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
Baxter Healthcare is recalling 28 SIGMA Spectrum Infusion Pump V8 units due to incorrect software versions. Affected facilities should contact Baxter immediately.
Encore Medical is recalling 20 EMPOWR 3D knee tibial inserts due to incorrect products being packaged together. Using the wrong implant could require revision surgery.
Medtronic SmartSync Device Manager software displays a false electrical reset warning during device interrogation that could prompt unnecessary revision procedures. No actual reset occurs and the device functions normally.
Waismed Ltd. is recalling the NIO Intraosseous Device Adult due to a manufacturing defect where the built-in stabilizer may not release properly after deployment, potentially affecting emergency medical access procedures.
The NIO Intraosseous Device Adult manufactured by Waismed Ltd. may not properly release its built-in stabilizer after insertion due to a manufacturing error, potentially complicating emergency intraosseous access procedures.
Encore Medical is recalling EMPOWR 3D Knee Tibial Inserts due to packaging discrepancies that could result in incorrect implants being selected during surgery. Patients may require revision surgery if the wrong implant is used.
Beckman Coulter's Access Vitamin B12 Reagent lot 439850 may produce falsely low or high results, potentially causing misdiagnosis or unnecessary repeat testing.
Ortho-Clinical Diagnostics is recalling certain lots of VITROS Chemistry Products Performance Verifier II due to quality control drift that may produce inaccurate laboratory results when used 2-7 days after reconstitution.
Beyond Laser Systems recalls laser light show projectors (Models DIODE 1000/2000/3000) due to remote interlock safety device that may not be properly installed or wired, potentially preventing emergency shutdown of Class IV lasers. Affected units were distributed nationwide.
Beyond Laser Systems is recalling laser light show projectors for missing safety interlocks and required labels. Affected models lack the remote interlock connector needed to prevent user exposure to Class IV laser radiation.
ICU Medical is recalling SwabCap Disinfecting Caps due to a manufacturing defect that may prevent proper disinfection of needlefree connectors. The incomplete seal may cause isopropyl alcohol to evaporate, reducing effectiveness.
Ortho-Clinical Diagnostics recalls VITROS Chemistry CHE Slides due to quality control drift occurring 2-7 days after reagent reconstitution, despite labels claiming 7-day stability. This may result in inaccurate and erroneous patient test results.
Microbiologics Inc is recalling KWIK-STIK and LYFO DISK quality control kits because they contain the wrong organism, which could cause laboratory quality control to fail and delay patient diagnosis.
Ortho-Clinical Diagnostics recalls VITROS Chemistry CHE Slides due to quality control drift in certain lots that may produce inaccurate test results when used within the labeled stability period.
Beyond Laser Systems is recalling laser light show projectors with missing or non-functional remote safety interlocks that prevent safe shutdown of Class IV lasers. Projectors also lack required labeling and user documentation.
Ortho-Clinical Diagnostics recalled certain lots of VITROS Chemistry Performance Verifier because quality control drift can cause inaccurate lab test results when used 2-7 days after reconstitution.
NeuroSync recalled 27 EYE-SYNC eye-tracking headset units in New York, Texas, and Georgia because the devices became inoperable after support for the embedded Pico 2 platform ended August 31, 2023, and cannot be repaired.
Edwards Lifesciences is recalling Optisite Arterial Cannula units due to wire sections 3-4mm in length protruding from the cannula body, posing a patient injury risk.
Given Imaging's Bravo CF capsule delivery device is recalled due to misapplied adhesive that may prevent the pH monitoring capsule from attaching to the esophagus or detaching from the delivery device. The recall affects 128,202 units distributed nationwide and globally.
The Hillrom Q-Link 13 quick-release hook component used in mobile patient lifts may improperly latch, potentially causing it to detach and result in patient falls.
Edwards Lifesciences recalls the FEM-FLEX II Femoral Arterial Cannula due to exposed wire protruding from the device body that could cause vascular injury.
Edwards Lifesciences is recalling the FEMFLEXII Femoral Arterial Cannula due to complaints of a 3mm to 4mm section of wire protruding from the cannula body, posing a risk of injury.
Hillrom LikoScale adapter kits for patient lifts have false-latching defects in the Quick-Release Hook that can cause improper attachment and unexpected detachment, risking patient falls.
Edwards Lifesciences is recalling OptiSite Arterial Cannulas (Model OPTI18) due to exposed wire protruding from the device body. Approximately 13,240 units distributed worldwide are affected.
Edwards Lifesciences is recalling FEM-FLEX II Femoral Arterial Cannula devices due to exposed or protruding wire sections on the cannula body. Approximately 6,801 units were distributed worldwide.