A portion of this lot was manufactured using Gentamicin instead of Vancomycin. Gentamicin is an inhibitory agent of Neisseria organisms. This product is a selective plated medium to provide…
The firm received a complaint where, during patient positioning, the technologist was adjusting the patient table height and the table failed to stop when the control was released and…
Class IIFDA: TerminatedHitachi Medical Systems America Inc.
Ortho Kinematics notified customers that errors were contained in Radiological Read Report and VMA Report for the VMA test. The error resulted from an administrative error of VMA user…
One lot of product is from product code AK-22502 so it contains a 2-lumen, 5 Fr x 5 cm catheter. However, this product is incorrectly labeled as AK-25502, so the lidstock says it contains a…
Johnson and Johnson Vision Care received a number of reports of a partially formed contact lens, which appears to the customer or consumer as visibly smaller in diameter, thicker/stiffer to…
Class IIFDA: TerminatedJohnson & Johnson Vision Care, Inc.
A May 2015 design change in the cushion seal replacement part and accompanying elbow replacement part resulted in incompatibility of the new cushion seal with the previous design of the…
Class IFDA: TerminatedCompass Health Brands (Corporate Office)
In rare cases of insufficient maintenance or high clinical workload, the first rope of the ceiling stand, which is designed to take the load, could break without triggering the safety lock…
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
The PPK System Spacer Block Alignment Tower mating feature that mates with the spacer block was undersized, which could potentially lead to mating issues between the devices. This could…
Philips has received several reports in which monitors with lithium ion batteries that had exceeded their battery life expectancy have overheated or ignited. These batteries should be…
Class IIFDA: OngoingPhilips Electronics North America Corporation
Philips has received several reports in which monitors with lithium ion batteries that had exceeded their battery life expectancy have overheated or ignited. These batteries should be…
Class IIFDA: OngoingPhilips Electronics North America Corporation
Philips has received several reports in which monitors with lithium ion batteries that had exceeded their battery life expectancy have overheated or ignited. These batteries should be…
Class IIFDA: OngoingPhilips Electronics North America Corporation
Pasta Spinach with Cavatappi Reser's Fine Food is recalled due to a potential contamination with Cyclospora. The pasta salad contains spinach that was recalled due to a potential…
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.