South Africans are being urged to check certain medicines and medical products following a series of recalls issued by the South African Health Products Regulatory Authority (SAHPRA), with another medical device recall added to the regulator’s public register on Wednesday, 19 August 2026.
The latest notice concerns Percutaneous Insertion Kits 100 and 150, commonly referred to as PIKs, supplied in South Africa by Surgical Innovation.
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While the recall was initiated on 12 August 2026, SAHPRA published the notice on its recall register on Wednesday morning.
According to SAHPRA, the original equipment manufacturer, Maquet Cardiopulmonary GmbH, identified failures during sterile-barrier integrity verification testing.
As a result, there is concern that the sterile barrier on affected products could potentially have been compromised.
The six affected lot numbers are: 04037691519883, 04037691730660, 04037691519876, 04037691730677, 04037691746500 and 04037691746517.
The recall has been classified as Class II Type B.
Healthcare professionals and distributors have been instructed to immediately discontinue the use and distribution of affected stock, check inventories and quarantine the products.
Surgical Innovation will arrange collection or credits where applicable.
This follows another recall published by SAHPRA just a day earlier involving Frusemide 20 mg/2 ml Fresenius (Furosemide), manufactured by Fresenius Kabi South Africa.
Nine batches are affected: 90TEA870, 90TIA300, 90TKB190, 90TLA480, 90UCA000, 90UEA840, 90UIA510, 90UIA530 and 90WEA230.
In this instance, the problem does not concern contamination or a defect in the medicine itself, but incorrect expiry dates printed on the affected batches.
SAHPRA’s recall information shows that the labelled expiry dates extend approximately two years beyond the products’ registered expiry dates.
However, the regulator stressed that all of the affected batches are currently still within their correct shelf lives and are therefore considered unlikely to cause an adverse health reaction at present.
The recall is classified as Class III Type B, with healthcare professionals and distributors being requested to return affected stock to their supplying warehouse or distributor with immediate effect.
Of greater direct relevance to members of the public is the ongoing recall of certain batches of Enalapril 10 mg Arya, a medicine commonly used to manage high blood pressure.
SAHPRA issued a public warning on 16 August 2026 after out-of-specification results were identified during post-marketing surveillance. The regulator stressed that the recall applies only to four specific batches and not all Enalapril products.
The affected Enalapril 10 mg Arya batches are:
GQQ24053 — expiry August 2026
GQQ24064 — expiry September 2026
GQQ24066 — expiry September 2026
GQQ24067 — expiry September 2026
Patients currently taking Enalapril 10 mg Arya are encouraged to check the batch number appearing on their medicine packaging.
Those who find that they have medication from one of the affected batches should contact their pharmacist, doctor or other healthcare professional for guidance and, where necessary, arrange an alternative medicine.
Importantly, patients should not stop taking their blood-pressure medication without first consulting a healthcare professional, SAHPRA stressed.
Pharmacies, healthcare professionals, wholesalers and medicine suppliers have been instructed to stop dispensing, selling or distributing the affected batches, quarantine the stock and return it through the supply chain. The Enalapril recall is classified as Class II Type A.
Meanwhile, laboratories and healthcare facilities have also been alerted to a recall involving ZS70658 VAC Tube Clot Activ+Gel Sep 5 ml blood-collection tubes, specifically batches A10015 and A10016.
According to SAHPRA, the recall followed customer complaints involving potassium test results exceeding allowed and expected ranges.
The concern is significant because inaccurate potassium results could potentially contribute to a misdiagnosis or delay appropriate treatment.
Gen Analytica has instructed healthcare professionals and distributors to stop using, selling or distributing affected tubes and return them for replacement. The recall is classified as Class II Type B and was initiated on 12 August 2026.
Another recent recall concerns certain lots of Smart Bag Flexpack Acid Concentrates, products associated with dialysis treatment and distributed by Fresenius Medical Care South Africa.
SAHPRA said a defective pump used during manufacturing was identified and subsequently replaced.
Testing of previously produced Smart Bags nevertheless detected the sporadic presence of neodymium, a metal which had leached from the magnetic drive of the defective pump.
This recall carries a Class I Type B classification and was initiated on 7 August 2026.
Fresenius Medical Care has distributed a SAHPRA-approved recall notice to affected distribution points and advised healthcare facilities to ensure that anyone who may have received transferred stock is also informed.
The string of recent notices does not mean that every product bearing these medicine names or used for these purposes is affected. In several instances, the recalls are restricted to clearly identified batches or lot numbers.
For members of the public, the Enalapril recall is particularly important because the medicine may be sitting in patients’ homes.
Consumers using Enalapril 10 mg Arya should therefore check their packaging against the four affected batch numbers rather than discontinuing treatment unnecessarily.
The remaining recalls primarily require action from hospitals, laboratories, pharmacies, distributors and other healthcare facilities.
Members of the public and healthcare professionals can also report suspected adverse reactions or problems involving health products through SAHPRA’s Med Safety reporting system.
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