The Recall Desk

State

Connecticut product recalls

72,969 recalls have nationwide distribution and so reach Connecticut. 6,566 additional recalls listed Connecticut specifically in their distribution scope.

What the numbers show

Total
6,566
Critical
838
Severe
1,588
Most recent
2026-09-09

Of the 6,566 recalls naming Connecticut we have scored against our rubric, 838 (13%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,588 (24%) are Severe.

Which agencies issued them

These figures cover only the 6,566 recalls whose distribution notice names Connecticut specifically. The 72,969 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

6151–6175 of 79535

  • SevereFDA (Devices)·Z-2082-2025·2025-07-16

    FEM-FLEX II FEMII016A cannulas may have wire protruding from body

    Edwards FEM-FLEX II Femoral Arterial Cannulas, model FEMII016A, are being recalled after complaints of a 3 mm to 4 mm section of wire exposed or protruding from the cannula body. 6,801 units affected.

    Product
    Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2047-2025·2025-07-16

    Bravo CF capsule delivery devices may have misapplied adhesive causing malfunction

    The Bravo CF capsule delivery device is being recalled because misapplied adhesive may prevent the pH capsule attaching to the oesophagus or detaching from the delivery device. 128,202 units affected.

    Product
    Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2084-2025·2025-07-16

    FEM-FLEX II FEMII018A cannulas may have wire protruding from body

    Edwards FEM-FLEX II Femoral Arterial Cannulas, model FEMII018A, are being recalled after complaints of a 3 mm to 4 mm section of wire exposed or protruding from the cannula body. 13,240 units affected.

    Product
    Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0213-2025·2025-07-16

    JLM dark chocolate nonpareils recalled over undeclared milk allergen

    JLM Manufacturing Dark Chocolate Nonpareils in 14 oz tubs are being recalled because of undeclared milk. 971 cases are affected, distributed nationwide.

    Product
    JLM Manufacturing Dark Chocolate Nonpareils, 14oz clear plastic tub, UPC 7 60208 12450 1, item # 392303, 12 retail units per wholesale case
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2081-2025·2025-07-16

    Optisite OPTI18 arterial cannulas may have wire protruding from the body

    Edwards Optisite OPTI18 Arterial Cannulas are being recalled after complaints of a 3 mm to 4 mm section of wire exposed or protruding from the outside of the cannula body. 13,240 units affected.

    Product
    Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorpo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2083-2025·2025-07-16

    FEM-FLEX II femoral arterial cannulas may have wire protruding from body

    Edwards FEM-FLEX II Femoral Arterial Cannulas are being recalled after complaints of a 3 mm to 4 mm section of wire exposed or protruding from the outside of the cannula body. 847 units affected.

    Product
    Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2080-2025·2025-07-16

    Optisite OPTI16 arterial cannulas may have wire protruding from the body

    Edwards Optisite OPTI16 Arterial Cannulas are being recalled after complaints of a 3 mm to 4 mm section of wire exposed or protruding from the outside of the cannula body. 27,022 units affected.

    Product
    Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorpo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2105-2025·2025-07-16

    VersaCross transseptal sheath kits may have a punctured sterile barrier pouch

    VersaCross Transseptal Sheath Kits are being recalled because of a potential hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. 14,724 units affected.

    Product
    VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112 VERSACROSS SHEATH (63CM 45DEG D0)-J Used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, includ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2104-2025·2025-07-16

    VersaCross RF wire lots may have a punctured sterile barrier pouch

    The VersaCross RF Wire is being recalled because of a potential hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. 14,724 units are affected.

    Product
    VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. Product ID VXW0002 Device approved and commercialized in Japan only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2097-2025·2025-07-16

    Infinia nuclear medicine systems may show unintended radial detector motion

    Infinia, Infinia Hawkeye, Infinia II and Infinia II Hawkeye 4 nuclear medicine systems are being recalled because unintended radial detector motion may occur without the correct gantry software. 1,822 units affected.

