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
Biomerieux Inc is recalling VITEK 2 AST-N447 TEST KIT (Lot 0853293604) distributed internationally due to potential false resistant carbapenem and/or cephalosporin results when pouch foil fractures are present.
Siemens is recalling an A1c blood test assay (Material Number 11097536) for the Atellica CH and Atellica CI analyzers due to potential intermittent bias that could cause falsely high or low hemoglobin A1c patient results.
Boston Scientific is recalling Intracept Access Instruments due to potential sterile barrier breach in the outer tray seal, which could introduce infection risk.
Medtronic MiniMed's 780G Insulin Pump can stop delivering insulin due to a software anomaly when paired with the Instinct sensor, potentially leading to delayed therapy and increased risk of hyperglycemia or diabetic ketoacidosis.
Fresenius Medical Care is recalling 5008X Blood Tubing Sets due to potential online port errors that may occur when connecting the SafeLine to the substitution fluid port of the 5008X CAREsystem.
Medline Industries is recalling specific lots of Open Heart Peds Pack Convenience Kits containing Covidien Mon-a-Therm temperature probes due to a distribution control process error.
Olympus Corporation of the Americas is replacing the previous design of its Single Use Distal Cover (MAJ-2315) with a newly designed version for use with EVIS EXERA III Duodenovideoscopes.
Encore Medical is recalling EMPOWR 3D KNEE insertion instruments because some packages contain incorrect product sizes due to a packaging discrepancy.
Klowen Braces is recalling 3 units of the KL Owen Custom Orthodontic Solution (model CIAS-800033) due to a product error that may cause incorrect bracket placement.
CMR Surgical Limited is recalling the Versius Surgeon Console (Model V-SS-1020, Software Version Pratchett 1 version 62.1) due to Secure Boot not being enabled at manufacturing, presenting a potential cybersecurity risk.
Encore Medical, LP is recalling EMPOWR 3D KNEE surgical devices due to a packaging discrepancy where incorrect product sizes were mixed up in packaging.
WALLAC OY is recalling GSP Neonatal GALT Kit units due to reduced on-board stability that may increase run-QC failures and delay patient test results.
Integra LifeSciences is recalling the OmniTract Surgical Retractor System because the sterilization instructions require a longer dry time than stated in the current manual. The dry time must be extended to 90, 110, or 120 minutes depending on the sterilization cycle used.
Medline Industries is recalling Convenience Kits containing Covidien Mon-a-Therm General Purpose Temperature Probes due to an error in distribution control. The recall affects 75 kits distributed nationwide.
ConvaTec is recalling Aquacel Ag Surgical SP dressings (Lot 5G00809) that were manufactured with greater-than-specified thickness. The dressing is used in surgical wound care.
Medline Industries is recalling Anesthesia Kit Peds (Model DYNJAP10125A, Lot 24JBR072) nationwide because they contain Covidien Mon-a-Therm temperature probes affected by a distribution control error.
Insulet Corporation is recalling Omnipod DASH Pods worldwide due to external soft cannula damage during manufacturing that can cause insulin to leak around the pod instead of being delivered. This may lead to high blood glucose levels and, in severe cases, diabetic ketoacidosis or death.
A M S Preop Kit-NS surgical convenience kits are being recalled due to contamination with Paenibacillus phoenicis bacteria discovered during sterilization testing. The kits were distributed nationwide in PA, GA, CA, and WA.
Medline is recalling convenience kits containing Swan-Ganz catheters due to failures of the proximal injectate lumen hub that can cause leaks, lumen damage, and breakage, potentially resulting in infection, medication loss, or blood loss.
Baxter Healthcare is recalling Hillrom VOLARA System patient circuits due to reports of air and medication leakage from the nebulizer cup, which can reduce oxygen levels and prevent proper medication delivery.
Baxter Healthcare is recalling Hillrom VOLARA System patient circuits due to reports of air and medication leakage from the nebulizer cup, which can cause oxygen level drops and ineffective medication delivery.
Baxter Healthcare is recalling the Hillrom VOLARA System P.CIRCUIT KIT (Model REF M08085) due to reports of air and medication leakage from the nebulizer cup, which can cause oxygen level drops and reduce treatment effectiveness.
Hamilton Medical AG is recalling coaxial breathing circuit sets used with three ventilator models because membranes may stick to the expiratory valve body, preventing proper gas exhalation and potentially causing inadequate ventilation.
Medtronic is recalling certain lots of the Harmony Delivery Catheter System due to a manufacturing issue that may cause the distal tip to detach from the delivery system during procedures.
Boston Scientific Corporation is recalling the CRE Wireguided 6-8mm 240cm device worldwide due to a potential sterile breach of the packaging pouches.