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
Certain lots of Thermalon Back Wrap may have been exposed to excessive moisture, potentially resulting in mold and mildew growth. The product is distributed nationwide in the US and Canada.
Bio-Rad Laboratories is recalling a diagnostic test kit due to incorrect calibrations and controls that may produce inaccurate test results. Patients and healthcare providers should contact the manufacturer.
Ortho-Clinical Diagnostics is recalling 10,911 units of VITROS Performance Verifier I worldwide due to mismatched diluent components that could cause inaccurate quality control test results.
Bruder Healthcare Company is recalling Thermalon Eye Compress Item 2434 from certain lots due to potential mold and mildew growth from excessive moisture exposure. Affected products were distributed in the US and Canada.
Olympus recalls the SOLTIVE Premium SuperPulsed Laser due to non-compliant power cords incompatible with regional electrical outlets. Approximately 203 units were distributed to Australia, Chile, Germany, Hong Kong, Japan, New Zealand, and Singapore.
Baxter is recalling Supple Peri-Guard Repair Patch units due to elevated endotoxin levels that may exceed allowable limits for cerebrospinal fluid-contacting devices. The product should not be used in neurosurgery.
Baxter is recalling specific lot codes of Supple Peri-Guard Repair Patch because endotoxin levels may exceed limits for cerebrospinal fluid-contacting devices. The product should not be used in neurosurgery.
The CareEvent Event Management System's Care Assist mobile application fails to play custom ringtones when iOS device screens are locked with a passcode. This may result in missed alerts or notifications.
Beckman Coulter is recalling Access Substrate reagent bottles (REF 81906) due to missing product labels on certain manufacturing lots. While the missing labels may delay patient test result reporting, no incorrect results have been reported.
Philips Patient Information Center iX running software version 4.X may not play custom ringtones when iOS screens are locked with a passcode. Approximately 257,183 units have been distributed worldwide. No injuries have been reported.
Bruder Healthcare recalls Thermalon Heating Pad model 24002 due to potential mold and mildew growth from moisture exposure. Affected units were distributed nationwide in the US and to Canada.
Bruder Healthcare Company is recalling Thermalon Neck Wrap (Item Number 24322) from certain lots due to potential mold and mildew growth from excessive moisture exposure. Consumers should discontinue use and contact the manufacturer.
The FDA is recalling the HeartMate 3 Left Ventricular Assist System due to observed outflow graft deformation that can obstruct blood flow. Patients with implanted devices should contact their healthcare provider.
Smiths Medical Pneupac Plus 300 ventilators may intermittently deliver continuous airflow instead of cycling breaths as designed. This malfunction affects 2,902 units distributed worldwide.
ARROW International is recalling 1,160,470 QuickFlash radial artery catheterization devices due to a defective guidewire handle that can cause arterial vasospasm and vessel injury.
Thoratec Corp. recalls HeartMate II left ventricular assist system kits due to outflow graft deformation that could obstruct blood flow. The FDA has classified this as a Class I recall affecting 2,240 units distributed worldwide.
Smiths Medical is recalling paraPAC plus 310 ventilators that may malfunction by delivering continuous gas flow instead of cycling breaths. The defect affects 10,140 units distributed worldwide and prevents proper ventilation.
D.O.R.C. recalls 78 directional laser probes with Alcon/Lumenis connectors due to difficulties extending, retracting, or directing the laser fiber. The Class II recall affects units distributed across multiple U.S. states and Puerto Rico.
Beckman Coulter recalls Access Total T4 thyroxine assay due to imprecision that may cause erroneous or delayed diagnostic results.
Mc3 Inc is recalling 188 Nautilus Smart ECMO modules nationwide due to potential water path restrictions in the heat exchanger that may cause inadequate heat transfer and risk of hypothermia during use.
Sarnova HC is recalling the Curaplex Nasal Intubation Kit because the endotracheal tube holder is incompatible with nasal intubation, preventing practitioners from securing the tube. The recall affects 550 units distributed nationwide.
Baxter Healthcare is recalling HDS Traction Boot II units due to incorrect assembly. The boot key socket locking ridge faces upward, preventing proper attachment to the traction system.
A Class II medical device recall has been issued for Directional Laser Probes due to potential difficulties extending, retracting, and directing the laser fiber tip. The issue affects 126 units distributed across multiple US states.
Angiodynamics recalls the MINI STICK MAX vascular guidewire introducer due to internal defects in the sheath hub that may prevent guidewire insertion during surgery, potentially requiring equipment exchange.
Angiodynamics recalls approximately 5,840 guidewire introducers with manufacturing defects that may prevent proper guidewire insertion during vascular procedures. The defect could cause procedural delays requiring equipment exchange.