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273 reported ongoing
306 records in this archive. Latest source date Aug 17, 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.
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
Class IIReported ongoing
Distribution: US Nationwide distribution.
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
Class IIReported ongoing
Distribution: US Nationwide distribution.
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
Class IIReported ongoing
Distribution: US Nationwide distribution.
There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Failed pH Specifications
Class IIReported completed
Distribution: Nationwide in the USA
Baxter is issuing an Urgent Medical Device Correction for the Novum IQ Syringe Pump. Baxter identified that after multiple downstream occlusion alarms, the pump may display an Infusion Complete alarm even though uninfused fluid remains in the syringe.
Class IReported ongoing
Distribution: US Nationwide Distribution to states of: AR, AZ, CA, FL, GA, HI, IA, IN, KS, LA, MD, MI, MN, MO, NC, NE, NH, NJ, NY, PA, TX, UT, VA, VT, WA, WI AND WV.
Progressa+ beds have the potential for static buildup from the casters and/or power drive. This static electricity could be passed to the operator through the transport handle during transport, resulting in a mild static electric shock.
Class IIReported ongoing
Distribution: US Nationwide Distribution in the states of: CA, FL, IN, MA, NY, OH, TX, VA
CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
Class IIReported terminated
Distribution: Nationwide in the USA
Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
Class IIIReported completed
Distribution: Nationwide in the U.S.A.
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Class IIReported terminated
Distribution: Nationwide in the USA
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Class IIReported terminated
Distribution: Nationwide in the USA
Product is being recalled due to the improper placement of a copper tape on the back of the liquid-crystal display.
Class IIReported ongoing
Distribution: US Nationwide distribution in the state of CA.
Epiphany, now a Baxter Healthcare company, is issuing an Urgent Medical Device Correction for the Cardio Server E3 ECG Management System software listed below due to a report of the caliper tool becoming non-responsive, preventing the caliper function from ...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AL, AR, AZ, CA, CA, CT, FL, FL, GA, IA, ID, IL, IN, KS, KY, MA, MD, MO, MS, MT, NE, NH, NM...
An issue was identified where the LCD monitor display may not indicate the correct active channel. The issue occurs when the monitor is turned on using battery power, and channel B was selected as the last active channel prior to powering down.
Class IIReported ongoing
Distribution: US
A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an increase in reported false upstream occlusion alarms following upgrades to sof...
Class IReported ongoing
Distribution: US Nationwide distribution.
A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an increase in reported false upstream occlusion alarms following upgrades to sof...
Class IReported ongoing
Distribution: US Nationwide distribution.
Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring features may enter a permanent state of alert suppression. In this state, a caregiver may not be alerted remotely when assigned patient protocols (bed exit, siderail ...
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of OR, SC, VA, TN, GA, NC, CO, NC, FL.
Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring features may enter a permanent state of alert suppression. In this state, a caregiver may not be alerted remotely when assigned patient protocols (bed exit, siderail ...
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of OR, SC, VA, TN, GA, NC, CO, NC, FL.
Potential for the device to crack where the Chest Base Prone support attaches to the carbon fiber operating room (OR) table rail.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Singapore, Taiwan, Thailand, Belgium, Croatia, De...
There is a potential for mattress cover damage (delamination) which may result in fluid absorption in the mattress (fluid ingress).
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Qatar.
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 306 records, including 273 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.