Recalls Archives - Medical Design Sourcing

FDA hits Olympus with warning letters after factory inspections

The FDA today released warning letters against Olympus Medical Systems Corp. and Olympus Corp. subsidiary Aizu Olympus following inspections of their endoscope and reprocessor manufacturing facilities.

The warning letters allege medical device reporting (MDR) and quality system violations at the manufacturing operations.

An Olympus representative told Medical Design & Outsourcing that the medtech manufacturer would issue a public response as soon as today.

FDA issued the first letter to Aizu Olympus President and CEO Yasuo Takeuchi on Nov. 2, 2022, following a July 5-8 inspection. The warning letter covers the company’s endoscope and automated reprocessing equipment manufacturing operations in Aizuwakamatsu, Fukushima, Japan.

FDA issued the second letter to Olympus Medical Systems President Tomohisa Sakurai on Dec. 12, 2022, following a Sept. 6-9 inspection. That warning letter covers the company’s gastrointestinal and surgical end…

FDA hits Olympus with warning letters after factory inspections

The FDA today released warning letters against Olympus Medical Systems Corp. and Olympus Corp. subsidiary Aizu Olympus following inspections of their endoscope and reprocessor manufacturing facilities.

The warning letters allege medical device reporting (MDR) and quality system violations at the manufacturing operations.

“Olympus’ highest priority is providing patients and users with safe and effective medical devices that comply with all applicable legal and regulatory requirements,” the company said in a statement to Medical Design & Outsourcing. “For that reason, we are committed to working together with FDA to address concerns.”

FDA issued the first letter to Aizu Olympus President and CEO Yasuo Takeuchi on Nov. 2, 2022, following a July 5–8 inspection. The warning letter covers the company’s endoscope and automated reprocessing equipment manufacturing operations in Aizuwakamatsu, Fukushima, Japan.

FDA issued …

ResMed finds a solution to semiconductor shortage, as well as some humor in it

ResMed (NYSE:RMD) can’t go back in time to solve its semiconductor shortage, but it’s found a solution that might be the next best thing — for now.

President and COO Rob Douglas (serving as interim president of Sleep and Respiratory Care at ResMed after Jim Hollingshead left to be CEO of Insulet) offered an update on the San Diego-based company’s supply chain issues as it tries to capture more of the market while Philips works through its recall.

ResMed President and COO Rob Douglas [Photo courtesy of ResMed]

“We’ve been managing a higher than normal rate of decommits coupled with a competitor recall that sucked all the inventory out of our systems and out of all of our customers’ systems as well,” Douglas said Wednesday at the William Blair Growth Stock Conference. “And so there is a huge shortage of devices. … We joke that the head of our supply cha…

FDA can’t explain record-low medical device recalls

Medical device product recalls were down 14.3% in the federal government’s fiscal year 2021, according to a recent Medical Design & Outsourcing analysis of recall data.

The drop was the biggest since the FDA began publicly reporting the data in 2013, and came as the regulating agency put more emphasis on fighting the COVID-19 pandemic.

We reached out to the agency for more information and connected with FDA press officer Jim McKinney, who said in an email that the FDA could not speculate on the significant reduction in device recalls and recall events, but that the numbers should not be viewed as an indicator of general safety.

The following has been lightly edited for space and clarity.

MDO: We found that medical device recalls were down 14.3% and device recall events were down 18.1% in fiscal 2021. Why was the recall rate down? Was it driven by COVID-19?

McKinney: The number of devices recalled in a year is not an indicator of t…