Hazard
137 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 137 non sterile recalls we have scored against our rubric, 3 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 21 (15%) are Severe.
Which agencies issued them
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all non sterile recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.
A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.
Medline Industries is recalling over 626,000 laboratory kits because the included specimen container is labeled as sterile but is actually non-sterile. Non-sterile containers risk sample contamination and may result in unnecessary treatment or prolonged hospitalization.
Medline has recalled 626,305 urine collection kits because specimen containers are labeled as sterile but are actually non-sterile, potentially leading to unnecessary treatment or prolonged hospitalization.
MEDLINE's UA Kit specimen containers are labeled as sterile but have been identified as non-sterile, posing a risk of contaminated specimens that could lead to incorrect test results and unnecessary treatment.
Medline urine kit specimen containers labeled as sterile are actually non-sterile. This risks sample contamination, infection, and unnecessary treatment.
Medline medical procedure kits may contain non-sterile product if the breather pouch seal is opened or compromised. The recall affects 320 units distributed in the US, Canada, and Panama.
Medline Industries is recalling 2,740 surgical convenience kits with breather pouches that may result in non-sterile product if the vendor seal is opened. The recall affects units distributed in the US, Canada, and Panama.
Medline is recalling 88 convenience kits used in gynecological medical procedures due to potential non-sterility if the breather pouch seal is compromised. The affected lots are distributed in the US, Canada, and Panama.
Medline is recalling 2,371 medical procedure convenience kits because certain kits packaged in specific breather pouches may contain non-sterile product if the seal is compromised.
Medline is recalling 160 units of EYE PACK medical procedure kits due to potential compromises in sterilization. If the vendor seal on the breather pouch is opened or unsealed, the contents may become non-sterile.
Medline is recalling 8,830 medical procedure convenience kits with potential breather pouch seal failure that could allow non-sterile product use.
Medline is recalling approximately 1,048 medical procedure convenience kits that may become non-sterile if their protective pouch seal is compromised. The affected kits were packaged with breather pouches from lot 323080002.
Medline is recalling certain medical procedure convenience kits due to a breather pouch seal defect. If the pouch seal is opened or compromised, the product may not be sterile and could pose a health risk during surgical use.
Medline is recalling certain Ambulatory Mini Pack convenience kits from lot 23LBO804 because they may be non-sterile if the vendor seal on the breather pouch is opened or unsealed.
Medline brand medical procedure convenience kits packaged in breather pouch lot 323080002 may be non-sterile if the vendor seal is opened or compromised. Affected kits are distributed in the US, Canada, and Panama.
Medline brand obstetric convenience kits packaged in breather pouch lot 323080002 may become non-sterile if the vendor seal is opened or unsealed.
Medline is recalling certain Centurion tracheostomy kits due to potential non-sterility if the packaging seal is compromised. The affected kits may allow non-sterile product use.
Medline's Centurion OB TRAY convenience kits with breather pouch lot 323080002 may be non-sterile if the pouch seal is opened or becomes unsealed, posing a risk in obstetric procedures.
Medline Industries is recalling 90 units of Centurion EP LAB INSTRUMENT KIT convenience kits from lot 23LBK889. The kits may contain non-sterile product if the breather pouch vendor seal is opened or compromised.
Medline brand medical procedure convenience kits are recalled because their packaging may allow product sterility to be compromised. The affected units were packaged in breather pouch lot 323080002.
Medline is recalling certain medical procedure kits packaged in breather pouch lot 323080002 because seals may not prevent non-sterile product use. Affected units were distributed in the US, Canada, and Panama.
Canadian Hospital Specialties is recalling HIGH FLOW INSUFFLATION TUBING with incomplete seals that may result in non-sterile product. The defect affects 6,300 units and poses patient safety concerns.
FDA is recalling approximately 1.64 million GMAX non-sterile syringes manufactured by Jiangsu Shenli Medical because they were sold in configurations not approved by the agency.
GMAX SYR 20ML/LS non-sterile syringes do not meet FDA-cleared specifications. The recall affects approximately 62,000 units distributed nationwide across 14 lot codes.
Jiangsu Shenli Medical is recalling 754,600 non-sterile syringes because the piston syringe sizes and configurations exceed those cleared by the FDA. Affected units were distributed nationwide.
GMAX non-sterile syringes in various sizes and configurations have been recalled because they fall outside the FDA 510(k) scope of the manufacturer's clearance. Affected lots were distributed across six U.S. states.