Stryker Corp. (NYSE:SYK) fell back in open trade in New York after the firm issued a recall notice on some of its products following a recent warning from the Food and Drug Administration and cautioned that its revenues will be at the lower end of forecasts.
After around 20 minutes of trading, Stryker shares were 3.5% lower at US$140.29.
The NYSE-listed firm said it now expects full year adjusted earnings to be at the lower end of its previously stated range of US$6.45 to US$6.55, with third quarter adjusted earnings to be at the lower end of a previously stated US$1.50 to US$1.55 range.
The group also said it has issued a voluntary recall on certain lots of Oral Care products sold through Stryker's Sage Products business unit that were manufactured by a third-party supplier and distributed between July 2015 and August 2017.
Stryker said there was a possibility of cross-contamination due to equipment that manufactured Oral Care products being shared with non-pharmaceutical products.
Stryker has not been told of any serious safety issues
The firm said there have been some reports of minor irritation and allergic reaction but that the company has not been told of any serious safety issues.
The company has stopped doing business with the third-party supplier, is now manufacturing Oral Care products in house and expects to continue shipping the products in September.
Stryker is also placing a temporary shipment hold on cloth-based products - which make up about half of the company's revenue – and expects to begin shipping again in September.
In a letter in July, the FDA said it had concerns about microbiological testing methods for all products containing solutions sold by Sage, including the recalled Oral Care products and solutions in cloth-based products.
The regulator said they should be tested using a different method that takes a longer time to do, which accounts for Stryker's temporary ship hold.