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
Arrow International is recalling EVOLUTION Pressure Injectable PICC catheters because the peel-away component hub tabs may prematurely detach during use.
ICU Medical is recalling 100 units of MicroClave extension set kits because the connection between the Female Luer and the NanoClave manifold may develop a leak.
Natus Neurology is recalling 2,335 Elite Obstetric probes because excessive background noise may mask fetal heart rate and blood flow monitoring.
Toshiba American Medical Systems Inc. is recalling 307 APLIO 500 diagnostic ultrasound systems because they may display incorrect values when using the Continuous Trace method on Spectral Doppler.
Fujifilm Medical Systems is recalling four units of the EG-530UT ultrasonic endoscope following a retrospective review.
Exactech, Inc. is recalling nine tibial augment screws because they were packaged one per carton instead of the required two per carton.
bioMerieux is recalling 742 units of VIDAS Testosterone assays because they may produce falsely overestimated results.
Toshiba American Medical Systems is recalling seven XARIO 100 diagnostic ultrasound systems because they may display incorrect values when using the Continuous Trace method for velocity measurements.
Beckman Coulter is recalling Synchron AQUA CAL Level 1 kits due to a sodium recovery shift that may affect system calibration.
CryoLife, Inc. is recalling 52 On-X Prosthetic Heart Valves because the sewing ring type was mislabeled as Standard instead of Anatomic.
Natus Medical is recalling Olympic Pasteurmatic 3000 and 3500 systems because they do not fully meet current regulatory requirements due to design age and component obsolescence.
AMS Diagnostics is recalling 9 units of Medica ISE Module Calibrant A because the lot was not functioning properly and did not exhibit correct physical properties.
CareFusion 303, Inc. is recalling Alaris PC Unit Model 8015 devices because a software error can interrupt infusions.
CardioTek BV is recalling EP-TRACER Software V1.x and V2.0 due to a bug that allows parameters to be changed unintentionally during use.
Exactech is recalling the Equinoxe Narrow Modular Reverse Pilot-Tip Starter Reamer to update instructions for use, clarifying proper reaming technique to prevent instrument breakage.
Ion Beam Applications S.A. is voluntarily recalling six Proteus 235 Proton Therapy Systems worldwide due to a software issue. Five of these units are located in the United States.
Siemens is recalling 13 Sensis Vibe diagnostic computers in the US due to a software error that may combine patient data from different examinations into a single report.
Smiths Medical is recalling specific lots of Jelco Hypodermic Needle Pro needles because syringe assemblies used in their manufacture contained pin holes in the hub.
PerkinElmer is recalling 241 Multiphor II Electrophoresis Systems due to a potential electric shock hazard if grommets are not installed.
JAS Diagnostics Inc. is recalling 14,064 units of Drew Scientific DREW 3-PAC Reagent Kits because they may result in elevated platelet backgrounds during routine startup checks.
Ion Beam Applications is recalling Proteus 235 and Proteus ONE proton therapy systems because on-site software installations were not performed consistently with standard operating procedures.
Encore Medical is recalling 9 units of 3DKnee Tibial Inserts because a size 6 left box contained a size 8 right insert.
Exactech is recalling 928 Equinoxe Modular Reverse Pilot-Tip Starter Reamers to update instructions for use. The update clarifies proper reaming technique to prevent instrument breakage.
Exactech is recalling Equinoxe Glenoid Reamers to update instructions for use, clarifying that off-axis reaming may cause instrument breakage.
Exactech is recalling Equinoxe Narrow Modular Reverse Pilot-Tip Reamers to update instructions for use, clarifying that off-axis reaming may cause instrument breakage.