Hazard
117 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 117 seal defect recalls we have scored against our rubric, 1 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (3%) 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 seal defect 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.
Thoratec HeartMate 3 left ventricular assist system implant kits may develop a leak at the seal interface between the inflow cannula and titanium apical cuff, potentially compromising device function.
Smiths Medical is recalling 31,685 HIGH PRESSURE ROTATOR infusion devices with a manufacturing defect that may cause an inadequate seal. The defect could lead to medication leaks and under-infusion.
Smiths Medical is recalling specific injection line rotating adapters due to a manufacturing defect causing oversized O-rings that may lead to inadequate seal integrity and medication under-infusion.
Smiths Medical is recalling approximately 31,685 units of a braided injection line due to manufacturing defects in the O-ring seal. The defect may cause medication leaks that reduce drug delivery.
Smiths Medical is recalling Medex 700PSI stopcocks with rotators due to a manufacturing defect affecting the O-ring seal. The defect may cause medication leakage and under-infusion during patient treatment.
Smiths Medical is recalling Medex injection line rotating adapters due to a manufacturing defect where the O-ring inner diameter may be oversized, potentially causing medication leaks during infusion.
Smiths Medical Asd Inc is recalling approximately 31,685 Stopcock Left Rotator devices due to oversized O-rings that may compromise seal integrity. The defect may cause medication leaks, potentially resulting in under-infusion during treatment.
Medtronic is recalling Protege GPS Self-Expanding Peripheral Stent Systems due to seal defects in product packaging that could compromise sterility. Affected lot B644679 had national distribution.
Medline is recalling 2,304 probe cover kits because the seams may not provide adequate barrier protection during ultrasound procedures. Affected kits were distributed worldwide from December 2017 to May 2023.
The Harvard Drug Group is recalling Carbidopa and Levodopa Tablets due to inadequate sealing of the blister packaging. The recall affects Lot M04145 distributed nationwide.
Stradis Healthcare is recalling surgical trays due to incomplete outer bag sealing that may compromise sterility of the surgical kit.
Stradis Healthcare is recalling 162 surgical implant trays distributed nationwide due to incomplete outer bag seals that may compromise sterility.
Stradis Healthcare is recalling Endo Pack surgical trays (Item 682-509) because manufacturing defects may result in incompletely sealed outer bags, potentially compromising kit sterility. Products were distributed in the US and Canada.
Stradis Healthcare recalls its Phlebectomy Pack (Item No. 682-001) due to incomplete sealing of outer bags, which may compromise sterility of surgical kits distributed nationwide.
Stradis Medical recalls Vein & Laser surgical procedure kits due to incomplete outer bag sealing that may compromise sterility. The recall affects 10 units distributed in the US and Canada.
Stradis Medical recalled Henry Schein Basic Pack medical and surgical procedure trays due to manufacturing defects causing incomplete outer bag seals that may compromise sterility. The affected kits were distributed nationwide in the US and Canada.
Abbott Laboratories recalls Pedialyte Unflavored 2 fl oz bottles for compromised seal integrity that could allow spoilage. Affected bottles were distributed across the United States and multiple countries.
Medline is recalling 240 Radiology Procedure Packs because some breather pouches show seal openings that could compromise sterility. The affected kits were distributed nationwide.
Medline has recalled LINQ TRAY surgical kits with breather pouch seal openings that could compromise sterility. The recall affects 40 kits distributed nationwide; no injuries have been reported.
Medline Industries is recalling 800 Bausch + Lomb Basic Ophthalmic surgical kits (Lot 22DBN365) for defective breather pouch seals. Opened seals in the packaging compromise the sterile conditions required for surgical procedures.
Medline has recalled Bausch + Lomb cataract surgical kits due to breather pouches with seal openings that could compromise sterility. Affected kits were distributed nationwide.
Fresenius Medical Care is recalling 656 cases of NATURALYTE Liquid Acid dialysate nationwide (lot 22CTAC106) because alternate bottle caps are not qualified for use, potentially compromising product integrity.
Medtronic recalls its C304-HIS cardiac catheter device due to potential sterility barrier defects in certain manufacturing lots. Approximately 1,385 devices distributed worldwide were affected.
Cardinal Health is recalling 169,262 SmartSleeve surgical gowns due to potential package seal defects that could compromise sterility. Multiple affected lot numbers span 2020-2021 production with worldwide distribution.
ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect may prevent a proper seal.