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
Smiths Medical ASD Inc. is recalling its Portex Y-Piece 15MM airway connector (9,133 units, worldwide) due to uncertainty in the sterile packaging seal integrity.
Medline recalled pediatric drape kits that may become non-sterile if the pouch seal is compromised. Affected units were distributed in the US, Canada, and Panama.
Baxter Healthcare is recalling the TruSystem 7000 V operating table due to reports of battery and connector short-circuits and smoke emissions. Four units with worldwide distribution are affected.
Medline Industries recalls 22,327 units of medical procedure convenience kits distributed in the US, Canada, and Panama. The FDA Class II recall affects multiple kit variants and is currently ongoing.
Mckesson Medical-Surgical is recalling Quantimetrix Urine Chemistry Control Sets shipped without validated summer packaging, potentially exposing them to temperatures above 25°C.
Blue Ortho is recalling 136 units of Predict+ software because it lacks FDA pre-market clearance or approval.
Diasol, Inc. is recalling 852 gallon bottles of Diasol Acid Concentrate because the gallon label shows a lower calcium concentration than the box label.
Smiths Medical is recalling 34,141 units of 15mm Double Swivel Connectors worldwide due to uncertainty in the seal integrity of the sterile packaging.
Olympus Corporation is recalling the Gastrointestinal Videoscope Model GIF-1100 due to incorrect color correction data programmed into CCD imaging sensors. The affected units do not meet device specifications.
Certain GE HealthCare Giraffe OmniBed and Carestation neonatal incubators may have door-securing screws that were not torqued to specification, potentially causing the doors to become loose. These units are distributed worldwide.
GE HealthCare is recalling certain Giraffe OmniBed Carestations because a screw securing the heater doors may not be torqued to specification, potentially causing the doors to become loose.
Kinova Inc is recalling 949 KINOVA Jaco assistive robots due to a potential fire hazard that may occur if a damaged robot arm interacts with a wheelchair exhibiting electrical leakage.
Leica Biosystems Cryostat Model CM1510 S is recalled due to missing warning labels about flammable freezing sprays, which can ignite and cause serious injury. The device labeling lacked fire hazard warnings prior to 2019.
Medline Industries is recalling 123 kits of its Open Heart Pack after discovering that model 30001 vessel cannulae were incorrectly labeled as model 30000. This labeling error could lead to use of the wrong surgical instrument during open heart procedures.
Beckman Coulter is recalling two lots of IGM reagent used in IMMAGE immunochemistry systems because they don't meet sensitivity specifications. The reagent measures immunoglobulin M levels in blood samples.
Leica Biosystems is recalling Cryostat Model CM1850 (322 units, US nationwide) due to missing warnings about fire hazard from flammable freezing sprays. The device's labeling prior to 2019 did not warn users that flammable sprays used in the chamber can ignite and cause serious injuries.
Medline Industries recalls certain open-heart surgical kits (Lot 23LBR364) due to incorrect model labeling, where model 30001 units were labeled as model 30000. The recall affects 30 units distributed nationwide.
Change Healthcare is recalling Cardiology Hemo software versions 13.0 through 14.0 because incorrect unit configurations can lead to inaccurate hemodynamic calculations and potential misdiagnosis.
Change Healthcare Cardiology Hemo software versions 14.1.1–15.1 may produce inaccurate hemodynamic calculations due to unit-of-measurement configuration errors, potentially leading to misdiagnosis and inappropriate patient treatment.
Merit Medical Systems is recalling 1,120 Monarch Inflation Devices due to manufacturing defects causing holes and breaches in the sterile Tyvek barrier. Affected devices distributed worldwide may pose contamination risk during cardiac interventions.
Nova Ortho-Med is recalling the MONARCH ROLLATOR PURPLE due to a fall hazard: the backrest may disengage when users shift from a slouched to upright seated position.
Horizon Cardiology Hemo Version 12.2 is recalled for a unit-of-measurement configuration issue that can produce incorrect hemodynamic calculations, potentially resulting in misdiagnosis and inappropriate treatment. The recall affects 3 worldwide systems.
Boston Scientific is recalling 5 units of its AVVIGO+ Guidance System due to a software error that displays an incorrect grid overlay when connected to OptiCross 18 Peripheral Imaging Catheters in Live or Record mode.
Merit Medical Systems is recalling the basixTOUCH Inflation Device (REF: IN8140/A) because devices may have a small hole in the sterile barrier, potentially exposing users to pathogens and pyrogens that could lead to infection.
Stryker is recalling 307 units of 1.2mm Cross Cut Fissure saw blades due to potential endotoxin levels exceeding 2.15 EU/device, which may cause fever, inflammation, or meningitis.