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.

76–100 of 304

  • HighFDA (Devices)·Z-2328-2024·2024-07-17

    Cardinal Health Cardiac Catheterization Kits Recalled for Potential Syringe Design Defect

    Cardinal Health is recalling Presource Cardiac Catheterization Kits because the included syringes may have design defects that could cause inaccurate dosing or leakage, creating a risk of patient harm.

    Product
    Presource kits and trays, labeled as: 1) Cardiac Catheterization Kit, Catalog Number SAN69CCKRB; 2) Cardiac Catheterization Kit, Catalog Number SAN73CCV10; 3) Cardiac Catheterization Kit, Catalog Number SAN73CCV11; 4) Cardiac Catheterization Kit, Catalog Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2330-2024·2024-07-17

    Presource Neurological Surgical Kits Recalled for Syringe Design Defect

    Cardinal Health is recalling Presource neurological surgical kits containing defectively designed syringes that may cause inaccurate dosing or device leakage. The recall affects 13,487 kits distributed nationwide.

    Product
    Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number SAN29NICCA; 2) Neurological Tray, Catalog Number SAN29NRCC1; 3) Neurological Tray, Catalog Number SAN29NRCC2; 4) Neurological Tray, Catalog Number SAN29NRCC3; 5) Neurological Tray, Catalog Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1835-2024·2024-05-22

    Cardinal Health Curity Adhesive Bandages Recalled for Latex Contamination

    Cardinal Health is recalling Curity Flexible Adhesive Bandages (Model 44102, Lot #A14722) due to potential contamination with latex adhesive residual. The hypoallergenic product was distributed nationwide to approximately 2,000 packages.

    Product
    CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9.5 cm), Model 44102, Sterile, Hypoallergenic.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1739-2024·2024-05-08

    Jackson-Pratt Surgical Drain Kits Recalled for Unsterilized Shipments

    Cardinal Health is voluntarily recalling Jackson-Pratt 3-Spring surgical drain kits from specific lot numbers that were shipped unsterilized. Distributed worldwide including the US, the kits pose an infection risk if used without sterilization.

    Product
    Jackson-Pratt 3-Spring Reservoir with Silicone Adapters, 400mL, REF SU130-475
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1735-2024·2024-05-08

    Jackson-Pratt 3-Spring Reservoir Drain Kits Shipped Without Sterilization

    Cardinal Health is recalling specific lots of Jackson-Pratt 3-Spring Reservoir Kits because they were shipped to users before sterilization. Unsterilized surgical drains pose an infection risk.

    Product
    Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr., REF SU130-401D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1738-2024·2024-05-08

    Jackson-Pratt Drainage Kits Shipped Unsterilized in Voluntary Removal

    Cardinal Health is voluntarily removing Jackson-Pratt drainage kits (Lot 210751D6) that were shipped without sterilization. The unsterilized devices pose an infection risk if used in patient care.

    Product
    Jackson-Pratt Universal Connector PVC Tubing Anti Reflux Transparent Y, REF SU130-4601
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1736-2024·2024-05-08

    Unsterilized Jackson-Pratt surgical drain kits recalled by Cardinal Health

    Cardinal Health recalls Jackson-Pratt 3-Spring Reservoir Kits because specific lots were shipped before sterilization. Unsterilized surgical devices pose risk of infection.

    Product
    Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 10Fr., REF SU130-402D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1737-2024·2024-05-08

    Jackson-Pratt 3-Spring Reservoir Kit Recalled Due to Non-Sterile Shipment

    Cardinal Health is recalling Jackson-Pratt 3-Spring Reservoir Kits after shipping specific lots before sterilization. The affected devices pose an infection risk if used without proper sterilization.

    Product
    Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 15Fr., REF SU130-403D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1046-2024·2024-02-28

    Dover Foley catheter kits recalled due to defective supplier components

    Cardinal Health is recalling Dover brand Foley catheter kits due to components recalled by supplier Nurse Assist. Approximately 435,060 units were distributed to the US, Europe, Japan, and Latin America.

    Product
    Dover URINE METER ADD-A-FOLEY TRAY, 200 ML, NEEDLE SAMPLING PORT, DRAIN TUBE, PREP TRAY; Dover UNIVERSAL TRAY, 1000 ML BASIN, PVP SWAB STICKS, PREPPING COMPONENTS, 30 CC PRE-FILLED SYRINGE; Dover URINE DRAINAGE ADD-A-FOLEY TRAY, NEEDLE SAMPLING, A/R, DRAIN TUBE, PREP TRAY, 30 ML…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1048-2024·2024-02-28

    Dover Foley catheter convenience kits recalled due to component defects

    Cardinal Health is recalling Dover-branded Foley catheter convenience kits with components that were subsequently recalled by Nurse Assist. The recall affects 195,600 units distributed in the US, EMEA region, Japan, and Latin America.

    Product
    Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED LATEX FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML BAG…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1050-2024·2024-02-28

    Dover Foley Catheter Kits Recalled Due to Defective Components

    Cardinal Health is recalling 4,620 Dover Foley catheter convenience kits due to components that were recalled by Nurse Assist. The kits, distributed in the US, EMEA, Japan, and Latin America, contain silicone and latex catheters.

    Product
    Dover" 100% SILICONE FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, 2000 ML…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1052-2024·2024-02-28

    Dover Foley Catheter Kits and Drain Trays Recalled

    Dover Foley catheter kits and silicone drain trays manufactured with subsequently recalled components were distributed to 924 units across the US, EMEA, Japan, and Latin America.

