Complete FDA and NHTSA recall records dated in 2021, 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.
Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected devices may malfunction caused…
Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The…
Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The…
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
The Hershey Company, 19 East Chocolate Avenue, Hershey PA 17033 is voluntarily recalling of a specific lot of Hershey s Chocolate Shell Topping in a 7.25-oz. (205g) bottle UPC (346000)…
Notified by packaging supplier of recall due to potential loose particles of CPET in product packaging that could become imbedded in the finished baked goods.
Firm determined that pesticide Bifenazate MRL is out of compliance for the US market. US MRL = 5ppm. Product tested = 5.8ppm.
The firm was notified by its ingredient supplier of Medium Chain Triglycerides (MCT) that the ingredient potentially contained traces of milk. This affected two of the firm's products that…
Incorrect active ingredient is listed on product label
The firm was notified by an ingredient supplier of Medium Chain Triglycerides (MCT) that the ingredient potentially contained traces of milk. This affected two of the firm's products that…
Presence of foreign substance: identified as activated carbon.
Defective Delivery System: An increase in complaints identified endcap being loose or falling off upon activation releasing glass shards containing the solution.
Incorrect size printed on the device; packaging is labeled correctly.
When the Cross Enterprise Display option is enabled on the Centricity Universal Viewer and Workflow Manager option is used as the PACS worklist launching the viewer, the patient jacket may…
During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.
A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No…
During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.
The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field.
A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No…
There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device triggers its…
A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No…
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.
