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
Boston Scientific is replacing specific FARASTAR PFA generators that are not compatible with the FARAPOINT PFA catheter. The FDA Class II recall affects 6 units distributed internationally.
Medline Industries, LP is recalling 980 Medline convenience kits containing Bard Silastic Foley Catheters because excess raw material on the catheter surface may be harmful.
Medtronic is recalling its MiniMed Go app because a software bug can prevent insulin dose alerts during nighttime, potentially leading to missed doses and hyperglycemia.
Medtronic Neurosurgery is recalling Ventriculostomy Kit (REF: 46154) because endotoxin levels may exceed acceptable limits for devices contacting cerebrospinal fluid.
Karl Storz Endoscopy is recalling 45 Flexible Hystero-Fiberscope Kits that contain expired Single Use Endoscopic Seals, which could compromise sterility assurance during gynecological procedures.
AVID Medical is recalling 112 Halyard STANDARD LINE INSERTION PACKs due to silicone seal defects that may cause fluid leakage or occlusion.
Medline Industries, LP is recalling 980 Medline convenience kits containing Bard Silastic Foley Catheters because excess raw material on the catheter surface may be harmful.
Boston Scientific recalls 400 units of a cardiac catheter sheath due to potential air embolism risk from valve damage during preparation.
Boston Scientific Corporation is recalling the TheraSphere 360 Y-90 Management Platform (Model M00139509001) due to a software anomaly that may cause incorrect dose calculations.
Micro Therapeutics, Inc. is recalling Pipeline Flex Embolization Devices because the labeled implant length does not match the actual device length.
Paragon 28 is recalling specific Phantom Hindfoot TTC/TC Ball Tipped Guide Rods because of complaints regarding breaches in the sterile pouch packaging.
AVID Medical, Inc. is recalling certain Halyard EYE PACK convenience kits because the Betadine solution contained within them has an incorrect concentration.
Prismatik Dentalcraft, Inc. is recalling Silent Nite Sleep Appliances because the device does not have FDA clearance.
Medline Industries, LP is recalling specific Medline NEURO PACK convenience kits because they may contain low levels of Bacillus species contamination.
Boston Scientific is recalling 18 FARASTAR Ablation Generator EU devices due to missing FARAPOINT PFA catheter information in the Instructions For Use.
Micro Therapeutics, Inc. is recalling Pipeline Flex Embolization Devices because the labels may incorrectly state the implant length.
Kent Imaging, Inc. is recalling SnapshotGLO Wound Imaging Devices (Models KB100 and KB100AA) because software issues may prevent the device from recharging.
Boston Scientific Corporation is recalling 11 units of FARASTAR PFA Generators and Percutaneous Cardiac Ablation Catheters because the Instructions For Use did not include FARAPOINT PFA catheter information.
Olympus Corporation of the Americas is recalling 10 Olympus 4K UHD LCD Monitors (Model OEV321UH) because the HDMI and DisplayPort connectors may become faulty.
Boston Scientific recalls cardiac ablation generators due to incomplete Instructions For Use that omit information about a compatible catheter.
Abiomed is recalling the Impella RP Flex heart pump due to potential introducer sheath leakage from the sheath cap and hub score lines. The manufacturing defect is not visually detectable.
ICU Medical is recalling Plum Duo Infusion Pump v1.2.3 units due to a software defect that may cause the pump to deliver up to twice the programmed volume without decrementing the display, risking patient overdose.
Abiomed is recalling ABIOMED Insertion Kits due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines. The manufacturing defect is not visually detectable by users.
Argon Medical Devices is recalling One-Piece Introducer Tray kits containing Lidocaine HCL Injection because they do not meet sterility release criteria. The kits were distributed nationwide and internationally.
ABIOMED Impella CP heart pump sets contain introducers that may leak from under the sheath cap and along hub score lines. These manufacturing defects are not visible during use.