Product Recalls

News & Analysis as of

A “Good” Deed Goes Unpunished

Alabama Supreme Court Rejects “Good Samaritan” Liability in Gray Market Case - Last month, I wrote about the “Good Samaritan” rule, codified in Restatement (Second) of Torts, section 324A, “Liability to Third Persons...more

GLOBAL: How to protect brand reputation and sales from the risks associated with a product recall

In the past decade or so, manufacturers in the developed world that would previously have created their entire product in their own country now outsource manufacture to other parts of the world. This has had significant...more

Protect Your Safety Investigations and Deliberations From Prying Eyes

Every day companies deal with an ongoing safety analysis of their own products. These Safety Teams are routinely interdepartmental. The Safety Teams must consider design changes, manufacturing issues, potential recalls,...more

Airbag Automotive Recalls Continue

New Takata Air Bag Recall For Infiniti SUVs - Can you trust that your airbags will function properly if you are in a car accident? Over the last year, the automotive parts maker Takata has been responsible for airbag...more

FDA Regulatory and Compliance Monthly Recap - October 2014

In This Issue: - FDA issues final guidance on discerning device recalls from market withdrawals related to medical device enhancements in apparent bid to appease industry concern over draft being overly broad, lacking...more

Medical Device Update: Distinguishing Medical Device Recalls from Medical Device Enhancements

On October 15, the U.S. Food and Drug Administration (FDA) issued the final guidance “Distinguishing Medical Device Recalls from Medical Device Enhancements.” This guidance revises and finalizes the draft version that...more

Stop Product Liability Claims Now!

More and more recalls mean more and more product liability claims. Even without recalls, for companies in the Automotive Industry product liability claims are a way of life. So, what do you do to prevent such claims? Knowing...more

How to protect brand reputation and sales from the risks associated with a product recall

Q: I am in charge of risk management for a global organisation and have been asked to investigate product risk. What suggestions can you offer on managing global supply and distribution? A: in the past decade or so,...more

FDA Issues Final Medical Device Recalls Guidance - Explains How to Distinguish Enhancements from Recalls

On October 15, 2015, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (“CDRH”) issued a final guidance document, Distinguishing Medical Device Recalls from Medical Device Enhancements (“Final...more

Is There Anything “Good” about the “Good Samaritan” Rule?

Every first-year law student can recite the “Good Samaritan” rule: The ordinary bystander has no legal duty to rescue a drowning person, but if you voluntarily undertake the duty to rescue her, you must not be negligent in...more

CPSC Clarifies Changes to Monthly Recall Report Form

In May, we advised readers conducting recalls that the CPSC’s new monthly “recall progress report” form may catch you by surprise. Among other changes, the form included new provisions requesting companies to report recall...more

Retailer Pays $2M Fine for Alleged Distribution of Recalled Products by Contractor, Agrees to Maintain Internal Compliance Program

In a press release issued on September 17, 2014, the U.S. Consumer Product Safety Commission (CPSC) announced that Michigan-based retailer, Meijer Inc., will pay a $2 million dollar fine to resolve allegations that it...more

Do Not Pass Go: Federal Judge Orders Execs Jailed for Contempt of Recall Order

A recent federal decision has made clear that court-ordered recalls can have real teeth, not just for manufacturers but also their officers—especially when the court has reason to suspect a company’s execs are deliberately...more

Drug Recalls at Record High

Drug Recalls May Hit ‘Record High’ in 2014 - According to a recent article from Becker’s Hospital Review, 2014 may prove the worst year for drug recalls on record. Dangerous drugs and defective medical devices can...more

FDA Posts Largest-Ever Medical Device Recall

On August 29, 2014, the FDA issued 233 Class I medical device recalls for products manufactured by Customed. According to its website, Puerto Rico-based Customed is a medical supplies leader and distributes a wide range of...more

FDA Initiative — Recall Information Now Readily Available

The Food and Drug Administration is modernizing the way it reports recalls of products that pose risks to consumers. Through the development of an application programming interface, all recalls reported to the Recall...more

Recent Recalls Aimed at Infant Products - Child Product Recalls: Hazardous High Chairs and Cribs

It is always distressing to learn that a product you have purchased has been recalled. For new parents, information about a defective infant product can be particularly alarming. According to a recent article in the...more

House Appropriations Amendments Would Halt CPSC’s Voluntary Recalls Rule; Fund Testing Relief

The House of Representatives is currently considering H.R. 5016, the Financial Services and General Government Appropriations Act of 2015, which provides funding to many different parts of the federal government for the next...more

Helpful Hints: The Revision Decision – What Should I Do?

Virtually all Rejuvenate and ABG II patients have received notice from their doctor that the devices have been recalled. These patients are all now faced with the prospect of a painful and risky revision surgery. Rejuvenate...more

Risk Planning and Board Liability

Board members are in the hot seat, or to put it another way – they are in a hot kitchen. The question is whether they can stand the heat of the hot kitchen....more

Recall of Blood Thinner Product

Alere Defective Medical Testing Strips Recalled - Are you currently taking a blood thinner to prevent the risk of a stroke, blood clot, or other medical condition? A recent article in Forbes alerted patients that...more

FDA Launches Huge Online Database of Adverse Events

As part of the Obama administration's effort to make public information more accessible, the FDA launched openFDA on June 2, 2014. This new database makes nearly 4 million pharmaceutical adverse event reports the FDA...more

Former CPSC Chairman Brown Expresses Concern over CPSC’s Voluntary Recalls Rule

Former CPSC Chairman Ann Brown recently sent a letter to the leaders of the CPSC’s congressional oversight committee asking for them to “urge the Commission to consider its proposed [voluntary recalls] rule carefully and to...more

The Epic Buckyballs® Saga Settles

May 2014 brought an ordinary end to a series of extraordinary events, with the Consumer Product Safety Commission (CPSC) settling an unprecedented proceeding against Craig Zucker, the former CEO of Buckyballs® manufacturer...more

Check Your CAP: CPSC Releases Revised Monthly Progress Report Form for Recalls

The CPSC recently released a new monthly progress report form for companies conducting recalls with the agency. The revised form is in some respects better written than its predecessor and retains many of the old information...more

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