Dispositivos Médicos Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
FDA DevicesHalyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08
Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08
Devices are not suitable for organ transplant.
FDA DevicesImpella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Device packaged in incorrect outer box carton.
FDA DevicesThe AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
Vision RT is informing customers of an omission identified in the Instructions for Use for AlignRT InBore systems. Information identifying the lasers and their characteristics was omitted from the Instructions for Use for the subject system as required by 21 CFR 1040,10(h), via conformance with recognized consensus standard IEC 60825-1 Ed. 3 (FDA Laser Notice 56).
FDA DevicesArial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3
Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3
Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lots that may cause Call Stations in the Affected Lots to (1) not transmit a low battery alert to the Arial Wireless Emergency Call System prior to battery failure, or (2) not transmit a low battery alert to the Arial Wireless Emergency Call system at least seven (7) days prior to the battery failing.
FDA DevicesPhilips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.
Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.
It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead and Trident 1.4 GHz access points if the signal strength changed quickly.
FDA DevicesBeckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit
Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit
Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed results.
UKField Safety Notices for 05-09 January 2026
Field Safety Notices for 05-09 January 2026
List of Field Safety Notices for 05-09 January 2026...
AustraliaAnko Small and Large Gel Paks
Anko Small and Large Gel Paks
Kmart Australia Ltd is recalling their Anko Small Gel Pak and Anko Large Gel Pak because they contain ethylene glycol, a toxic substance....
FDA DevicesMaterial Processing Laser Products
Material Processing Laser Products
Lack of Remote Interlock Connector - required per 21 CFR 1040.10(f)(3)
UKField Safety Notices: 29 December 2025 to 2 January 2026
Field Safety Notices: 29 December 2025 to 2 January 2026
List of Field Safety Notices from 29 December 2025 to 2 January 2026....
FDA DevicesVortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;
Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;
Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.
FDA DevicesBrand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Number: 0523-48 Product Description: Liquid adhesive, 2/3 mL vial, 48 vials per carton Component: No
Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Number: 0523-48 Product Description: Liquid adhesive, 2/3 mL vial, 48 vials per carton Component: No
Butyrate tube cracks during actuation, rendering product unusable.
FDA DevicesPhilips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795234 REF: 795117, 795122
Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795234 REF: 795117, 795122
Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer.
FDA DevicesSheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L (2.2cm Tapered to 7.4cm x 30cm), Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Tapered, Rolled, Extra-Long, Individually Wrapped, Box of 50 Item Number 76339,
Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L (2.2cm Tapered to 7.4cm x 30cm), Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Tapered, Rolled, Extra-Long, Individually Wrapped, Box of 50 Item Number 76339,
Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.
FDA DevicesBVI Leos Laser and Endoscopy System. Model Number: OME6000U.
BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended. The omission of the ferrites on the USB communication cable results in non-conformance to the design specifications, which require two ferrites (one at each end of the cable).
UKField Safety Notices: 22-26 December 2025
Field Safety Notices: 22-26 December 2025
List of Field Safety Notices for 22-26 December 2025...
UKField Safety Notices: 15 - 19 December 2025
Field Safety Notices: 15 - 19 December 2025
List of Field Safety Notices (FSNs) for week 15 - 19 December 2025...
AustraliaChanges to the supply of insulin products
Changes to the supply of insulin products
Pharmaceutical companies Novo Nordisk and Eli Lilly are discontinuing some of their insulin products....
AustraliaCellAED: Non-rechargeable public automated external defibrillator
CellAED: Non-rechargeable public automated external defibrillator
The company which has supplied the CellAED devices, RRR Manufacturing Pty Ltd, has gone into liquidation. The liquidators for RRR Manufacturing, are conducting a Critical Recall for all lots of the Ce...
AustraliaKey Sun Kids Travel Sickness Homeopathic Product
Key Sun Kids Travel Sickness Homeopathic Product
Key Sun Laboratories Pty Ltd is recalling one batch of Key Sun Kids Travel Sickness Homeopathic Product, due to the risk of a small metal wire being present in the lozenge....
UKField Safety Notices: 8 - 12 December 2025
Field Safety Notices: 8 - 12 December 2025
List of Field Safety Notices from 8-12 December 2025...
UKField Safety Notices: 1 to 5 December 2025
Field Safety Notices: 1 to 5 December 2025
List of Field Safety Notices from 1 to 5 Deceber 2025....
AustraliaCancer Council Sunscreen Clear Zinc Kids SPF50+ 110g
Cancer Council Sunscreen Clear Zinc Kids SPF50+ 110g
Vitality Brands Worldwide Pty Ltd is recalling three batches of Cancer Council Sunscreen Clear Zinc Kids SPF50+ 110g due to the potential for the product to become separated....
UKField Safety Notices: 24 to 28 November 2025
Field Safety Notices: 24 to 28 November 2025
List of Field Safety Notices from 24 to 28 November 2025....