Medical Device Recalls
RSS ↗8,553 medical device recalls from federal enforcement feeds.
Showing 251–300 of 8,553
- Class II
Medical Device Recall · July 10, 2026
Medline convenience kits labeled as: 1) GYN ROBOTIC CDS, Medline Kit SKU CDS982888Q; 2) GYN ROBOTIC ADD ON PACK, Medline Kit SKU DYNJ43837D; 3) OH GYN/LAP ROBOT PACK, Medline Kit SKU DYNJ89759;Kits contain a potentially contaminated component which were recalled by the manufacturer
- Class III
Medical Device Recall · July 10, 2026
Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implantDevice was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
- Class II
Medical Device Recall · July 10, 2026
Medline convenience kits labeled as: 1) MAJOR PROCEDURE, Medline Kit SKU CDS982040U; 2) OPERATIVE LAP P&S SURGICAL, Medline Kit SKU DYNJ89608; 3) LAPAROSCOPY, Medline Kit SKU DYNJ903479L; 4)Kits contain a potentially contaminated component which were recalled by the manufacturer
- Class II
Medical Device Recall · July 10, 2026
Medline convenience kits labeled as: 1) OPEN HEART PACK, Medline Kit SKU CDS840393P; 2) OPEN HEART PACK, Medline Kit SKU CDS840393Q; 3) OPEN HEART PROCEDURE, Medline Kit SKU CDS980895W; 4) VAKits contain a potentially contaminated component which were recalled by the manufacturer
- Class II
Medical Device Recall · July 10, 2026
GE Medical Systems Information Technologies Inc
GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring systemA software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient monitoring, missed patient alarms, and/or access to Protected Health Information (PHI).
- Class II
Medical Device Recall · July 10, 2026
Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907).The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.
- Class II
Medical Device Recall · July 10, 2026
Medline convenience kits labeled as: 1) MAJOR GYN PACK, Medline Kit SKU DYNJG001030C; 2) GYN LITHOTOMY PACK, Medline Kit SKU DYNJT8166; 3) OPEN HEART PACK, Medline Kit SKU DYNJ47638B; 4) EASTKits contain a potentially contaminated component which were recalled by the manufacturer
- Class II
Medical Device Recall · July 10, 2026
Medline convenience kits labeled as: MAJOR HEAD AND NECK PPS, Medline Kit SKU DYNJ9425991SKits contain a potentially contaminated component which were recalled by the manufacturer
- Class II
Medical Device Recall · July 10, 2026
Medline convenience kits labeled as: 1) C-SECTION, Medline Kit SKU DYNJ904612L; 2) C-SECTION, Medline Kit SKU DYNJ911755; 3) AHR C-SECTION KIT, Medline Kit SKU DYNJ912014.Kits contain a potentially contaminated component which were recalled by the manufacturer
- Class II
Medical Device Recall · July 10, 2026
Medline convenience kits labeled as: LTP CDS-LF, Medline kit SKU CDS980375MKits contain a potentially contaminated component which were recalled by the manufacturer
- Class II
Medical Device Recall · July 9, 2026
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
- Class II
Medical Device Recall · July 9, 2026
Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
- Class II
Medical Device Recall · July 9, 2026
Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm, Product Codes: 1) 949-3594, Mfr Product Code 1840; Lots 2529604, 2538147, 2608145 2) 949-3595, Mfr Product Code 1841; Lots 253Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.
- Class II
Medical Device Recall · July 9, 2026
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
- Class I
Medical Device Recall · July 9, 2026
Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheterPotential for arterial sheath tip separation or partial tip separation during use.
- Class II
Medical Device Recall · July 9, 2026
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
- Class II
Medical Device Recall · July 9, 2026
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
- Class I
Medical Device Recall · July 9, 2026
Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheterPotential for arterial sheath tip separation or partial tip separation during use.
- Class II
Medical Device Recall · July 9, 2026
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
- Class II
Medical Device Recall · July 9, 2026
Structur 2 SC Temporary Resin Cartridge Refill 75Gm, Product Codes: 1) 114-3933, Mfr Product Code 1479; Lots 2536179, 2606429 2) 114-3934, Mfr Product Code 1480; Lot 2539064 3) 114-3935, Mfr ProSpecific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.
- Class II
Medical Device Recall · July 9, 2026
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
- Class II
Medical Device Recall · July 8, 2026
TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an internal short circuit. This may cause localized heating and gas venting within the device enclosure.
- Class II
Medical Device Recall · July 8, 2026
Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131The Automated Field Steam Sterilizer's water recovery system 120V Amphenol connector may experience an intermittent loss of ground continuity, which could result in an unreliable fault current return path.
- Class II
Medical Device Recall · July 8, 2026
Medline medical convenience kits, labeled as: 1) CRANIOTOMY PACK, Medline Kit SKU DYNJT6545; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ88056A; 3) ENT SINUS PACK, Medline Kit SKU DYNJ89001; 4)Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.
