Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.
24,725 detailed records are currently available in this category.
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) using the cobas SARS-CoV-2 & Influenza A/B assay for use under emergency use authorization on…
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 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
Possible false negative or false positive results due to the product being compromised during shipment.
Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing
bioMerieux received complaints about calibration issue observed on several lots of VIDAS CMV IgM (ref 30205 ; 30205-01).
When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than normal growth making zones difficult to measure.
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Discoloration and turbidity were present in the specified lots of STMs because of Longer Monsoon season at the South Korean Manufacturing Facility.
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…
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing
Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat.
Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result
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…
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
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…
It was identified that tissue culture bags were incorrectly labeled as free of phthalates.
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.
