The Recall Desk

State

North Carolina product recalls

72,986 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.

These figures cover only the 10,261 recalls whose distribution notice names North Carolina specifically. The 72,986 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

7726–7750 of 83247

  • HighFDA (Devices)·Z-1344-2025·2025-03-26

    Labor and Delivery System Recalled for Sterilization Assurance Issue

    American Contract Systems is recalling 1,836 Labor and Delivery PPS kits due to inability to confirm sterilization requirements were met. The affected units may lose functionality, potentially delaying patient treatment.

    Product
    LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1383-2025·2025-03-26

    Microstream CO2 Sampling Line May Not Disconnect From Intubation Tube

    Microstream intubated CO2 sampling lines may be difficult or impossible to disconnect from endotracheal tubes. This could delay necessary procedures and cause unintended extubation, potentially leading to respiratory failure.

    Product
    Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Luer Intubated Adult Pediatric, PT00156355 - Microstream Luer Adult-Pediatric Intubated CO2 Sampling Line 2m/6.5ft Short-term use: Procedural/Emergency, MLAI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1359-2025·2025-03-26

    Cardiac Surgical Training Kits Recalled for Sterilization Verification Failure

    American Contract Systems Inc is recalling OPEN HEART A PACK surgical training kits (Models UTOH19AI, UTOH19AJ-01, UTOH19AJ-02) because sterilization assurance requirements cannot be confirmed. Lack of sterilization could impair functionality.

    Product
    OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1375-2025·2025-03-26

    BD Pyxis Medication Dispensing Systems Software Sync Error Recall

    BD Pyxis medication dispensing systems may disconnect from their server due to a software error, preventing them from receiving medication updates. This could lead to incorrect medication administration or delayed access to medications.

    Product
    BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF: 1116-00, CII Safe ES Desktop PC, REF: 1156-00, CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01, CII Safe ES Desktop PC, W-less SCNR, REF: 107-255-01,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1388-2025·2025-03-26

    DxI 9000 Access Immunoassay Analyzer Encoder Wheel Misalignment

    Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer (206 units) because an encoder wheel misalignment on the motor shaft can cause the instrument to stop and delay patient test results.

    Product
    DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0644-2025·2025-03-26

    HOT ONES Verde hot sauce recalled for possible plastic contamination

    HOT ONES brand VERDE hot sauce by Heatonist is being recalled due to possible plastic foreign object contamination. Multiple sizes were distributed in North Carolina, Ohio, Indiana, and Illinois.

    Product
    HOT ONES brand VERDE, Los Calientes Hot Sauce, BY HEATONIST; 1 gallon, 5 oz, and 5 gallon sizes; UPC: 8-51444-00803-5
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1364-2025·2025-03-26

    Surgical Drape Packs Recalled for Potential Sterility Breach in Packaging

    Medline Industries is recalling Proxima Sterile Surgical Drape packs due to a potential breach in the pouch packaging that could lead to loss of sterility. The recall affects 1,490 units distributed nationwide.

    Product
    Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,UNIVERSAL II,SIRUS,7/CS; PACK,LAPAROTOMY,NO GOWN,10/CS; PAC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1394-2025·2025-03-26

    Medline Medical Convenience Kits Recalled for Defective Plastic Syringes

    Medline is recalling 880 medical convenience kits containing plastic syringes with potential leaks and breakage. The syringes were identified as defective and may pose health risks to patients.

    Product
    Medline procedure kits labeled as: 1) EYE PACK, Pack Number VAL038BSCLC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1352-2025·2025-03-26

    Laparoscopy Surgical Packs Recalled Due to Unconfirmed Sterilization

    American Contract Systems Inc is recalling 237 laparoscopy surgical packs because sterilization assurance could not be confirmed. The packs may experience loss of functionality and require treatment delays.

    Product
    LAPAROSCOPY PACK , Model No SFLA02A SFLA02B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0291-2025·2025-03-26

    FDA Recalls Super-Potent Levothyroxine Sodium Tablets Due to Potency Deviation

    Mylan Institutional is recalling 1,068 cartons of levothyroxine sodium 125 mcg tablets (Lot 3115773) distributed nationwide due to out-of-specification potency. The tablets contain higher-than-specified amounts, potentially resulting in excessive doses.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0286-2025·2025-03-26

    Injectable Drug Recalled for Stability Issues at Expiration

    Amgen recalls 258,750 vials of Neupogen (filgrastim) injection due to stability concerns. Stability data shows products may be out of specification at expiration; patients should consult healthcare providers about affected lots.

