Complete FDA and NHTSA recall records dated in April 2020.
These records include useful source details for the selected month.
The firm has become aware that there is a potential that the glass cover at the distal end of the camera/led lighting on the video laryngoscope could become loose during reprocessing or…
During an FDA audit, it was discovered that the product was not properly registered with FDA.
Menu selections for users to access the oxygen (O2) sensor calibration were changed and not incorporated into the device s Instructions for Use. As a result, the instructions for performing…
Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.
Distributed without an approved 510(k)
Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.
A lot of Avalon Elite Vascular Access Kits (VAK) are being recalled due to a material mix-up with the needle portion of the kit; 81 of 255 kits were assembled with an incorrect Arterial…
Solder connection failure on Power Management printed circuit board assembly of ventilators may cause 1) Blower to lose power, spool down, and trigger visual and audible High Priority Check…
During an FDA audit, it was discovered that the product was not properly registered with FDA.
The firm has identified that parts from the kit, lot: TSL007202, have the potential to contain the incorrect contents of the 8mm HTR Sterile Hammer Toe Reaming Kit. The kit should contain…
There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation.
Customer reports of label error. Front panel states strength of 1000 mg although supplement fact is correct in stating 1000 mcg.
The firm was notified by their rice supplier that the product contains blue plastic slivers.
Testing found Acephate of 2.8ppm on fresh blackberries. There is no US MRL for Acephate on blackberries.
The firm initiated a recall on 03/13/20 of frozen oven-safe Cook-in-bag Salmon for undeclared wheat
The firm initiated a recall on 03/13/20 of frozen oven-safe Cook-in-bag Salmon for undeclared wheat
The firm was notified that the labeling does not include the word milk on the ingredient statement
Undeclared almond and milk allergens
Firm testing found Vibrio parahaemolyticus in cooked butterfly shrimp from Thailand.
California Department of Public Health collected samples at retail and found Listeria monocytogenes in Enoki mushrooms from Korea
Undeclared peanut and milk allergens
Defective Container: Recall is due to breaking and shattering of ampules upon opening
Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.1% (Limit: NMT 3.0%) during retained sample testing.
Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
