Medical Devices Archives - SAHPRA

Covid-19 | Subscribe

Archive

Home > 

13 Oct

Posted at 10:49h in

Company name & Address: Registration number Batch number Expiry date Pack size First Distribution date Re-call Classification Recall date Axim Nuclear and Oncology (Pty) Ltd 63 Old Pretoria Main Road, Midrand, Johannesburg, South Africa.     N/A 065005 065012 065022 065025 065029     13/09/2026 18/10/2026 15/11/2026 29/11/2026 13/12/2026     Kit       07 May 2026     Class II Type C     08 October 2026   Brief description of the problem (reason for recall) Axim Nuclear and Oncology (Pty) Ltd is recalling Humameter A1c Reagent...

29 Sep

Posted at 11:49h in

Company name & Address: Registration number Batch number(s) Expiry date Pack size First Distribution date Re-call Classification Recall date Boston Scientific No. 8 Anslow Crescent Anslow Office Park Bryanston 2021 N/A   As per recall letter Attachment 1 As per recall letter Attachment 1 As per recall letter Attachment 1 17 February 2026 Class I Type B 23 September 2026   Brief description of the...

23 Sep

Posted at 08:52h in

Company name & Address: Registration number Batch number(s) Expiry date Pack size First Distribution date Re-call Classification Recall date Stryker Building, 3 Tugela Lane Waterfall Logistics Precinct Cnr Bridal Veil & R101 Midrand Waterfall 2090 N/A   As per recall letter N/A N/A   21 December 2007   Class II Type B 17 September 2026   Brief description of the problem (reason for recall) Stryker has become aware that the...

18 Sep

Posted at 13:23h in

This document provides regulatory guidance for importers, exhibitors, and other applicants seeking SAHPRA approval to import medical devices, including in vitro diagnostic medical devices (IVDs) and unlicenced listed electronic products into the Republic of South Africa for exhibition, appraisal, demonstration, or training. The Medicines and...

10 Sep

Posted at 08:05h in

Company name & Address: Registration number Batch number(s) Expiry date Pack size First Distribution date Re-call Classification Recall date SafMed (Pty) Ltd 11 Mercury Crescent, Hillstar Industrial, Wetton, 7780, Cape Town, South Africa N/A 260810 261106 270116 270302 10 Aug 2026 06 Nov 2026 16 Jan 2027 02 Mar 2027 50/100   13 January 2026 and 14 August 2026   Class II Type C 07 September 2026   Brief description of the problem (reason for...

09 Sep

Posted at 08:59h in

Company name & Address: Registration number Batch number(s) Expiry date Pack size First Distribution date Re-call Classification Recall date Medtronic Africa Waterfall Distribution Campus, Cnr K101 & Bridal Road Midrand 1685 N/A   As per recall letter N/A each   Not specified     Class II Type B 04 September 2026   Brief description of the problem (reason for recall) The purpose of this letter is to advise customers that Medtronic...

09 Sep

Posted at 08:57h in

Company name & Address: Registration number Batch number(s) Expiry date Pack size First Distribution date Re-call Classification Recall date Surgical Innovations (Pty) Ltd (SI) Stand 208 C, Paddock Lane, Corner Epsom Avenue and Malibongwe Drive, Boundary Park, Northriding, Randburg, 2162   N/A H3913 H3928 H3X26 H3X27 H3Y10 H4227 H4617 H4801 H4802 H4X08     Not provided each June 2024 Class I, Type C 04 September 2026   Brief description of the problem (reason for recall) The MAJ-2315 is a...

06 Sep

Posted at 15:52h in

Company name & Address: Registration number Batch number(s) Expiry date Pack size First Distribution date Re-call Classification Recall date Surgical Innovations (Pty) Ltd (SI) Stand 208 C, Hoogland Ext 44, Corner Epsom Avenue and Malibongwe Drive, Boundary Park, Northriding, Randburg, 2169   N/A KR313754 KR313735 18/10/2026 06/10/2026 Each   KR313754 - 15/02/2024 KR313735 – 16/01/2025     Class II Type C 28 August 2026   Brief description of the problem (reason for recall) Olympus,...

31 Aug

Posted at 10:21h in

Company name & Address: Registration number Batch number(s) Expiry date Pack size First Distribution date Re-call Classification Recall date Medtronic Africa (Pty) Ltd. Waterfall Distribution Campus, Cnr. K101 & Bridal Veil Road Midrand 1685     N/A As per recall letter Expiration dates prior to and including 20 October 2027 5-pk & 1-pk   Not specified     Class II Type B 27 August 2026   Brief description of the problem...

27 Aug

Posted at 08:42h in

Company name & Address: Registration number Batch number(s) Expiry date Pack size First Distribution date Re-call Classification Recall date Boston Scientific No. 8 Anslow Crescent Anslow Office Park Bryanston 2021. N/A   As per recall letter 08 October 2026 to 09 June 2028 each   16 October 2024     Class II Type B 25 August 2026   Brief description of the problem (reason for recall) Boston Scientific is initiating...