What Does Response to Recall Mean?

A response to recall is the action you, as a patient, take after a healthcare professional and organisation informs you that there is a potential issue with a medical device you’ve used, a medication prescribed to you, or a surgical procedure and its follow-up care.

In this article, you’ll learn about recall notices, what steps to take if you receive one, your legal rights, and how a solicitor can help you pursue a claim for compensation.

Response to recall meaning

A “response to recall” means the steps you and your healthcare providers take when there is a concern about:

• A medical device you’ve used
• A medication you’ve been prescribed and taken
• A surgical procedure you’ve undergone (and the treatment afterwards)

Whenever a healthcare provider is alerted to or becomes aware of a safety risk, they have a legal duty of care to investigate the issue and provide support to their patients.

They might ask you to return faulty medicines or medical devices so they can repair them or safely dispose of them.

They might also want to get you in for an appointment or a test to check for any side effects and address any potential complications.

Common scenarios for medical recalls

There are three main reasons for recalls: safety concerns, defective products, and negligent treatment.

1. Safety concerns

Manufacturers sometimes recall medicines to protect your health. Here are a few real-life examples of why:

• The discovery of unexpected foreign objects in a medicine like small metal particles
• Mistakes on the packaging or in the instructions that could lead to you taking the wrong dosage
• A medicine has too little or too much of its active ingredient which could make it less safe or effective

According to The Human Medicines Regulations 2012, all medicine manufacturers must keep a close eye on the safety, quality, and performance of their products.

If they become aware of any issues, they must tell the Medicines and Healthcare products Regulatory Agency (MHRA). In some cases, they must also issue recall notices to healthcare professionals and patients.

2. Defective products

Even though they go through rigorous testing before they go on sale, some medical products don’t work as they should. Here are three real-life examples:

• CPAP and BiPAP devices, used to treat sleep apnoea and other breathing disorders, were recalled because the foam they used to reduce noise degraded. This resulted in users breathing in harmful volatile organic compounds.
• The coating used on an injector device during cataract surgery led to an increase in intraocular pressure, increasing the risk of permanent eye damage and vision loss. Read about our group action against EyeCee One
• The manufacturer of a dry power inhaler issued a recall when it became clear that it was not dispensing the right doses to patients.

According to The Medical Devices Regulations 2024, manufacturers must monitor the performance of their products and act if there is a problem.

That could include recalling a product, updating guidance notes, or fixing the issue with a software update.

3. Substandard care

Hospitals and other healthcare providers may recall patients if they become concerned that the quality of care they received was substandard.

Four examples of the patient recall process in real life are:

• Unnecessary surgery: Ian Paterson, a breast surgeon, performed unnecessary surgeries on over 1,000 patients during his career.
• Poor surgical practices: Fletchers Solicitors is leading a group action against Mian Munawar Shah, a consultant orthopaedic surgeon. He is alleged to have failed to provide proper post-operative care which led to long-term harm for his patients.
• Harmful use of surgical devices: We are also leading a group action against Yaser Jabbar. Also a consultant orthopaedic surgeon, there are allegations he misused limb-lengthening and straightening devices, causing significant harm to patients.
• Failures in surgical care: Our group action against John Bradley Williamson, whose right to practice has since been removed, alleges he performed surgeries without the proper level of care and without informing his patients of the risks.

In each of these suspected hospital negligence cases, the hospitals involved issued a recall to patients who had been treated by these surgeons.

Patient rights during a recall

When a recall happens, you have the right to clear and detailed information about the recall, including the reason for it. You’re also entitled to know what risks the product, device, or procedure might have exposed you to.

The MHRA’s ‘A Guide to Defective Medicinal Products’ directs healthcare organisations to provide you with a replacement medical device or a new prescription so that you can continue your treatment.

The company that manufactures the medicine or medical product also needs to put in place a way of handling returns and refunds for affected patients.

Legal implications of medical recalls

If the medicine, medical product or medical/surgical treatment resulted in a new injury or made an existing condition worse, you may be entitled to compensation.

To make a claim, your solicitor needs to show that the duty of care the healthcare organisation or company has to you was breached and that this was the reason for the harm it caused you.

When they can prove that, the next stage is to approach the responsible party for compensation on your behalf. If your injury was life-changing, you may be due a significant award.

