Recall products
When to initiate a product recall
When a defective product is considered to present a risk to the intended user or public health, HSA may require company to remove it from the market by recalling the affected batches or all batches of the product in extreme cases.
Company may also initiate a product recall for other reasons such as commercial reasons.
Product recall classification
The classification of a product recall will depend on the severity of the defect and its impact on a person's health.
Class 1 recall
A Class 1 recall involves the use or exposure to a product with a critical defect that may reasonably lead to serious adverse health consequences or death.
Class 2 recall
A Class 2 recall involves the use or exposure to a product with a non-critical defect that results in either one of the following scenarios:
- Temporary or medically reversible adverse health consequences.
- Remote probability of serious adverse health consequences.
Level of recall
The level of product recall describes the action required based on the extent of distribution of the affected product and potential hazard to public health.
The recalled products or batches should be segregated in a secured area before the implementation of follow-up actions e.g. destruction of the products.
When to notify HSA on the intended recall
Company does not need to seek approval from HSA for initiating the recall but must notify HSA of the intended recall no later than 24 hours (excluding Sundays and public holidays) before the start of the intended recall i.e. issuance of a notice to the customers or public.
Recall timelines
Recall steps |
Class 1 recall |
Class 2 recall |
Notify HSA |
No later than 24 hours* prior to the start of the intended recall. |
No later than 24 hours* prior to the start of the intended recall. |
Issue Dear Purchaser Letter |
Within 1 day* of recall commencement |
Within 3 days* of recall commencement |
Issue Dear Healthcare Professional Letter |
Where required, within 1 day* of recall commencement |
Where required, within 3 days* of recall commencement |
Complete recall process |
Within 1 week, unless otherwise justified |
Within 3 weeks, unless otherwise justified |
*excluding Sundays and public holidays.