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.
Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.
The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.
Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.
Minimum severity
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.
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.
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.
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.
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.
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.
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.
Lumipulse G plasma calibrators may produce inaccurate test results, causing false positive or indeterminate classifications for Alzheimer's disease. 128 units are affected nationwide.
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.
Olympus recalls single-use sphincterotomes that may deform and lose performance if not properly thermoformed during manufacturing. No injuries have been reported.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.