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.
25,676 detailed records are currently available in this category.
On the Atellica CH 930 Analyzer, when scanning barcodes at the module console for Integrated Multisensor Technology (IMT) system fluids (Standard A (Std A) and Standard B (Std B)) for…
This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the devices premature battery depletion, caused by electrical leakage on the circuit board assemblies…
It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. The system's date and time setting are used to populate the DICOM header…
It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. The system's date and time setting are used to populate the DICOM header…
The catheter packaging incorrectly listed the balloon size as 8mm X 20mm instead of the intended size 8mm X 40mm. If undetected, the user will advance the longer than expected balloon to…
Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core,…
Labels with incorrect translations were identified by Exactech is a distributor in the Netherlands. The translations on the outer labels include the word " long" in all languages other than…
Customers have reported incidents where two sets of results report the same Specimen Identifier (Specimen ID) with different results, different Medical Record Number (MRN) and different…
There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from…
Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core,…
Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core,…
There is potential for the sterile wrap to become loose while in transit and compromise the sterile barrier.
Ophthalmic viscosurgical device may be difficult to remove from the eye, leading to increased postoperative intraocular pressure requiring additional intervention. Also, reports of clogging…
Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core,…
Three issues found: i) The Map ROI options in the ROI list in the Structure Definition module may generate unintended ROI geometries ii) Elekta guard leaf behavior. There is an…
The products may have been packaged with an incorrect Instructions for Use.
The products may have been packaged with an incorrect Instructions for Use.
On September 27, 2019 Energetiq Technology (the manufacturer) discovered a problem with their EQ-400-RH-QZ and EQ-400-LH-BK products during routine manufacturing functional testing. It was…
Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core,…
Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core,…
The gas spring on the front and rear protective cover may fail. There is a low risk of injury to the user resulting from failure of the gas spring. Injury may include impact to the arms,…
There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from…
A component (1961 TELFA PAD 2 X 3) contains LATEX and was used in the Medical Convenience Kit(PAK-19244). Case label and device label for product did NOT show that the Medical Convenience…
Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core,…
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.
