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
Safeguard US Operating LLC is recalling the HAWK Advanced Hypothermia Management Set due to incorrect expiration dates on affected units. The product may not perform reliably if used after the incorrect date.
Boston Scientific is recalling Flexima Biliary Catheter System Kit (Lot #33512376) due to potential holes in the device pouch's sterile barrier, which could compromise device sterility. No illnesses or injuries have been reported.
B. Braun Medical is recalling STREAMLINE LONG hemodialysis bloodline tubing because the patient connector may fail to fully insert into the Locksite, potentially causing blood flow obstruction during dialysis treatment.
Siemens Healthcare Diagnostics is recalling Atellica CH and ADVIA Chemistry Microalbumin test kits worldwide because they may not properly measure microalbumin in urine samples, potentially causing falsely low results that could delay diagnosis of kidney disease.
CareFusion recalls approximately 10,460 Alaris PCA Module Model 8120 infusion pumps worldwide due to potentially bent female IUI connectors that may prevent proper device operation and delay treatment initiation.
CareFusion's Alaris System PC Unit Model 8015 infusion pumps are being recalled due to a bent female IUI connector affecting over 125,000 devices. The defect may prevent the device from operating properly or delay infusion or monitoring startup.
B Braun's STREAMLINE FRESENIUS bloodline tubing used in hemodialysis may have a design issue where incomplete insertion of the patient connector prevents proper blood flow during certain procedures. Patients receiving dialysis may experience treatment delays.
GE Healthcare ViewPoint 6 medical imaging systems contain a software vulnerability (CVE-2023-43208) in Mirth Connect that could allow unauthorized access and patient data manipulation. 574 units are affected and distributed nationwide.
Unomedical A/S is recalling specific VariSoft Infusion Sets packaged in boxes incorrectly branded as 'Trusteel Infusion Set' instead of 'VariSoft.' No injuries or illnesses have been reported.
Cypress Medical Products is recalling BinaxNOW Respiratory Strep A Test Kits due to an inventory system error that resulted in shipment to customers without proper licensing to purchase medical devices.
Safeguard US Operating LLC is recalling 567 units of HAWK warming kits due to incorrect expiration date labeling. The kits were distributed nationwide in 16 states.
Cypress Medical Products is recalling McKesson 60 mL syringes that lack FDA clearance. The syringes were inadvertently shipped from a distribution center due to an order processing error and were on quarantine.
Marodyne-LiV low-intensity vibration exercisers with certain serial numbers are recalled due to a power supply voltage drop that unexpectedly interrupts treatment. Manual activation is required to restart the device.
Smiths Medical is recalling select BLUSelect tracheostomy tubes due to a manufacturing defect that could cause the pilot balloon to disconnect from the inflation line. No injuries have been reported.
Smiths Medical is recalling BLUperc and BLUselect tracheostomy tube kits worldwide due to a manufacturing defect that could cause the pilot balloon to disconnect from the inflation line, potentially compromising airway management.
Smiths Medical ASD Inc. is recalling 10,240 Pneupac paraPAC plus 310 ventilator kits due to risk of unintended tidal volume knob movement, affecting all serial numbers worldwide.
Smiths Medical is recalling approximately 12,234 BLUselect, BLUgriggs, and BLUperc tracheotomy tube kits due to a manufacturing defect that may cause the pilot balloon to disconnect from the inflation line.
Olympus Corporation recalled 2,525 electrosurgical knives (KD-645L) nationwide after reports of serious injury from knives breaking off during use. Users must follow Instructions for Use regarding proper electrosurgical unit compatibility and output settings.
Olympus Corporation recalls 4,507 Triangle Tip Electrosurgical Knives (Model KD-640L) due to device fragmentation during use. The issue is linked to reports of serious injury and improper adherence to usage instructions.
B Braun is recalling the Infusomat Space Infusion Pump due to a sensor malfunction that can trigger false alarms, risking improper medication delivery.
Medline is recalling medical convenience kits containing plastic syringes due to leaks, breakage, and quality issues that may pose a risk to patient health. The recall affects multiple syringe products distributed worldwide.
Medline is recalling convenience kits containing plastic syringes with quality issues including leaks and breakage that may affect patient safety. The kits have been distributed worldwide.
Medline is recalling multiple breast biopsy convenience kits with plastic syringes affected by an FDA Safety Alert. The syringes have leaks, breakage, and quality issues that may pose a risk to patient health.
PACIFIC LASERTECH's 25-LHP-928 HeNe laser systems have a safety defect: the key control can be removed while the laser is operating. The company is replacing affected units with corrected key switches.
Medline Industries is recalling medical convenience kits containing plastic syringes with quality defects including leaks and breakage. These defects may pose a risk to patient health.