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21 reported ongoing
22 records in this archive. Latest source date Apr 8, 2026.
FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
Class IIReported ongoing
Distribution: US Nationwide distribution.
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
Class IIReported ongoing
Distribution: US Nationwide distribution.
It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the manufacturer-installed settings. Modifications included disabling Barco Application Appearance Manager (AA...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Asia Pacific, Europe, and the Middle East.
Due to product exhibiting potential to generate either invalid or false negative results.
Class IIReported ongoing
Distribution: U.S. Nationwide distribution in the states of CA, FL. IA, IL, MO, NC, NM, PR, and TN.
Presence of particulates in affected devices that can be deposited into breast tissue during use.
Class IIReported ongoing
Distribution: US Nationwide distribution.
Fungal contamination of affected lot with Parengyodontium album.
Class IIReported ongoing
Distribution: US Nationwide distribution.
Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.
Class IIReported ongoing
Distribution: Domestic: Nationwide Distribution
Three lots of Rapid fFN Specimen Collection kit (901164, 901165, and 904850) contain Rapid fFN Specimen Collection Tubes which may be empty, underfilled, or overfilled with extraction buffer. The transport tubes are used with the Fetal Fibronectin Enzyme Im...
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND,...
Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment.
Class IIReported ongoing
Distribution: AR, CA, CT, FL, IN, KS, LA, MA, ME, MI, NC, NJ, NV, NY, PR, TX, UT, VT, WA, WV, and Canada.
SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.
Class IIReported ongoing
Distribution: US: AK
Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.
Class IReported ongoing
Distribution: Domestic: US Nationwide Distribution.
Identified an issue with Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software when used in combination with C-View software in which the quality of the final C-View synthesized 2D image is impacted and may appear blurry and result in misdiagnosis...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Belgium, Canada, Israel, Korea, Republic of, Netherlands.
Non-conformance pertains to electromagnetic compatibility requirements according to the international technical standard IEC 60601-1-2 for the safety and essential performance of medical electrical equipment, where the result from the Horizon DXA System exc...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of India, Australia, Spain, Estonia, Germany, Italy, Canada, Thailand, Dominican Republic, Portugal, Islas Canarias, And...
Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the breast, and the need for additional medical ...
Class IReported ongoing
Distribution: US Nationwide Distribution
Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive.
Class IIReported ongoing
Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AR, CA, CO, CT, FL, IL, IN, MA, ME, MI, MN, MO, MT, NC, ND, NH, NJ, NM, NV, NY, OH, PA, Puerto Rico, TX, ...
Use of assay along with plasma specimen may result in error code which would invalidate sample.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of CA, CT, FL, ID, IL, MD, MI, MO, TN, TX, WI and the countries of Australia, Germany, Denmark, Spain, France, Great Britain...
The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery
Class IIReported ongoing
Distribution: US Nationwide distribution.
C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual
Class IIReported ongoing
Distribution: US Nationwide distribution.
IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set
Class IIReported completed
Distribution: US Nationwide distribution.
Hologic BioZorb LP Marker, (Product number F0221), lot number 22A0RL, contained removable labels with an expiration date that indicated the product had already expired. The expiration date on the removable label is actually manufacturing date, and it's diff...
Class IIReported ongoing
Distribution: US Nationwide distribution including in the states of FL, IL, MD, NJ, AZ, TX, WA, VA, OK, NC, NH, GA, CA, CT, OH, CO, MI, MO, KS, TN, ID, MS, MT, AL, OR, IA, PA, MA.
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 22 records, including 21 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.
This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.
Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.