FDA (Devices) recall action 95843
The FDA (Devices) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Medline is recalling 21,440 surgical needleholders due to weak seals that may compromise sterility and increase risk of contamination and infection during surgical use.
Medline is recalling 21,440 reprocessed Bruns curettes due to weak sterile seals that may fail without user detection. This increases the risk of contamination and infection.
Medline has recalled Sterile Magill Forceps (Item No. 66790) due to weak seals that may compromise sterility. The defect affects approximately 21,440 units distributed nationwide.
Medline O.R. scissors may have weak seals that compromise sterility, increasing risk of contamination and infection. Approximately 21,440 units from lot 2023052490 have been recalled nationwide.
Medline's STERILE STRT KELLY HEMOSTAT (SK8039S) is being recalled due to weak seals that could compromise sterility, increasing the risk of contamination and infection. The recall affects 21,440 units distributed nationwide.
Medline Industries is recalling 21,440 units of the ST IUD Removal Hook due to weak seals that may compromise sterility. The defect is undetectable to users and could increase infection risk.
Medline RUMMELL units may have weak seals that could compromise sterility and increase infection risk. Approximately 21,440 units distributed nationwide are affected.