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52 reported ongoing
52 records in this archive. Latest source date May 21, 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.
Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Class IIReported ongoing
Distribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ,...
Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Class IIReported ongoing
Distribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ,...
Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Class IIReported ongoing
Distribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ,...
Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Class IIReported ongoing
Distribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ,...
Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Class IIReported ongoing
Distribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ,...
Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Class IIReported ongoing
Distribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ,...
Laser surgical instruments have no specific evidence of a validated reprocessing method, therefore these instruments lack sterility assurance, so once the instruments have gone through reprocessing after use and then are used again, there is an increased ri...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide in the states of OH, CA, FL, MA, TX, KY, WI, MI, MN, AR, NE, IL, NY, HI and the country of Argentina.
Inadequate reprocessing validation evidence
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of AR, CA, CO, CT, DC, FL, GA, IA, IL, LA, MA, MI, MN, MO , ND, NY, OH, OR, SD, TN, TX, UT, VA, WA, WV.
Inadequate reprocessing validation evidence
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of AR, CA, CO, CT, DC, FL, GA, IA, IL, LA, MA, MI, MN, MO , ND, NY, OH, OR, SD, TN, TX, UT, VA, WA, WV.
Inadequate reprocessing validation evidence
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of AR, CA, CO, CT, DC, FL, GA, IA, IL, LA, MA, MI, MN, MO , ND, NY, OH, OR, SD, TN, TX, UT, VA, WA, WV.
The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.
Class IIReported ongoing
Distribution: US: MI, NH, SC, PA, FL, NY, NC, MS, MO, CA, NJ, IL, NV, OK, CO, OH, WA, WI, VA, IN, IA, AR, TX, WV, MD, MN, GA, MA, NM, VT, AK, OR, ID, LA, KS, DC, KY, HI OUS: Mexica, Canada, G...
The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.
Class IIReported ongoing
Distribution: US: MI, NH, SC, PA, FL, NY, NC, MS, MO, CA, NJ, IL, NV, OK, CO, OH, WA, WI, VA, IN, IA, AR, TX, WV, MD, MN, GA, MA, NM, VT, AK, OR, ID, LA, KS, DC, KY, HI OUS: Mexica, Canada, G...
The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.
Class IIReported ongoing
Distribution: US: MI, NH, SC, PA, FL, NY, NC, MS, MO, CA, NJ, IL, NV, OK, CO, OH, WA, WI, VA, IN, IA, AR, TX, WV, MD, MN, GA, MA, NM, VT, AK, OR, ID, LA, KS, DC, KY, HI OUS: Mexica, Canada, G...
The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.
Class IIReported ongoing
Distribution: US: MI, NH, SC, PA, FL, NY, NC, MS, MO, CA, NJ, IL, NV, OK, CO, OH, WA, WI, VA, IN, IA, AR, TX, WV, MD, MN, GA, MA, NM, VT, AK, OR, ID, LA, KS, DC, KY, HI OUS: Mexica, Canada, G...
The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.
Class IIReported ongoing
Distribution: US: MI, NH, SC, PA, FL, NY, NC, MS, MO, CA, NJ, IL, NV, OK, CO, OH, WA, WI, VA, IN, IA, AR, TX, WV, MD, MN, GA, MA, NM, VT, AK, OR, ID, LA, KS, DC, KY, HI OUS: Mexica, Canada, G...
Flexible intubation endoscopes sterility assurance can not be confirmed.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MEX, MI, MN, MO, MS, NC, NE, NH...
Metal sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for the first time specific to the tray models, that also includes information regarding the sterilization modality.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution including in the states of IN, MS, MN, AZ, FL, IL, CA, AK, NY, VA, TX, PA, LA, ND, AS, MD, NH, SC, AR, GA, NJ, NC, WA, WI, SD, TN, KY, AL,...
Plastic sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for the first time specific to the tray models, that also includes information regarding the sterilization modality.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution including in the states of AK, AR, AZ, CA, CT, DC, DE, FL, GA, HI, IL, IN, KS, LA, MA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OR, PA, RI,...
The endoscope may experience a loss of image when activating monopolar electrocautery, due a manufacturing assembly process issue.
Class IIReported ongoing
Distribution: Worldwide distribution - U.S. Nationwide distribution in the states of AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NH, NJ, NM, NY, OH, OK, PA, RI...
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Class IIReported ongoing
Distribution: U.S. Nationwide distribution in the states of FL, KY, LA, MA, MI, MO, MT, NC, NH, NJ, OK, SC, TX and WA.
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 52 records, including 52 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.