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  1. FDA Recalls
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FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 1–6 of 6 recalls for “Salmonella”

Class IIOngoing

Oxoid Agglutinating Sera, Salmonella 9-0 R30957301

Remel Europe Ltd.

Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds. Cross-reactivity may result in the misidentification of a Salmonella 9-O serotype as a 2-O serotype.

March 25, 2026 · DeviceView details →
Class IIOngoing

FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W

BioFire Diagnostics, LLC

Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024 were calibrated with internal equipment that may lead modules and instruments to report higher melting temperatures, which may lead to erroneous results including false positive Salmonella, Giardia lamblia, false positive/negative Norovirus, and false negative MRSA.

August 7, 2024 · DeviceView details →
Class IIOngoing

FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U

BioFire Diagnostics, LLC

Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024 were calibrated with internal equipment that may lead modules and instruments to report higher melting temperatures, which may lead to erroneous results including false positive Salmonella, Giardia lamblia, false positive/negative Norovirus, and false negative MRSA.

August 7, 2024 · DeviceView details →
Class IIOngoing

VIDAS CLINICAL VIDAS SALMONELLA 60T, CATALOG 30702

Biomerieux Inc

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

November 9, 2022 · DeviceView details →
Class IIOngoing

GENE-UP REAGENT GENE-UP Salmonella 2, CATALOG 423105

Biomerieux Inc

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

November 9, 2022 · DeviceView details →
Class IIOngoing

VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticle probe technology.

Luminex Corporation

Potential for a false-negative result for Vibrio parahaemolyticus, Salmonella, and/or Shigella spp when used with the VERIGENE Enteric Pathogens Nucleic Acid Test Kit.

March 18, 2021 · DeviceView details →