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
BD COR System Software has a potential functionality issue with the Over labeling feature that could produce false negative results. The 7 affected systems are distributed in Florida, Texas, Michigan, Sweden, and Belgium.
Certain DIGIMED DIOX-602 portable X-ray systems do not meet the minimum source-to-skin distance safety requirement of 18 centimeters. This non-compliance may increase patient radiation exposure during diagnostic imaging.
GE Medical Systems recalled SIGNA PET/MR imaging systems because gradient coils produce acoustic noise exceeding 99 decibels during scanning, surpassing established safety limits even with hearing protection.
CooperSurgical is recalling 991 Endosee System Convenience Kits (Model ES-TRAY) because the iodine pouches are non-sterile but labeled as sterile on the peel-away lid labels. The affected devices were distributed nationwide.
Olympus recalls Ellik Evacuator Adapter 190-NRS due to discrepancies between Japanese and English sterilization instructions that could lead to improper device sterilization.
Encore Medical is recalling EMPOWR Dual Mobility hip acetabular components due to incorrect tibial inserts being packaged with products. The discrepancy was discovered through a customer complaint.
CooperSurgical HSG Procedure Trays contain non-sterile iodine pouches incorrectly labeled as sterile. The mislabeling affects 171 units distributed nationwide.
The Covidien Nellcor Bedside SpO2 Patient Monitoring System may not produce audible alarms, preventing caregivers from responding to low oxygen saturation or sensor disconnection. This can delay treatment and cause respiratory failure or arrhythmia.
Encore Medical is recalling EMPOWR Dual Mobility hip implants due to incorrect components being packaged. Approximately 35 devices are affected.
Bridge to Life EasiSlush (0.9% sodium chloride irrigation) has been recalled because three lots did not complete required quarterly sterilization process monitoring audits on time during Q1 2024. Routine lot testing was completed properly.
Philips is recalling Azurion 7 M20 fluoroscopic X-ray systems due to potential loosening of bolts connecting the gearbox to the C-arm mounting flange. No injuries have been reported.
Olympus Corporation is recalling Ellik Evacuator surgical devices due to discrepancies between sterilization instructions in Japanese product package inserts and the English product Instructions For Use.
Olympus Corporation recalls 41 Green Silicone Seal accessories (CS-G7) for endoscopes distributed to Japan. Sterilization instructions differ between Japanese product inserts and manufacturer documentation, potentially affecting proper device sterilization.
Baxter Healthcare recalls 14 SIGMA Spectrum Infusion Pump V6 units due to incorrect software version. The recalled units were distributed to 10 US states.
The Medtronic CareLink SmartSync Device Manager software displays a false electrical reset message, potentially prompting unnecessary device removal. Two patients have undergone unnecessary device explant procedures due to this error.
Intersurgical Inc is recalling the i-view video laryngoscope (Model 8008000) due to the potential for faulty devices caused by depleted batteries. A total of 2,152 affected units were distributed across the United States.
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.