New Zealand Recall Code 2015: how device recalls actually work

1. Key takeaways

Device recalls in New Zealand stack three layers. Layer one is the compulsory recall order under reg 50 of the Medicines Regulations 1984 (SR 1984/143): the Director-General may order the importer, manufacturer or seller to withdraw — recall in (a) and (b), disposal and destruction in (c) and (d), with device disposal or destruction expressly in (d). Reg 50(2) requires the recipient to state how and when the order will be met, then give written notice afterwards. Breach of a reg 50(1) order is an offence under reg 64(1)(b), with a fine of up to NZ$500 under reg 64(2).

Reg 50(1) has two gateways of sharply different weight for devices. Paragraph (a) requires a ministerial notice under s 35 or s 37 in effect plus reasonable belief (the text: “believes on reasonable grounds”) that recall is necessary to protect the public. Section 35 revokes or suspends a consent, covering medicines only; s 37 is the ministerial prohibition notice provision covering devices. So (a) needs a s 37 notice in force — a narrow path; in practice (b) applies: non-conformance with the claims made for the device, no prior notice needed.

The second layer is the court order under s 86 of the Medicines Act 1981 (1981 No 118), two gateways both preconditioned on a prior criminal conviction: s 86(1) only on conviction under s 61 (misleading branding), when the court may order withdrawal of same-description products; s 86(4) extends to s 57, s 58 or s 61 convictions and covers similar containers, advertisements or labelling materials. The s 86(1) defendant is limited — the text reads “any person who manufactures, packs, or imports” — not sellers or distributors, caught only after Gazette publication under s 86(2). s 86(2) mandates Gazette publication of the order and offence details; s 86(3) allows cost recovery; s 86(5) is discretionary where no order exists. There is little public case law on s 61 (practical estimate). The conclusion: s 86 is not a general recall tool and is almost never used; the routine instrument is the reg 50 order.

The third layer is the coordination procedure, the New Zealand Medicines and Medical Devices Recall Code: in force 1 December 2015, replacing the Uniform Recall Procedure for Medicines and Medical Devices. The text runs 49 pages (PDF 468 KB: https://www.medsafe.govt.nz/safety/RecallCode.pdf), plus Appendix 6, Guidance on Legal Issues (https://www.medsafe.govt.nz/safety/RecallCode_Appendix6.pdf). Not legislation — its own statements:

“It is a technical document and is not intended to cover commercial relationships and obligations.”

— Medsafe, Recall Code page, https://www.medsafe.govt.nz/safety/recall-code-2015.asp (Revised: 4 September 2019)

“Sponsors should ensure their processes and procedures for conducting recall and non-recall actions are in accordance with this edition of the Recall Code.”

“Where the term ‘should‘ is used throughout the Code, it is expressing the intent that the guidance be followed in all cases, unless it is agreed with Medsafe that it would be inappropriate to do so in a particular instance.”

Read together: a self-declared technical document (not legislation) defining “should” as compliance in all cases unless otherwise agreed with Medsafe — soft in wording, hard in constraint — Medsafe will not approve a departing plan, and a recall without Medsafe agreement cannot in practice be completed.

2. Legal basis

The instruments behind the recall framework:

3. Expert insights

Insight 1: a document soft in wording, hard in constraint. The Code has no penalties, yet section 1 defines “should” as compliance in all cases unless otherwise agreed with Medsafe. It becomes the benchmark for s 38 assessments, reg 50 compliance and later inspections; the harder constraint sits in operations: Medsafe agreement before initiating, Medsafe review of the recall letter.

Insight 2: recall is not only returns — there is also Recall for Product Correction. Action types: Recall (withdrawal); Recall for Product Correction (devices: repair, modification, adjustment, relabelling, IFU updates, expressly including software updates); Hazard Alert (implantables only); Product Alert (medicines only). “Software updates” in the correction list means a SaMD recall may target a software version.

Insight 3: significance grading and supply chain levels set recall granularity. Grades: Class I (risk to life or serious health), Class II (may cause illness or mistreatment), Class III (not expected to compromise health). Supply chain levels run to 5 tiers: Consumer, Pharmacy-Retail, Hospital-Laboratory, Healthcare Professional, Wholesale. The Sponsor must know in advance which tiers a product reaches.

Insight 4: three milestones carry the prefix “should” — but “should” here is not negotiable. The Code timeline: progress reports at 2 weeks, follow-up at 6 weeks, closure by default at 3 months — not statutory periods like the 30 working days of reg 6 or 10 working days of reg 8; no standalone criminal liability (this guide assessment). Nor are they elastic: under section 1, “should” means compliance in all cases by default, the sole exception being prior Medsafe agreement for the specific instance. Milestones can be adjusted only by Medsafe; GRZAN recommends treating them as the default baseline, documenting reasons in writing before changes.

4. Practical recommendations

• Four recall touchpoints with Medsafe: consult and obtain agreement before initiating (except out-of-hours emergencies); Medsafe review of the recall letter before issue; reports at 2 weeks / 6 weeks / 3 months; notify Medsafe of overseas recalls as soon as practicable.
• GRZAN requires a supply chain tier map: place every SKU into its tiers within the Code 5 tiers, annotate contact templates and lead times, and design the distribution list from it; otherwise a Class I recall has blind spots.
• A written recall procedure is mandatory — Medsafe expressly requires one, covering: the grading owner, the Medsafe liaison window, letter templates and review workflow, action-type choice, control of returns and destruction, effectiveness verification, record retention.
• Put Code Appendix 6 on legal reading lists: it covers recall, product liability and contract intersections outside the quality team view.
• Search MORD periodically for recalls of comparable devices as risk benchmarking (frequency is a practical estimate) — it exposes similar failure modes.
• On a reg 50 order: notify the intended course and timing on receipt, and give written notice after compliance — keep fillable templates with proof of dispatch.

5. Verification checklist

• □ Is the recall procedure updated to the Code version in force 1 December 2015, version number recorded?
• □ Is reg 50(1)(b) (non-conformance with claims) the primary self-check provision, knowing (a) requires a s 37 notice for devices (s 35 is medicines-only)?
• □ Is a consultation and agreement mechanism with Medsafe in place, including out-of-hours emergencies?
• □ Does the recall letter template include a Medsafe review step before issue?
• □ Has every SKU been mapped to its tiers within the Code 5-tier supply chain?
• □ Does Recall for Product Correction cover repair, modification, adjustment, relabelling and IFU updates, including software updates?
• □ Are the 2 weeks / 6 weeks / 3 months milestones the written default baseline, adjustments requiring prior Medsafe agreement?
• □ Is the overseas recall notification route documented, with reg 50 templates ready (practical estimate)?
• □ Is it known that s 86 is not a routine recall tool (needs a s 61 conviction; Gazette publication under s 86(2)), and breaching a reg 50(1) order caps at NZ$500?

Regulatory information verified as of 29 October 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the New Zealand market. Our team manages adverse event reporting and recall coordination with Medsafe, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com