The Recall Desk

Manufacturer

Cardinal Health 200, LLC

151 recalls in our database name Cardinal Health 200, LLC as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 151

  • HighFDA (Devices)·Z-1768-2026·2026-04-08

    Cardinal Health Tuberculin Syringe Packages Mislabeled, Contain Wrong Insulin Syringes

    Cardinal Health is recalling 198,900 units of Monoject Tuberculin Syringes because packages labeled as Tuberculin Syringes contain U-100 Insulin syringes instead. This mislabeling could lead to dosing or injection errors.

    Product
    Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0528-2026·2026-03-25

    Webcol Alcohol Prep Pads Recalled Due to Microbial Contamination

    Cardinal Health is recalling approximately 174.3 million boxes of Webcol Alcohol Prep pads nationwide due to non-sterile conditions caused by microbial contamination. The contaminated products should not be used.

    Product
    Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply, 200 count boxes, Cardinal Health 200 LLC 3651 Birchwood Drive, Waukegan, IL 60085.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1203-2026·2026-02-04

    Chest drainage units recalled due to inadequate patient age clarification

    Cardinal Health chest drainage units are being recalled because the instructions needed clarification about intended use in adults aged 18+. When used on infants, the units may not show expected visual indicators, potentially leading to improper treatment assessment.

    Product
    Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 8888571513 Cardinal Health Sentinel Seal CDU, Dual Drain 3. 8888571489 Cardinal Health Sentinel Seal CDU, with Easy Change Connector 4. 8888571370 Cardinal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0897-2026·2025-12-17

    ChemoPlus Gowns Recalled for Mislabeled Expiration Date

    Cardinal Health is recalling ChemoPlus protective gowns (251,165 units) distributed nationwide and in Canada due to incorrect expiration dating on packaging. The gowns have a three-year shelf-life but are mislabeled as five years.

    Product
    ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-sterile; CT5502T ChemoPlus Full Coverage Gown, Closed Back, Regular/Medium, Medium Blue, Non-sterile; CT5503T ChemoPlus Full Coverage Gown, Closed Back, Large
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0209-2026·2025-10-29

    Salem Sump Anti-Reflux Valve May Break During Use

    Cardinal Health is recalling Salem Sump Anti-Reflux Valves due to reports of valve breakage during use. The company is providing additional guidance to address the issue.

    Product
    Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-Reflux Valve CE Marked 8888266197 Salem Sump" Anti-Reflux Valve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0210-2026·2025-10-29

    Salem Sump stomach tubes recalled due to anti-reflux valve breakage

    Cardinal Health is recalling Salem Sump stomach tubes because the anti-reflux valve may break when excessive force is applied during use. No patient injuries have been reported. The manufacturer is providing updated guidance for proper device use.

    Product
    Salem Sump PVC Tubes: Product Code/Product Name: 266122 Salem Sump" Stomach Tube, Dual Lumen with Anti-Reflux Valve, 14 Fr/Ch (4.7 mm) 266130 Salem Sump" Stomach Tube, Dual Lumen with Anti-Reflux Valve, 16 Fr/Ch (5.3 mm) 266148 Salem Sump" Stomach Tube, Dual Lumen with Anti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0206-2026·2025-10-29

    Salem Sump PVC Tubes Anti-Reflux Valve Breakage During Use

    Cardinal Health is expanding a recall of Salem Sump PVC tubes due to anti-reflux valve breakage from excessive force during use. The company is providing additional usage guidance.

    Product
    Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 8888264929E ENFit" SALEM SUMP" PVC TUBE 12FR 48IN 8888264945E ENFit" SALEM SUMP" PVC TUBE 14FR 48IN 8888264960E ENFit" Salem Sump" PVC Tube 16Fr 48IN 8888264986E ENFit" SA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0208-2026·2025-10-29

    Salem Sump Stomach Tubes: Anti-Reflux Valve breakage risk identified

    Cardinal Health is recalling Salem Sump Silicone Dual Lumen Stomach Tubes with Anti-Reflux Valve due to complaints of valve breakage from excessive force during use. The manufacturer is providing additional guidance for proper use.

    Product
    Salem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 10 Fr/Ch (3.3 mm), 36 (91 cm) 8888265116 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 12 Fr/Ch (4.0 mm), 48 (122 cm) 8888265124 Salem
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0207-2026·2025-10-29

    Salem Sump Stomach Tubes Recalled for Anti-Reflux Valve Breakage Risk

    Cardinal Health is recalling Salem Sump stomach tubes because the anti-reflux valve can break when excessive force is applied during use. The firm is providing additional guidance to help users prevent valve damage.

    Product
    Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stomach Tube, Dual Lumen, 12 Fr/Ch (4.0 mm) 264945 Salem Sump" Stomach Tube, Dual Lumen, 14 Fr/Ch (4.7 mm) 264960 Salem Sump" Stomach Tube, Dual Lumen, 16 Fr/Ch (5.3 mm) 264986 Salem Sump" Stomach Tube, Du
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0211-2026·2025-10-29

    Salem Sump Gastroduodenal Tubes: Anti-Reflux Valve breakage risk

    Cardinal Health is recalling Salem Sump PVC and polyurethane gastroduodenal tubes due to reports of anti-reflux valve breakage during use. The company is issuing updated usage guidance.

