FDA (Devices) recall action 96393
The FDA (Devices) publishes a recall like this one as 14 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 14 pages.
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
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.
Stryker is recalling over 182,000 Nasopore nasal dressings due to potential bubbles in the blister seal that could compromise the sterile barrier. The affected units were distributed nationwide.
Stryker Corporation is recalling 182,344 Otopore Cylinder Standard outer ear dressings due to potential defects in blister seals that may compromise sterility. Bubbles in packaging seals indicate the sterile barrier is breached.
Stryker Corporation is recalling Nasopore nasal dressings due to defects in blister seals that may compromise sterility. Affected products may have bubbles on the seal, indicating the sterile barrier has been breached.
Stryker recalls Nasopore 4cm fragmentable nasal dressings due to potential blister seal damage that compromises the sterile barrier. Nationwide distribution affected.
Stryker Corporation recalls Otopore Cylinder outer ear wound dressing due to potential bubbles in blister seals that may breach the sterile barrier. Affected units were distributed nationwide.
Stryker's Nasopore 8cm nasal dressing is being recalled because packaging seals may have bubbles indicating the sterility barrier has been breached. The recall affects 182,344 units distributed nationwide.
Stryker Corporation is recalling 182,344 units of Nasopore FD nasal dressing nationwide due to potentially breached sterile seals that may allow product contamination.
Stryker Corporation is recalling Nasopore nasal dressings due to potentially compromised sterile packaging seals. Affected units totaling 182,344 may have lost sterility, posing a contamination risk.
Stryker is recalling Nasopore Standard 4cm nasal dressings because the blister seals may develop bubbles, potentially compromising the sterility barrier. Affected units should not be used.
Stryker Corporation is recalling Nasopore nasal dressings due to potential breaches in packaging sterility seals that could compromise product sterilization. Approximately 182,344 units have been distributed nationwide.
Stryker Corporation is recalling Otopore Square outer ear wound dressings nationwide because sterile packaging seals may develop bubbles, indicating a potential breach of the sterile barrier. Consumers should stop using affected units and contact their healthcare provider.
Stryker Corporation is recalling 182,344 units of Hemopore nasal/sinus wound dressing due to potential packaging seal defects that could compromise sterility. A bubble on the blister seal may indicate the sterile barrier has been breached.
Stryker Corporation is recalling 182,344 units of Hemopore 2PK nasal/sinus wound dressing due to potential bubbles in blister seals that indicate sterility breach. Affected lot numbers are 2024020221, 2024051720, and 2024082321.
Stryker is recalling 182,344 units of Nasopore Standard nasal dressings nationwide due to potential bubbles in blister seals that may breach the sterility barrier and increase contamination risk.