    Product
    Dover" 100% SILICONE FOLEY TRAY, NEEDLELESS, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" HYDROGEL COATED LATEX FOLEY CATHETER KIT, 5 CC, 2-WAY, 14 FR (4.7 MM), 10 CC WATER SYRINGE
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1049-2024·2024-02-28

    Dover Irrigation Convenience Kits Recalled for Component Defects

    Cardinal Health is recalling Dover Irrigation convenience kits that contained components which were separately recalled. The recall affects over 63,000 units distributed across the US, EMEA, Japan, and Latin America.

    Product
    Dover" IRRIGATION 1200 CC TRAY, 60 CC PISTON SYRINGE, STERILE SALINE, TIP PROTECTOR, ALCOHOL, LIDDED
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1044-2024·2024-02-28

    Tracheostomy Supply Kits Recalled for Defective Components

    Cardinal Health is recalling 661,560 tracheostomy kits because they were manufactured with components that were subsequently recalled by another manufacturer.

    Product
    TRACH KIT W/HYDROGEN & SALI
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1045-2024·2024-02-28

    Dover Foley Catheter and Urinary Drainage Kits Recalled for Defective Components

    Cardinal Health is recalling Dover foley catheter and urinary drainage kits containing components previously recalled by supplier Nurse Assist. The FDA Class I recall affects 17,640 units distributed to the US, EMEA, Japan, and Latin America.

    Product
    Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, NEEDLE, 16 FR (5.3 MM), 5 CC, 2000 ML BAG; Dover" UNIVERSAL TRAY, 1000 ML BASIN, PVP SOLUTION, PREPPING COMPONENTS, 10 ML…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1043-2024·2024-02-28

    Argyle Suction Catheter Trays with Chimney Valve recalled for defective components

    Cardinal Health is recalling multiple Argyle Suction Catheter Tray models due to defective components. The kits containing these recalled components were distributed in the US, Europe, Japan, and Latin America.

    Product
    Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline 18 Fr/Ch (6.0mm); Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline, 6 Fr/Ch (2.0 mm); Argyle" Graduated Suction Catheter Tray with Chimney Valve Sterile Saline 8 Fr/Ch (2.67 mm); Argyle" Suction…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1051-2024·2024-02-28

    Cardinal Health Foley Catheter Kits Recalled Over Supplier Component Defect

    Cardinal Health is recalling 36,300 Foley urinary drainage convenience kits due to components that were subsequently recalled by supplier Nurse Assist.

    Product
    Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC, 2000ML DRAIN BAG, CSD
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1047-2024·2024-02-28

    Dover Foley catheters recalled due to defective supplied components

    Cardinal Health Dover Foley catheters (7,800 units distributed in the US, EMEA, Japan, and Latin America) are being recalled because convenience kits were manufactured with components previously recalled by Nurse Assist.

    Product
    Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LL, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, CSD; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M TEMP SENSE FOLEY TRAY, 16FR (5.3 MM), 5CC, CSD; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M TEMP SENSE FOLEY…
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0857-2024·2024-02-14

    Cardinal Health Monoject Syringes Recalled Due to Manufacturing Changes

    Cardinal Health is recalling all sizes of Monoject sterile syringes—including Luer-Lock and Enteral syringes with ENFit connections—due to manufacturing and rebranding changes. Products distributed across the U.S. and Canada.

    Product
    Cardinal Health Monoject, 60 mL Syringe Luer-Lock Tip Soft Pack, REF 1186000777T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0855-2024·2024-02-14

    Cardinal Health Monoject Syringe and Enteral Syringe Removal Due to Manufacturing Changes

    Cardinal Health is removing Monoject sterile syringes (Luer-Lock and Enteral with ENFit) from the market due to manufacturing and rebranding changes. Distribution affected US and Canada.

    Product
    Cardinal Health Monoject, 20 mL Syringe Luer-Lock Tip Soft Pack, REF 1182000777
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0853-2024·2024-02-14

    Cardinal Health Monoject Syringes Recalled Due to Manufacturing Changes

    Cardinal Health is removing all sizes of Monoject sterile syringes and enteral syringes from the market due to manufacturing and rebranding changes. Products were distributed in the US and Canada.

    Product
    Cardinal Health Monoject, 6 mL Syringe Luer-Lock Tip Soft Pack, REF 1180600777
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0849-2024·2024-02-14

    Cardinal Health Enteral Feeding Syringes Recalled for Pump Compatibility Issues

    Cardinal Health Monoject enteral syringes in sizes 6mL to 60mL have compatibility issues with certain feeding pumps and may not properly connect. Cardinal Health recommends not using these syringes with enteral feeding pumps.

    Product
    Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0852-2024·2024-02-14

    Cardinal Health Monoject Sterile Syringes Recalled for Manufacturing Change

    Cardinal Health is recalling Monoject sterile syringes due to manufacturing changes. The recall affects Luer-Lock and Enteral syringe models distributed in the US and Canada.

    Product
    Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 1180300777
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0847-2024·2024-02-14

    Cardinal Health Monoject Enteral Syringes Recalled for Pump Incompatibility

    Cardinal Health Monoject enteral syringes (6, 12, 35, 60 mL) in Lot 230503 and 230701 have compatibility issues with certain feeding pumps and should not be used.

    Product
    Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0858-2024·2024-02-14

    Cardinal Health Monoject Sterile Syringes Removed Due to Manufacturing Change

    Cardinal Health 200, LLC is recalling all sizes of Monoject brand sterile syringes (both Luer-Lock and ENFit enteral types) due to manufacturing and rebranding changes. The recall expands previous correction actions to a complete product removal.

    Product
    Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 401SE
    Category
    Medical Device
    Distribution
    Distributed nationwide