Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
BioGX SARS-CoV-2 Reagents for BD MAX" System rehydration buffer tubes were not adequately sealed causing some tubes to be partially filled or empty upon use. A partially filled or empty…
When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than normal growth making zones difficult to measure.
The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging.
It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Inadequate images resizing and 2D measurement errors may occur when biplanar acquisition has been performed with patient orientation different from AP (Antero-Posterior).
Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing
Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload from being erroneously fired a second time. If the safety interlock fails and the…
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Centinel Spine learned through five customer complaints that the product was missing the "UP" etching on the superior plate of the prodisc C device. Per the Surgical Technique, the "UP" is…
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Their is a potential that Video Processor/Illuminators may exhibit flickering, loss of image or unintended reboots.
It was identified that tissue culture bags were incorrectly labeled as free of phthalates.
Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload from being erroneously fired a second time. If the safety interlock fails and the…
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Investigations related to customer complaints received for particulate matter inside of the Surgiwand" II device tubing components identified the root cause as a damaged Y-Connector…
Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result
Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat.
Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Interference condition between the 10mm Drill Guide Inserter and the inner shaft that mates with the inserters. As a result, inner shafts do not mate flush with the collet inserters, and…
Discoloration and turbidity were present in the specified lots of STMs because of Longer Monsoon season at the South Korean Manufacturing Facility.
Browse recent months with enough recall history for useful comparison.
