State

North Carolina product recalls

73,092 recalls have nationwide distribution and so reach North Carolina. 10,294 additional recalls listed North Carolina specifically in their distribution scope.

What the numbers show

Total: 10,294
Critical: 1,486
Severe: 2,536
Most recent: 2026-09-23

Of the 10,294 recalls naming North Carolina we have scored against our rubric, 1,486 (14%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,536 (25%) are Severe.

Which agencies issued them

These figures cover only the 10,294 recalls whose distribution notice names North Carolina specifically. The 73,092 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

9501–9525 of 83386

HighFDA (Devices)·Z-0365-2025·2024-11-20
Stryker Neptune SafeAir Electrosurgical Pencil Recalled for Unintended Activation Risk
Stryker has recalled over 1.1 million Neptune SafeAir Smoke Evacuation Pencils due to potential unintended activation that may cause electrical burns to patients and surgical staff. The device may activate without user input or remain active after buttons are released.
Product
Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0346-2025·2024-11-20
Cook Approach CTO Micro Wire Guide recalled for incorrect expiration date labels
Cook Incorporated is recalling Approach CTO Micro Wire Guide devices due to incorrect expiration dates on affected lot labels. The recall affects 2,005 units in the US and 1,145 units overseas.
Product
Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers: CMW-14-190-12G CMW-14-190-18G CMW-14-190-25G CMW-14-190-6G CMW-14-300-12G CMW-14-300-18G CMW-14-300-25G CMW-14-300-6G
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0436-2025·2024-11-20
AVID Medical Recalls Halyard GYN PAC Kits Due to Metal Flakes
AVID Medical is recalling Halyard GYN PAC medical convenience kits because sponge forceps and towel clamps may release metal flakes that could enter a patient's surgical site.
Product
Halyard GYN PAC - Medical convenience kits Model Number: SJGY20-02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0398-2025·2024-11-20
Halyard FOOT ANKLE PACK surgical instruments recalled due to loose metal flakes
AVID Medical recalls Halyard FOOT ANKLE PACK surgical kits due to loose metal flakes from sponge forceps and towel clamps that could enter surgical sites and cause local reactions.
Product
Halyard FOOT ANKLE PACK - Medical convenience kits Model Number: EUOR005-02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0369-2025·2024-11-20
Stryker Neptune SafeAir smoke evacuation pencil recalled for unintended activation
Stryker Corporation is recalling 21,490 Neptune SafeAir Smoke Evacuation Pencils due to risk of unintended activation that could cause electrical burns. The device may activate without user input or remain active after buttons are released.
Product
Stryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm Blade Push-Button - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0464-2025·2024-11-20
IMMULITE 2000 PSA assay does not meet high-dose analytical performance claim
Siemens Healthcare is recalling certain IMMULITE 2000 PSA assay diagnostic kits because they do not perform as claimed for high-concentration samples used on IMMULITE 2000 analyzers.
Product
IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0336-2025·2024-11-20
IV Fluid Bags Found to Leak During Filling; Manufacturer Recalls Affected Units
The Metrix Company is recalling 2549 cases of SECURE 100 mL empty IV fluid bags because a limited number were found to leak during filling, which could result in contamination during fluid administration.
Product
SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed), REF 66041; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0392-2025·2024-11-20
Halyard cardiac surgical kit recalled for loose metal flakes risk
AVID Medical is recalling Halyard cardiac surgical kits (Model ESJH017-03) due to sponge forceps and towel clamps that may shed small metal flakes during surgery. These metal flakes could enter the patient's surgical site, potentially causing local or foreign body reactions.
Product
Halyard KIT, CARDIAC ROBOTIC - Medical convenience kits Model Number: ESJH017-03
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0333-2025·2024-11-20
IV Bag Containers Recalled Due to Leaking During Filling
The FDA has recalled CORMIX 250 mL empty IV bags made by The Metrix Company due to leaking during the filling process. Approximately 3,456 cases were distributed across the US and Canada.
Product
CORMIX 250 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0349-2025·2024-11-20
Surgical hip procedure kit recalled for incomplete product seals
Medline is recalling CARROLLTON HIP FX surgical kits due to incomplete seals on items within the kit. Affected units contain Lot Number 24EBP466 and were distributed in Tennessee.
Product
CARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0390-2025·2024-11-20
Halyard Total Knee Surgical Kit Recalled for Loose Metal Flakes
AVID Medical is recalling Halyard total knee surgical kits due to loose metal flakes on sponge forceps and towel clamps that could enter and contaminate the surgical site. The defect poses a risk of local reactions or foreign body complications.
Product
Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: ESJH012-07
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0387-2025·2024-11-20
Halyard Open Heart Surgical Kits Recalled for Loose Metal Flakes in Instruments
AVID Medical is recalling Halyard Open Heart Pack Main surgical kits because sponge forceps and towel clamps may contain loose metal flakes that could detach and enter a patient's surgical site.
Product
Halyard OPEN HEART PACK MAIN - Medical convenience kits Model Number: ESJH003-02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0355-2025·2024-11-20
Medical Laboratory Kit Recalled Due to Non-Sterile Specimen Container
