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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 1–12 of 12 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 →
Class IITerminated

Hardy Diagnostics cat no. G327 HardyCHROM SS Agar (HardyCHROM Salmonella Shigella) Cat no: G327 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2 to 8 degrees C. on receipt in dark A selective chromogenic medium for the primary screening isolation, and differentiation of Salmonella & Shigella spp.

Hardy Diagnostics

The firm is recalling HardyCHROM SS, Cat. no. G327 Lot no. 15037 due to a report of possible lack of color development in Shigella organisms in the referenced lot.

March 4, 2015 · DeviceView details →
Class IITerminated

Salmonella typhi Antigen Test Card; LumiQuick, Santa Clara, CA 95054

LumiQuick Diagnostics Inc.

Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.

March 4, 2014 · DeviceView details →
Class IITerminated

Salmonella typhi IgG/IgM Duo Test; LumiQuick. Santa Clara, CA 95054

LumiQuick Diagnostics Inc.

Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.

March 4, 2014 · DeviceView details →
Class IITerminated

Salmonella typhi/paratyphi Antigen Test; LumiQuick. Santa Clara, CA 95054

LumiQuick Diagnostics Inc.

Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.

March 4, 2014 · DeviceView details →
Class IITerminated

The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria and genetic virulence markers from liquid or soft stool preserved in Cary-Blair media, collected from individuals with signs and symptoms of gastrointestinal infection. The test is performed on the automated Nanosphere Verigene System utilizing reverse transcription (RT), polymerase chain reaction (PCR), and array hybridization to detect specific gastrointestinal microbial nucleic acid gene sequences associated with the following pathogenic bacteria: - Campylobacter Group (comprised of C. coli, C. jejuni, and C. lari), - Salmonella species, - Shigella species (including S. dysenteriae, S. boydii, S. sonnei, and S. flexneri), - Vibrio Group (comprised of V. cholerae and V. parahaemolyticus), - Yersinia enterocolitica. In addition, EP detects the Shiga toxin 1 gene and Shiga toxin 2 gene virulence markers. Shiga toxin producing E. coli (STEC) typically harbor one or both genes that encode for Shiga Toxins 1 and 2. EP is indicated as an aid in the diagnosis of specific agents of gastrointestinal illness, in conjunction with other clinical, laboratory, and epidemiological information; however, is not to be used to monitor these infections. EP also aids in the detection and identification of acute gastroenteritis in the context of outbreaks. Due to the limited number of positive specimens collected for certain organisms during the prospective clinical study, performance characteristics for Yersinia enterocolitica, Vibrio Group and Shigella species were primarily established with contrived specimens. Concomitant culture is necessary for organism recovery and further typing of bacterial agents. EP results should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Confirmed positive results do not rule out co-infection with other organisms that are not detected by this test, and may not be the sole or definitive cause of patient illness. Negative EP results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.

Nanosphere, Inc.

Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in Tip Holder Assemblies for the following products and lots of Extraction Trays.

October 10, 2013 · DeviceView details →
Class IITerminated

chromID Salmonella Agar, Reference No. 43621. A selective isolation and differentiation medium for the detection of Salmonella in human specimens.

bioMerieux, Inc.

Complaints for Salmonella strains growing on this medium producing an uncharacteristic white colored colony instead of the expected pale pink to mauve colored colonies. This could potentially lead to Salmonella colonies not being detected.

September 6, 2013 · DeviceView details →