The Recall Desk

Manufacturer

Cardinal Health 200, LLC

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

What the numbers show

Total
304
Critical
5
Severe
28
Most recent
2026-10-14

Of the 304 recalls from Cardinal Health 200, LLC we have scored against our rubric, 5 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 28 (9%) are Severe.

Which agencies issued them

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.

26–50 of 304

  • HighFDA (Devices)·Z-2946-2026·2026-08-19

    Cardinal Health Presource Kits Recalled for Endotoxin Variability in Sponges

    Cardinal Health is recalling 602 Presource surgical kits because they contain MEDICOM Ritmed Neurological Sponges with unexpected endotoxin variability.

    Product
    Cardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Number: SEN73NSKCF; 2) PACK NEURO MINOR CRANIOTOMY , Catalog Number: SNE30CNOHE; 3) NEURO MAJOR 2 PACK , Catalog Number: SNE30CRJGY; 4) NEURO PACK , Catalog Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2942-2026·2026-08-19

    Procedure kits with MEDICOM Ritmed Neurological Sponges are recalled due to endotoxin variability.

    The FDA is recalling procedure kits containing MEDICOM Ritmed Neurological Sponges because of unexpected variability in endotoxin levels. This affects consumers who have received or plan to receive these kits.

    Product
    Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD , Catalog Number: 21-4720C; 3) KIT,BOSC MICROLARYNGOSCOPY , Catalog Number: PECGMLBOB; 4) KIT,ASLMC NASAL PACK , Catalog Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1768-2026·2026-04-08

    Monoject tuberculin syringe packages actually contain U-100 insulin syringes

    Cardinal Health is recalling two lots of Monoject Tuberculin Syringes because the packaging identifies them as 1 mL Luer Lock tuberculin syringes but the contents are U-100 insulin syringes.

    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 as Class I for microbial contamination

    Cardinal Health is recalling Webcol Alcohol Prep pads because of non-sterility, with microbial contamination identified as Paenibacillus phoenicis. The FDA has classified this recall as Class I.

    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 to limit their use to adults

    Cardinal Health is updating the instructions for use on 1,169,726 chest drainage units to clarify that the intended patient population is adults 18 years and older.

    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

    Chemotherapy gowns recalled over an expiration date printed two years late

    Cardinal Health is recalling 251,165 ChemoPlus gowns and sleeves because the packaging shows a five-year shelf life when the product's actual shelf life is three 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0209-2026·2025-10-29

    Gastric sump anti-reflux valves recalled after breakage complaints from excessive force

    Cardinal Health is recalling all lots of Salem Sump Anti-Reflux Valves after complaints of valve breakage due to excessive force during use, and is providing additional guidance for use.

    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

    Dual lumen stomach tubes recalled after anti-reflux valve breakage complaints

    Cardinal Health is recalling all lots of Salem Sump dual lumen stomach tubes with anti-reflux valve after complaints of valve breakage due to excessive force during 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0211-2026·2025-10-29

    Gastroduodenal sump tubes recalled after anti-reflux valve breakage complaints

    Cardinal Health is recalling all lots of Salem Sump PVC gastroduodenal tubes after complaints of anti-reflux valve breakage due to excessive force during use.

    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-0208-2026·2025-10-29

    Silicone stomach tubes recalled after anti-reflux valve breakage complaints

    Cardinal Health is recalling all lots of Salem Sump silicone dual lumen stomach tubes after complaints of anti-reflux valve breakage due to excessive force during 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0206-2026·2025-10-29

    ENFit sump tubes recalled after anti-reflux valve breakage complaints

    Cardinal Health is recalling all lots of ENFit Salem Sump PVC tubes after complaints of anti-reflux valve breakage due to excessive force during use.

    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"…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0207-2026·2025-10-29

    PVC stomach tubes recalled after anti-reflux valve breakage complaints

    Cardinal Health is recalling all lots of Salem Sump dual lumen stomach tubes after complaints of anti-reflux valve breakage due to excessive force during use.

