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
Acclarent's TruDi NAV Suction Instruments may be incorrectly calibrated, affecting surgical navigation accuracy. If undetected, the error could cause tissue damage, arterial injury, or nerve damage.
Beaver Visitec International recalls 920 units of Malosa Core LASIK Pack due to packaging holes that may compromise product sterility. Compromised sterility creates infection risk in surgical use.
Hill-Rom's NaviCare and Voalte nurse call communication systems may experience an unrecoverable software error causing components to fail reboot cycles and become non-functional, requiring replacement.
Beaver Visitec is recalling Malosa Core Phaco Pack 1 cataract surgery kits (Part Number: MMK833/2) because packaging may have small holes that compromise product sterility. The recall affects 120 units distributed across nine states.
Beaver Visitec is recalling the Malosa Core Surface Treatment Pack surgical kit because packaging may have holes that compromise sterility during eye procedures.
Set screws on ceiling-mounted extra monitors can loosen, causing monitors to fall and potentially injure patients, staff, or service technicians.
A surgical navigation tracker used in neurosurgery may experience weld failure, leading to navigation inaccuracy, prolonged procedure time, and potential tissue injury. 98 affected units were distributed across US and international healthcare facilities.
Civco Medical recalls VirtuTRAX Instrument Navigator sensors that may fail to tighten onto instruments during use. No injuries reported.
Beaver Visitec is recalling 1,170 units of its Malosa Core SMILE Pack 2 surgical refractive kit because packaging may contain small holes that could compromise sterility. Affected units were distributed across nine states.
Civco Medical Instruments is recalling VirtuTRAX Instrument Navigator devices due to a potential mechanical failure that could prevent proper securing of instruments. The device may not tighten onto the instrument as intended.
Essential Medical Supply is recalling approximately 272,000 Endurance Hand Bed Rails because users can become entrapped within the rail or between the rail and mattress, posing a risk of asphyxiation. One death has been reported.
Datascope is recalling Cardiosave Rescue Intra-Aortic Balloon Pump devices due to possibility of fluid ingress, which could short electronic components and cause unsafe system shutdown.
Datascope Corp. is recalling Cardiosave Hybrid IntraAortic Balloon Pumps due to the risk of fluid entering the device, which could cause system failure and hemodynamic instability.
Cardinal Health has recalled RoyalSilk Non-Reinforced Surgical Gowns XX-large due to the potential for packaging seals to open, which could compromise product sterility. The recall affects approximately 9,990 units distributed worldwide.
Activbody is recalling the Activ5 smart fitness device due to manufacturing defects causing inaccurate force measurements, which may lead to incorrect treatment planning. The device was distributed nationwide.
Smith & Nephew is recalling 41 units of the EVOS Condylar Medial Distal Femur Plate due to erroneous MRI scanning conditions in the instructions for use.
Cardinal Health is recalling 363,480 units of SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns due to potential open packaging seals that could compromise product sterility.
Medline Industries is recalling the Neuro Convenience Kit because a NaCl injectable component expired in April 2020 while the kit's overall expiration date was later. The expired component may pose a safety risk.
Cardinal Health is recalling SmartGown Breathable Surgical Gowns because packaging seals may not remain intact, potentially compromising the gowns' sterility. The recall affects 224,312 units distributed in the US and internationally.
Cardinal Health is recalling 8,950 units of RoyalSilk Non-Reinforced Surgical Gowns due to potential packaging seal defects that could compromise sterility. The affected gowns were distributed worldwide.
Medline Industries is recalling the Major Vascular CDS Convenience Kit because a 250 mL saline injectable component expired in April 2020, while the overall kit's expiration date was July 31, 2021. Medical professionals should stop using affected kits immediately.
Medline Industries is recalling EVLP Convenience Pack/Kit due to a NaCl injectable component that expired in April 2020, despite the kit's label showing a later expiration date. Users may unknowingly use expired medication.
Boston Scientific recalled 7 ROTAPRO rotational atherectomy system consoles due to incomplete manufacturing instructions regarding proper handling of the pneumatic kit component upon failure. Affected devices were distributed in six US states and Germany.
Cardinal Health Poly-Reinforced Surgical Gowns (XX-large, SKU 9070) are recalled due to potential open packaging seals that could compromise sterility. Approximately 29,893 units distributed worldwide may be affected.
Medline is recalling Venous Access Pack-LF Convenience Kits because the included saline solution component expired before the kit's labeled expiration date, creating a quality and safety issue.