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
Monthly reportSAHPRA

South African Health Products Regulatory Authority — September 2026

What this register recorded from SAHPRA in September 2026, what other African authorities published in the same month that bears on it, and what we could not read in SAHPRA’s own notices. Every figure here is a count of published regulatory actions. None of it is a finding about South African Health Products Regulatory Authority.

What SAHPRA published

12 action(s) recorded: 12 recall.

ReferenceDateCountryProductBatchesActionClassSource
DEA-ZA-0000-4806866404 Sept 2026ZASingle Use Distal Cover – Model: MAJ-2315H3913 · H3928 · H3X26 · H3X27 · H3Y10 · H4227 · H4617 · H4801 · H4802 · H4X08RecallClass ITier 1 · Regulator-published
DEA-ZA-0000-6940092104 Sept 2026ZANDI Passive Sphere™ – Model No. 8801071, 8801074, 8801075 & Medtronic Biopsy Needle Kit – Model No. 9733068As per recall letterRecallClass IITier 1 · Regulator-published
DEA-ZA-2026-5029679204 Sept 2026ZANDI Passive Sphere™ – Model No. 8801071, 8801074, 8801075 & Medtronic Biopsy Needle Kit – Model No. 9733068none publishedRecallUnclassifiedTier 1 · Regulator-published
DEA-ZA-2026-6045275604 Sept 2026ZASingle Use Distal Cover – Model: MAJ-2315none publishedRecallUnclassifiedTier 1 · Regulator-published
DEA-ZA-0000-9931599107 Sept 2026ZASteris VERFIY Dual Specific Self-Contained Biological Indicators for Steam and ETO (S3060)260810 · 261106 · 270116 · 270302RecallClass IITier 1 · Regulator-published
DEA-ZA-2026-3045444307 Sept 2026ZASteris VERFIY Dual Specific Self-Contained Biological Indicators for Steam and ETO (S3060)none publishedRecallUnclassifiedTier 1 · Regulator-published
DEA-ZA-2026-1272092317 Sept 2026ZADiamet XR 1000 (Metformin Hydrochloride)none publishedRecallUnclassifiedTier 1 · Regulator-published
DEA-ZA-2026-4899572117 Sept 2026ZATrident 0 DEG Constrained Insert UHR Bipolarnone publishedRecallUnclassifiedTier 1 · Regulator-published
DEA-ZA-2026-5689652122 Sept 2026ZAComplementary Medicines (Multiple products)none publishedRecallUnclassifiedTier 1 · Regulator-published
DEA-ZA-2026-7530067322 Sept 2026ZAEribulin DRL (Eribulin Mesylate)none publishedRecallUnclassifiedTier 1 · Regulator-published
DEA-ZA-2026-4435055423 Sept 2026ZADirexion™ and Direxion HI-FLO™Microcathetersnone publishedRecallUnclassifiedTier 1 · Regulator-published
DEA-ZA-2026-8050686025 Sept 2026ZACiplavasc 5 (Amlodipine besylate 5mg)none publishedRecallUnclassifiedTier 1 · Regulator-published

What other authorities published

Nothing published elsewhere this month joins to SAHPRA by either of the two links this register will draw — a shared event, or a manufacturer SAHPRA has itself named. That is a statement about those two links and not about the month.

What we could not read in SAHPRA’s notices

Our failures on SAHPRA’s coverage, across the whole register rather than this month. Published because a report that told an authority only what it was missing would be an audit sent by someone with no standing to conduct one.

  • 130 record(s) held from SAHPRA in total
  • 0 carry no publication date we could read
  • 34 name neither a batch nor a stated reason
  • 57 name no manufacturer
  • 34 are searchable and API-available but carry noindex, because they are too incomplete for a public URL
  • 0 have no archived copy of the original notice

Each of these is something SAHPRA published and this register did not capture, or captured incompletely. None of them is a failure by SAHPRA.

Correcting this

Anything on this page that is wrong about South African Health Products Regulatory Authority can be corrected by South African Health Products Regulatory Authority, and a record published by one of its officers carries verification tier 0 — the rank only the issuing regulator can create. Nothing else on this register does.

Write to notices@drugeyeafrica.org. Corrections to existing records are logged and published on the corrections page; a superseded record keeps its URL and points forward to the one that replaced it.

Every month for SAHPRA · South Africa · The authorities we read · How this register’s coverage is assessed