    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1917-2025·2025-06-18

    SCD Comfort Knee Length sleeves recalled for software logic errors

    Cardinal Health is recalling SCD Comfort Knee Length Small sleeves (SKU 84021) due to incorrect software logic that may cause frequent E1 errors and delay patient treatment.

    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-1919-2025·2025-06-18

    Kendall SCD Blended Comfort Sleeves Recalled for Software Logic Error

    Cardinal Health is recalling Kendall SCD Blended Comfort Sleeves (Knee Length Small, SKU 84021B) due to incorrect software logic that may cause frequent E1 errors. The issue may delay treatment or therapy.

    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-1918-2025·2025-06-18

    Kendall SCD Comfort Sleeves Pediatric Knee Length Software Error Recall

    Kendall SCD Comfort Sleeves Knee Length Small Pediatric models may experience frequent E1 errors due to incorrect software logic, potentially delaying treatment or therapy.

    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
  • HighFDA (Devices)·Z-1875-2025·2025-06-04

    Umbilical Vessel Catheter 5 French Triple Lumen Recall

    Cardinal Health is recalling Umbilical Vessel Catheter 5 French triple lumen devices due to a packaging defect that may compromise sterility. Non-sterile catheters could lead to infection in neonates.

    Product
    Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1874-2025·2025-06-04

    Umbilical Vessel Catheter 5 French Dual Lumen Packaging Defect Recall

    Cardinal Health is recalling umbilical vessel catheters due to a packaging defect that may compromise product sterility. Use of non-sterile catheters could lead to infection in neonates.

    Product
    Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1872-2025·2025-06-04

    Cardinal Health Umbilical Vessel Catheter recalled for sterility defect

    Cardinal Health is recalling Umbilical Vessel Catheters (Catalog No. 8888160333, 3.5 French single lumen) due to a packaging defect that may compromise sterility. Use of a non-sterile product could lead to infection in neonates.

    Product
    Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1870-2025·2025-06-04

    Cardinal Health Umbilical Vessel Catheter Insertion Tray Recall

    Cardinal Health is recalling one lot of umbilical vessel catheter insertion trays due to a packaging defect that may compromise sterility. Use of a non-sterile product on neonates could lead to infection.

    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-1873-2025·2025-06-04

    Umbilical Vessel Catheter 5 French Single Lumen Packaging Defect Recall

    Cardinal Health is recalling umbilical vessel catheters due to a packaging defect that may compromise sterility, risking infection in newborns if non-sterile products are used.

    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

    Cardinal Health Umbilical Vessel Catheter Recall for Sterility Defect

    Cardinal Health is recalling 1,710 units of Umbilical Vessel Catheter 2.5 French single lumen due to a packaging defect that may compromise sterility. Non-sterile catheters could cause infection in neonates.

    Product
    Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1136-2025·2025-02-19

    Cardinal Health Presource Surgical Kits Recalled for Potential Endotoxin Contamination

    Cardinal Health is recalling Presource Kits (surgical strips and patties used in ophthalmic procedures) due to potential endotoxin contamination in non-sterile components.

    Product
    Cardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVA; 2) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVB 3) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVC 4) OCULAR PLASTIC PACK, Catalog Number:SEY35OP961 5)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1129-2025·2025-02-19

    Cardinal Health Presource Surgical Kits Recalled for Endotoxin Contamination

    Cardinal Health Presource Kits may contain endotoxin-contaminated non-sterile surgical strips and patties. These kits are used in surgical procedures and have been distributed worldwide including the US, Canada, and Saudi Arabia. Affected facilities should verify lot numbers against the recall list.

    Product
    Cardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110B; 2) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110D 3) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA103 4) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10T 5) KIT,CAROTID…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1137-2025·2025-02-19

    Cardinal Health Presource Kits recalled for endotoxin contamination risk

    Cardinal Health is recalling certain Presource ACDF Kits due to potential endotoxin contamination in non-sterile surgical strips and patties used in spinal fusion procedures.

    Product
    Cardinal Health Presource Kits: 1) ACDF PACK, Catalog Number: SNEHBACSCA; 2) ACDF PACK, Catalog Number: SNEHBACSCB
    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