Proving medical negligence is hard. To give yourself the best chance of compensation, you should work with an experienced medical negligence solicitor.

Claiming compensation related to a recall

If you want to claim compensation for medical negligence related to a recall, this is the process your solicitor goes through.

Identify the extent of your injury

Their first job is to identify the harm or injury that’s been caused to you. You could have contracted a new condition or injury, an existing condition or injury may have gotten worse, or both.

Your solicitor will use your medical records and consult with independent healthcare professionals to pinpoint exactly how your health has been affected.

Determine the cause of your injury

Your solicitor and their team then need to prove that it was either the medicine, the medical product, or the medical procedure that led directly to the harm you experienced.

When they have identified the responsible party, they approach them with your compensation claim. That could be the manufacturer of the medicine or medical device or your healthcare provider (like an NHS Trust or private hospital).

Negotiate your compensation

The compensation claim your solicitor approaches the other side for varies depending on:

• The severity of your injury or condition
• The impact it’s had on your life
• Costs and expenses you’ve incurred because of your injury or condition

In most cases, the other side will make an offer after your solicitor presents the evidence.

They then let you know what that offer is. If you’re happy with the offer, your solicitor makes the necessary arrangements so that you receive your award as quickly as possible.

If you’re not satisfied with the offer, your legal firm can progress it to court in many cases. Please be aware that this may delay your payout by a few months or sometimes longer depending on how complex the case is.

How to respond effectively to a recall

When a medical recall happens, here’s how you can stay safe and reduce risks:

Check for Notifications: Your GP or healthcare provider will usually inform you of a recall, as they receive alerts from the MHRA (Medicines and Healthcare products Regulatory Agency). Also, stay updated by checking the manufacturer’s website, MHRA updates, and media reports.

• Read the Recall Notice Carefully: Understand why the recall happened, the potential risks, and the specific actions you need to take.
• Respond Quickly: Follow any instructions from your GP, healthcare provider, or the recall notice without delay. You may need to return the affected product, undergo extra tests, or book a specialist appointment if complications are a risk.
• Return or Replace Items: If requested, return any recalled medicine or medical device promptly. In most cases, you’ll receive a replacement to continue your treatment without interruption.
• Speak to Your Doctor: If you’re unsure about the recall, ask your doctor or pharmacist to explain the situation, provide advice, and help with next steps.
• Keep Documentation Safe: Store all recall-related paperwork, including notices, emails, invoices for treatments, and medical notes. These may be important for future reference, especially if legal advice is needed.
• Stay Informed: Continue monitoring communications from your doctor or healthcare provider and regularly check reliable sources like the MHRA website for updates.

Importance of seeking legal advice

Medical negligence cases are complex. To give you the best chance of being awarded compensation, you need an experienced solicitor representing you.

The lawyers at Fletchers are experienced medical malpractice solicitors who understand the recall process and know what standards of care you should expect as a patient.

They’ll take you through the process and let you know whether you have a strong claim you can bring against the manufacturer or healthcare provider.

Why choose Fletchers Solicitors?

For over 30 years, Fletchers Solicitors have worked on behalf of clients who have been harmed or injured through medical negligence.

We’re the practice that claimants trust to bring forward some of the UK’s most important group action cases – you read about them earlier in this article.

We work on a “no-win, no-fee” conditional arrangement basis. This is how it works:

• Get in touch with us and tell us what happened to you
• We’ll let you know if we think you’ve got a strong enough case
• If you do, we’ll offer to represent you in your claim
• If we’re successful, you pay us an agreed amount, usually 25% including VAT of the settlement fee
• If we’re not successful, you don’t pay us anything.

Your case will be led by experienced professionals like Peter Rigby, and Fiona Swarbrick. You’ll find your lead solicitor and their team approachable, friendly, and professional.

If you need them to explain anything about your case at any stage, get in touch. They’ll be very happy to hear from you. Start your claim or call 0330 013 0243.

Related Information and Guides

For more information on medical negligence cases and the legal issues surrounding them, you can access the following resources:

• GP negligence claims: understanding your legal rights
• The role of your lawyer for medical malpractice cases
• Factual vs medical causation in medical negligence
• The importance of medical negligence claims
• Medical negligence group actions