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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 98 of 100

Device	Model / Reference	Registries	Class	Status
Dover	894672	FDA UDI	Class II	Active
SharpSafety	8901SA	FDA UDI	Class II	Unknown
Curity	9026G	FDA UDI	Class I	Unknown
Genius 2	V303030	FDA UDI	Class II	Active
Uni-Patch	MT70000	FDA UDI	Class I	Unknown
Argyle	160409	FDA UDI	Class II	Active
Argyle	12102	FDA UDI	Class II	Active
T.e.d.	4317	FDA UDI	Class II	Unknown
T.e.d.	MKN34898	FDA UDI	Class II	Unknown
Argyle	8888513002	FDA UDI	Class I	Unknown
Curity	7832AMD	FDA UDI	Class I	Active
Argyle	31077	FDA UDI	Class II	Active
T.e.d.	4284	FDA UDI	Class II	Unknown
Dover	P4P16ULD	FDA UDI	Class II	Active
Monoject	8881682119	FDA UDI	Class I	Unknown
Monoject	1188818113	FDA UDI	Class II	Active
Monoject	1180126038	FDA UDI	Class II	Active
Kerlix	1892	FDA UDI	Class I	Active
Monoject	SC3353	FDA UDI	Class I	Active
Devon	573402	FDA UDI	Class I	Active
Dover	20516ICC	FDA UDI	Class II	Active
Monoject	8881314440	FDA UDI	Class II	Active
Vaseline	8884425600	FDA UDI	U	Active
A-V Impulse	5107	FDA UDI	Class II	Active
Argyle	8888301515	FDA UDI	Class II	Active
SharpSafety	1525SA	FDA UDI	Class II	Active
Argyle	43250	FDA UDI	Class II	Active
SharpSafety	V8980	FDA UDI	Class II	Active
Devon	31142790	FDA UDI	Class I	Active
Argyle	8888531038	FDA UDI	Class I	Active
Dover	6162MF	FDA UDI	Class II	Active
Curity	6241G	FDA UDI	Class I	Active
Vistec	6591	FDA UDI	Class I	Active
Argyle	8888301630	FDA UDI	Class II	Active
T.e.d.	7604	FDA UDI	Class II	Unknown
Dover	402724	FDA UDI	Class II	Active
Devon	31451126	FDA UDI	Class I	Active
Devon	52000031	FDA UDI	Class II	Active
Dover	40520L	FDA UDI	Class II	Active
Monoject	1180323114E	FDA UDI	Class I	Active
Novaplus	V7194	FDA UDI	Class I	Active
Monoject	1270013000	FDA UDI	Class II	Active
SharpSafety	8781	FDA UDI	Class II	Active
Devon	31142550	FDA UDI	Class I	Active
Devon	31349361	FDA UDI	Class I	Active
SharpSafety	8990Y	FDA UDI	Class II	Active
Curity	2187	FDA UDI	Class I	Active
Devon	31155354	FDA UDI	Class I	Active
Devon	31144507	FDA UDI	Class I	Active
Argyle	30820	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

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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