WSJ News Exclusive | Medical-Device Maker Recalls Sterilization Containers Over Potential Breaches

In a letter to customers this week, BD said the containers haven’t consistently met testing requirements for something called an aerosol challenge, in which the containers are exposed to aerosolized microbes to see whether they penetrate the container.

BD said failing test results could indicate the containers won’t keep surgical tools sterile, under conditions outside of normal use. This “might lead to transmission of infectious pathogens to the surgical patient,” potentially causing fevers, chills, abscess formation, sepsis, and worsening if left untreated, the company said in the letter to customers.

The Franklin Lakes, N.J., medical-products company said there have been no reports of adverse events associated with this issue.

About 8,075 Genesis containers are being recalled, including 6,777 in the U.S., a BD spokesman said. The recalled products represented less than 1% of total sterilization container sales over the last five years. The company stopped making the recalled products earlier this year and many customers have moved away from the product, though some still use them, the spokesman said.

The recalled Genesis containers were distributed between April 2011 and August 2022, BD said. Not all Genesis containers are part of the recall.

BD advised customers to dispose of any recalled products, and the company will issue credit to customers. U.S. and Canadian customers can find more information, including affected product codes, at BD’s website.

BD, which also makes catheters, syringes and infusion pumps, acquired the Genesis container product line with its $12 billion purchase of CareFusion in 2015.

A former BD medical director who monitored product safety, Hooman Noorchashm, recently reported his concerns about the Genesis containers to the U.S. Food and Drug Administration, citing the failed aerosol challenge tests.

Dr. Noorchashm said in an interview that BD is doing the right thing by recalling the devices because the potential breaches in the containers pose a safety threat to surgical patients. “These containers are a foundational device in keeping operating rooms sterile,” he said. “If these get breached that means you can contaminate the surgical field.”

Dr. Noorchashm said BD fired him in August and told him it was because of unprofessional conduct. He alleges he was wrongfully terminated because he voiced dissent internally about how BD was handling the Genesis devices. Dr. Noorchashm said he contacted the FDA after he was fired.

The BD spokesman said the company couldn’t comment on personnel matters. The spokesman said BD had initiated its quality review of the Genesis containers before Dr. Noorchashm was invited to join the review. The company shared the test results with the FDA before implementing the recall, the spokesman said.

Before this week’s recall, an FDA spokeswoman said the agency was aware of a recent allegation concerning the Genesis device, and couldn’t comment on any possible or ongoing investigations. The FDA didn’t immediately respond to a request for comment about the recall.

Before he worked for BD, Dr. Noorchashm previously led a campaign against a common hysterectomy device after the device spread a malignant uterine cancer in his wife, Dr. Amy Reed, during a 2013 procedure and worsened her prognosis. The campaign led to warnings by the FDA that power morcellators shouldn’t be used on most women because they could inadvertently spread a cancer that couldn’t be detected before surgery. Dr. Reed, who also led the campaign, died in 2017.

Corrections & Amplifications
Hooman Noorchashm is a former Becton Dickinson medical director who monitored product safety. An earlier version of this article incorrectly spelled his surname Noorchahsm. (Corrected on Oct. 7)

Write to Peter Loftus at [email protected]