Edge Pharma Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe recall — FDA D-0335-2021
Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility
Complete FDA and NHTSA recall records dated in April 2021.
These records include useful source details for the selected month.
Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility
Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could…
Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could…
Hyundai Motor America (Hyundai) is recalling certain 2021 Elantra vehicles. The driver and front passenger seat back recliners may have been improperly welded.
Hyundai Motor America (Hyundai) is recalling certain 2019-2020 Elantra, 2019-2021 Kona and Veloster vehicles equipped with 2.0L Nu MPI engines. The piston oil rings may not have been…
Volkswagen Group of America, Inc. (Audi) is recalling certain 2021 Q7, Q8, Q5 Sportback, SQ5 Sportback, RS6 Avant, RS7, RS Q8, 2020-2021 Audi S6 sedan, Q5, A8, S8, A7, A6 Allroad, A5…
Nissan North America, Inc. (Nissan) is recalling certain 2021 Rogue vehicles. The rear left and/or right brake caliper assemblies may be missing an internal bushing, allowing the O-ring…
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
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.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.