United States Product Recall Guide For Importers and Manufacturers

Unsafe and non-compliant products can be recalled as a result of consumer complaints, reported injury, or an investigation by certain government agencies. Sometimes, manufacturers and importers act on self-identified defects, quality issues, and hazards.

Product recalls can be extremely costly for importers or manufacturers – as the process may involve tracing and refunding consumers.

In this guide, we explain some of the more common causes of product recalls, and how the process works. We also include examples of recalls for children’s products, medical devices, and other product categories.

What is a product recall?

Product recall is the process of retrieving from the market unsafe goods that could pose serious or life-threatening injuries to consumers.

The Consumer Product Safety Commission (CPSC), which is responsible for recalls on a large number of categories of consumer products, provides a “Resellers Guide to Selling Safer Products” on this topic.

The guide explains how importers and manufacturers must take action when they find any potential hazards in their products, including product recalls. It also explains how the public can stay informed about recalls and product safety.

Why are products subject recalls?

Product recalls are often associated with potential hazards in a product, such as the following:

• Burn hazard
• Electrical shock hazard
• Injury hazard
• Suffocation hazard

The CPSC or other agencies (e.g FDA, EPA) might recall your product if it is deemed unsafe or non-compliant. Products with incorrect labeling or warnings might also be subjected to product recall as they are misleading to consumers.

Physical Hazards (Children’s Products)

Below we list some common hazards that might lead to children’s products.

Strangulation Hazards

Children could get strangled by the drawstrings of a sweatshirt, or other long cords. The risk is higher when children are playing or doing sports.

Here are some examples of products that were recalled due to the risk of strangulation:

• Children’s sweatshirt
• Children’s toys
• Children’s bunk beds

Suffocation Hazards

Textile products, product’s small parts, and product packaging can cause suffocation. For example, children can ingest small toys and suffocate.

Here are some examples of products that were recently recalled due to the risk of suffocation:

• Children’s costumes
• Children products’ plastic packaging

Entrapment Hazards

Entrapment hazards can pose serious injuries to children. For example, a child can get stuck within or inside the fences of a baby crib.

Here are some examples of products that were recently recalled due to the risk of entrapment:

• Children’s beds
• Children’s swing chairs
• Children’s walkers

Choking Hazards

A child can choke if he or she swallows small parts of a product, for example, breakable handles and beads. Thus, a product recall often occurs to small products, products that can easily come off in small pieces, or that contain small detachable parts.

Here are some examples of products that were recently recalled due to the risk of choking:

• Children’s dolls
• Children’s clothing
• Children’s puzzles

Physical Hazards (General Products)

Product recalls are not limited to children’s products. Below we list some common hazards for general products that might lead to a recall.

Electric Shock or Burn Hazards

Insufficient insulation or earthing protection can cause electric shock when using the product. For example, users can get an electric shock or burn injury when they touch some specific parts of a product (eg. exposed wires).

Here are some examples of products that were recently recalled due to the risk of electric shock:

• Extension leads
• AC adapters

Asphyxiation Hazards

Asphyxiation risks are related to smoke detector products such as smoke alarms. When a detector fails to perform its task, it can pose asphyxiation risks to the users.

Here are some examples of products that were recently recalled due to the risk of asphyxiation:

• Gas detectors
• Gas alarms

Drowning Hazards

Drowning risks are related to water-sport equipment such as boats and life jackets. For example, a life jacket with insufficient floating ability might pose such a risk to the user.

Here are some examples of products that were recently recalled due to the risk of drowning:

• Life-jacket
• Rescue ropes
• Motorboats

Injury Hazards

Injury hazards are related to a wide range of consumer products. For example, a table can collapse during use, and it can hurt the users on many levels.

Here are some examples of products that were recently recalled due to the risk of injury:

• Toy trolleys
• Children’s bicycles
• Wooden tables

Chemical Hazards

Products that pose chemical hazards can also lead to a product recall, especially if they fall into the scope of regulations or acts to restrict dangerous chemical substances in consumer products, such as California Prop 65 or the Federal Hazardous Substances Act.

Examples of restricted substances include phthalates and heavy metals like lead, cadmium, and mercury. Here are some more examples of products that were recently recalled due to the risk of chemical hazards:

• Children’s necklace
• Sippy cup
• Plastic package
• Backpack

Fire Hazards

Textile and furniture products may lead to fire hazards due to their material properties. For example, upholstered furniture made of softwood can cause fire accidents. Electric products can also pose fire hazards, for example, a defective wall plug might start a fire.

Fire hazards increase the probability of uncontrolled fire and it may even cause death to consumers. In general, these hazards include:

• Flames
• Sparks
• Hot objects
• Flammable chemicals
• Chemicals accelerants

Here are some examples of products that were recently recalled due to the risk of fire hazards:

• Bath Wraps
• Therapy massagers
• Hoodies
• Wooden chair

Can a business continue selling products after being subject to a recall?

