Medical device recalls (page 9)
2545 recalls.
- 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... - 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... - L-Cath Midline S/L Catheter 20ga recall (Argon Medical Devices, Inc)
Medical deviceClass IIReported August 5, 2026 · Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may... - L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga recall (Argon Medical Devices, Inc)
Medical deviceClass IIReported August 5, 2026 · Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may... - 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... - Pack Angiography NCMC 3/Cs BANNER recall (Medical Action Industries, Inc. 306)
Medical deviceClass IReported August 5, 2026 · Cardiovascular procedure kits contain manifolds, the subject of another recall, that may have particulate within the fluid path, which has the potential to be... - 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... - 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... - 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... - 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 medical convenience kits labeled as: 1) TOTAL JOINT PACK Medline Kit SKU... recall (Medline Industries, LP)
Medical deviceClass IIReported July 29, 2026 · Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of... - Medline medical convenience kits labeled as: NEURO PACK recall (Medline Industries, LP)
Medical deviceClass IIReported July 29, 2026 · Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of... - Medline medical convenience kits labeled as: 1) SHOULDER PACK recall (Medline Industries, LP)
Medical deviceClass IIReported July 29, 2026 · Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of... - Medline medical convenience kits labeled as: 1) KIT PEDIATRIC OPEN HEART MOSES recall (Medline Industries, LP)
Medical deviceClass IIReported July 29, 2026 · Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of... - 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... - 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... - 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... - 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 - 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... - MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF recall (Medline Industries, LP)
Medical deviceClass IReported July 29, 2026 · The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to... - MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF recall (Medline Industries, LP)
Medical deviceClass IReported July 29, 2026 · The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to... - Halyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit. recall (AVID Medical, Inc.)
Medical deviceClass IIReported July 29, 2026 · Incorrect concentration of Betadine solution contained within certain AVID convenience kits. - SeaSpine Polyaxial Head REF Number: 41-3010 recall (SEASPINE ORTHOPEDICS CORPORATION)
Medical deviceClass IIReported July 29, 2026 · Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion. - Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual... recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported July 29, 2026 · Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities. - 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... - Hotline Fluid Warming Set recall (ICU Medical Inc.)
Medical deviceClass IIReported July 29, 2026 · ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent... - P28 PHANTON INTRAMEDULLARY NAIL SYSTEM recall (Paragon 28, Inc.)
Medical deviceClass IIReported July 29, 2026 · Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging. - FARADRIVE STEERABLE SHEATH CLEAR OUS recall (Boston Scientific Corporation)
Medical deviceClass IIReported July 29, 2026 · Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to... - FARADRIVE STEERABLE SHEATH recall (Boston Scientific Corporation)
Medical deviceClass IIReported July 29, 2026 · Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to... - FARADRIVE STEERABLE SHEATH CLEAR recall (Boston Scientific Corporation)
Medical deviceClass IIReported July 29, 2026 · Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to... - FARADRIVE Steerable Sheath Clear IDE recall (Boston Scientific Corporation)
Medical deviceClass IIReported July 29, 2026 · Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to... - FARASTAR Ablation Generator EU recall (Boston Scientific Corporation)
Medical deviceClass IIReported July 29, 2026 · Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter. - FARASTAR PFA Generator recall (Boston Scientific Corporation)
Medical deviceClass IIReported July 29, 2026 · Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information. - FARASTAR Pulsed Field Ablation Generator recall (Boston Scientific Corporation)
Medical deviceClass IIReported July 29, 2026 · Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information. - FARASTAR Ablation Generator EU recall (Boston Scientific Corporation)
Medical deviceClass IIReported July 29, 2026 · Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information. - MEDLINE convenience kits labeled as: 1) TOTAL JOINT KIT recall (Medline Industries, LP)
Medical deviceClass IReported July 29, 2026 · Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose... - MEDLINE convenience kits labeled as: 1) C-SECTION recall (Medline Industries, LP)
Medical deviceClass IReported July 29, 2026 · Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose... - MEDLINE ANTERIOR HIP recall (Medline Industries, LP)
Medical deviceClass IReported July 29, 2026 · Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose... - The intended use is to be paired with a weapon for aiming purposes. recall (Wilcox Industries Corp.)
Medical deviceClass IIReported July 29, 2026 · Wilcox is notifying all customers who have purchased a product from the BOSS Xe family that a software enhancement to increase safety has been released and all... - ST AIA-Pack Testosterone recall (Tosoh Bioscience Inc)
Medical deviceClass IIReported July 22, 2026 · The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA) which could... - Photera 600 3-D recall (Daavlin Distributing Company)
Medical deviceClass IIReported July 22, 2026 · Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000... - Photera 600 recall (Daavlin Distributing Company)
Medical deviceClass IIReported July 22, 2026 · Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000... - Photera 400 recall (Daavlin Distributing Company)
Medical deviceClass IIReported July 22, 2026 · Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000... - The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System recall (Maquet Cardiovascular, LLC)
Medical deviceClass IIReported July 22, 2026 · Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization... - Medtronic Bio-Medicus Adult Cannula Kit recall (Medtronic Perfusion Systems)
Medical deviceClass IIReported July 22, 2026 · Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood. - Medtronic DLP One-Piece Pediatric Arterial Cannula recall (Medtronic Perfusion Systems)
Medical deviceClass IIReported July 22, 2026 · Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood. - Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK-LF ... recall (Medline Industries, LP)
Medical deviceClass IIReported July 22, 2026 · Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health... - Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK ... recall (Medline Industries, LP)
Medical deviceClass IIReported July 22, 2026 · Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health... - Papablic Replacement Brush Heads. Model Number: PAPA317AA. recall (Papablic Inc)
Medical deviceClass IIReported July 22, 2026 · Potential for brush heads to break. - Papablic Replacement Brush Heads. Model Number: Papablic18B recall (Papablic Inc)
Medical deviceClass IIReported July 22, 2026 · Potential for brush heads to break. - Orthofix MINIRAIL recall (Orthofix U.S. LLC)
Medical deviceClass IIReported July 22, 2026 · Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was... - Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111 recall (Orthofix U.S. LLC)
Medical deviceClass IIReported July 22, 2026 · Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was... - Orthofix MINIRAIL recall (Orthofix U.S. LLC)
Medical deviceClass IIReported July 22, 2026 · Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was... - Orthofix MINIRAIL recall (Orthofix U.S. LLC)
Medical deviceClass IIReported July 22, 2026 · Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was... - Optima XR240amx recall (GE Medical Systems, LLC)
Medical deviceClass IIReported July 22, 2026 · GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety... - Optima XR220amx recall (GE Medical Systems, LLC)
Medical deviceClass IIReported July 22, 2026 · GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety...