The Recall Desk

State

North Carolina product recalls

72,936 recalls have nationwide distribution and so reach North Carolina. 10,261 additional recalls listed North Carolina specifically in their distribution scope.

What the numbers show

Total
10,261
Critical
1,476
Severe
2,520
Most recent
2026-09-09

Of the 10,261 recalls naming North Carolina we have scored against our rubric, 1,476 (14%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,520 (25%) are Severe.

Which agencies issued them

These figures cover only the 10,261 recalls whose distribution notice names North Carolina specifically. The 72,936 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

3176–3200 of 83197

  • SevereFDA (Devices)·Z-1362-2026·2026-02-25

    Wilson-Cook Medical Recalls Teslatome Bipolar Sphincterotomes Over Current Path Risk

    Wilson-Cook Medical Inc. is recalling 153 Teslatome Bipolar Sphincterotomes due to a potential void in the material separating the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting.

    Product
    Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B2535-450 Model Number: G60785 UDI-DI code: 00827002607859 These devices are used for cannulation of the ductal system and for sphincterotomy. If preloade
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1397-2026·2026-02-25

    Medline Sterile Surgical Kits Recalled Over Sterilization Equipment Calibration

    Medline is recalling 4,757 units of convenience surgical kits distributed worldwide due to calibration issues with sterilization and packaging equipment that may affect sterility assurance.

    Product
    Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117C; 3) KIT PLASTIC INSERT TISSUE EXPA, Model Number: DYKMBNDL158; 4) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170; 5) KIT PLASTIC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1365-2026·2026-02-25

    Integra CVS Wound Dressing Recall Over Sterile Barrier Breach Risk

    Integra LifeSciences is recalling 2,906 units of its Private Label CVS wound dressings (Model CVS405406) due to potential packaging failures that could compromise the sterile barrier.

    Product
    Private Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment, which has shown to be conducive to wound healing. Intended for minor scalds & burns, minor cuts, lacerations & minor abrasions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1371-2026·2026-02-25

    Olympus Thunderbeat Surgical Device Recall Due to Adverse Events

    Olympus is recalling 9,542 Thunderbeat surgical devices worldwide due to continued reports of adverse events. The recall affects all lots of the TB-0545FCS model.

    Product
    Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1385-2026·2026-02-25

    Medline Tracheostomy Convenience Kits Recalled Over Sterilization Calibration Concerns

    Medline is recalling 753 units of its tracheostomy convenience kits and trach tote due to potential sterilization equipment calibration issues that may affect the sterility assurance level of the devices.

    Product
    Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55; 2) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55A; 3) TRACH TOTE, Model Number: DYNJ85691
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1415-2026·2026-02-25

    Medline Recalls Surgical Convenience Kits Over Sterilization Calibration Issues

    Medline is recalling 12,418 units of various surgical convenience kits due to calibration issues with equipment used for sterilization and packaging, which may affect the sterility assurance level of the devices.

    Product
    Medline Convenience Kits: 1) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 2) GYN LAPAROSCOPY CDS, Model Number: CDS983300J; 3) NHP ROBOTIC GYNE CDS, Model Number: CDS984243G; 4) ROBOTIC-LF, Model Number: CDS984543D; 5) ROBOTIC-LF, Model Number: CDS984543F; 6) ROBOTIC-L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1414-2026·2026-02-25

    Medline Labor and Delivery Convenience Kits Recalled Over Sterilization Calibration

    Medline is recalling 27,320 labor and delivery convenience kits due to calibration issues with sterilization equipment that may affect the sterility assurance level of the devices.

    Product
    Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBNDL165; 3) KIT LABOR & DELIVERY D&C/D&E, Model Number: DYKMBNDL31; 4) KIT LABOR & DELIVERY CERCLAGE, Model Number: DYKMBNDL38; 5) L & D PACK-LF, Model Numbe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1354-2026·2026-02-25

    Olympus High Flow Insufflation Unit Recalled Due to Software Overpressure Risk

    Olympus is recalling 485 High Flow Insufflation Units (Model UHI-3) nationwide due to a software algorithm issue that may cause dangerous overpressure during abdominal surgery.

    Product
    Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1382-2026·2026-02-25

    Olympus Thunderbeat Surgical Device Recall Over Adverse Events

    Olympus is recalling 1,538 Thunderbeat 5 mm surgical devices worldwide due to continued reports of adverse events. The recall affects all units of Model No. TB-0510IC.

    Product
    Olympus Thunderbeat 5 mm, 10 cm, Inline Grip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1387-2026·2026-02-25

    Medline Nerve Block Trays Recalled Over Sterilization Calibration Issues

    Medline is recalling 448 units of its BASIC NERVE BLOCK TRAY W/LINEN (Model PAIN0150C) due to calibration issues with sterilization and packaging equipment that could affect the sterility assurance level of the devices.

    Product
    Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number: PAIN0150C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1352-2026·2026-02-25

    Olympus High Flow Insufflation Unit Recalled Due to Software Algorithm Issue

    Olympus Corporation of the Americas is recalling the Olympus High Flow Insufflation Unit (Model UHI) because a software algorithm issue may cause overpressure events.

    Product
    Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1404-2026·2026-02-25

    Medline Burn Care Kits Recalled Over Sterilization Calibration Issues

    Medline is recalling 291 units of three burn care convenience kits due to calibration issues with sterilization and packaging equipment that may affect sterility assurance.

    Product
    Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BURN CARE PACK-LF, Model Number: DYNJT3437
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1388-2026·2026-02-25

    Endoscopy and angiography kits recalled over sterilization calibration issues

    Medline is recalling 3,561 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.

    Product
    Medline Convenience Kits: 1) ENDO KIT W/SYRINGE, Model Number: DYKE1743; 2) BGMC ANGIOGRAPHY PACK-LF, Model Number: DYNJ0800934D; 3) GENERAL ENDO PACK-LF, Model Number: DYNJ0842873J; 4) OR ANGIO PACK-LF, Model Number: DYNJ43415C; 5) ANGIO PACK II, Model Number: DYNJ44066
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1407-2026·2026-02-25

    Triple lumen insertion kits recalled over sterilization calibration issues

    Medline is recalling 15 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.

    Product
    Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1426-2026·2026-02-25

    Cervical disc implants recalled after 5mm product was labeled 6mm

    Centinel Spine is recalling 20 Prodisc C SK total cervical disc replacements because products were mislabeled as the 6mm product but included the 5mm product.

    Product
    Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1367-2026·2026-02-25

    Catheter cutdown trays recalled over damage to the outer tray

    Bard Peripheral Vascular is recalling 14,935 Broviac 4.2 Fr single-lumen CV catheter cutdown trays because damage to the outer tray can potentially compromise the sterile barrier.

    Product
    Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1383-2026·2026-02-25

    Bronchoscopy robots recalled over arms that may move toward patient-left

    Auris Health is recalling 173 MONARCH Platform bronchoscopy systems because a software restart can re-initialize the system to patient-left, leading to unanticipated robotic arm positioning.

    Product
    MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1396-2026·2026-02-25

    GI endoscopy kits recalled over sterilization equipment calibration issues

    Medline is recalling 23,238 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.

    Product
    Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Number: DYKE1721
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1406-2026·2026-02-25

    Choice drape packs recalled over sterilization equipment calibration issues

    Medline is recalling 72 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.

    Product
    Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1394-2026·2026-02-25

    Cochlear and head kits recalled over sterilization equipment calibration issues

    Medline is recalling 9,051 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.

    Product
    Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I; 3) HEAD & NECK CDS-LF, Model Number: CDS983782C; 4) BAPTIST FLOYD BRONCHOSCOPY, Model Number: DYKE1456D; 5) BRONCHOSCOPY SETUP KI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1373-2026·2026-02-25

    Thunderbeat Type S devices removed after continued adverse event reports

    Olympus is removing the Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S from the market, stating the action is due to continued reports of adverse events.

    Product
    Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0537-2026·2026-02-25

    Liquid Dietary Supplements Recalled Due to Undeclared Milk Allergen

    Pure Solutions, Inc. is recalling Pure Factors Professional Nighttime Sleep Formula and Pure Formulas Sleep Reset because the labels do not declare milk as an allergen.

    Product
    Pure Factors Professional Nighttime Sleep Formula and Pure Formulas Sleep Reset, Net Wt., 1 fl oz (30 ml) liquid dietary supplement, Glass bottle with dropper cap. (Individual 1 fl oz bottles (not sold in case lots)
    Category
    Food
    Distribution
    36 states
  • HighFDA (Devices)·Z-1416-2026·2026-02-25

    Urology kits recalled over sterilization equipment calibration issues

    Medline is recalling 59 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.

    Product
    Medline Convenience Kits: 1) KIT UROLOGY SLING, Model Number: DYKMBNDL106; 2) KIT UROLOGY SLING, Model Number: DYKMBNDL106A; 3) KIT UROLOGY PENILE REPAIR, Model Number: DYKMBNDL188; 4) KIT UROLOGY PERIPHERAL STIMULA, Model Number: DYKMBNDL189; 5) KIT UROLOGY PERIPHERAL S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1412-2026·2026-02-25

    Medline Convenience Kits Recalled Due to Potential Sterility Assurance Issues

    Medline Industries, LP is recalling specific Medline Convenience Kits (CHEST/BREAST-LF) because equipment calibration issues may have impacted the sterility assurance level of the products.

    Product
    Medline Convenience Kits: 1) CHEST/BREAST-LF, Model Number: DYNJ83950
    Category
    Medical Device
    Distribution
    Distributed nationwide