Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

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951–975 of 13381

HighFDA (Devices)·Z-1223-2026·2026-02-11
Olympus electrosurgical knife recalled due to deterioration and tip breakage risk
Olympus is recalling its KD-645 electrosurgical knife due to deterioration of the cutting knife that can cause overheating, burning, and tip breakage during endoscopic surgery. A total of 3,361 units have been distributed nationwide.
Product
Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Model/Catalog Number: KD-645L Product Description: An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1301-2026·2026-02-11
Lumipulse G Alzheimer's Disease Diagnostic Test Recalled for Inaccurate Results
Fujirebio Diagnostics is recalling the Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio diagnostic test because it may produce falsely elevated positive or indeterminate results, causing patients to be incorrectly classified as having Alzheimer's disease or requiring unnecessary further testing.
Product
Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Software Version: Not Applicable Product Description: Lumipulse G pTau217/¿-Amyloid 1-42 Plasma Ratio is an in vitro diagnostic (IVD) test that combines the test results of the Lumipulse
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1307-2026·2026-02-11
Lumipulse β-Amyloid Plasma Controls Recalled for Inaccurate Test Results
Fujirebio Diagnostics is recalling Lumipulse β-Amyloid Plasma Controls due to falsely elevated test results that may cause incorrect classification of Alzheimer's disease status. The quality control product may provide false positive or unnecessary indeterminate results.
Product
Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: Not Applicable Product Description: Lumipulse ¿-Amyloid Plasma Controls: This quality control product can be used as an objective judgement of the laboratory s procedures and perso
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1246-2026·2026-02-11
Laser Probe Pouches Recalled Due to Sterile Barrier Defect Risk
Vortex Surgical is recalling Oertli laser probes due to voids in Tyvek pouches that could compromise the sterile barrier and lead to infection risk.
Product
Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VK401213 3. 23G Laser Probe OS4 Intuitive Exendable VK401323 4. 25G Laser Probe OS4 Flex-Tip VK401115 5. 25G Laser Probe OS4 Illuminated Flex-Tip VK401215 6. 25G Laser
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1250-2026·2026-02-11
Vortex Surgical Internal Delivery Device Recalled for Compromised Sterile Barrier
Vortex Surgical is recalling its 25GA Internal Delivery Device due to voids in pouch seals that may compromise sterility, allowing potential bacterial contamination that could lead to infection.
Product
Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1305-2026·2026-02-11
FDA Recalls Lumipulse G Plasma Test Cartridges for Inaccurate Results
FDA is recalling Lumipulse G β-Amyloid 1-42-N Plasma Immunoreaction Cartridges due to inaccurate test results that may falsely classify patients as having Alzheimer's disease pathology or requiring unnecessary clinical testing.
Product
Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges Model/Catalog Number: 235447 Software Version: Not Applicable Product Description: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges (IRC): Lumipulse G ¿-Amyloid 1-42-N Plasma is an assay
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1240-2026·2026-02-11
NAEOTOM Alpha CT diagnostic software applications recalled for lacking FDA clearance
Siemens is recalling software applications used in NAEOTOM Alpha CT systems because they lack FDA 510(k) clearance. The recall affects 88 units.
Product
NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1251-2026·2026-02-11
Tecfen Retractable Membrane Polisher recalled for sterile barrier defect
Vortex Surgical is recalling Tecfen Retractable Membrane Polishers due to potential voids in sterile pouches that could compromise the barrier and allow bioburden contamination. Approximately 8,651 units were distributed in the US.
Product
Tecfen Retractable Membrane Polisher, QTPR1267-23
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1258-2026·2026-02-11
Urinalysis Test Strips Recalled for Inaccurate Results Without FDA Approval
Three brands of urinalysis and ketone test strips have been recalled because they were distributed without required FDA approval and may produce inaccurate diagnostic results. False or incorrect readings could lead to inappropriate medical decisions.
Product
The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED Urinalysis Reagent Strips URS-5, Rapid UTI Test Includes Ketones: Leukocytes, Nitrite, pH, Ketone, Protein; Vivoo Ketone Test
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1293-2026·2026-02-11
Olympus Sphincterotome Devices Recalled for Deformation and Performance Loss
Olympus recalls 999 units of Disposable Triple Lumen Sphincterotomes due to manufacturing defects. Devices that did not undergo proper thermoforming may deform and lose performance during use.
Product
Brand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0320 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-fr
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1248-2026·2026-02-11
Subretinal Injection Cannulas Recalled for Compromised Sterile Seal
Vortex Surgical Inc. is recalling 25GA Subretinal Injection Cannulas due to voids in the sterile Tyvek pouches that could allow bioburden contamination and potentially lead to infection.
Product
25GA Subretinal Injection Cannula VS0220.25
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1264-2026·2026-02-11
Vivoo pH Test Strips Recalled for Inaccurate Diagnostic Results
Vivoo pH Test strips were distributed before obtaining required FDA clearance. The devices may produce false or inaccurate results when used by consumers, potentially leading to inappropriate medical treatment.
Product
