RECORDS ARE PUBLISHED REGULATORY ACTIONS. FIELDS THE ISSUING AUTHORITY DID NOT PUBLISH ARE MARKED AS NOT STATED, NEVER FILLED IN.
Drug Eye AfricaNational Actions, Continental Reach
Register / South Africa / DEA-ZA-2026-50296792
South African Health Products Regulatory Authority · South Africa
DEA-ZA-2026-50296792
Tier 1 · Regulator-publishedUnclassifiedRecallStatus · activeNot shown in search engines
Authority reference
Not stated by the issuing authority
Date issued
04 Sept 2026SAHPRA heads this column "Date Updated" rather than the date of the recall.
Recorded by us
2026-09-24 10:25:14 UTC
Product
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
Manufacturer
Not stated by the issuing authority
Manufacturer country
Not stated by the issuing authority
MAH or importer
Not stated by the issuing authority
Batch numbers
Not published with the notice
Expiry dates
Not published with the notice
Action type
Recall
Classification
Not stated by the issuing authority
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
Notice text
Not captured. The notice itself is linked below.
Status
Active
Superseded by
Not superseded. This is the current version.
Version
2

Provenance

Verification tier 1

Where this record came from, and what is held to show it.

Copy of the source
Taken and held by Drug Eye Africa, so the record survives the link above being moved or withdrawn. Not yet published at an address you can open.
Ask us for it and check it against the fingerprint below.
Fingerprint
8ee160fd70dbd114271dd9105a30604f8992a88fafb54f2294d6f381b62f78a1
SHA-256 of the copy held. Any file that produces this number is that copy, byte for byte; any file that does not is a different document.
Copy taken
2026-09-24 10:29:34 UTC
Cite this record
Drug Eye Africa (2026). DEA-ZA-2026-50296792: NDI Passive Sphere™ – Model No. 8801071, 8801074, 8801075 & Medtronic Biopsy Needle Kit – Model No. 9733068 — Recall, South African Health Products Regulatory Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/za/2026/dea-za-2026-50296792

Version 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 kept out of search engines, because the notice carries neither a batch number nor a stated reason. That lasts until the missing part is filled in. The record is held here in full in the meantime, and is found by searching this site.

DEA-ZA-2026-50296792 — NDI Passive Sphere™ – Model No. 8801071, 8801074, 8801075 & Medtronic Biopsy Needle Kit – Model No. 9733068 · Drug Eye Africa