🏥 Medical Devices • 15,203 recalls
MEDLINE INDUSTRIES, LP - Northfield
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.
X-NAV Technologies
The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not fit onto the doctor's dental handpiece.
Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that may lead to falsely elevated results when processed as below on the same instrument: " ARCHITECT Syphilis TP (LN 8D06) and/or ARCHITECT AdviseDx SARS-CoV-2-IgG II (LN 6S60) precedes ARCHITECT Anti-HCV testing (LN 1L79). " Alinity i Syphilis TP (LN 07P60) precedes Alinity i Anti-HCV testing (LN 08P05).
MEDLINE INDUSTRIES, LP - Northfield
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 potential for trocar seal disengagement when using mesh products incorrectly with the device.
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
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 packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
Fresenius Medical Care Holdings
The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
Bio-Rad Laboratories
Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values.
Bruder Healthcare Company
Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.
Baxter Healthcare
A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices and Supple Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices.
Bruder Healthcare Company
Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.
Bruder Healthcare Company
Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.
Baxter Healthcare
A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices and Supple Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices.
Bruder Healthcare Company
Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.
Boston Scientific
An investigation determined that delivery of the Obsidio embolic using the aliquot technique for lower gastrointestinal bleeding embolization poses a high risk of bowel ischemia. The most serious and the most common adverse health consequence, reasonably foreseeable to occur, is the need to perform major surgery such as bowel resection and/or diverting colostomy. Therefore, Boston Scientific does not recommend that the aliquot technique be used to deliver the Obsidio device for lower GI bleed embolization procedures.
Olympus Corporation of the Americas
Olympus has become aware of an increased trend of both repairs and customer complaints reporting "UHI-4 stopping air supply due to the front panel LED turning off".
Ortho-Clinical Diagnostics
The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) results that could lead to testing delays and erroneous patient results. This issue caused positive or negative bias in the quantification of sodium (Na+) and total carbon dioxide (ECO2). The incorrect diluent into the Performance Verifier II exhibited a potential negative bias of up to 6 mmol/L for ECO2 and Na+ testing.