FDA (Devices) recall action 94136
The FDA (Devices) publishes a recall like this one as 29 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 29 pages.
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
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 alcohol swabsticks that may have weak seals potentially compromising product sterility. The defect may not be visible to users.
Medline Industries is recalling Swabsticks PVP swabs (2,458 units) due to weak seals that may compromise sterility. The defect may not be visible to users.
Medline Industries is recalling Centurion manual surgical kits due to weak seals that may compromise sterility. Approximately 7,950 units were distributed nationwide and internationally.
Medline Industries is recalling Centurion Clamp kits due to potential weak seals that could compromise sterility. Affected units were distributed nationwide and internationally.
Centurion Sterile Cotton Dental Rolls with weak seals may have compromised sterility. Affected products may allow contamination if the seal fails.
Medline's Centurion Manual surgical kits may have weak seals that fail to maintain sterility. If seals breach, microorganisms could contaminate the sterile contents, posing infection risk during surgery.
Medline Industries is recalling Centurion surgical scissors due to potentially weak seals that may compromise sterility. Users cannot reliably detect the defect, creating risk if compromised instruments are used in surgery.
Medline Industries is recalling 1700 Centurion Sterile Trach Brush devices due to a potential weak seal that may breach product sterility if the seal fails. The defect may not be obvious to users.
Medline is recalling Centurion manual surgical kits with potentially weak seals that may result in a breach of sterility if the seal fails. The weak seal may not be detectable by all users.
Medline has recalled Centurion dental kits due to weak seals that may compromise sterility. No illnesses or injuries have been reported.
Medline Industries is recalling 1700 units of Centurion Manual surgical kits due to potential weak seals that could compromise sterility. The weak seal may not be detectable by users.
Medline's Centurion umbilical cord clamp cutters may have weak seals that could compromise sterility. The defect may not be detectable during normal inspection.
Medline is recalling Centurion STERILE #5 Laryngeal Mirrors due to weak packaging seals that may not be detectable by users. The defect could result in a breach of the product's sterility if the seal fails.
Medline Industries, LP is recalling Centurion STERILE #16 rubber bands because the package seal may be weak, potentially compromising product sterility. The defect may not be visible to users before opening.
Medline Industries is recalling Centurion scalpel handle kits due to weak seals that may compromise sterility. Users cannot always detect the defect.
MEDLINE INDUSTRIES is recalling Centurion Manual uterine dilator surgical kits due to weak seals that may breach sterility. The weak seal could allow contamination and may not be detectable by users.
Medline Industries is recalling 800 units of 4.5-inch wire cut scissors due to a weak seal that could compromise sterility if it fails during use or storage.
Medline is recalling its Centurion FCP Magill Catheter (7.5 in. pediatric) because the product may have a weak seal that could compromise sterility. The affected units were distributed in the US, Panama, and Canada.
Medline Industries is recalling Centurion Curette kits because some may have weak seals that could compromise product sterility. The weak seal may not be detectable during inspection.
Medline Industries recalls 274,410 units of Centurion and Medline branded surgical forceps kits for potentially weak seals that could compromise sterility and may not be detectable during use.
Medline Industries is recalling 1,520 Centurion surgical hook kits worldwide due to weak seals that may compromise sterility. The seal defect may not be detectable by users.
Medline Industries is recalling Centurion ear speculum sets due to weak seals that could compromise sterility. The defect may not be detectable by users and could allow contamination if the seal fails.
Medline Industries is recalling Centurion Hemostat kits because weak seals may allow sterile contents to become contaminated. The weak seal may not be apparent to users before the instrument is used.
Medline M1S0179 sterile tape/pen packs may have weak seals that could compromise product sterility. The weakness may not be visible during normal inspection.
Medline is recalling Centurion surgical retractor kits (760 units) due to a weak seal that could compromise sterility if it fails. The weakness may not be detectable by users.