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
Medline Industries is recalling 19 units of semi-rigid suction liners due to reported adverse events involving potential loss of suction during use.
Medline is recalling C Scope Disposable Kits because they contain plastic syringes affected by a March 2024 FDA Safety Alert regarding leaks and breakage.
Medline is recalling ER Suture Convenience Kits because the included plastic syringes have leaks, breakage, or other quality issues that may pose a risk to patient health.
B Braun is recalling the Infusomat Space Infusion Pump due to a sensor malfunction that can trigger false alarms, risking improper medication delivery.
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.
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 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.
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.
Medline is recalling specific lots of semi-rigid suction liners due to reported adverse events involving potential loss of suction during use.
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.
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.
BioFire Diagnostics is recalling FilmArray 2.0 diagnostic instruments that may have been incorrectly calibrated, leading to false positive and false negative results for infectious disease tests including Salmonella, Giardia, Norovirus, and MRSA.
A non-sterile Mastisol component was included in certain sterile craniotomy packs without proper labeling. If users assume the component is sterile, it could increase infection risk during surgery.
Medline is recalling medical convenience kits containing plastic syringes that may leak or break. These quality defects, linked to an FDA safety alert, pose a potential risk to patient health.
Zimmer GmbH is recalling Biolox Option Taper Sleeves due to mislabeling where packaging labels one neck size but contains the opposite size. These components are used in hip replacement surgery.
Medline Industries is recalling 2,860 units of its ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider due to potential incomplete seals on packaging trays, which could compromise sterility assurance.
Sol-Millennium Medical Inc. is recalling multiple Luer Slip Tip Syringe models because they are substantially different from FDA-approved designs and include major modifications to their intended use without approval.
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 medical convenience kits due to plastic syringe leaks, breakage, and quality issues that may pose a risk to patient health.
Sol-Millennium Medical Inc. recalls SOL-M eccentric tip syringes (10ml, 20ml, 60ml) worldwide due to substantial differences from FDA-cleared specifications and major modifications to intended use.
Medline is recalling multiple convenience kits containing plastic syringes affected by a March 2024 FDA safety alert. The syringes may leak or break, potentially posing a risk to patient health.
Medline is recalling convenience kits containing plastic syringes following an FDA safety alert. Identified leaks, breakage, and quality issues in these kits may pose a risk to patient health. The affected kits are distributed worldwide.
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.
Sol-Millennium Medical Inc. is recalling multiple syringe models found to differ substantially from their FDA-cleared designs. The recalled products include SOL-M, SOL-CARE, MEDLINE, MONOJECT, and HENRY SCHEIN branded syringes distributed in the United States and internationally.
Medline recalls convenience kits with defective plastic syringes due to leaks, breakage, and quality issues identified in an FDA Safety Alert. The defects may pose a risk to patient health.