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
Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2112) because the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Medline Industries is recalling Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects syringes distributed worldwide, including the US, Canada, Panama, and Barbados.
Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2114) because the Version 2 reprocessor connecting tube lock levers may fail prematurely, potentially affecting equipment operation and patient safety during endoscope reprocessing.
Integra LifeSciences is recalling the CUSA Clarity C7000 Console (Software Version 2.1.1.909) due to a software issue that renders the touch screen unresponsive during surgical use.
Arrow International is recalling 395 pressure injectable central venous catheters across nine U.S. states due to incorrect manufacturing of the liquid adhesive by a supplier.
Magellan Diagnostics is recalling LeadCare II Blood Lead Test Kits because certain third-party micro-collection devices may produce falsely elevated lead results, potentially causing unnecessary testing and delayed results.
SurgiSmoke Solutions is recalling certain lots of the Flamingo Funnel Large (Model SQ20012-03) surgical device due to a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
Foundation Medicine is recalling Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx due to potential spontaneous closures of Hamilton HxRunControl software during protocol execution.
XTANT Medical Holdings is recalling nanOss 3D Advanced Bone Graft Substitute products due to incorrect labeling showing a 5-year shelf life when the approved shelf life is four years.
The FDA has rescinded the regulatory clearance for Medline's Breast Pack Kit (Model DYNJ66777D) because certain Control Syringes, Guidewires, and High-Pressure Tubing components no longer meet regulatory standards.
B. Braun Medical Inc is recalling STREAMLINE BLOODLINE SET FOR DIALOG (Model Number: SL-2010M2096) because air bubbles may accumulate in the arterial line.
B. Braun is recalling StreamLine Fresenius bloodlines supplied for DaVita because small air bubbles can accumulate in the arterial line under negative pressure. 1,174,271 units are affected.
B. Braun is recalling StreamLine Bloodline Long Version sets because small air bubbles can accumulate in the arterial line under negative pressure. 328,640 units are affected.
B. Braun is recalling StreamLine Bloodline Sets for Dialog DR because small air bubbles can accumulate in the arterial line under negative pressure. 3,158,104 units are affected.
B. Braun is recalling hemodialysis bloodlines with a 4.8 mm pump segment because small air bubbles can accumulate in the arterial line under negative pressure. 4,884 units are affected.
B. Braun is recalling one model of hemodialysis bloodline because small air bubbles can accumulate in the arterial line when blood gases adhere to the tubing under negative pressure.
Omnipod 5 Pods from 49 lots have an internal soft cannula tear that lets insulin leak inside the Pod instead of being delivered. 1,240,115 units are affected.
Cytal Wound Matrix 2-Layer 5x5 cm dressings are being recalled because of an increased rate of out-of-specification endotoxin results. 148 units are affected.
Cytal Wound Matrix 2-Layer 7x10 cm dressings are being recalled because of an increased rate of out-of-specification endotoxin results. 46 units are affected.
Arjo Tenor mobile passive patient lifts are being recalled because an internal actuator component in one production batch may not meet the required mechanical strength.
Cellex Photopheresis Kits are being recalled because the centrifuge bowl is harder to install and, if fitted improperly, may dislodge and break during priming or treatment.
Philips is recalling AneurysmFlow because the Mean Aneurysm Flow Amplitude ratio does not reliably predict aneurysm occlusion after flow diverter stent treatment, yet is relied on clinically.
ARTIS Pheno VE30A and VE40A systems are being recalled because 3D acquisitions may capture lighter and darker images, reducing reconstruction accuracy. 73 units are affected.
The Instinct Plus Endoscopic Clipping Device is being recalled after increased complaints indicating the device has the potential to malfunction. 713,702 units are affected.
Cytal Wound Matrix 2-Layer 10x15 cm dressings are being recalled because of an increased rate of out-of-specification endotoxin results. 452 units are affected.