Esc

Site search arrives with the platform catalogue. Until then, start from one of these:

Incidents, recalls and authorities Manufacturer · Importer 5 min read

We do not know whether to withdraw or recall

The General Product Safety Regulation (EU) 2023/988 defines a withdrawal as any measure that prevents a product in the supply chain from being made available, and a recall as any measure to get back a product already with consumers (Article 3). Which one you need follows from the risk assessment: a dangerous product requires corrective measures that bring it into conformity effectively, including withdrawal or recall as appropriate (Article 9(8)).

Free account · no card · opens in the Demo Company

Reviewed 28 September 2026 by the Conphora compliance team · Not legal advice

Why this happens

The General Product Safety Regulation (EU) 2023/988 defines both words. A withdrawal is any measure aimed at preventing a product in the supply chain from being made available on the market (Article 3(26)); a recall is any measure aimed at achieving the return of a product that has already been made available to the consumer (Article 3(25)). The first stops units that have not reached consumers, the second brings back those that have.[1]

The choice is framed by the duty behind it. A manufacturer who considers, or has reason to believe, that a product it placed on the market is dangerous must immediately take the corrective measures necessary to bring the product into conformity in an effective manner, including a withdrawal or recall, as appropriate; inform consumers under Article 35 or 36, or both; and inform the market surveillance authorities of the Member States where the product was made available, through the Safety Business Gateway, with details of the risk, the measures already taken and, if available, the quantity of products still circulating by Member State (Article 9(8)). Importers and distributors ensure the same measures are taken (Articles 11(8) and 12(4)).[1]

"As appropriate" is answered by the risk assessment. A dangerous product is any product that is not safe (Article 3(3)); Article 6 lists the aspects to assess, from the product's characteristics and presentation to the consumers who use it; and a serious risk is one that requires rapid intervention by the authorities, including where the effects are not immediate (Article 3(5)). If the units that carry the risk are with consumers, only a measure that reaches consumers is effective.[1]

The authorities' own rules point the same way. Under Regulation (EU) 2019/1020, corrective action may include withdrawing or recalling the product immediately and alerting the public; warnings and conditions may only be required where the risk exists only in certain conditions or for certain end users; and products presenting a serious risk are withdrawn or recalled where there is no other effective means to eliminate the risk (Articles 16(3), 16(4) and 19(1)). Where the operator fails to act, the authority ensures the measure itself (Article 16(5)).[2]

Whichever measure you choose, it belongs in the internal register of complaints, recalls and corrective measures (Articles 9(12) and 11(10)), best with the decision and its reasons, and the authority may ask for progress reports and decide when the measure is completed (Article 15(6)).[1]

How to solve it

  1. Establish where the affected units are

    Count the units in your warehouse, at distributors and marketplaces, and with consumers, by batch or serial number and by Member State. A withdrawal can only reach the first two groups; the third decides whether a recall is needed.

  2. Assess the risk, not the cost

    Assess the product against the aspects the regulation names: characteristics, effect with other products, presentation and warnings, the consumers who use it, foreseeable use. A serious risk is one that requires rapid intervention by the authorities, including where the effects are not immediate. The measure follows the risk, and a notice may not describe it as voluntary or precautionary.

  3. Choose the measure that removes the risk effectively

    Corrective measures must bring the product into conformity in an effective manner. Where dangerous units are with consumers, a withdrawal alone leaves the risk in place; a recall reaches them. Where the units are still in the supply chain, a withdrawal stops them from being made available. Authorities themselves ensure that products presenting a serious risk are withdrawn or recalled where there is no other effective means.

    Recall managerTools Open the app
  4. Notify and inform according to the measure

    Either measure is notified to the market surveillance authorities of the Member States where the product was made available, through the Safety Business Gateway, with the risk, the measures already taken and the quantities still circulating. A recall, and any safety warning consumers need, also means informing consumers directly and through a recall notice.

  5. Record the decision

    Enter the measures taken in the internal register of complaints, recalls and corrective measures, with the decision and its reasons, so that the description of the risk and the corrective measures can be given to the authority on request.

Work through the steps in the platform with your own product.

What you need to show

DocumentWhere it comes fromLegal ground
The risk assessmentThe manufacturer or importer, against the Article 6 aspectsGPSR Articles 6 and 9(8)
The decision recordYour internal registerGPSR Article 9(12)
The notification of the corrective measureThe Safety Business GatewayGPSR Articles 9(8)(c), 11(8)(d) and 12(4)(c)
The recall notice, where the measure is a recallThe economic operator responsible for the recallGPSR Article 36

If you do nothing

The authority chooses for you

Where an operator fails to take corrective action or the risk persists, the authority ensures that the product is withdrawn or recalled, or that its being made available is prohibited or restricted (Regulation (EU) 2019/1020, Article 16(5)); products presenting a serious risk are withdrawn or recalled where no other effective means exists (Article 19(1)).[2]

The measure is not finished until the authority says so

Market surveillance authorities may request regular progress reports and decide whether or when the corrective measure can be considered completed (GPSR Article 15(6)).[1]

Penalties under national law

Each Member State lays down effective, proportionate and dissuasive penalties for infringements of the regulation (GPSR Article 44).[1]

Questions about this problem

What is the exact difference between a withdrawal and a recall?

A withdrawal is any measure aimed at preventing a product in the supply chain from being made available on the market; a recall is any measure aimed at achieving the return of a product that has already been made available to the consumer (GPSR Article 3(26) and (25)).

Can a safety warning replace a recall?

The regulation treats a safety warning as information consumers need to use a product safely (Article 35(1)). In the authorities' toolbox, warnings may only be required where the product presents a risk only in certain conditions or to certain end users (Regulation (EU) 2019/1020, Article 16(4)). For a dangerous product in consumers' hands, the corrective measure must bring the product into conformity in an effective manner (GPSR Article 9(8)(a)).

Do we have to notify a withdrawal, or only a recall?

Both. Corrective measures, including withdrawal or recall, are notified to the authorities of the Member States where the product was made available, through the Safety Business Gateway (GPSR Article 9(8)).

May we call the recall voluntary because no authority ordered it?

No. 'Voluntary' and 'precautionary' are named among the terms a recall notice must avoid (GPSR Article 36(2)(c)).

Who decides when the measure is complete?

The market surveillance authority may decide whether or when the corrective measure can be considered completed and may ask for progress reports until then (GPSR Article 15(6)).

Follow changes to the rules behind this problem

One mail when the rules change. Unsubscribe in any mail.

Sources

  1. Regulation (EU) 2023/988 on general product safety EUR-Lex · accessed 27 September 2026
  2. Regulation (EU) 2019/1020 on market surveillance and compliance of products EUR-Lex · accessed 27 September 2026

About this page

Reviewer
Conphora compliance team
Reviewed
28 September 2026
Cite this page
Conphora (2026). We do not know whether to withdraw or recall. Retrieved 13 October 2026 from https://www.conphora.com/solutions/problem/withdrawal-or-recall/
Reviewed
Demo Company

See it working before you add a product

The Demo Company is a complete, read-only example — products, documents, supplier requests and deadlines. Open it with a free account; no card, no trial clock.

Free account · no card · opens in the Demo Company