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.

Agency

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976–1000 of 13414

HighFDA (Devices)·Z-1294-2026·2026-02-11
Olympus Disposable Sphincterotome Recall for Deformation and Performance Loss
Olympus Corporation is recalling Disposable Triple Lumen Sphincterotomes (Model KD-401Q-0725) because some units did not undergo proper thermoforming during manufacturing and could deform and lose performance.
Product
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0725 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-1259-2026·2026-02-11
LH One Step Ovulation Test Device Recalled for Inaccurate Results
The LH One Step Ovulation Test Device was distributed before obtaining required FDA clearance. These test devices may provide false or inaccurate results, potentially leading to inappropriate medical intervention.
Product
LH One Step Ovulation Test Device (Urine)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1300-2026·2026-02-11
Venous Bubble Sensor connecting cable durability defect may cause malfunction
Maquet's Venous Bubble Sensor (Model 701055720) is recalled due to connecting cable durability issues that may cause sensor damage or disconnection errors on connected medical devices.
Product
Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1241-2026·2026-02-11
CT System Software Recalled for Lack of FDA 510(k) Clearance
Siemens has recalled NAEOTOM Alpha.Prime CT system software applications that were distributed without FDA 510(k) clearance. Affected systems are located in the US, Canada, Costa Rica, India, and Israel.
Product
NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1282-2026·2026-02-11
Sphincterotome recalled for potential deformation and performance loss
Olympus is recalling 413 units of Single Use 3-Lumen Sphincterotomes (Model KD-VC412Q-0215) distributed in the United States because some devices may not have undergone proper thermoforming and could deform and lose performance.
Product
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC412Q-0215; 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-1262-2026·2026-02-11
Male Fertility Sperm Test Distributed Without FDA Clearance Poses Inaccuracy Risk
Changchun Wancheng Bio-Electron's male fertility sperm test was distributed without required FDA clearance. The device may produce false diagnostic results when used at home.
Product
Male Fertility Sperm Test for Home Use (Cassette)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1236-2026·2026-02-11
VITEK 2 Gram-negative Susceptibility Cards Risk of False Antibiotic Resistance Results
Biomerieux is recalling VITEK 2 Gram-negative Susceptibility Cards due to potential quality control failures and false antibiotic resistance results. The cards are used in clinical laboratories for antibiotic susceptibility testing.
Product
VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev01n) o Imipenem (ipm05n) o Imipenem/Relebactam (ipr01n); CARD NAME/ PRODUCT REFERENCE: AST-N399 423701 AST-N402 423644 AST-N403 42364
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1266-2026·2026-02-11
FDA recalls Vivoo Vaginal pH Test for inaccurate diagnostic results
The FDA is recalling Vivoo Vaginal pH Test kits distributed without FDA clearance. The tests may produce false or inaccurate results, potentially leading to inappropriate medical decisions.
Product
Vivoo Vaginal pH Test
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1263-2026·2026-02-11
Exploro Male Fertility Test Recalled for Inaccurate Diagnostic Results
Changchun Wancheng Bio-Electron's Exploro male fertility test was distributed without required FDA clearance and may produce false or inaccurate results, potentially leading to inappropriate medical decisions.
Product
Exploro Highly Sensitive Male Fertility / Sperm Concentration Test
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1289-2026·2026-02-11
Olympus Disposable Sphincterotome Recalled for Potential Performance Loss
Olympus recalls 1,490 Disposable Triple Lumen Sphincterotomes due to a manufacturing defect where improper thermoforming could cause the devices to deform and lose performance during surgical use.
Product
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730 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-1281-2026·2026-02-11
Olympus Sphincterotome Recall: Risk of Device Deformation and Performance Loss
Olympus is recalling sphincterotomes that did not undergo proper thermoforming, which could cause device deformation and loss of performance. The 5,089 affected units were distributed throughout the US and internationally.
Product
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0330; 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-1267-2026·2026-02-11
Vivoo Urine Test Strips Recalled for Inaccurate Diagnostic Results
Vivoo Sodium, Vitamin C, and Hydration test strips distributed without FDA clearance may provide inaccurate diagnostic results, potentially leading to inappropriate medical intervention.
Product
Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1309-2026·2026-02-11
Molift Mover 300 mobile hoist recalled for bolt deformation defect
ETAC A/S recalls Molift Mover 300 mobile hoists due to bolt deformation in the lifting bar joint that can prevent proper device functionality.
Product
Brand Name: Molift Product Name: Molift Mover 300 Model/Catalog Numbers: (1) M1501, (2) M1502, (3) M1504, (4) M15050, (5) M15151, (6) M15001, (7) M15002; Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1302-2026·2026-02-11
