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Cardinalhealth

Last updated September 17, 2026

What Cardinalhealth makes

The company manufactures reusable electrocardiographic lead sets, nasoenteral and gastrostomy feeding tubes, adult indwelling urethral catheterization kits, non-woven gauze pads, single-use transcutaneous electrical stimulation electrodes, disposable incontinence pants, and medicine bottles. It also produces nitrile examination gloves labeled for chemotherapy drug compatibility, radiopaque bone cement, and various wound care and urinary drainage products under branded lines such as Devon, Kendall, Kangaroo, Argyle, SharpSafety, and Uni-Patch.

These devices are regulated under FDA classifications including Class I, Class II, and unclassified (U), with submissions recorded in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. The company operates from the United States, where its products are tracked in the relevant regulatory registries.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
Address: 8322 Eagle Palm Drive, Riverview, FL, 33578
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3011200334
DUNS Number: —

Catalogue (4967)

Page 18 of 100

Device	Model / Reference	Registries	Class	Status
Kendall SCD	9530R	FDA UDI	Class II	Active
Dover	155731	FDA UDI	Class I	Active
T.e.d.	4301	FDA UDI	Class II	Unknown
Curity	8044G	FDA UDI	Class I	Active
ChemoPlus	CP3001O	FDA UDI	Class II	Active
Monoject	8881352788	FDA UDI	Class II	Active
Kangaroo	704655	FDA UDI	Class II	Active
Simplicity	1850R	FDA UDI	Class I	Active
Wings	949	FDA UDI	Class I	Active
Monoject	8881512597	FDA UDI	Class II	Unknown
Kendall	31287363A	FDA UDI	Class II	Active
T.e.d.	7203	FDA UDI	Class II	Active
Argyle	8888265322	FDA UDI	Class II	Active
Kangaroo	724300	FDA UDI	Class II	Active
Devon	31434104	FDA UDI	Class II	Active
Dover	145516	FDA UDI	Class I	Unknown
non branded	9661	FDA UDI	Class I	Active
Dover	1520C	FDA UDI	Class II	Active
Dover	5204	FDA UDI	Class II	Active
Magellan	8881850810	FDA UDI	Class II	Active
Wings	66032	FDA UDI	Class I	Active
Curity	1903	FDA UDI	Class I	Active
non branded	9699	FDA UDI	Class I	Unknown
ChemoPlus	CP3030B	FDA UDI	Class II	Active
Dover	P4P14TSD	FDA UDI	Class II	Active
Devon	50001040	FDA UDI	Class I	Active
Devon	31145215	FDA UDI	Class I	Active
Vistec	6493	FDA UDI	Class I	Active
Kangaroo	384400	FDA UDI	Class II	Active
Curity	66100	FDA UDI	Class I	Active
Dover	20522ICC	FDA UDI	Class II	Active
Kangaroo	8884721096E	FDA UDI	Class II	Active
Kendall	31118733	FDA UDI	Class II	Unknown
Devon	580032	FDA UDI	Class I	Active
Wings	708A	FDA UDI	Class I	Unknown
Devon	573789	FDA UDI	Class I	Active
Kangaroo	672027	FDA UDI	Class II	Unknown
Dover	PP14XSD	FDA UDI	Class II	Active
Covidien	30806726	FDA UDI	Class II	Active
Wings	63065	FDA UDI	Class I	Unknown
Adcon Gel	8881106168	FDA UDI	Class II	Active
Monoject	8881225115	FDA UDI	Class II	Active
Monoject	8881682585	FDA UDI	Class I	Unknown
Dover	8887660184	FDA UDI	Class II	Unknown
Argyle	8888571026	FDA UDI	Class II	Active
SharpSafety	8991	FDA UDI	Class II	Active
Curity	6309	FDA UDI	Class I	Active
Kangaroo	10ES	FDA UDI	Class II	Active
Devon	573741	FDA UDI	Class I	Active
Kendall	50000224A	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (100)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Cardinal Health has 199 recall records initiated between June 2, 2003, and November 1, 2022, with statuses including completed, open, classified, and terminated. Recalled items involved issues such as improper storage conditions, non-compliance with flammability standards, incorrect assembly or sterilization, labeling errors, missing FDA registrations for components, manufacturing defects affecting sterility, and products shipped without sterilization. Reasons also included inadvertent release of products under regulatory holds and mislabeled packaging.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Nov 1, 2022	Z-0360-2023	—	open, classified	Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention
Nov 1, 2022	Z-0358-2023	—	open, classified	Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention
Nov 1, 2022	Z-0356-2023	—	open, classified	Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention
Nov 1, 2022	Z-0361-2023	—	open, classified	Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention
Nov 1, 2022	Z-0359-2023	—	open, classified	Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention
Nov 1, 2022	Z-0357-2023	—	open, classified	Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention
Nov 2, 2021	Z-0374-2022	—	open, classified	Potential for open packaging seals compromising the sterility of the surgical gowns
Nov 2, 2021	Z-0368-2022	—	open, classified	Potential for open packaging seals compromising the sterility of the surgical gowns
Nov 2, 2021	Z-0371-2022	—	open, classified	Potential for open packaging seals compromising the sterility of the surgical gowns
Nov 2, 2021	Z-0373-2022	—	open, classified	Potential for open packaging seals compromising the sterility of the surgical gowns
Nov 2, 2021	Z-0370-2022	—	open, classified	Potential for open packaging seals compromising the sterility of the surgical gowns
Nov 2, 2021	Z-0376-2022	—	open, classified	Potential for open packaging seals compromising the sterility of the surgical gowns