    Product
    NEUPOGEN — NEUPOGEN (FILGRASTIM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1357-2025·2025-03-26

    General Laparoscopic Pack Recall Due to Unconfirmed Sterilization

    American Contract Systems Inc is recalling 534 kits of General Laparoscopic Pack-LF surgical instruments because sterilization assurance could not be confirmed. This could result in loss of functionality and treatment delays.

    Product
    GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1365-2025·2025-03-26

    Sterile Surgical Drape Recalled Due to Potential Packaging Breach

    Medline Industries is recalling 114 units of Proxima Drape surgical drapes due to a potential breach in pouch packaging that could compromise sterility. Affected units were distributed nationwide.

    Product
    Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0279-2025·2025-03-26

    Cinacalcet Hydrochloride Tablets Recalled for Nitrosamine Impurity Above Safe Limits

    Slate Run Pharmaceuticals is recalling Cinacalcet Hydrochloride Tablets 60 mg for containing nitrosamine impurity above acceptable daily intake limits. The recall affects 2,444 bottles distributed nationwide.

    Product
    Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-008-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1358-2025·2025-03-26

    Vascular Pack Sterilization Assurance Requirements Cannot Be Confirmed

    American Contract Systems cannot confirm Major Vascular Pack surgical kits were properly sterilized. Sterilization assurance failure could result in loss of functionality and delayed patient treatment.

    Product
    MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1372-2025·2025-03-26

    Modular Stem Orthopedic Implant Recalled Due to Incorrect Product Identifier

    37 units of a modular stem orthopedic implant (Product Code 880-601/11) have been recalled due to an incorrect GTIN product identifier on the carton label, which belongs to a different product. No illnesses or injuries have been reported.

    Product
    Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1373-2025·2025-03-26

    Hip Prosthetic Stem Recalled for Incorrect Product Code Label

    A modular hip prosthetic stem (52 units) is being recalled due to an incorrect GTIN barcode on the outer carton label, which displays the code for a different product. No injuries have been reported.

    Product
    Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 12 mm, Product Code: 880-601/12
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1374-2025·2025-03-26

    Modular Stem Orthopedic Implants Recalled for Incorrect GTIN Labeling

    Waldemar Link is recalling 20 units of Modular Stem orthopedic implants due to incorrect GTIN labeling on the outer carton. The label bears a barcode for a different product.

    Product
    Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1391-2025·2025-03-26

    IsoLoc Prostate Treatment Balloon Devices Recalled for Incorrect Fill Volume Labeling

    Angiodynamics is recalling 1,800 units of IsoLoc prostate treatment balloons due to incorrect fill volume labeling. The affected devices were distributed nationwide.

    Product
    IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1387-2025·2025-03-26

    Beckman Coulter DxI 9000 Analyzer Communication Failure Recall

    Beckman Coulter recalls certain DxI 9000 immunoassay analyzers due to firmware issues that can cause communication failures, potentially delaying patient result reporting.

    Product
    DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0288-2025·2025-03-26

    Medline Alcohol Prep Pads Recalled for Subpotent Isopropyl Alcohol

    Medline Industries has voluntarily recalled over 6.6 million alcohol prep pads nationwide because the product contains less isopropyl alcohol than labeled. The subpotent product was first reported on March 26, 2025.

    Product
    MEDLINE ALCOHOL PREP — MEDLINE ALCOHOL PREP (ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0282-2025·2025-03-26

    Ciprofloxacin Ophthalmic Solution Recalled Nationwide for Defective Container Cap

    Ciprofloxacin Ophthalmic Solution is being recalled because the cap spike is lodged in the bottle nozzle, preventing patients from accessing the medication. Affected lot 084A067 was distributed nationwide.

    Product
    CIPROFLOXACIN — CIPROFLOXACIN (CIPROFLOXACIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1386-2025·2025-03-26

    Access 2 Immunoassay Analyzer motor alignment issue may delay results

    Beckman Coulter is recalling Access 2 Immunoassay Analyzers due to sample motor misalignment that may delay patient test result reporting. The recall affects 873 units distributed worldwide.

    Product
    Access 2 Immunoassay Analyzer, Catalog Number 81600N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1371-2025·2025-03-26

    Helix Elite SARS-CoV-2 QC Material Recall Due to Potential Ct Value Issues

    Microbiologics Inc is recalling Helix Elite Inactivated SARS-CoV-2 quality control material (Lot HE0065-29) because the A549 human cell target may produce late Ct values, potentially affecting test result validity.

    Product
    Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N
    Category
    Medical Device
    Distribution
    Distributed nationwide