Diagnostic Cartridges Recalled for Inaccurate Alzheimer's Disease Test Results
Fujirebio Diagnostics is recalling Lumipulse G pTau 217 Plasma test cartridges due to inaccurate test results that may falsely classify patients as having or requiring additional testing for Alzheimer's disease amyloid pathology.
Product
Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Catalog Number: 81550 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges (IRC): Lumipulse G pTau 217 Plasma is an assay system, including a set o
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1260-2026·2026-02-11
Menopause Test Cassette Recalled for Risk of Inaccurate Diagnostic Results
Menopause test cassette distributed before FDA approval recalled due to risk of false or inaccurate diagnostic results that could lead to inappropriate medical intervention.
Product
Menopause Test Cassette (Urine)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1256-2026·2026-02-11
Vortex Surgical Scleral Markers Recalled Due to Compromised Sterile Pouches
Vortex Surgical is recalling Lindsell Sutured IOL Marker scleral markers due to potential voids in sterile pouches. Compromised seals could allow bioburden contamination that may lead to infection.
Product
Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1249-2026·2026-02-11
Vortex Surgical 25GA Convenience Kits Recalled for Compromised Sterile Barriers
Vortex Surgical Inc. is recalling 25GA Convenience Kits due to potential voids in Tyvek pouch seals that could compromise sterility and lead to infection risk.
Product
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES VS0644.25-XES
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1296-2026·2026-02-11
FDA Recalls 3-Lumen Sphincterotome Devices for Deformation Risk
Olympus has recalled its Single Use 3-Lumen Sphincterotome V devices due to manufacturing defects. Devices that did not undergo proper thermoforming may deform and lose performance during endoscopic procedures.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 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-1271-2026·2026-02-11
Single Use 3-Lumen Sphincterotome Recalled Due to Manufacturing Defect
Olympus Corporation is recalling Single Use 3-Lumen Sphincterotome V devices due to manufacturing defects. Some devices did not undergo thermoforming and could deform and lose performance.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330; 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-1290-2026·2026-02-11
Sphincterotome V surgical instruments recalled for potential deformation
Olympus is recalling 3,954 Single Use 3-Lumen Sphincterotome V devices due to a manufacturing defect where some units may have failed thermoforming, potentially causing deformation and loss of performance.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 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-1270-2026·2026-02-11
Olympus Disposable Triple Lumen Sphincterotome Recall Due to Deformation Risk
Olympus recalls Disposable Triple Lumen Sphincterotomes due to incomplete thermoforming that could cause device deformation and loss of performance. Affected units may not function properly during papillotomy procedures.
Product
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-431Q-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-1308-2026·2026-02-11
Molift Mover 205 patient lift devices recalled due to structural bolt failure
ETAC A/S is recalling 95 Molift Mover 205 patient lift devices due to a defective mounting bolt that can break and cause material deformation, limiting joint mobility and device functionality.
Product
Brand Name: Molift Product Name: Molift Mover 205 Model/Catalog Number: (1) M14000, (2) M1401, (3) M1402, (4) M14050, (5) M14150, (6) M1402-01, (7) M14050-00 (8) M14001;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1310-2026·2026-02-11
Molift 2-Point Sling Bars Recalled for Structural Bolt Failure
ETAC A/S is recalling Molift 2-point sling bars due to bolts breaking during assembly and testing. The defect causes material deformation that prevents proper functionality in this assistive device.
Product
Brand Name: Molift Product Name: Molift 2-point sling bars (Accessory to mobile hoists) Model/Catalog Numbers: (1) 1530101, (2) 1530102 Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due t
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1232-2026·2026-02-11
Robotic surgical systems recalled for undetected arm defects
Intuitive Surgical recalled da Vinci X, Xi, and 5 surgical systems due to a software error that failed to detect bent manipulator arms. The faulty arms pose a risk of failure during surgery.
Product
Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS4000; IS4200; IS5000 Software Version: N/A Product Description: The da Vinci Xi, X, and da Vinci 5 surgical systems each consist of three main components:
Category
Medical Device
Distribution
30 states
HighFDA (Devices)·Z-1291-2026·2026-02-11
Olympus Sphincterotome Devices Recalled for Potential Deformation and Performance Loss
Olympus is recalling Single Use 3-Lumen Sphincterotome V devices that may not have undergone proper thermoforming, which could cause deformation and performance loss during use.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530 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

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