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
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.
Mallinckrodt is recalling ArterX Surgical Sealant because improper labeling led to improper storage. The affected units were distributed to the UK.
Medacta USA Inc. is recalling one lot of GMK Hinge Tibial Inserts because they are missing a screw required for attachment to the tibial base plate.
Exactech is recalling 382 Equinoxe Reverse Starter Reamers to update instructions for use, clarifying that off-axis reaming may cause instrument breakage.
Boston Scientific is recalling 32 units of Extractor Pro RX-S Retrieval Balloon Catheters because the labels incorrectly identify the injection location relative to the balloon.
Exactech, Inc. is recalling 573 Logic Fit Tibial Tamp Heads to update surgical labeling. The update clarifies proper removal techniques to prevent instrument breakage.
Beckman Coulter is recalling 43 PrepPlus systems because they may produce imprecise absolute counts in the first tube of a flow cytometry run.
Boston Scientific is recalling 39 units of the Extractor Pro RX-S Retrieval Balloon Catheter because the label incorrectly identifies the injection location.
Sterilmed is recalling 963 reprocessed EP ablation cables because they are Class III devices that lack required premarket approval.
Beckman Coulter is recalling 473 PrepPlus 2 units because they may produce imprecise absolute counts in the first tube of a flow cytometry run.
Leica Microsystems is recalling 812 ASP6025 Tissue Processors because the voltage labels on the rear alarm connectors are incorrect.
Exactech is recalling Equinoxe Modular Reverse Pilot-Tip Reamers to update instructions for use, clarifying that off-axis reaming may cause instrument breakage.
Boston Scientific is recalling Imager II Angiographic Catheters because some units are missing the bottom pouch seal. The defect is obvious to the user.
Encore Medical is recalling 3DKnee Tibial Inserts because a size 6 left box contained a size 8 right insert.
DeRoyal Industries is recalling 426 Dolphin Inflation Devices due to a primary packaging defect that may compromise sterility.