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.
ROi CPS, LLC manufactured custom procedure packs using Clearlink Continu-Flo devices which were subsequently recalled by Baxter Healthcare Corporation.
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,…
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,…
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…
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 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,…
The firm has become aware that there is a potential problem relating to the blood gas and immunoassay analyzer Systems that may result in patient mix-up when connected to some third-party…
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 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,…
The products may have been packaged with an incorrect Instructions for Use.
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…
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 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…
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 products may have been packaged with an incorrect Instructions for Use.
Multiple lots of LEGION AP Femoral Cutting Blocks were manufactured with an oversize green plunger hole and therefore do not meet their design specifications.
The products may have been packaged with an incorrect Instructions for Use.
103 packaged and labeled tubes (103 product tubes with 6 pins per tube) of KM168-39-76 Single Diamond Smooth Steinmann Pins were labeled with the incorrect product labels. The tubes were…
The products may have been packaged with an incorrect Instructions for Use.
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.
