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
Philips North America is recalling 5,164,600 units of Infant Heel Warmers due to labeling changes made after FDA clearance without new approval. The devices cannot be distributed or sold without new FDA 510(k) clearance.
Philips is recalling 2,925,800 Medichoice Infant Heel Warmer units because labeling was modified beyond the scope of FDA clearance. The devices cannot be sold without new 510(k) approval.
Philips North America recalled approximately 2.5 million Heel Snuggler units because labeling was modified after FDA clearance without obtaining updated regulatory approval.
Getinge Usa Sales Inc recalls Vaporizer Sevoflurane components in anesthesia systems due to potential chemical degradation that may cause hydrogen fluoride exposure via inhalation or skin contact.
Technomed Europe is recalling 117,672 disposable subdermal needle electrodes due to risk of the blue hub detaching, potentially leaving the needle in the patient's scalp.
The Proteus 235 proton therapy system can start clinical processes while test processes are still running, potentially using test components in clinical treatments without user notification. This could impact patient treatment if versions differ.
Siemens SOMATOM Confidence CT scanners with software version VB20_SP5 may experience degraded head image quality, creating a potential risk of misdiagnosis. The recall affects 108 units distributed nationwide.
Philips recalls 10 Azurion interventional X-ray systems due to intermittent startup communication failures and emergency stop recovery issues that could prevent system restart and movement functionality.
Reflexion Medical is recalling three RefleXion X1 radiotherapy systems due to a potential dose discrepancy when delivering treatment in Feet First Supine patient orientation.
DePuy Orthopaedics is recalling GLOBAL UNITE REV STEM SZ 10 implants because the spigot bore may be undersized, preventing proper separation of components during revision surgery and potentially causing bone damage.
Canon Medical's flat panel detectors used in Alphenix surgical systems may display abnormal horizontal stripes and fail to recover by restarting, potentially causing operators to work without proper visual guidance during procedures.
Medtronic is recalling approximately 6,653 Custom Perfusion kits used in cardiac procedures because they were labeled as non-pyrogenic without completing required endotoxin testing.
Siemens SOMATOM Edge Plus CT systems running software version VB20_SP5 may produce degraded head images, potentially leading to patient misdiagnosis.
DePuy Orthopaedics' GLOBAL UNITE STD STEM prosthetics may have undersized spigot bores, complicating removal during revision surgery. Affected patients may experience surgical delays or bone damage.
DePuy Orthopaedics is recalling approximately 870 GLOBAL UNITE STD STEM implants worldwide because an undersized spigot bore may prevent proper separation, causing potential surgical delay or bone damage.
DePuy Orthopaedics is recalling 781 hip stem implants that may have an undersized spigot bore diameter, potentially preventing surgical removal without additional surgical delay or bone damage.
DePuy Orthopaedics has recalled 3 units of GLOBAL UNITE REV STEM SZ 8 due to an undersized spigot bore. Separation of the implant components may not be possible without surgical delay and/or bone damage.
PTW North America is recalling BeamAdjust 2.2 and VeriSoft 8.0 software due to measurement errors that can report incorrect radiation doses in patient treatment plans.
Covidien is recalling LigaSure Blunt Tip Laparoscopic Sealer/Divider devices (lot 11320187X) due to an assembly defect that may prevent the device jaws from opening after tissue application, creating a risk of bleeding and tissue injury.
Haag-Streit USA is recalling OCT-Camera 211 01 A3 units due to malfunction of the automatic laser beam shut-off. The device may not correctly recognize when the laser beam is safely switched off.
Siemens SOMATOM Definition Edge CT scanners with software version VB20_SP5 may produce degraded head images, increasing the risk of patient misdiagnosis. Devices have been distributed nationwide.
DePuy is recalling GLOBAL UNITE STD STEM SZ 6 orthopedic stems due to undersized spigot bore that may prevent safe removal during revision surgery, risking surgical delays and bone damage.
Haag-Streit OCT-Camera devices with automatic laser shut-off malfunction may fail to recognize when the laser is safely switched off, posing a potential safety risk.
DePuy Orthopaedics is recalling GLOBAL UNITE STD STEM orthopedic implants due to undersized spigot bore diameter that may prevent proper removal during revision surgery, risking surgical delay and bone damage.
Software version VB20_SP5 in certain Siemens CT scanners may degrade head image quality, increasing misdiagnosis risk. The recall affects 794 units distributed nationwide.