The Recall Desk

State

South Carolina product recalls

72,913 recalls have nationwide distribution and so reach South Carolina. 7,116 additional recalls listed South Carolina specifically in their distribution scope.

What the numbers show

Total
7,116
Critical
1,268
Severe
1,870
Most recent
2026-09-09

Of the 7,116 recalls naming South Carolina we have scored against our rubric, 1,268 (18%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,870 (26%) are Severe.

These figures cover only the 7,116 recalls whose distribution notice names South Carolina specifically. The 72,913 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

2001–2025 of 80029

  • HighFDA (Devices)·Z-2068-2026·2026-05-13

    Mint Lesion Software Data Loss During Server Connection Interruption

    Mint Medical is recalling Mint Lesion software versions 3.4.0 through 3.9.5 due to a risk of data loss or incorrect patient data linking when the workstation-to-server connection is interrupted during a read operation.

    Product
    Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2051-2026·2026-05-13

    Prodisc C SK cervical disc implant labeling mix-up recalled

    Centinel Spine is recalling Prodisc C SK U.S. Implant Extra Large cervical disc replacement devices due to a labeling mix-up where 6mm implants were labeled as 5mm and 5mm implants were labeled as 6mm.

    Product
    Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2121-2026·2026-05-13

    Medline Convenience Kits General Closure sterilization calibration issue

    Medline Industries is recalling Convenience Kits (Model DYKMBNDL200A) due to calibration issues in sterilization equipment that may have compromised sterility assurance. The kits were distributed nationwide.

    Product
    Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·26E030000·2026-05-13

    Hale Recalls Weldon UV800 Display Units for Emergency Equipment Failure

    Hale Products Inc is recalling Weldon UV800 Display Units that may fail to power on or respond to touch, preventing the activation of emergency lights and firefighting equipment.

    Product
    EQUIPMENT:EMERGENCY:FIRE SUPRESSION recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2048-2026·2026-05-13

    LUX-DX II Arrhythmia Detector Monitoring Function Data Collection Issue

    Boston Scientific is recalling the LUX-DX II Model M302 and M312 arrhythmia detectors because some upgraded devices are not collecting PVC Burden data or monitoring for Bradyarrhythmia and Pause, with conflicting information shown in programming screens.

    Product
    LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2067-2026·2026-05-13

    BioFire Joint Infection Panel diagnostic test kit contamination recall

    BioFire Diagnostics is recalling its Joint Infection (JI) Panel diagnostic test kits due to contamination that may produce false positive results.

    Product
    BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2127-2026·2026-05-13

    Medline Arthroscopy Convenience Kits Recalled Due to Sterilization Equipment Calibration

    Medline is recalling five models of arthroscopy convenience kits due to calibration issues with sterilization equipment that may affect the sterility assurance level of the devices.

    Product
    Medline Convenience Kits: 1) ARTHROSCOPY CDS, Model Number: CDS984609B; 2) ARTHROSCOPY TRAYS, Model Number: DYNJ22501G; 3) ARTHROSCOPY PACK, Model Number: DYNJ32715F; 4) CHS ARTHROSCOPY PACK, Model Number: DYNJ50834C; 5) ARTHROSCOPY TRAY-LF, Model Number: DYNJ51069
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2103-2026·2026-05-13

    Medline Convenience Kits Recalled Over Sterilization Calibration Issues

    Medline is recalling three models of medical convenience kits (central line, LVAD driveline, and surgical oncology) distributed nationwide due to calibration issues in sterilization equipment that may have reduced sterility assurance.

    Product
    Medline Convenience Kits: 1) CENTRAL LINE UNIVERSAL INSERTI, Model Number: CVI3780; 2) LVAD DRIVELINE TRAY, Model Number: DM1035; 3) KIT SURG ONC INSERT CENT.VENOU, Model Number: DYKMBNDL43
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2109-2026·2026-05-13

    Medline Surgical Device Kits Recalled Due to Sterilization Equipment Calibration Issues

    Medline Industries is recalling approximately 15,806 surgical device kits used in gynecology, urology, and thoracic procedures. Calibration issues with sterilization and packaging equipment may have compromised the sterility assurance level of the devices.

    Product
    See full list in RES, exceeds character limit 1) GYN LAPAROSCOPY CDS, Model Number: CDS981504G; 2) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407P; 3) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 4) GYN LAPAROSCOPY CDS, Model Number: CDS983300J; 5) NHP ROBOTIC GY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2116-2026·2026-05-13

    Medline Basic Nerve Block Tray sterilization calibration issue

    Medline is recalling Basic Nerve Block Trays due to calibration issues with sterilization equipment that may have compromised 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
  • HighFDA (Devices)·Z-2102-2026·2026-05-13

    Medline Convenience Kits Recalled Due to Sterilization Equipment Calibration Issues

    Medline Industries is recalling multiple Convenience Kits nationwide because sterilization equipment calibration issues may have compromised the sterility assurance level of the products, despite exposure to validated sterilization cycles.

    Product
    Medline Convenience Kits: 1) CVC PACK, Model Number: CVI4500A; 2) TOTE KAMAL OSC HAND REPAIR, Model Number: DYKM1730A; 3) TOTE CHANGE OSC HAND REPAIR, Model Number: DYKM1751A; 4) TOTE SB NGUYEN CAPSULOTOMY, Model Number: DYKM1756A; 5) TOTE MOMENI SB CAPSULOTOMY REC, Mode
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2101-2026·2026-05-13

    Medline Medical Device Convenience Kits Sterilization Calibration Recall

    Medline Industries is recalling multiple Convenience Kit medical devices due to calibration issues in sterilization and packaging equipment that may affect sterility assurance. The devices were distributed nationwide.

