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17 reported ongoing
18 records in this archive. Latest source date Dec 15, 2025.
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.
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Class IReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Class IReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Class IReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Class IReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.
The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone. Using the incorrect values in the Red zone could lead to shocking a patient with an excessive dose of joules...
Class IReported ongoing
Distribution: US distribution nationwide. International distribution to Canada.
Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient use, there would be interruption or delay in patient resuscitation, which may lead to life ...
Class IReported ongoing
Distribution: US Nationwide distribution via Medline.
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Class IIReported ongoing
Distribution: US Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, NC, ND, NH, NJ, NM, NV, NY, OH, SC, TN, TX, UT, VA, & WV.
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Class IIReported ongoing
Distribution: US Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, NC, ND, NH, NJ, NM, NV, NY, OH, SC, TN, TX, UT, VA, & WV.
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Class IIReported ongoing
Distribution: US Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, NC, ND, NH, NJ, NM, NV, NY, OH, SC, TN, TX, UT, VA, & WV.
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Class IIReported ongoing
Distribution: US Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, NC, ND, NH, NJ, NM, NV, NY, OH, SC, TN, TX, UT, VA, & WV.
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Class IIReported ongoing
Distribution: US Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, NC, ND, NH, NJ, NM, NV, NY, OH, SC, TN, TX, UT, VA, & WV.
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Class IIReported ongoing
Distribution: US Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, NC, ND, NH, NJ, NM, NV, NY, OH, SC, TN, TX, UT, VA, & WV.
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Class IIReported ongoing
Distribution: US Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, NC, ND, NH, NJ, NM, NV, NY, OH, SC, TN, TX, UT, VA, & WV.
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Class IIReported ongoing
Distribution: US Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, NC, ND, NH, NJ, NM, NV, NY, OH, SC, TN, TX, UT, VA, & WV.
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Class IIReported ongoing
Distribution: US Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, NC, ND, NH, NJ, NM, NV, NY, OH, SC, TN, TX, UT, VA, & WV.
There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed text on the device. If the clinician is unable to pass a gastric catheter through one of the channels, the clinician may use a smaller-diameter gastric catheter.
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of AL, CA, FL, MI, OH, TN, TX, WA.
There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed text on the device. If the clinician is unable to pass a gastric catheter through one of the channels, the clinician may use a smaller-diameter gastric catheter.
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of AL, CA, FL, MI, OH, TN, TX, WA.
The kits are being recalled due to a lack of sterility of a spare needle contained within the kits. There is a potential for skin infection or sepsis if the patient is exposed to a non-sterilized, unused needle.
Class IIReported terminated
Distribution: Domestic distribution to AL, FL, GA, IL, LA, MO, NJ, NY, TN, TX.
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 18 records, including 17 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.