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
Covidien is recalling 2,462 units of Palindrome SI Chronic Catheters due to a potential leaking condition in the hub that may cause unanticipated fluid return during treatment.
Menarini Silicon Biosystems is recalling CELLSEARCH Circulating Tumor Cell Kit due to potential false positive results in patient samples. The device may generate unassigned events that could affect diagnostic accuracy.
Luminex Corporation is recalling VERIGENE Enteric Pathogens tests worldwide due to potential false negative results caused by hydrophobic characteristics of the sampling swab. The defect could lead to missed detection of infections in stool specimens.
Siemens imaging systems with syngo VE20 software may display CT images mirrored horizontally and vertically when loading Toshiba data, potentially causing misinterpretation of patient positioning and inappropriate treatment.
Ossur has recalled 410 Variflex Suba Junior prosthetic feet due to cracking and breaking under impact stress. The device is designed for children and adolescents worldwide.
Covidien is recalling EEA Autosuture Circular Staplers (25mm) because the staple guide may not be securely attached and could disengage during use, potentially allowing the device to cut tissue without forming staples.
Rayner is recalling RayOne intraocular lens injection systems because the outer package is mislabeled and contains a different lens strength than indicated. Approximately 162 devices were distributed in 13 US states.
Siemens is recalling 88 Artis Icono X-ray systems in the U.S. due to increased fan wear that could lead to electrical failure and malfunction of the imaging system during operation.
DePuy Spine is recalling 61 units of the EIT CIF cage spinal fusion device due to a labeling mismatch. The outer carton label does not match the labels on the blister packages and patient information labels.
DePuy Spine's EIT CIF intervertebral fusion cage (46 units, Part No. CUI8070S) is recalled due to a labeling discrepancy where the outer carton label does not match the labels on the product packaging and patient materials.
The ProudP Everyday Uroflow Tracker app may record lower-than-actual urination measurements when a hearing aid or AirPods Live Listen feature is active on the same iPhone, due to interference with the app's sound-based measurement system.
Wright Medical is recalling 35 units of the Stryker INFINITY Resect Guide for INBONE Talus (Model #33620254) due to incorrect color coding. The color coding error could lead to misidentification and improper use during ankle surgery.
RayStation 11B radiation therapy planning software has two display issues affecting Linear Energy Transfer values. These errors could lead to incorrect dose calculations if not identified during clinical review.
Haemonetics Corporation is recalling TEG 5000 Functional Fibrinogen Reagent kits because the reference ranges in the instructions have shifted. Clinicians using these outdated ranges could misdiagnose patients or fail to provide necessary treatment.
Davol HydroSurg Plus Laparoscopic Irrigators cannot provide irrigation. The FDA issued a Class II recall affecting 4,780 units worldwide.
ROi CPS LLC is recalling 180 CV Minor Kit units due to a nonsterile component accidentally packaged in the sterile kit, posing a contamination and infection risk.
The Alphenix 4D CT system may fail to operate due to a system error that activates an interlock restriction. Six affected systems were distributed to hospitals in five U.S. states.
GE Healthcare recalls backup batteries for anesthesia devices worldwide that may fail earlier than expected. The batteries are used in Avance CS2, Avance, Amingo, and Aespire View systems.
One lot of DVR Anatomic distal radius orthopedic plates was incorrectly etched during manufacturing and may have been placed into kits labeled as a different plate model. The affected plates were distributed to healthcare facilities nationwide.
The NaviCare Nurse Call system software (versions 3.9.100-3.9.300) has a wireless integration defect causing patient calls to be canceled when answered on wireless phones. The issue affects 283 installations in the US and Canada.
Haemonetics' TEG5000 Analyzer displays incorrect PlateletMapping assay values when connected to TEG Manager Software versions 1.1–4.3.1, potentially affecting laboratory test interpretation.
Arrow International is recalling the Arrow Three-Lumen CVC due to incorrect gravity flow rates on the product lidstock. The defect may affect fluid and medication delivery through the catheter.
Davol, Inc. is recalling the HydroSurg Plus Laparoscopic Irrigator because the device cannot provide irrigation as intended. The recall affects 4,390 units in the US and 390 in Canada.
Siemens Artis Pheno fluoroscopic X-ray systems may lose video signals from the Large Display during procedures. In rare cases, both transceivers could fail, affecting displays in the examination and control rooms.
K2M Inc. is recalling certain Yukon Straight Rod spinal implants due to discoloration from trace amounts of inorganic phosphorous compound. The contaminated devices may cause mild irritation or adverse tissue reactions.