Vivoo pH Test
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1247-2026·2026-02-11
Vortex Disposable Forceps and Cannula Surgical Instruments Recall
Vortex Surgical is recalling disposable forceps and cannulas due to voids in Tyvek pouch seals that could compromise sterile barriers and allow bioburden contamination, potentially leading to infection.
Product
Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA ACTU8 Forceps Adaptive VS0740.25 3. 25GA ACTU8 Forceps ILM VS0744.25 4. 25GA ACTU8 Forceps ILM -Myopic VS0744.25-35 5. 25GA ACTU8 Forceps Pro-Grip VS0713.25 6. 25GA ACTU8
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1235-2026·2026-02-11
Sample preparation system software error causes sample loss and instrument malfunction
A software error in the CellMek SPS Sample Preparation System causes samples to be dispensed incorrectly, resulting in sample loss of 60-100 microliters. This could lead to incorrect laboratory results and patient management decisions.
Product
CellMek SPS Sample Preparation System, REF: C44603, with software
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1306-2026·2026-02-11
Medical device calibrator recall due to inaccurate Alzheimer's test results
Lumipulse G plasma calibrators may produce inaccurate test results, causing false positive or indeterminate classifications for Alzheimer's disease. 128 units are affected nationwide.
Product
Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators Model/Catalog Number: 235454 Software Version: Not Applicable Product Description: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators: The ¿-Amyloid 1-42 plasma concentration of a specimen is automatically calculated
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1269-2026·2026-02-11
Olympus Single Use Sphincterotome V Recalled for Potential Deformation
Olympus is recalling its Single Use Sphincterotome V devices that may not have undergone proper thermoforming, which could cause them to deform and lose performance.
Product
Product Name: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1278-2026·2026-02-11
Olympus Sphincterotome V Recalled Due to Potential Device Deformation
Olympus recalls single-use sphincterotomes that may deform and lose performance if not properly thermoformed during manufacturing. No injuries have been reported.
Product
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1287-2026·2026-02-11
Disposable Sphincterotome Recall by Olympus for Potential Deformation and Performance Loss
Olympus is recalling 886 units of its Disposable Triple Lumen Sphincterotome (Model KD-401Q-0330) because some devices may not have undergone proper thermoforming and could deform and lose performance during use.
Product
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1304-2026·2026-02-11
Lumipulse pTau 217 Plasma Controls recalled for inaccurate test results
Fujirebio's Lumipulse pTau 217 Plasma Controls may produce inaccurate test results, causing false positive or indeterminate readings. This could lead to incorrect Alzheimer's disease diagnosis or unnecessary clinical testing.
Product
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Product Description: Lumipulse pTau 217 Plasma Controls: This quality control product can be used as an objective judgement of the laboratory s procedures and personn
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1311-2026·2026-02-11
Molift Sling Bars Recalled for Structural Defect in Patient Lift Devices
Molift 4-point sling bars are being recalled due to a bolt defect caused by material deformation between the lifting bar and device arm, which prevents proper device functionality.
Product
Brand Name: Molift Product Name: Molift 4-point sling bars (Accessory to mobile hoists) Model/Catalog Number: 1430116,1430117,1430115 Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due to
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1273-2026·2026-02-11
Olympus Sphincterotome V Devices Recalled for Potential Deformation
Olympus has recalled Single Use 3-Lumen Sphincterotome V devices (Model KD-V411M-0725) worldwide because some units may not have undergone proper thermoforming, which could cause deformation and performance loss.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1226-2026·2026-02-11
OXIRIS Dialyzer Set Recalled Due to Potential Deaeration Chamber Dislodgement
VANTIVE US HEALTHCARE LLC is recalling 2,724 units of OXIRIS SET dialyzers nationwide due to potential dislodgement of the deaeration chamber, which could impair device function.
Product
OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1234-2026·2026-02-11
EMPOWR Acetabular System Hip Implant Liners Recalled for Packaging Discrepancy
Encore Medical recalls EMPOWR Acetabular System hip implant liners due to packaging errors where wrong device components were found in packaging. The discrepancy may cause surgical delay or need for revision surgery.
Product
EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree Hooded, HXe+, 36J, REF: 942-01-36J; Liner, 10 degree Hooded, HXe+, 40G, REF: 942-01-40G; Liner, 10 degree Hooded, HXe+, 32C, REF: 942-01-32C
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-1298-2026·2026-02-11
Nasal Jejunal Feeding Tube Recalled Due to Missing Component
Nasal jejunal feeding tubes (NJFT-10) from Wilson-Cook Medical are recalled for being packaged without the required nasal transfer tube component, preventing safe use.
Product
Product Name: Nasal Jejunal Feeding Tube REF: NJFT-10
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1253-2026·2026-02-11
Rumex Surgical Elevators Recalled for Compromised Sterile Barrier
Vortex Surgical Inc. is recalling Rumex Disposable Diamond Dusted ILM Elevators due to voids in sterilization pouch seals. The compromised barrier could allow contamination and lead to infection during surgical procedures.
Product
Rumex Disposable Diamond Dusted ILM Elevator, 12-7523
Category
Medical Device
Distribution
Distributed nationwide

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