FDA (Devices) recall action 91124
The FDA (Devices) publishes a recall like this one as 78 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 78 pages.
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
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.
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 is recalling surgical procedure trays due to incomplete sealing of the outer bag, which may compromise the sterility of the kit.
STRADIS HEALTHCARE surgical procedure trays and kits are being recalled due to a manufacturing condition that may result in incomplete sealing of the outer bag, potentially compromising kit sterility.
Stradis Medical recalls medical and surgical procedure trays due to manufacturing defects causing incomplete outer bag seals that may compromise kit sterility.
Stradis Healthcare is recalling Angio Pack surgical trays due to manufacturing defects that may leave the outer bag incompletely sealed, compromising product sterility. Affected units were distributed nationwide in the US and Canada.
Stradis Medical recalls medical and surgical procedure trays and kits due to incomplete outer bag sealing that may compromise sterility. Units were distributed nationwide in the US and Canada.
Stradis Medical is recalling HENRY SCHEIN ENT surgical kits distributed nationwide due to defective outer bag sealing that may compromise sterility. Affected kits were distributed across the US and Canada.
Stradis Medical is recalling 800 units of HENRY SCHEIN Vein Clinics 1 surgical trays because the outer bag may be incompletely sealed, potentially compromising sterility. No infections have been reported.
Stradis Healthcare recalls Henry Schein Rhino Pack surgical trays due to potentially incomplete outer bag sealing that may compromise kit sterility. The recall affects 328 units distributed in the US and Canada.
HENRY SCHEIN Amnio Trays (Item No. 570-3059) manufactured by Stradis Medical are being recalled because the outer bag may be incompletely sealed, potentially compromising the sterility of the medical kit.
Stradis Medical recalls surgical trays with incomplete outer bag seals that may breach kit sterility. No illnesses or injuries reported.
Henry Schein bone marrow kits may have incompletely sealed outer bags, compromising sterility. Affected units were distributed in the US and Canada.
Stradis Medical recalls Henry Schein temp stimulator supplies due to incomplete outer bag sealing that may compromise kit sterility. Affected units should not be used until reviewed.
Stradis Healthcare is recalling surgical procedure trays that may have incompletely sealed outer bags, risking sterility breach. Sixteen units were distributed nationwide and in Canada.
ACE Surgical Supply oral surgery tray kits are recalled because the outer packaging may be incompletely sealed, potentially compromising sterility. The kits were distributed throughout the United States and Canada.
Stradis Healthcare is recalling medical surgical procedure trays and kits with potentially incomplete outer bag seals that could compromise sterility. These products were distributed nationwide in the US and Canada.
Stradis Healthcare is recalling cotton applicator 3 inch kits used in medical and surgical procedures due to incomplete outer bag sealing that may compromise kit sterility. Kits were distributed nationwide in the U.S. and Canada.
Stradis Medical recalls Henry Schein procedure trays because the outer bag may be incompletely sealed, risking sterility breach. The trays were distributed nationwide and in Canada.
Stradis Healthcare is recalling surgical and dental procedure kits due to manufacturing defects that may result in incomplete outer bag sealing and compromised sterility.
Stradis Healthcare is recalling dental implant trays with incomplete outer bag seals that may compromise sterility. Affected units were distributed in the US and Canada.
Stradis Medical recalls Henry Schein breast augmentation trays due to incomplete outer bag sealing during manufacturing, which may compromise sterility. The affected kits were distributed nationwide in the US and Canada.
Thoracic Phleb procedure kits from Stradis Healthcare are being recalled due to incomplete outer bag sealing during manufacturing, which may compromise kit sterility.
Stradis Medical is recalling STRADIS HEALTHCARE oral surgery trays because the outer bag may be incompletely sealed, risking sterility compromise. No illnesses have been reported.
Stradis Healthcare is recalling dental surgical procedure kits due to manufacturing issues that may result in incompletely sealed outer bags, potentially compromising kit sterility.
Stradis Medical is recalling Henry Schein GYN Pack surgical kits with potentially incompletely sealed outer bags that may compromise sterility. The affected kits were distributed nationwide in the US and Canada.