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
Johnson & Johnson Surgical Vision is recalling tray ring covers (Model OM271000) worldwide due to a potential breach in the sterility barrier that could allow contamination.
A software defect in Philips Azurion imaging systems causes the Patient Type to change unexpectedly during study initiation, altering dose control parameters without operator notification.
Olympus recalls the GF-UC140P-AL5 ultrasonic gastrovideoscope nationwide because it is no longer compatible with the OER-Pro reprocessing system, creating an infection control risk to patients.
restor3d Inc. is recalling 14 units of its Non-Sterile Double Ended Trial Kit because the product was labeled as Small Footprint when it is actually Medium. The lot was distributed nationwide across seven states.
Intuitive Surgical recalled SureForm surgical staplers after tissue pushout events caused unexpected bleeding during procedures. The actual harm rate exceeded safety predictions.
The Puritan Bennett 980 Series Ventilator may fail to sound its audible alarm or display its visual alarm during critical alarm states, potentially delaying treatment response.
Celltrion USA Inc. is recalling Celltrion DiaTrust COVID-19 Ag Rapid Test kits distributed to facilities without valid CLIA certification. The tests were distributed nationwide from December 2021 through February 2022.
Sight Sciences is recalling 921 TearCare version 1.0 SmartHubs ophthalmic devices distributed nationwide because they were distributed prior to FDA 510(k) clearance without premarket evaluation of their performance characteristics.
ROi CPS LLC is recalling 1,501 convenience kits containing regard IV Start Kits due to inadequate validation of manufacturing test methods. Products were distributed in Missouri.
Siemens Healthcare is recalling IMMULITE 2000 hCG diagnostic systems due to potential sample carryover that could produce falsely elevated hCG test results.
Stryker GmbH recalls 246 Smart Toe II orthopedic implants due to label obstruction that obscures the nickel-sensitivity contraindication, potentially allowing inappropriate use.
Freudenberg Medical is recalling Empower Introducer Sheath devices (Model 668782-200) due to potential adhesive residue inside the catheter shaft that may cause blood clots and tissue damage. Affected devices were distributed in the US and Netherlands.
Roche Diabetes Care Platform Software version 2.5.2 may display incorrect patient data when users navigate between patient records using the browser back button. No illnesses have been reported.
Siemens CT scanner software upgrade may display incorrect laser offset coordinates during patient marking. This defect affects 15 systems in the US across multiple states.
Siemens is recalling 31 Acuson 9vE4 ultrasound transducers that may exceed thermal index limits, creating a potential risk of thermal injury. Affected units were distributed in US states and international locations.
The PrisMax dialysis system has a software bug that silently reverts treatment parameters to default values without notifying operators, affecting 1,253 units worldwide.
Siemens CT scanner software upgrade may cause incorrect laser offset coordinates to display during patient positioning. No injuries reported.
Siemens syngo.via RT imaging software upgraded to VB60 automatically modifies laser configuration, potentially displaying incorrect laser offset coordinates during radiation therapy patient marking.
Carl Zeiss Meditec is recalling the ZEISS miLOOP Lens Fragmentation Device due to high friction in the slider mechanism that may cause it to stick or fail to move as intended during cataract surgery.
The PrisMax System has a software defect that can silently revert custom therapy parameters to defaults when using the Same Patient function without notifying the operator.
The PrisMax System may revert custom treatment parameters to default values without notifying the operator when the Same Patient function is used. This could cause patients to receive unintended treatment settings.
Drager is recalling Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12 due to a temporary loss of central monitoring functionality. The software is used for patient monitoring with wireless telemetry devices.
Instrumentation Laboratory recalls ACL TOP coagulation analyzers due to potential carryover contamination that may cause inaccurate anticoagulation test results. When specific reagents are used together, tests for heparin, apixaban, and rivaroxaban may show elevated results.
Siemens CT scanner imaging software upgraded to version VB60 may display incorrect laser offset coordinates during patient marking. Fourteen units are affected in the United States.
Waters Medical Systems LLC is recalling WAVES WCM Kidney Cassette Modules due to a potential for the pump head to leak solution. The recall affects medical facilities in Tennessee and France.