Medline Industries is recalling over 626,000 laboratory kits because the included specimen container is labeled as sterile but is actually non-sterile. Non-sterile containers risk sample contamination and may result in unnecessary treatment or prolonged hospitalization.
Product
Lab Kit, SKU DYLAB1018; Component No. 503581
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0329-2025·2024-11-20
SafeControl Bed Handset May Move Unexpectedly After Power Restoration
The SafeControl handset component of Sentida beds may revert to an active mode after power restoration, potentially causing unintended bed movement. Consumers should ensure beds are safely positioned before power interruptions.
Product
SafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers: 01-011539, 01-011541, 01-01198
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0388-2025·2024-11-20
Halyard AORTA PACK Surgical Kit Recalled for Loose Metal Flakes
Halyard AORTA PACK surgical kits are recalled because sponge forceps and towel clamps may contain loose metal flakes that could enter a patient's surgical site, causing local or foreign body reactions.
Product
Halyard AORTA PACK - Medical convenience kits Model Number: ESJH004-02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0364-2025·2024-11-20
Olympus UroPass Ureteral Access Sheaths recalled for UV-induced brittleness
Olympus is recalling UroPass Ureteral Access Sheaths because ultraviolet radiation exposure can cause the dilator tip to become brittle and break during surgery or in storage. Approximately 14,093 units have been distributed worldwide.
Product
Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number: 61024BX, 61038BX, 61046BX, 61054BX, 61124BX, 61138BX, 61146BX, 61154BX, 61224BX, 61238BX, 61246BX, 61254BX, 61324BX, 61338BX, 61346BX, 61354BX Software Version: N/A Product
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0366-2025·2024-11-20
Stryker electrosurgical smoke evacuation pencils recalled for unintended activation risk
Stryker is recalling smoke evacuation pencils used in electrosurgery that may activate without manual input, creating a risk of electrical burns to patients or healthcare providers.
Product
Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk Non-Sterile - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuat
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0424-2025·2024-11-20
Halyard Vaginal Gyn Pack Recalled Due to Loose Metal Flakes Risk
AVID Medical is recalling the Halyard MAJOR VAGINAL GYN PACK due to sponge forceps and towel clamps that may shed loose metal flakes. These flakes could enter a surgical site undetected, causing local reactions or foreign body reactions.
Product
Halyard MAJOR VAGINAL GYN PACK - Medical convenience kits Model Number: SAMM021-11
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0384-2025·2024-11-20
Halyard IR Biopsy Pack recalled for loose metal flakes in surgical kit
AVID Medical is recalling Halyard IR BIOPSY PACK due to loose metal flakes in forceps and towel clamps that could detach and enter the surgical site, potentially causing local or foreign body reactions.
Product
Halyard IR BIOPSY PACK - Medical convenience kits Model Number: AVMD019-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0440-2025·2024-11-20
Halyard Biopsy Pack surgical instruments recalled due to loose metal flakes
AVID Medical is recalling Halyard BIOPSY PACK surgical kits due to loose metal flakes from sponge forceps and towel clamps. Metal flakes could enter a patient's surgical site, potentially causing local or foreign body reactions.
Product
Halyard BIOPSY PACK - Medical convenience kits Model Number: VANW019-04
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0367-2025·2024-11-20
Stryker smoke evacuation pencil recall: unintended activation risk
Stryker is recalling Neptune SafeAir Rocker-Switch Smoke Evacuation Pencils due to risk of unintended activation when plugged in or after button release, which may cause localized electrical burns requiring medical intervention.
Product
Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70mm - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation sys
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0368-2025·2024-11-20
Stryker Neptune SafeAir Smoke Evacuation Pencil May Activate Unintentionally
Stryker recalls Neptune SafeAir Smoke Evacuation Pencils that may activate without user input, risking electrical burns to patients or healthcare workers. Approximately 1,996,010 units were distributed worldwide.
Product
Stryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push Button Switch - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacu
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0330-2025·2024-11-20
VYGON 100 mL IV Container Pouch Recalled for Potential Leakage
The Metrix Company is recalling a limited number of VYGON 100 mL empty IV containers (Lot Numbers 62040-A8375 and 62040-A8432) due to leakage found during the filling process. The affected containers are distributed in multiple U.S. states and Canada.
Product
VYGON 100 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9601; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0327-2025·2024-11-20
Baxter AK 98 Dialysis Machine Recalled for Potential Chemical Exposure
Baxter is recalling AK 98 Dialysis Machines due to potential exposure to polychlorinated biphenyl acids and polychlorinated biphenyls.
Product
Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is Vantive.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0447-2025·2024-11-20
Halyard Angiography Drape Pack Recalled for Potential Metal Flakes in Surgical Site
AVID Medical recalls Halyard angiography drape packs due to potential metal flakes that could detach from sponge forceps and towel clamps. These flakes could enter a surgical site undetected and cause local or foreign body reactions.
Product
Halyard ANGIOGRAPHY DRAPE PACK - Medical convenience kits Model Number: VMCC021-06
Category
Medical Device
Distribution
Distributed nationwide