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Sources: EU EUDAMED, US FDA
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FDA Recall
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Waterpik Sonic-Fusion Professional, Model: SF-02 Product Usage: The device is composed of a unit base and an oral irrigator/ battery operated brush power handle. The device provides a pulsating stream of potable water and/or powered toothbrush action to remove plaque and food particles from between the teeth and below the gum line. The power handle can also function as a rechargeable battery powered mechanical toothbrush.
FDA Recall
Terminated
·Water Pik, Inc.·Product code JET·July 2, 2018
Water Pik Sinusense battery operated device including a blue semi-transparent water reservoir, a white hand held button initiated injector device, and a soft seal nozzle affixed to the white injector. The product is sold individually in white, blue red and orange cartons with a photo of the device as well as a stream of water flowing through it. The contents of the container include the device as well as a package insert with utilization instructions. Product Usage: Sinus washing device to keep sinus passages clear of congestion.
FDA Recall
Terminated
·Water Pik, Inc.·Product code KMA·April 3, 2012
HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J
FDA Recall
Open, Classified
·HeartSine Technologies Ltd
207 Airport Road West
Belfast United Kingdom·Product code MKJ·September 18, 2025
Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A
FDA Recall
Open, Classified
·Alcon Research LLC Aspex Facility·Product code LRO·July 15, 2024
Product Name: 25+ CMB PAK 10K CPM,V,STD 0.9 Model/Catalog Number: 8065752450 Software Version: N/A Component: N/A
FDA Recall
Open, Classified
·Alcon Research LLC Aspex Facility·Product code HQC·July 15, 2024
Product Name: 25+ CMB PAK 7.5CPM,V,STD 0.9 Model/Catalog Number: 8065751767 Software Version: N/A Component: N/A
FDA Recall
Open, Classified
·Alcon Research LLC Aspex Facility·Product code HQC·July 15, 2024
Product Name: 25+ TOTALPLUSr CP PAK 20K CPM BWV .9 IU Model/Catalog Number: 8065000093 Software Version: N/A Component: N/A
FDA Recall
Open, Classified
·Alcon Research LLC Aspex Facility·Product code HQC·July 15, 2024
Product Name: 25+ CMB PAK 10K CPM,V,WA 0.9 Model/Catalog Number: 8065752451 Software Version: N/A Component: N/A
FDA Recall
Open, Classified
·Alcon Research LLC Aspex Facility·Product code HQC·July 15, 2024
Product Name: 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU Model/Catalog Number: 8065000095 Software Version: N/A Component: N/A
FDA Recall
Open, Classified
·Alcon Research LLC Aspex Facility·Product code HQC·July 15, 2024
Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A
FDA Recall
Open, Classified
·Alcon Research LLC·Product code LRO·April 28, 2025
Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.4 Model/Catalog Number: 8065772445 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
FDA Recall
Open, Classified
·Alcon Research LLC Aspex Facility·Product code HNN·July 15, 2024
Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.2MM ANGCE Model/Catalog Number: 8065983265 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
FDA Recall
Open, Classified
·Alcon Research LLC Aspex Facility·Product code HNN·July 15, 2024
Product Name: TOTALPLUS,25+ 7.5CPM VALV WD6 Model/Catalog Number: 8065751618 Software Version: N/A Component: N/A
FDA Recall
Open, Classified
·Alcon Research LLC Aspex Facility·Product code HQC·July 15, 2024
Product Name: TOTAL PLUS,25+,10K VALVE WD Model/Catalog Number: 8065752438 Software Version: N/A Component: N/A
FDA Recall
Open, Classified
·Alcon Research LLC Aspex Facility·Product code HQC·July 15, 2024
Product Name: 25GA VALVED ENTRY SYSTEM,3CT Model/Catalog Number: 8065751658 Software Version: N/A Product Description: Valved Trocar Entry System Component: N/A
FDA Recall
Open, Classified
·Alcon Research LLC Aspex Facility·Product code HQC·July 15, 2024
Product Name: 25+TTLPL VPK 20000CPM BEV VAL Model/Catalog Number: 8065753106 Software Version: N/A Component: N/A
FDA Recall
Open, Classified
·Alcon Research LLC Aspex Facility·Product code HQC·July 15, 2024
Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992245 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
FDA Recall
Open, Classified
·Alcon Research LLC Aspex Facility·Product code HNN·July 15, 2024
Product Desc: Product Name: A-OK SATINSLIT FULL HANDLE2.75MM ANG SG Model/Catalog Number: 8065992761 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
FDA Recall
Open, Classified
·Alcon Research LLC Aspex Facility·Product code HNN·July 15, 2024
Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE2.75MM AN Model/Catalog Number: 8065992745 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
FDA Recall
Open, Classified
·Alcon Research LLC Aspex Facility·Product code HNN·July 15, 2024
Product Desc: Product Name: CLEARCUT SAFETY SLIT SB,2.75MMANG Model/Catalog Number: 8065772745 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
FDA Recall
Open, Classified
·Alcon Research LLC Aspex Facility·Product code HNN·July 15, 2024