Nov 2, 2021	Z-0372-2022	—	open, classified	Potential for open packaging seals compromising the sterility of the surgical gowns
Nov 2, 2021	Z-0377-2022	—	open, classified	Potential for open packaging seals compromising the sterility of the surgical gowns
Nov 2, 2021	Z-0369-2022	—	open, classified	Potential for open packaging seals compromising the sterility of the surgical gowns
Nov 2, 2021	Z-0378-2022	—	open, classified	Potential for open packaging seals compromising the sterility of the surgical gowns
Nov 2, 2021	Z-0375-2022	—	open, classified	Potential for open packaging seals compromising the sterility of the surgical gowns
Aug 4, 2021	Z-2285-2021	—	open, classified	Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
Aug 4, 2021	Z-2284-2021	—	open, classified	Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
Aug 4, 2021	Z-2286-2021	—	open, classified	Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
Jun 16, 2021	Z-2244-2021	—	terminated	The current Argyle UVC Insertion Tray does not include a specific IFU to operate the Safety Scalpel N11. The Safety Scalpel N11 features a permanent locking feature that will not allow the clinician to unlock the scalpel once the safety shield is closed and pushed forward into a locked position may result in a delay treatment/therapy, which could ultimately result in death.
Jun 9, 2021	Z-2095-2021	—	terminated	A caution statement is being added to remind the user to activate away from face and infant as reports of pack rupture or leaking during activation may resulting in the contents splashing into the user s eyes or onto the infant. Potential harms associated with contact of the liquid inside the pouch are rash, burn and inflammation.
Jun 9, 2021	Z-2094-2021	—	terminated	A caution statement is being added to remind the user to activate away from face and infant as reports of pack rupture or leaking during activation may resulting in the contents splashing into the user s eyes or onto the infant. Potential harms associated with contact of the liquid inside the pouch are rash, burn and inflammation.
Mar 16, 2021	Z-1938-2021	—	open, classified	Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Mar 16, 2021	Z-1929-2021	—	open, classified	Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Mar 16, 2021	Z-1935-2021	—	open, classified	Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Mar 16, 2021	Z-1941-2021	—	open, classified	Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Mar 16, 2021	Z-1934-2021	—	open, classified	Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Mar 16, 2021	Z-1940-2021	—	open, classified	Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Mar 16, 2021	Z-1931-2021	—	open, classified	Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Mar 16, 2021	Z-1933-2021	—	open, classified	Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Mar 16, 2021	Z-1942-2021	—	open, classified	Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Mar 16, 2021	Z-1937-2021	—	open, classified	Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Mar 16, 2021	Z-1936-2021	—	open, classified	Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Mar 16, 2021	Z-1932-2021	—	open, classified	Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Mar 16, 2021	Z-1939-2021	—	open, classified	Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Mar 16, 2021	Z-1930-2021	—	open, classified	Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Feb 9, 2021	Z-1251-2021	—	terminated	Safety shield not locking into the cannula. If the safety shield activation fails to lock a contaminated needle, a needlestick may occur and there is the potential for exposure to bloodborne pathogens
Feb 9, 2021	Z-1250-2021	—	terminated	Safety shield not locking into the cannula. If the safety shield activation fails to lock a contaminated needle, a needlestick may occur and there is the potential for exposure to bloodborne pathogens
Feb 9, 2021	Z-1252-2021	—	terminated	Safety shield not locking into the cannula. If the safety shield activation fails to lock a contaminated needle, a needlestick may occur and there is the potential for exposure to bloodborne pathogens
Sep 25, 2020	Z-0424-2021	—	terminated	Potential for the needle to detach from the cartridge after the bottom of the cartridge is twisted and removed. If the needle is not securely seated, the needle can fall out of the sheath and cause the unused needle to project out of the cartridge, and result in a needle stick/puncture from the clean/unused needle
Sep 22, 2020	Z-0452-2021	—	open, classified	The feeding spike sets may leak at the interface of the tube and spike connector.
Sep 22, 2020	Z-0453-2021	—	open, classified	The feeding spike sets may leak at the interface of the tube and spike connector.
Apr 20, 2020	Z-2049-2020	—	terminated	Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature abused products may result in misdiagnosis of the patient.
Apr 20, 2020	Z-2051-2020	—	terminated	Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature abused products may result in misdiagnosis of the patient.
Apr 20, 2020	Z-2050-2020	—	terminated	Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature abused products may result in misdiagnosis of the patient.