    Product
    Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2106-2025·2025-07-16

    Torflex transseptal guiding sheath kits may have a punctured sterile pouch

    Torflex Transseptal Guiding Sheath Kits are being recalled because of a potential hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. 14,724 units affected.

    Product
    Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM 45DEG TF85-32-63-55 TORFLEX 8.5F 63CM 55DEG Used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, including the left atri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2101-2025·2025-07-16

    O-arm O2 imaging system gantry support may have been damaged

    The O-arm O2 Imaging System is being recalled because a mechanical component supporting the gantry to the support structure may have been damaged during manufacture. 3 units affected.

    Product
    O-arm O2 Imaging System. Mobile X-Ray System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2103-2025·2025-07-16

    VersaCross access kits may have a hole in the sterile pouch

    VersaCross Access Solution kits are being recalled because of a potential hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. 14,724 units affected.

    Product
    VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45DEG/D0) VXSK0101 VXSK (180J RF WIRE 63CM/45DEG/D1) VXSK0102 VXSK (180J RF WIRE 63CM/55DEG/D0) VXSK0103 VXSK (180P RF WIRE 63CM/45DEG/D0) VXSK0121 VXSK (180P RF WIRE 63CM/45DEG/D1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2110-2025·2025-07-16

    Alcon Custom Pak surgical kits may have damaged lidding compromising sterility

    Alcon Custom Paks, customer-designed sterile surgical kits, are being recalled because some units within specific lots may have been damaged during manufacture in the lidding area. 15,557 kits affected.

    Product
    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 intende
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2109-2025·2025-07-16

    Alcon Constellation procedure packs may have damaged lidding compromising sterility

    Alcon Constellation Vision System Combined Procedure Paks are being recalled because some units within specific lots may have been damaged during manufacture in the lidding area. 89,495 units affected.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constellati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2098-2025·2025-07-16

    Nuclear medicine systems may show unintended radial detector motion during scans

    Varicam, Millennium VG, Millennium VG Hawkeye and Discovery VH nuclear medicine systems are being recalled because unintended radial detector motion may occur without the correct gantry software version. 21 units affected.

    Product
    Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2108-2025·2025-07-16

    Alcon Constellation vitrectomy packs may have damaged lidding compromising sterility

    Alcon Constellation Vision System Vitrectomy Procedure Paks are being recalled because some units within specific lots may have been damaged during manufacture in the lidding area. 198,205 units affected.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constella
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2091-2025·2025-07-16

    TrueDent Cyan dental resin cartridges carry an expiration date formatting error

    TrueDent Cyan dental resin cartridges are being recalled because a formatting error switches the day and month in the expiration date. 100 units are affected.

    Product
    TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental appliances
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2107-2025·2025-07-16

    Preat Astra dental analogs have rotational feature 180 degrees off

    Preat Astra EV-compatible 4.2 mm Digital Analogs are being recalled because a manufacturing error left the digital analog rotational feature 180 degrees off. 44 units are affected.

    Product
    Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2090-2025·2025-07-16

    TrueDent Clear dental resin cartridges carry an expiration date formatting error

    TrueDent Clear dental resin cartridges are being recalled because a formatting error switches the day and month in the expiration date. 78 units are affected.

    Product
    TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliances
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2094-2025·2025-07-16

    TrueDent White dental resin cartridges carry an expiration date formatting error

    TrueDent White dental resin cartridges are being recalled because a formatting error switches the day and month in the expiration date. 109 units are affected.

    Product
    TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental appliances
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2092-2025·2025-07-16

    TrueDent dental resin cartridges carry a formatting error in expiration dates

    TrueDent Magenta dental resin cartridges are being recalled because a formatting error switches the day and month in the expiration date. 94 units are affected.

    Product
    TrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-based resin that enables fabrication of dental appliances
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2093-2025·2025-07-16

    TrueDent Yellow dental resin cartridges carry an expiration date formatting error

    TrueDent Yellow dental resin cartridges are being recalled because a formatting error switches the day and month in the expiration date. 68 units are affected.

    Product
    TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental appliances
    Category
    Medical Device
    Distribution
    Distributed nationwide