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 recalls OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2115) due to a defect. The recall affects approximately 2,089 units distributed nationwide and internationally.
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.
Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2111) because the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Medline Industries has issued a recall of Medline Namic Guidewires because their FDA 510(k) regulatory clearances have been rescinded. The affected units were distributed nationwide.
Medline Industries is recalling D and C Pack kits (Model DYNJ41254B) nationwide because regulatory clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing have been rescinded.
B. Braun is correcting gravity and pump administration sets used with specific infusion pumps due to risk of medication backflow from secondary containers into primary containers and occlusion during priming.
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.
SurgiSmoke Solutions is recalling certain lots of the Flamingo Funnel Small (Model SQ20012-01) due to a manufacturing issue involving use of a non-gamma sterilization compatible drape.
The FDA has rescinded regulatory clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing included in Medline's Arthroscopy Pack (Model DYNJ82440). Affected units should not be used.
Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2113) because the Version 2 reprocessor connecting tube lock levers may fail prematurely. The defect could affect proper connection during endoscope reprocessing.
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 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 StreamLine Bloodline Long Version sets because small air bubbles can accumulate in the arterial line under negative pressure. 328,640 units are affected.
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.
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.
iLet Ace Pump Kits are being recalled because active status bar icons on the lock and passcode screens allow those screens to be bypassed, permitting unauthorized access.
Cytal Burn Matrix 7x10 cm wound dressings are being recalled because of an increased rate of out-of-specification endotoxin results. Seven 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.
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.
Yeastone Broth is being recalled because the product may report incorrect antifungal susceptibility results during quality control, which could delay treatment or force a change of agent.
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.
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.
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.