Ref: 2025/2937 - 18 November 2025
Important Customer Notice Status Update Type Product Recall
The root cause was identified as trace calcium which interacted with the gluconate present in the formulation to form insoluble calcium gluconate, which crystallised out of solution under storage conditions.
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Ref: 2025/3149 - 17 November 2025
Important Customer Notice Status New Type Product Alert
Rocket Medical have issued a Field Safety Notice informing of an update to the Instructions for Use (IFU) (ZDOCK180) for affected Rocket Seldinger Chest Drain Kits.
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Ref: 2025/3143 - 7 November 2025
Important Customer Notice Status New Type Product Recall
Drager has issued a Field Safety Notice having been made aware of instances where cracks have formed in the hose of some specific ErgoStar catheter mounts.
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Ref: 2025/3128 - 3 November 2025
Important Customer Notice Status New Type Product Alert
Karex, UK Distributor Pasante, has issued a Field Safety Notice for their Ultrasound Probe Cover following discovery that the QR Code expiry date differs from the printed date on the packaging for a single lot number.
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Ref: 2025/3127 - 24 October 2025
Important Customer Notice Status New Type Product Alert
Fisher & Paykel Healthcare have issued a Field Safety Notice informing of an update to the Disinfection Kit User Manual for Airvo 2 and myAirvo 2 devices.
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Ref: 2025/3122 - 23 October 2025
Important Customer Notice Status New Type Product Recall
Olympus has issued a Field Safety Notice regarding specific lots of SD-400U-10 and SD-400U-15 Single Use Electrosurgical Snares.
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Ref: 2025/3114 - 16 October 2025
Important Customer Notice Status New Type Product Alert
L. Gore & Associates (Gore) issued a Field Safety Notice in August 2025 regarding the updating of the Instructions for Use (IFU) related to the GORE® ACUSEAL Vascular Graft, all catalogue numbers, following a number of reports of delamination.
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Ref: 2025/3089 - 23 September 2025
Important Customer Notice Status New Type Product Alert
Intersurgical has issued a Field Safety Notice following reports that the two housings of some HMEF devices have been found to separate when a force is applied during handling of these products or movement and torsion due to repositioning of the patient.
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Ref: 2025/3085 - 11 September 2025
Important Customer Notice Status New Type Contractual Change
We have been informed of a contractual change on Guidion, TrapIT, Nhancer Pro X and Recross products that will terminate on 30 September 2025.
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Ref: 2025/3068 - 3 September 2025
Important Customer Notice Status New Type Product Recall
Boston Scientific has issued a Field Safety Notice regarding batches of Carotid WALLSTENT™ Monorail Endoprosthesis (Carotid WALLSTENT) devices.
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Ref: 2025/3077 - 2 September 2025
Important Customer Notice Status New Type Product Recall
ICU Medical has issued a Field Safety Notice regarding a potential issue with specific models and Lots of 50ml and 100ml CADD Medication Cassette Reservoirs.
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Ref: 2025/3072 - 29 August 2025
Important Customer Notice Status New Type Product Recall
Mediplus has issued a Field Safety Notice regarding specific Lot numbers of their 5775 Silicone 2 Way Foley (open tip) Catheter Kit, 18Fr. 10cc, Standard, 42cm - FUS85043 due to a labelling error.
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Ref: 2025/3039 - 20 August 2025
Important Customer Notice Status New Type Product Alert
Cook Medical has issued a Field Safety Notice following reports of a malfunction that occurs when the user attempts to open the clip jaws by actuating the handle of the Instinct Plus Endoscopic Clipping Device.
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Ref: 2025/3050 - 12 August 2025
Important Customer Notice Status New Type Product Recall
Rocialle has issued a Field Safety Notice withdrawing specific lot numbers of their RSET5003 Pack Minor Op (Bronze) due to a labelling error.
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Ref: 2025/3049 - 12 August 2025
Important Customer Notice Status New Type Product Recall
Integra Sciences has issued a Field Safety Notice having identified packaging failures related to the MediHoney® Wound and Burn product range, which could lead to a breach in the sterile barrier.
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