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
The JMC5A Ni/TruAire-5 Oxygen Concentrator (Model O2C5L) is being recalled. The device may catch fire or melt during use, creating a risk of serious injury from fire and burns.
Maquet Cardiovascular is recalling the Vasoview Hemopro 2 Vessel Harvesting System due to potential heater wire and silicone defects. These could affect device function during minimally invasive surgery.
Fresenius Kabi is recalling 1,520 Ivenix infusion pumps (model LVP-0004) due to potential pneumatic valve failure that may stop active infusions or prevent pump operation. Affected units were distributed to healthcare facilities in six U.S. states.
FDA recalls VasoView HemoPro 2 endoscopic vessel harvesting systems due to risk of heater wire detachment and silicone peeling from the harvesting tool jaws, which could affect device function.
Beckman Coulter is recalling Access PTH assay reagent packs from lot 339071 due to under- or over-filling in well 0, which could cause sealing issues, contamination, and inaccurate test results.
GE Healthcare Optima XR200amx mobile radiographic systems may have missing bolts in the Column Safety mechanism, which could allow the X-ray arm to drop if an internal cable fails.
Applied Medical Technology is recalling AMT Mini Enteral Extension Sets due to incorrect ENFit connector type. Affected units have ENFit connections instead of non-ENFit, preventing proper compatibility with intended systems.
GE Medical Systems recalls Tec 850 SEV anesthesia vaporizers due to a manufacturing defect that may cause them to deliver less anesthetic agent than the dial setting indicates. Affected devices distributed nationwide and globally.
Spacelabs Healthcare's Xhibit Telemetry Receiver (Model 96280) may experience a Windows proxy issue causing the system to restart and go offline for 1-1.5 minutes, creating a temporary gap in patient monitoring.
GE Healthcare Optima XR mobile X-ray systems with column replacements may have missing bolts in the Column Safety mechanism. If bolts are missing and the internal cable fails, the arm could drop, creating a risk of injury to staff or patients.
Fresenius Medical Care is recalling Dialyzer Optiflux 160NRe units nationwide due to potential internal blood leaks caused by cracked polyurethane in the dialyzer material.
Certain Tec 6 Plus and Tec 800 series anesthesia vaporizers may deliver less anesthetic agent than the dial setting indicates due to a manufacturing issue. Approximately 1,573 units are affected, distributed in the United States and globally.
3B Medical recalled 5,010 Ultrasoft Oxygen Cannula units (Model O2U2012, Lot 20170403) distributed in Massachusetts and Arkansas because they were shipped after their expiration date.
Elucent Medical is recalling the EnVisio Patient Pad Transition Cushion due to a potential safety risk of the surgical bed frame's back section detaching during use. Approximately 283 units are affected across 16 U.S. states.
Nipro Renal Solutions USA is recalling Citric Complete dry citric acid concentrate due to mislabeled outer cases that show incorrect potassium and calcium content values.
Certain GE Tec anesthesia vaporizers (Tec 6 Plus and Tec 800 series) may deliver less anesthetic agent than the dial indicates due to a manufacturing issue. Users should cease use and contact GE Medical for instructions.
Aerin Medical is recalling 479 units of VivAer Stylus (Lot #10235) due to incorrect programming in units from a single lot. When connected to the Aerin Console, affected devices will be incorrectly identified as RhinAer Stylus.
GE Medical Systems is recalling 644 Tec 820 ISO Anesthesia Vaporizers due to a manufacturing issue that causes them to deliver less anesthetic than the dial setting indicates. Distributed nationwide and globally.
IDS LTD is recalling 23 Smaxel Fractional CO2 Laser systems worldwide due to missing Certification label and inadequate instructions for safe operation.
GE Healthcare Optima XR240amx systems with column replacement may have missing bolts in the Column Safety mechanism. If these bolts are missing and the counterpoise cable fails, the X-ray arm could drop.
GE Medical Systems is recalling approximately 928 Tec 820 SEV anesthesia vaporizers due to a manufacturing defect that can cause them to deliver less anesthetic agent than the dial setting indicates. The devices are distributed nationwide and globally.
Stryker's Neptune 3 and Neptune S Rover surgical suction systems are recalled due to improperly tightened bolts on the vacuum pump filter housing. Loose bolts may cause loss of suction force during medical procedures.
Greiner Bio-One GmbH is recalling VACUETTE SAFELINK blood collection holders because the protective rubber sleeve may bunch up and fail to retract, causing potential blood leakage from the device.
Telemetry receivers with affected software versions may unexpectedly shut down for 1-1.5 minutes, temporarily disabling patient monitoring. This could delay clinical response if a patient event occurs during the outage.
Qualigen is recalling 426 units of FastPack SHBG diagnostic kits due to incorrect expiration date labels on three lots. The kits were distributed to 15 U.S. states.