Archive

18 Sep Regulatory Requirements for Importation of Unregistered or Listed Medical Devices for Exhibition, Appraisal, Demonstration, or Training

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 Steris VERFIY Dual Specific Self-Contained Biological Indicators for Steam and ETO (S3060)

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 NDI Passive Sphere™ – Model No. 8801071, 8801074, 8801075 & Medtronic Biopsy Needle Kit – Model No. 9733068

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 Single Use Distal Cover – Model: MAJ-2315

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 BiCOAG Hemostasis Probe

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 Bravo™ CF capsule delivery device, 5-pk & 1-pk

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 Imager™ II Angiographic Catheter

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...

25 Aug CARDIOROOT Woven grafts

Posted at 14:37h in

Company name & Address: Registration number Batch number(s) Expiry date Pack size First Distribution date Re-call Classification Recall date Marcus Medical (Pty) Ltd 63 Old Pretoria Main Road Midrand Johannesburg South Africa. N/A 24E09 24G04 24F06 24E23 24E16 24G04 24F20 25D03 N/A Set 23 September 2024 Class I Type C 24 August 2026 Brief description of the problem (reason for recall) Marcus Medical (Pty) Ltd has received URGENT FIELD SAFETY ACTION...

24 Aug INFrame™ Implant 2.0mm x 28mm and INFrame™ Implant 2.0mm x 34mm

Posted at 13:50h in

Company name & Address: Registration number Batch number(s) Expiry date Pack size First Distribution date Re-call Classification Recall date Medhold Medical (Pty) Ltd Block@Nature Office Park Block C3 472 Botterklapper Street Die Wilgers Pretoria, Gauteng 0041 N/A 22311-25 22311-32 N/A Set 17 August 2023 Class III Type C 21 August 2026 Brief description of the problem (reason for recall) Acumed has initiated a Voluntary...

19 Aug Percutaneous Insertion Kits 100 and 150 (PIK)

Posted at 08:48h in

Company name & Address: Registration number Batch number(s) Expiry date Pack size First Distribution date Re-call Classification Recall date Surgical Innovation Pty Ltd Stand 208C Hoogland Ext 44 Cnr Apsom Avenue and Malibongwe Drive Boundary Park Northriding Randburg 2169 N/A 04037691519883 04037691730660 04037691519876 04037691730677 04037691746500 04037691746517 N/A 1 set April 2021 Class II Type B 12 August 2026 Brief description of the problem (reason for recall) Maquet Cardiopulmonary GmbH the Original Equipment Manufacturer (OEM)...