    Product
    See RES for complete list. Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326A; 3) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326B; 4) DRAWER #5, Model Number: ACC010475; 5) DRAWER 1 NEURO CAR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2104-2026·2026-05-13

    Medline PPE Kit recalled for sterilization calibration issues

    Medline is recalling Convenience Kits (PPE Kit, Model DYK1011945P) due to calibration issues with sterilization and packaging equipment that may compromise sterility assurance. The product was distributed nationwide.

    Product
    Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2065-2026·2026-05-13

    Physio-Control Defibrillators May Lack Required Performance Inspection

    Physio-Control defibrillators (LIFEPAK 15, 1000, 35, and 20e models) serviced between July 2023 and November 2025 may not have undergone required Performance Inspection Procedures, potentially preventing therapy delivery.

    Product
    LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-001935, 99577-001964, 99577-001955, 99577-001956, 99577-001588, 99577-001958, 99577-001950, 99577-001962, 99577-002178, 99577-001372, 99577-00193
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2093-2026·2026-05-13

    Medline Cardiac Surgery Kits Recalled Due to Sterilization Equipment Calibration Issues

    Medline Industries is recalling cardiac surgery convenience kits because sterilization and packaging equipment calibration issues may have affected the sterility assurance level of the devices.

    Product
    See RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS, Model Number:CDS840015AQ; 2) OPEN HEART CDS, Model Number:CDS840015AQ; 3) OPEN HEART CDS, Model Number:CDS840023T; 4) OFF PUMP CABG CDS, Model Number:CDS840087AI; 5) OFF PUMP CABG CDS, Model Number:CDS840087A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2090-2026·2026-05-13

    Medline Convenience Kits recalled for potential sterilization compromise

    Medline Industries is recalling eight models of Convenience Kits due to calibration issues with sterilization equipment that may have affected the sterility assurance level of the devices.

    Product
    Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number:DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number:DYNJ56436B; 3) SCC RF PAIN MGMT, Model Number:DYNJ56436C; 4) CPNB SETUP TRAY, Model Number:DYNJRA1979; 5) CPNB SETUP TRAY, Model Number:DYNJRA1979A; 6) CPNB SETUP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2046-2026·2026-05-13

    da Vinci X and Xi Surgical Systems Recalled for Manipulator Arm Screw Breakage

    Intuitive Surgical is recalling certain Universal Surgical Manipulator arm sub-assemblies in da Vinci X and Xi Surgical Systems due to screws that may be susceptible to breaking during use.

    Product
    Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Version: N/A Product Description: he da Vinci Xi, X Surgical systems each consist of three main components: the Surgeon Console (SC), the Vision
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2085-2026·2026-05-13

    QUCARE Total Cholesterol in vitro Diagnostic Test Recalled

    DFI Co., Ltd. is recalling QUCARE Total Cholesterol in vitro diagnostic test devices because they were distributed without required FDA premarket clearance or approval.

    Product
    QUCARE Total Cholesterol in vitro diagnostic test REF: 6407
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2132-2026·2026-05-13

    ZENBONE Resorbable Bone Void Filler Recall Outside Specifications

    Orthorebirth Co Ltd is recalling ZENBONE resorbable bone void filler because the product falls outside standard specifications. The recall affects specific lot numbers distributed nationwide in California and Florida.

    Product
    ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2070-2026·2026-05-13

    DEX Ophthalmic Tissue Forceps subject to IFU corrective action

    Katalyst Surgical is issuing a field safety corrective action for instructions for use (IFU) in DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH (Model DVF4005-25).

    Product
    DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps, Model/Catalog Number: DVF4005-25
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2071-2026·2026-05-13

    DEX Ophthalmic Tissue Forceps instructions for use correction

    Katalyst Surgical is issuing a corrective action for instructions in DEX Ophthalmic Tissue Forceps (Model DVF4014-25-S). The recall affects 80 units distributed worldwide including the US and Peru, Argentina, South Korea, Japan, and France.

    Product
    DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog Number: DVF4014-25-S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2082-2026·2026-05-13

    One Step 10A In Vitro Diagnostic Test Distributed Without FDA Clearance

    DFI Co., Ltd. is recalling the One Step 10A in vitro diagnostic test because it was distributed without required FDA premarket clearance or approval. The recall affects 6533 units distributed nationwide in Florida, Pennsylvania, and England.

    Product
    One Step 10A in vitro diagnostic test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2076-2026·2026-05-13

    DEX Ophthalmic Tissue Forceps require instructions-for-use correction

    Katalyst Surgical is correcting the instructions for use (IFU) for DEX Ophthalmic Tissue Forceps (Model DVF4019-27) and related scissors due to a field safety issue.

    Product
    DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-27
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2052-2026·2026-05-13

    Spacelabs SL Command Module patient monitor recall due to manufacturing defect

    Spacelabs Healthcare is recalling 57 SL Command Module (Model 91496) patient monitoring devices due to a manufacturing issue with the electrical leakage tester that could affect device safety and performance.

    Product
    Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A Product Description: The Command Module (91496) is the core of the Spacelabs patient monitoring system, providing the processing power for all b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0515-2026·2026-05-13

    Duloxetine Delayed-Release Capsules Recalled for Impurity Above FDA Limit

    Ajanta Pharma Ltd. is recalling Duloxetine Delayed-Release Capsules, 60 mg (Lot PA07434, expiration May 2026) because testing found N-nitroso-Duloxetine impurity above the FDA recommended limit of 0.83 ppm.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide