dynavox Llc)
Medical deviceClass IIReported August 26, 2026 · Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an... - TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798 recall (Tobii Dynavox Llc)
Medical deviceClass IIReported August 26, 2026 · Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an... - Arrow-LOK Implant recall (Arrowhead DE LLC)
Medical deviceClass IIReported August 26, 2026 · Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection. - Brand Name: Kico Knee Innovation Product Name: ARVIS SURGICAL NAVIGATION SYSTEM GEN 2... recall (Kico Knee Innovation Company)
Medical deviceClass IIReported August 26, 2026 · Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing - Cardiac Workstation 7000. Product Number: 860441. recall (Philips North America Llc)
Medical deviceClass IIReported August 26, 2026 · Device will intermittently provide inaccurate data related to native heart rate. - Cardiac Workstation 5000. Product Number: 860439. recall (Philips North America Llc)
Medical deviceClass IIReported August 26, 2026 · Device will intermittently provide inaccurate data related to native heart rate. - Dentsply Sirona Capsule Mixer Model No. 5546068 recall (SDI Limited)
Medical deviceClass IIReported August 26, 2026 · Potential for electrical discharge from unit when unplugged. - One-Piece Guedel Airway recall (Intersurgical Inc)
Medical deviceClass IIReported August 26, 2026 · Devices could potentially be occluded or partially occluded. - One-Piece Guedel Airway recall (Intersurgical Inc)
Medical deviceClass IIReported August 26, 2026 · Devices could potentially be occluded or partially occluded. - Hamilton Microlab STAR Liquid Handler recall (Foundation Medicine, Inc.)
Medical deviceClass IIReported August 26, 2026 · Software issue that can cause an increase in spontaneous software closures. - EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 ... recall (Covidien, LLC)
Medical deviceClass IIReported August 26, 2026 · The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures. - Ami HTX recall (Spectral Instruments Inc)
Medical deviceClass IIReported August 26, 2026 · Momentary absence of On-Screen "X-Ray On" banner during run readiness check. - Lago X recall (Spectral Instruments Inc)
Medical deviceClass IIReported August 26, 2026 · Momentary absence of On-Screen "X-Ray On" banner during run readiness check. - BD Needle Kit for Powered Driver 15mm x 15Ga recall (Bard Access Systems, Inc.)
Medical deviceClass IReported August 26, 2026 · After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary... - 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. - 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... - ProNephro AKI recall (Bioporto Diagnostics A/S)
Medical deviceClass IIReported August 19, 2026 · The use of a non-validated rework process for assay reagents which could lead to missed diagnosis of renal disease, inappropriate treatment decisions, or... - 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... - Endo-Model recall (Waldemar Link GmbH & Co. KG (Mfg Site))
Medical deviceClass IIReported August 19, 2026 · The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a... - 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... - Philips Azurion recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported August 19, 2026 · Two software related issues: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate... - Philips Azurion Rystem recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported August 19, 2026 · Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural... - 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. - 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...