Jan 15, 2020	Z-1454-2020	—	terminated	Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile. The usage of a needle that is not sterile could result in infection. Firm is not aware of any reports of patient harm.
Jan 15, 2020	Z-1455-2020	—	terminated	Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile. The usage of a needle that is not sterile could result in infection. Firm is not aware of any reports of patient harm.
Jan 15, 2020	Z-1453-2020	—	terminated	Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile. The usage of a needle that is not sterile could result in infection. Firm is not aware of any reports of patient harm.
Jan 15, 2020	Z-1456-2020	—	terminated	Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile. The usage of a needle that is not sterile could result in infection. Firm is not aware of any reports of patient harm.
Jan 11, 2020	Z-1018-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1017-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1031-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1028-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1007-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1016-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1029-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1002-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1011-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1027-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1019-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1036-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1021-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1012-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1037-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1032-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1013-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1040-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1024-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1034-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1022-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1026-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1023-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1033-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1025-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1035-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1006-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1014-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1039-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1004-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1015-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1003-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1010-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1038-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1030-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1005-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1009-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1008-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Jan 11, 2020	Z-1020-2020	—	terminated	The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Dec 26, 2019	Z-2105-2020	—	open, classified	The feeding spike sets may leak at the interface of the tube and spike connector.
Dec 26, 2019	Z-2104-2020	—	open, classified	The feeding spike sets may leak at the interface of the tube and spike connector.
Dec 26, 2019	Z-2101-2020	—	open, classified	The feeding spike sets may leak at the interface of the tube and spike connector.
Dec 26, 2019	Z-2103-2020	—	open, classified	The feeding spike sets may leak at the interface of the tube and spike connector.
Dec 26, 2019	Z-2102-2020	—	open, classified	The feeding spike sets may leak at the interface of the tube and spike connector.
Dec 26, 2019	Z-2100-2020	—	open, classified	The feeding spike sets may leak at the interface of the tube and spike connector.
Nov 14, 2019	Z-0729-2020	—	open, classified	Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information on the IFU. The correct classification is "MRI Conditional" not "MRI Safe".
Nov 14, 2019	Z-0730-2020	—	open, classified	Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information on the IFU. The correct classification is "MRI Conditional" not "MRI Safe".
Nov 14, 2019	Z-0728-2020	—	open, classified	Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information on the IFU. The correct classification is "MRI Conditional" not "MRI Safe".
Oct 28, 2019	Z-0991-2020	—	terminated	The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range ( 0.2C for Genius 2 and 0.3C for Genius 3 thermometers). The measurement readings drift upwards over time, which means that the thermometers could exceed the upper stated accuracy tolerance of +0.2C for Genius 2 or +0.3C for Genius 3.
Oct 28, 2019	Z-0990-2020	—	terminated	The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range ( 0.2C for Genius 2 and 0.3C for Genius 3 thermometers). The measurement readings drift upwards over time, which means that the thermometers could exceed the upper stated accuracy tolerance of +0.2C for Genius 2 or +0.3C for Genius 3.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Cardinal Health DELAND, FL · US FEI 1017768