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19 May

Posted at 15:07h in

Company name & Address: Product Name(s) registration number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date Boston Scientific No. 8 Anslow Crescent Anslow Office Park Bryanston 2021     CSK TC ELECTRODE 10CM   N/A   All   Not available   Not available   Not available   Class II Type B   14 May 2026 CSK 10CM TC ELECTRODE WITH 3M CABLE CSK TC ELECTRODE 15CM CSK 15CM TC ELECTRODE WITH 3M CABLE CSK...

19 May

Posted at 15:04h in

Company name & Address: registration number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date ZimmerBiomet S. A.Pty Ltd 2 Bridal Veil Road Waterfall DistributionCampus 2066   N/A       82395238 82395239 82395240 85390022 85390023 85390024 85390025 85390026 85390027 85390028 85390029 85682882 86970970   Not Available   20 pack   August 2025   Class II Type C   14 May 2026   Brief description of the problem (reason for recall) This recall has been initiated issue is related to...

14 May

Posted at 19:06h in

Company name & Address: Material Description Material Number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date Boston Scientific No. 8 Anslow Crescent Anslow Office Park Bryanston 2021         CRBS SMARTFREEZE CRYO Console     M004CRBS4000   PXC00144               N/A     Not available     18 August 2021     Class I Type C     06 May 2026 CRBS POLARX BALLOON CATHETER ST 28MM OUS M004CRBS2000 34158824 CRBS POLARX FIT BALLOON CATHETER ST OUS M004CRBS2010 33791785 CRBS POLARX FIT BALLOON...

07 May

Posted at 11:09h in

Company name & Address: registration number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date Bioweb (Pty) Ltd Ridgeview Office Park 248 Kent Avenue Unit 10 Randburg 2194   N/A   6253410   02 June 2028   2ml   Not available   Class III Type C   04 May 2026   Brief description of the problem (reason for recall) This recall has been initiated following an internal technical investigation, which determined...

28 Apr

Posted at 17:03h in

Company name & Address: registration number Batch number(s) Expiry date Pack size First release date Re-call Classification Recall date Pharmaco Distribution 91 Protea Road Chislehurston Sandton 2196     N/A       251485     23 October 2027     1 sterile unit per pack     22 December 2025     Class I Type B     17.April.2026 This recall is being conducted due to a manufacturing defect that may result in breakage of the handle...

31 Mar

Posted at 15:01h in

The purpose of the Medical Device Registration Feasibility Study was to support the South African Health Products Regulatory Authority (SAHPRA) in advancing the implementation of a comprehensive regulatory framework for medical devices, including in vitro diagnostics (IVDs), within South Africa. The study aimed to evaluate...

26 Mar

Posted at 15:05h in

This guideline is intended to provide guidance on obtaining a Certificate of Free Sale, which serves as confirmation that the listed medical devices, including in vitro diagnostic medical devices (IVDs), are legally sold or distributed in the market in South Africa, freely without restriction. It...