- Class II
Medical Device Recall · July 8, 2026
Medline medical convenience kits, labeled as: 1) LAMINECTOMY PACK, Medline Kit SKU DYNJT6548; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ44504G; 3) NEURO SPINE PACK, Medline Kit SKU DYNJ45419F;Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.
- Class II
Medical Device Recall · July 8, 2026
Medline medical convenience kits, labeled as: 1) NEURO CDS, Medline Kit SKU CDS985246J; 2) NEURO PACK, Medline Kit SKU DYNJ32770V; 3) NEURO BUNDLE-LF, Medline Kit SKU DYNJ40095D; 4) NEURO PACSpecific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.
- Class II
Medical Device Recall · July 8, 2026
TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an internal short circuit. This may cause localized heating and gas venting within the device enclosure.
- Class II
Medical Device Recall · July 8, 2026
Medline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Kit SKU DYNJ0966146F; 2) ENT PACK, Medline Kit SKU DYNJ40154D; 3) ENT PACK, Medline Kit SKU DYNJ40154F; 4) ENT SCOPE PASpecific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.
- Class II
Medical Device Recall · July 7, 2026
Olympus Corporation of the Americas
Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for displaying graphical information in color.Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities.
- Class II
Medical Device Recall · July 7, 2026
Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050. 2. Size 000, ISDevices could potentially contain an occluded or partially occluded Guedel Airway tip.
- Class II
Medical Device Recall · July 7, 2026
FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050.Devices could potentially contain an occluded or partially occluded Guedel Airway tip.
- Class II
Medical Device Recall · July 6, 2026
Pi-Cardia Inc. ShortCut REF: Z-A-20.003-USTransfemoral catheter, positing arm may detached due to weld issue.
- Class II
Medical Device Recall · July 6, 2026
Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an alternative product would be needed. If the incorrect plateau were to be implanted, this is associated with increased risk of wear, which could result in a reduced standing time of the implant.
- Class II
Medical Device Recall · July 6, 2026
Siemens Healthcare Diagnostics, Inc.
Atellica CH Urine Albumin REF: 11537225, in vitro diagnosticProcessing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results; Increased rate of reaction cuvette QC failures and Delayed results due to QC failures.
- Class II
Medical Device Recall · July 6, 2026
Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710, 423712, 423713, 423714, 423715, 423716, 423717, 423718, 423721, 423722, 423723, 4Urostomy Pouches may leak from cap during use.
- Class I
Medical Device Recall · July 6, 2026
Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride Flush for IV tubing systems and indManufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. This may trigger inflammatory responses, infections, micro-clots, and organ failure.
- Class II
Medical Device Recall · July 2, 2026
OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were filled with approx. 4.5 cc DBM (fill for 45 ¿ 11 mm configuration) instead of approx. 7.5 cc DBM (fill for 45 ¿ 17.5 mm configuration), which may lead to delayed fusion, incomplete fusion, pseudarthrosis, or lack of bone ingrowth.
- Class II
Medical Device Recall · July 1, 2026
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description: Intramedullary Bone Saw Blade Assembly 15mmZimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
- Class II
Medical Device Recall · July 1, 2026
Stryker Hoffmann II Connecting Rod Micro 3 x 50mm. Catalog Number: 50796050.Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
- Class II
Medical Device Recall · July 1, 2026
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description: Intramedullary Bone Saw Blade Assembly 12mmZimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
- Class II
Medical Device Recall · July 1, 2026
Cardiac Workstation 5000. Product Number: 860439.Device will intermittently provide inaccurate data related to native heart rate.
- Class II
Medical Device Recall · July 1, 2026
Stryker Hoffmann II Connecting Rod Micro 3 x 60mm. Catalog Number: 50796060.Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
- Class II
Medical Device Recall · July 1, 2026
5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.
- Class II
Medical Device Recall · July 1, 2026
Cardiac Workstation 7000. Product Number: 860441.Device will intermittently provide inaccurate data related to native heart rate.
- Class II
Medical Device Recall · July 1, 2026
Stryker Hoffmann II Connecting Rod Micro 3 x 120mm. Catalog Number: 50796120.Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
- Class II
Medical Device Recall · July 1, 2026
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Description: Intramedullary Bone Saw Blade Assembly 14mmZimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
- Class II
Medical Device Recall · July 1, 2026
5-PLASMA Bivalirudin Control, Model Number 5D-44905Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.
- Class II
Medical Device Recall · July 1, 2026
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product Description: Intramedullary Bone Saw Blade Assembly 13mmZimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
- Class II
Medical Device Recall · July 1, 2026
Stryker Hoffmann II Connecting Rod Micro 3 x 40mm. Catalog Number: 50796040.Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
- Class II
Medical Device Recall · July 1, 2026
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Description: Intramedullary Bone Saw Blade Assembly 16mmZimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.