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
Graphic Controls is recalling CLARAVUE Pre-wired Electrode sets because they fail to meet electrical safety specifications for defibrillators, potentially delivering inadequate charge during emergency treatment.
Cardinal Health PROTEXIS PI and PI Classic surgical gloves were distributed without proper sterilization. The affected 486,578 pairs should not be used, as non-sterile gloves present an infection risk during surgical procedures.
Nextremity Solutions is recalling the Nextra Hammertoe Correction System due to an oversized driver component that makes it difficult to properly connect and remove during surgery.
LIPOSORBER LA-15 LDL Adsorption Column labeling has been updated to address a risk of severe anaphylactoid reactions and shock in patients receiving treatment while taking ACE inhibitors.
Conformis is recalling specific units of the iTotal Identity Posterior Stabilised Knee Replacement System due to incorrect tibial base plate implants being packaged in surgical kits.
The CLARAVUE Pre-wired Electrode does not meet electrical safety standards for defibrillators. It may not deliver effective electrical charge during emergency defibrillation.
Nextremity Solutions is recalling the Nextra Hammertoe Correction System Driver (SKU: NX-DR) due to oversizing at the proximal end, which impairs connection and removal from the implant, causing surgical delays. The defect affects 239 units distributed in the US, Japan, and the Netherlands.
Merit Medical is recalling AccessPLUS Large Bore Hemostasis Valves due to an internal design gap that can trap guidewires, potentially delaying medical procedures.
Abbott Vascular is recalling the 20/30 Priority Pack w/COPILOT device due to an increase in complaints of leaks and loose connections. The recall affects 131 lots distributed nationwide and internationally.
Integra LifeSciences is recalling the Universal Flexible Arm (part number REF 1362275) because excess tightening force can break the internal cable at the tip, rendering the device unusable.
Abbott Vascular is recalling INDEFLATOR Plus 30 balloon inflators due to increasing complaints of leaks and intermittent loose connections that could affect device function during medical procedures.
Luminex Corporation is recalling 4 Verigene Processor SP diagnostic devices that repeatedly failed to produce results, returning No Call outputs instead. Two of three customer complaints involved this malfunction.
Stanbio Laboratory's Creamatocrit Plus breast milk analyzer was marketed without required FDA 510(k) clearance. Its performance has not been validated, and erroneous results could lead to inadequate nutritional supplementation for infants.
Varian ARIA radiation therapy management software versions 13.6 through 16.1 may generate incorrect treatment plan values that could direct radiation therapy to the wrong location. No illnesses have been reported.
Graphic Controls' CLARAVUE Pre-wired Electrode set does not meet required electrical specifications for defibrillation use. The device fails to withstand 5,000 volts without breakdown, potentially resulting in ineffective defibrillation.
Abbott Vascular is recalling seven lots of the Plus 30 Priority Pack due to increased reports of leaks and intermittent loose connections in the vascular devices.
Nextremity Solutions recalls the Nextra Hammertoe Correction System because the driver's proximal end is oversized, making it difficult to connect and remove from the implant, potentially delaying surgery.
Graphic Controls' CLARAVUE Pre-wired Electrode units fail to meet electrical safety specifications required for defibrillation. The device delivers an inefficient electrical charge and may result in ineffective defibrillation.
Siemens Healthcare is recalling Atellica CH Hemoglobin A1c reagent kits due to potential reagent carryover affecting quality control and patient test results. The issue may cause inaccurate diabetes monitoring measurements.
Nextremity Solutions recalls 459 units of the Nextra Hammertoe Correction System due to an oversized proximal driver end that prevents proper connection and removal during surgery.
Philips is updating instructions for cleaning and disinfecting reusable autoclavable temperature probes due to revisions needed in the disinfection process.
Medline Industries is recalling Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards due to improper storage controls that may affect test result timing. The recall affects 10 boxes distributed to healthcare facilities in six states.
Siemens Healthcare Diagnostics is recalling Atellica CH Fructosamine reagent (lots 211359, 211451) due to potential reagent carryover that could affect diagnostic test accuracy.
Volcano Corp is recalling MM-TSM touch screen modules used with IntraSight Integrated IVUS systems because they may crack or become damaged, potentially rendering the imaging equipment non-functional.
Medline's Hydroxybutyrate LiquiColor Tests are recalled due to improper storage that may cause delayed test results. The recall affects 45 units distributed across 16 U.S. states.