Register / South Africa / DEA-ZA-0000-69400921
South African Health Products Regulatory Authority · South Africa
DEA-ZA-0000-69400921
Tier 1 · Regulator-publishedClass IIRappelStatus · active
- Issuing authority
- South African Health Products Regulatory Authority (SAHPRA)
- Authority reference
- Not stated by the issuing authority
- Date issued
- 04 Sept 2026The recall date as SAHPRA states it on its own page for this notice. The index column is headed "Date Updated" and is written in a form that cannot be read without guessing.
- Recorded by us
- 2026-09-11 11:03:52 UTC
- Produit
- NDI Passive Sphere™ – Model No. 8801071, 8801074, 8801075 & Medtronic Biopsy Needle Kit – Model No. 9733068
- INN / active substance
- Not stated by the issuing authority
- Dosage form
- Not stated by the issuing authority
- Strength
- Not stated by the issuing authority
- Fabricant
- Not stated by the issuing authority
- Manufacturer country
- Not stated by the issuing authority
- MAH or importer
- Medtronic Africa
- Numéros de lot
- As per recall letter
- Dates de péremption
- Not published with the notice
- Action type
- Rappel
- Classification
- Class II as issued
- Indicative severity
- Not assessed by Drug Eye Africa
- Defect category
- Not stated by the issuing authority
- Product type
- Not stated by the issuing authority
- ATC code
- Not stated by the issuing authority
- Affected markets
- South Africa — no market beyond the issuing country was named on the notice
- Cross-border event
- Not linked to a cross-border event
- Texte de l’avis
- Not captured. The notice itself is linked below.
- Statut
- En vigueur
- Superseded by
- Not superseded. This is the current version.
- Version
- 3
Where this record came from, and what is held to show it.
- Copy of the source
- No copy was taken. If the link above stops working, this record has no fallback.
- Fingerprint
- No copy was taken, so there is nothing to fingerprint.
- Copy taken
- No copy was taken, so there is no time to record.
Cite this record
Drug Eye Africa (2026). DEA-ZA-0000-69400921: NDI Passive Sphere™ – Model No. 8801071, 8801074, 8801075 & Medtronic Biopsy Needle Kit – Model No. 9733068 — Rappel, South African Health Products Regulatory Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/za/2026/dea-za-0000-69400921Version history
—No version history recorded for this record.
—Corrections appear here and in the site-wide log. Records are superseded, never deleted.
Verification
Tier 1 — Published by the issuing regulator on its own channel and captured by Drug Eye Africa, with the source document archived.
Indexing
This record is indexable: it is dated, names a product, and carries either a batch number or a stated reason.