The Recall Desk

Manufacturer

Cardinal Health 200, LLC

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

What the numbers show

Total
297
Critical
5
Severe
27
Most recent
2026-09-09

Of the 297 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 27 (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 297

  • 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-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 PRE-FILL
    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 TRAY
    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-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 Cathet
    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-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 D
    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-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, D
    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-0851-2024·2024-02-14

    Cardinal Health Monoject Syringes and Enteral Syringes Removed

    Cardinal Health is removing all Monoject sterile syringes and enteral syringes due to manufacturing changes and rebranding efforts. These products are distributed across the U.S. and Canada.

    Product
    Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, REF 1180100777
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0854-2024·2024-02-14

    Cardinal Health Monoject Syringes Recalled Due to Manufacturing Changes

    Cardinal Health is removing Monoject sterile syringes in multiple sizes due to manufacturing and rebranding changes. The recall affects products distributed nationwide in the US and Canada.

    Product
    Cardinal Health Monoject, 12 mL Syringe Luer-Lock Tip Soft Pack, REF 1181200777T
    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-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
  • 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-0859-2024·2024-02-14

    Cardinal Health Monoject Syringes Removal Due to Manufacturing Changes

    Cardinal Health is removing Monoject brand syringes due to manufacturing changes and rebranding efforts. The removal includes Luer-Lock and ENFit connection models distributed nationwide in the US and Canada.

    Product
    Cardinal Health Monoject, 3 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 403SE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0856-2024·2024-02-14

    Cardinal Health Monoject sterile syringes recalled due to manufacturing changes

    Cardinal Health is recalling all sizes of its Monoject sterile syringes (Luer-Lock and ENFit models) nationwide due to manufacturing and rebranding changes. The FDA classified this as a Class I recall.

    Product
    Cardinal Health Monoject, 35 mL Syringe Luer-Lock Tip Soft Pack, REF 1183500777
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0850-2024·2024-02-14

    Cardinal Health Enteral Syringes Recalled for Pump Incompatibility

    Cardinal Health Monoject enteral syringes (6, 12, 35, 60 mL) have compatibility issues with certain feeding pumps. The affected lots should not be used with enteral syringe feeding pumps.

    Product
    Cardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 460SE
    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-0848-2024·2024-02-14

    Enteral Syringes Recalled for Incompatibility with Feeding Pumps

    Cardinal Health Monoject Enteral Syringes with ENFit connections are recalled due to compatibility issues with certain syringe feeding pumps. The manufacturer recommends they not be used with enteral syringe feeding pumps.

    Product
    Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit Connection System, REF 412SE
    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
  • HighFDA (Devices)·Z-0755-2024·2024-01-24

    Suction Canister Liners Recalled for Potential Loss of Suction Function

    Cardinal Health suction canister liners may lose suction on low settings due to liner misalignment. Approximately 203,244 units distributed to the US, Canada, Australia, and New Zealand.

    Product
    Cardinal Health MEDI-VAC CRD Suction Canister Liner, 1000 mL Suction Canister Liner Kit with 5 mm 1.8 m Tube, REF 65651-516
    Category
    Medical Device
    Distribution
    0 states