    Product
    Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" PVC Gastroduodenal Tube, 10 Fr/Ch (3.3 mm) x 90 cm 1180264416 Salem Sump" PVC Gastroduodenal Tube, 12 Fr/Ch (4.0 mm) x 114 cm 1180264424 Salem Sump" PVC Gastroduodenal Tube, 14 Fr/Ch (4.7 mm) x 114 cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1917-2025·2025-06-18

    SCD Comfort Knee Length Small Sequential Compression Device Recalled for Software Error

    Cardinal Health recalls SCD Comfort Knee Length Small compression sleeves due to software logic errors causing frequent high-pressure alerts. The malfunction may delay patient treatment or therapy.

    Product
    SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1918-2025·2025-06-18

    Kendall SCD Comfort Sleeves recalled due to software logic error

    Cardinal Health is recalling Kendall SCD Comfort Sleeves (small, pediatric knee-length) due to incorrect software logic that may cause frequent system high-pressure errors, potentially delaying treatment.

    Product
    Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Kendall SCD SmartFlow, SKU 84021P Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1919-2025·2025-06-18

    Kendall SCD Comfort Sleeves may cause treatment delays due to software error

    Kendall SCD Blended Comfort Sleeves may experience frequent E1 high-pressure errors due to software logic issues, potentially causing delays in therapy. Approximately 6517 cases distributed across the US and Japan are affected.

    Product
    Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall SCD SmartFlow SKU 84021B Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1874-2025·2025-06-04

    Cardinal Health Umbilical Catheters Recalled for Packaging Sterility Defect

    Cardinal Health is recalling 10,438 umbilical vessel catheters due to a packaging defect that may compromise sterility. Non-sterile catheters could cause infection in neonates.

    Product
    Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1873-2025·2025-06-04

    Umbilical Vessel Catheters Recalled for Sterility-Compromising Packaging Defect

    Cardinal Health is recalling 51,378 umbilical vessel catheters due to a packaging defect that may compromise sterility. Non-sterile catheters could cause infection in newborns.

    Product
    Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1871-2025·2025-06-04

    Umbilical Vessel Catheters Recalled Due to Sterility Packaging Defect

    Cardinal Health recalls 1,710 umbilical vessel catheters due to a packaging defect that may compromise sterility. Non-sterile devices could cause infection in newborns.

    Product
    Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1875-2025·2025-06-04

    Umbilical vessel catheter recalled due to packaging sterility defect

    Cardinal Health is recalling 2,280 umbilical vessel catheters due to a packaging defect that may compromise product sterility. Non-sterile catheters could cause infection in neonates.

    Product
    Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1870-2025·2025-06-04

    Umbilical Catheter Insertion Tray Recall Due to Packaging Defect Risk

    Cardinal Health is recalling 370 units of umbilical vessel catheter insertion trays due to a packaging defect that may compromise sterility, posing infection risk to neonates.

    Product
    Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1872-2025·2025-06-04

    Umbilical vessel catheters recalled due to packaging defect compromising sterility

    Cardinal Health is recalling umbilical vessel catheters due to a packaging defect that may compromise sterility. Non-sterile catheters used on neonates could cause infection.

    Product
    Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1130-2025·2025-02-19

    Cardinal Health Maxillofacial Surgical Kits Recalled for Potential Endotoxin Contamination

    Cardinal Health Presource maxillofacial surgical kits containing non-sterile strips and patties may have endotoxin contamination. 973,785 units distributed in the US, Canada, and Saudi Arabia are affected; users should stop using and contact the manufacturer.

    Product
    Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF104; 2) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF105 3) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF106 4) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF107 5)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1128-2025·2025-02-19

    Cardinal Health Urology Robotic Packs recalled for potential endotoxin contamination

    Cardinal Health Presource Kits for robotic urology surgery are being recalled due to potential endotoxin contamination in surgical strips and patties. No adverse events have been reported.

    Product
    Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFA; 2) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFB; 3) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1127-2025·2025-02-19

    Cardinal Health Presource Kits recalled for endotoxin contamination risk

    Cardinal Health is recalling Presource Kits containing surgical strips and patties due to potential endotoxin contamination. Approximately 973,785 units were distributed in the US, Canada, and Saudi Arabia.

    Product
    Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMM14; 2) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMD9; 3) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMDX;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1133-2025·2025-02-19

    Cardinal Health Robotic Hysterectomy Kits Recalled for Endotoxin Contamination

    Cardinal Health is recalling Presource Robotic Hysterectomy Kits due to potential endotoxin contamination in surgical strips and patties. Endotoxins are bacterial contaminants that could cause complications during surgical procedures.

    Product
    Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA; 2) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFB 3) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1135-2025·2025-02-19

    Cardinal Health Presource surgical kits recalled for endotoxin contamination risk

    Cardinal Health is recalling Presource Kits for potential endotoxin contamination in non-sterile surgical strips and patties. These surgical components could pose infection risks if used in procedures.

    Product
    Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP12 3) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP13 4) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP1E 5) CHI STD SPINE OPTION 2, Catalog
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1134-2025·2025-02-19

    Cardinal Health Presource Surgical Kits Recalled for Potential Endotoxin Contamination

    Cardinal Health Presource surgical kits containing non-sterile strips and patties may be contaminated with endotoxins, posing potential risk to patients during surgical procedures.

    Product
    Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC12; 2) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC13 3) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC14 4) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC15 5) CHI STD NEURO CRANI
    Category
    Medical Device
    Distribution
    Distributed nationwide