Complete FDA and NHTSA recall records dated in 2025, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
The MSOT Acuity Echo does not include an adequate instruction for safe operation of the device. The previous version of the user manuals contained a wrong value for the Nominal Ocular…
Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of device potentially resulting in minor and…
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk to patients or health care providers through inhalation and/or skin exposure. Potential…
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Spore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a printing error on the return envelope that may cause spore test results to be…
Device reaching End of Service prematurely.
Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications.
A premature failure condition was identified with the L2050R pulse oximeter SpO2 sensor that connects to the L2050G Vios chest sensor device. When a failure occurs, a Pulse Ox Sensor Off …
Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of device potentially resulting in minor and…
Software issues could potentially result in: 1) delays in accessing dispensing software application, 2) wrong therapy (dose, item, timing, etc.), or 3) unauthorized access and/or compliance…
Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.
Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. This resulted in the release of products that should have failed and been…
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. This resulted in the release of products that should have failed and been…
Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Potential that the induction seal is not completely sealed to the device tube packaging.
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.
