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 the agency’s own highest classification or reported deaths or serious injuries, 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
Arcoma AB recalls 47 Omnera 400A Digital Radiographic Systems due to potential electrical short circuits that could cause uncontrolled movement of the overhead tube crane.
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.
Siemens is recalling the Dimension LTNI cardiac troponin-I test due to positive bias in Lithium Heparin plasma samples, which may cause false-positive results and inappropriate medical intervention.
Chromsystems has recalled MassCheck Amino Acid, Acylcarnitines dried blood controls (batch 2821) for insufficient glycine concentration. This may affect laboratory test accuracy.
GE Centricity Universal Viewer Zero Footprint software can display inaccurate measurements on medical images. This Class II recall affects approximately 1,934 units distributed worldwide.
Siemens Artis and Artis Q.zeego fluoroscopic X-ray systems may lose stand mobility if the robotic control system's BIOS battery discharges at startup. Field service is required to restore function.
Luminex Corporation is recalling the Verigene CDF Nucleic Acid Test due to potential false negative results caused by the swab's hydrophobic characteristics, which could result in missed positive diagnoses.
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.
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.
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.
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.
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.
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.
GE Healthcare is recalling backup batteries in Avance CS2 and CS2 Pro anesthesia machines manufactured after April 1, 2019. Batteries may fail earlier than expected, affecting approximately 6,600 devices worldwide.
Skytron recalls its GCX Channel Mounting Accessory (model H8-300-40-A) because mounting screws may loosen or pull out when used as a monitor mount on surgical booms. Affected units were distributed worldwide.
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 QMS Tacrolimus Calibrator Set is recalled because calibrators recovered 82-94% of target values, causing inaccurate (over-quantitated) patient drug test results. This affects healthcare facilities in 20 US states and 9 countries.
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.
C.R. Bard is recalling 457 Sensica Urine Output System units nationwide due to complaints about urine output measurement accuracy.
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.
Medline is recalling over 840,000 pill splitters due to a defect where the product lid can come unhinged, exposing a sharp blade and posing a laceration risk.
Olympus is recalling certain SOLTIVE SuperPulsed Laser Fibers because device model and size may be mismatched between packaging and the actual device. This could result in the wrong laser fiber being used in medical procedures.
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.