According to page 2 of the above-mentioned Resellers Guide, “Selling recalled products is now unlawful”. In addition, businesses are responsible if the recalled products cause any injuries to consumers.

Recalls.gov

Recalls.gov is a website created by six US federal agencies as listed below:

• U.S. Food and Drug Administration (FDA)
• United States Department of Agriculture (USDA)
• U.S. Consumer Product Safety Commission (CPSC)
• U.S. Department of Transportation (DOT)
• Environmental Protection Agency (EPA)
• Department of Homeland Security (DHS)

It serves as a “gateway” for the US government’s specific recall databases.

Here are the product groups listed on Recalls.gov:

• Consumer products
• Motor vehicles
• Boats
• Food
• Medicine
• Cosmetics
• Environmental Products

As detailed below, different agencies are responsible for recalls on different categories of products. You can also sign up for email alerts for the latest recall information on their website.

CPSC Recalls

The CPSC regulates a wide range of consumer products such as electric, textile, kitchen utensils, and children’s products in order to protect the public from unreasonable risks.

Here are some recently recalled product examples and their associated risks:

• Espresso Machines – Burn hazard
• Children’s chest of drawers – Entrapment hazard
• Children’s robes – Burn hazard
• Dishwashers – Fire hazard
• Children’s fishing toy – Lead poisoning hazard

You can find more product recall cases and their details on the CPSC recalls page.

FDA Recalls

The FDA is responsible for product recalls of food, drugs, medical devices, cosmetics, and dietary supplements. The recall reasons are usually associated with food contamination or medical devices malfunction.

For medical devices, the FDA classifies recalls into three classes that indicate the relative degrees of health hazard presented by the products:

a. Class I – Product might cause serious adverse health consequences or death when used

b. Class II – Product may cause temporary or medically reversible adverse health consequences when used

c. Class III – Product is not likely to cause adverse health consequences

Here are some recently recalled product examples and their recall reason:

• Chicken salad sandwich – Potential monocytogenes contamination
• Hand sanitizer – Packaged in bottles that resemble drink containers
• Infusion Pumps – Deviations from the specified cleaning methods may impair infusion pump
• Colored contact lenses – Distributed without FDA clearance may pose health risks

You can find more examples of recently recalled products on the FDA recalls page.

USDA FSIS Recalls

The USDA FSIS and FDA are both responsible for the safety of foods rules. The USDA FSIS focuses on meat, poultry, and egg products; while the FDA regulates all other foods. The USDA FSIS is also responsible for product recall due to potential health issues such as product contamination, processing defect, and mislabeling.

Here are some recently recalled product examples and their recall reason:

• Ready-to-eat chicken products – Listeria contamination
• Poultry meatballs – Misbranding and undeclared allergens
• Beef jerky – Misbranding and undeclared ingredient
• Ready-to-eat ham products – Possible Salmonella enteritidis contamination

You can find more recently recalled products on the USDA recalls page.

EPA Recalls

The Environmental Protection Agency (EPA) is responsible for environmental protection matters of vehicles, engines, and equipment, such as air pollution and emission.

Under the Clean Air Act, the EPA can require manufacturers to recall and fix products that do not meet emission standards in actual use. The EPA also sets out the limits on the use of formaldehyde, which can be found in construction materials like plywoods and particleboards.

Importers and manufacturers should report emission-related defects to EPA and proceed to recall, when necessary. They should compile the information based on their categories divided by EPA as below:

• Light-duty cars and trucks
• Motorcycles
• All other equipment and heavy-duty vehicles

You can find more information on the EPA website.

California Proposition 65 Recalls

California Proposition 65 focuses on restricting substances that cause cancer, birth defects, or other reproductive harm. It covers consumer products to be sold in California such as food contact products, toys, batteries, and apparel products.

Businesses might be served a 60-day notice, for example, from a private attorney that believes a given product is non-compliant with the proposition. Businesses can then decide if it’s prudent to recall their own products, based on whether they think that the 60-day notice is justified.

Once a 60-day is filed, the California Attorney General’s Office might also fine or mandate companies to take appropriate action, such as product recall.

Here are some examples of recent 60 days notices, and the reason for which the importers or manufacturers of the product received such a notice:

• Canned Squid – Contain excessive cadmium
• Facial kit – Contain excessive phthalate
• Vacuum cleaning kit – Contain excessive phthalate
• Pan scrapers – Contain excessive Bisphenol A (BPA)

Here is an example of a 60-day notice.

Examples of Product Recalls in the United States

You can find the US product recall list on the CPSC, FDA, and other agencies’ websites. The recall list includes information such as:

• Product SKU
• Product picture
• Recall reason
• Recall units
• Manufacturer’s contact

Below are some examples of recalled products and the associated hazards of different products.

