Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.
23,781 detailed records are currently available in this category.
Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.
Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to…
The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants.
The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization.
The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization.
Label with the incorrect component listed on the inner kit Tyvek header bag
Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to…
Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to…
The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization.
Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which may lead to fluid leaks and loss…
Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.
Incorrect expiration date on product label. The manufacturing date was listed as the expiration date. Correct expiration date is "22.07.2027"
Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.
Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.
Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.
One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot 1916715, size 7 Evolution MP Tibial…
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
A single CF-Q180AL colonovideoscope was utilized in a veterinary endoscopy procedure in advance of being assigned to a medical facility as a service loaner in error, potential for microbial…
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.
