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.
27,577 detailed records are currently available in this category.
Ethicon discovered that specific lots of DERMABOND"PRINEO"System may not dry within the specified time after proper application, and thus may fall off.
The Apex Knee System Tibial Baseplate identified has an improper expiration date marked on the external packaging. The improper expiration date (2202-03) is marked on the external packaging…
Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an incomplete helium seal. The…
A misaligned pipette tip sensor poses the remote risk of cross-contamination when failing to cause a no-tip error, resulting in pipetting patient samples without pipette tips.
UOC received a customer compliant report from our distributor on October 31, 2017 which stated that contents of the package do not match the product labeling.
There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli.
Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
This voluntary recall is being conducted due to the potential for failure to detect the affected Situate" gauze - RF and Xray detectable products by the Situate" detection console due to a…
Certain systems may have leaking of the plastic coolant couplings, the liquid can enter into the flat panel detector leading to a failure of the detector. It may be necessary to cancel or…
The extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been packaged in the incorrect position (upside down in the plastic retainer).
Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an incomplete helium seal. The…
Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top Tubes can cause an underestimation of lead in blood samples when used with Magellan…
Certain lots of devices may have the working channel sleeve protruding from the camera cap which may result in injuries from minor tissue damage to significant bleeding.
UOC received a customer compliant report from our distributor on October 31, 2017 which stated that contents of the package do not match the product labeling.
The ultrasound system used in certain settings may result in overheating of the ultrasound probe head.
Certain Medfusion Syringe Pump Models, Series 3100, 3500, and 4000, may not recognize or may misidentify loaded medication syringes. The inability of a pump to recognize a syringe (i.e. the…
Using different fluid formulations of NxStage PureFlow B Solution at the same time during treatment may cause patient health risk. The NxStage PureFlow B Solution is for use with systems…
There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli.
Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli.
Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best…
Belts on the x-axis (and on the y-axis, to a lesser extent) manufactured from 2015 are showing premature failure, posing the remote risk of cross-contamination.
Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an incomplete helium seal. The…
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.