Children Products

Children’s products can carry choking, suffocation, and injury hazards. Below are some recall examples:

Toys

• Airplane and butterfly push toys – choking hazard
• Stuffed animal toys – choking hazard
• Toy trolleys – injury hazard
• Moose toys – chemical and injury hazard

Childcare Products

• Baby soothers – suffocation hazard
• Baby sleeper – suffocation hazard
• Infant teethers – choking hazard
• Sippy cup – chemical hazard

Other Children Products

• Baby walkers – entrapment hazard
• Science growing spiders – ingestion hazard
• Children’s bicycle – fall and injury hazard

Apparel & Textiles

Textile products can carry suffocation, strangulation, chemical and burn hazards. Below are some recall examples:

• Youth Jackets – strangulation hazard
• Bath Wraps – burn hazard
• Denim pants – choking hazard
• Sweatshirt with drawstrings – strangulation hazard
• Scarves – burn hazard

Electronic and Electrical Products

Electronic and electrical products can carry shock and fire hazards. Below are some recall examples:

• Electrical connection devices – shock hazard
• Outlet boxes – fire hazard
• Batteries – fire hazard
• Wall plug adapters – shock hazard
• Charing kits – shock hazard

Food Contact Products

Food contact products can carry laceration, injury, choking and chemical hazards. Below are some recall examples:

• Cutlery knife – laceration hazard
• Cuisinart food processors – laceration hazard
• Nut chopper – Injury hazard
• Miniware teething spoons – choking hazard
• Mugs – chemical hazard

Furniture

CPSC furniture product recalls can carry fire, fall, and chemical hazards. Below are some recall examples:

• Reclining furniture – fire hazard
• Baby’s cribs – chemical hazard
• Wooden table – injury hazard
• Drawers – injury hazard

Jewelry & Accessories

Jewelry products can carry choking and chemical hazards. Below are some recall examples:

• Children’s necklace – chemical hazard
• Children’s earrings – choking hazard
• Children’s rings – chemical hazard

Sport & Gym Equipment

Sport and gym equipment can carry injury and fall hazards. Below are some recall examples:

• Leg press machine – injury hazard
• Exercise ball – injury hazard
• Benches – fall hazard
• Chest exercise machine – fall hazard

Personal Protective Equipment

Personal Protective Equipment can carry injury hazards. Below are some recall examples:

• Bicycle helmets – injury hazard
• Safety shoes – injury hazard
• Diving masks – injury hazard
• Scuba mask – injury hazard

Cosmetics

Cosmetic products can carry chemical hazards. Below are some recall examples:

• Children’s cosmetics accessory bags – chemical hazard
• Skin repair cream – chemical hazard
• Lip gloss – chemical hazard

Medical Devices

Medical devices can carry health and fire risks. Below are some recall examples:

• Therapy massagers – fire risk
• Infusion pumps – health risk
• Resuscitator bags – health risk
• Blood glucose meter – health risk

Food

Food products can carry contamination risks such as salmonella and listeria monocytogenes. Below are some recall examples:

• Chicken salad sandwich – Potential Listeria monocytogenes contamination
• Frozen shrimp – salmonella risk
• Seafood mushrooms – Potential Listeria monocytogenes contamination

What is Amazon’s policy concerning recalled products?

Amazon has a strict policy regarding recalled products. You cannot list any regulator-announced (e.g USDA, FDA, CPSC, etc) or manufacturer-driven recalled products on Amazon. Once a product recall is announced, Amazon suppresses the products and notify past customers (ie. consumers that bought the product prior to the recall).

Amazon sellers are also responsible for reviewing their product list if their products are being recalled. They should notify Amazon immediately and provide the information below:

• Reason of recall
• Affected product ASINs
• Marketplaces affected by the recall
• Contact information
• Inventory disposition (return or destroy) if applicable
• Marketplaces affected by the recall

Amazon sellers must also remove all inventory for the recalled product and coordinate with regulatory agencies. You can find Amazon’s policy on recalled products on their official website.

What can I do to avoid a recall?

Avoiding product recalls requires, first and foremost, a thorough understanding of all applicable safety standards, labeling, certification, and other compliance requirements. Product compliance is, at the core, ultimately about ensuring that products are safe by design.

This in turn requires that the engineers and product designers developing the product know which specific standards apply to a product – and incorporates its technical elements into the product design.

You must also ensure the product is correctly labeled, certified and documented, and lab tested.

Further, you may also want to have implemented a periodic testing plan that can catch potential safety hazards in future production runs. Another recommendation is to include a traceability code, unique for each production run, to ensure that you can efficiently trace defective products in case of a product recall.

That said, both periodic testing plans and trainability are mandatory for certain product categories.

How can I report a dangerous product?

For most consumer products, you can report dangerous products via the CPSC business portal. You can find the “Report a potentially unsafe product” on the website, and submit the following information for CSPC investigation:

• General information
• Contact details
• Product details
• Product distribution
• Attachments
• Review and submission

For FDA-regulated products such as medical devices or tobacco products, you can report the dangerous goods through the methods below:

• Call an FDA consumer complaint coordinator
• Completed an electronic voluntary MedWatch form online
• Complete a paper voluntary MedWatch form that can be mailed to the FDA