Cardinal Health 200, LLC: FDA recalls

FDA enforcement reports name Cardinal Health 200, LLC as the recalling firm in 59 events. The events have 297 product records. The recalls started from 2016 to 2026.

See the 59 events

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Enforcement events

59 events, newest first.

FDA enforcement events of Cardinal Health 200, LLC
Initiated	Product (first record)	Type	Class	Records	Status
29 Jul 2026	Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,GYN LAPAROSCOPY DH , Catalog Number: PBOCGLN17	Device	Class II	12	Ongoing
14 Jul 2026	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: PECGNAAU8; 5) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU8; 6) KIT, TRIPOINT SPINE…	Device	Class II	8	Ongoing
2 Mar 2026	Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply, 200 count boxes, Cardinal Health 200 LLC 3651 Birchwood Drive, Waukegan, IL 60085.	Drug	Class I	1	Ongoing
27 Feb 2026	Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777	Device	Class II	1	Ongoing
26 Dec 2025	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 Health Altitude CDU, Dry Suction, with Easy…	Device	Class II	1	Ongoing
12 Nov 2025	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, Large, Medium Blue, Non-sterile; CT5504T…	Device	Class II	1	Ongoing
18 Sep 2025	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" SALEM SUMP" PVC TUBE 18FR 48IN 8888266106E PVC…	Device	Class II	6	Ongoing
13 May 2025	SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller	Device	Class II	3	Completed
2 May 2025	Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs	Device	Class II	6	Ongoing
8 Nov 2024	Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951; 2) KIT,ORP PLASTIC FLAP,Catalog Number PGHDOT952; 3) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT910; 4) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT911; 5) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT912; 6) KIT,ORP PLASTIC FLAP,Catalog Number…	Device	Class II	10	Ongoing
8 Nov 2024	Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog Number:PB23DFCM3; 2) KIT,DIEP FLAP , Catalog Number:PB23DFCM4; 3) KIT,DIEP FLAP , Catalog Number:PB23DFCM5; 4) KIT,DIEP FLAP , Catalog Number:PB23DFCM6; 5) KIT,DIEP FLAP , Catalog Number:PB23DFCM7; 6) KIT,DIEP FLAP , Catalog Number:PB23DFCMA; 7) KIT, HEAD AND…	Device	Class II	12	Ongoing
1 Nov 2024	Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL	Device	Class II	2	Ongoing
25 Sep 2024	Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777	Device	Class I	1	Ongoing
24 Jul 2024	(a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888264929, Sterile; (b) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 14 Fr/Ch (4.7 mm) x 48 in. (122 cm), Model #8888264945, Sterile; (c) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 16 Fr/Ch (5.3 mm) x 48…	Device	Class II	2	Ongoing
29 May 2024	Presource kits and trays, labeled as: 1) ANGIOGRAPHY PACK, Catalog Number SAN13BS605; 2) ANGIOGRAPHY PACK, Catalog Number SAN13BS606; 3) ANGIOGRAPHY PACK, Catalog Number SAN13BS607; 4) ANGIOGRAPHY PACK, Catalog Number SAN13BS608; 5) ANGIOGRAPHY PACK, Catalog Number SAN13BS609; 6) STERILE ANGIOGRAPHY PACK, Catalog…	Device	Class II	4	Ongoing
17 Apr 2024	CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9.5 cm), Model 44102, Sterile, Hypoallergenic.	Device	Class II	1	Ongoing
27 Mar 2024	Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr., REF SU130-401D	Device	Class II	5	Ongoing
28 Dec 2023	Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE	Device	Class I	13	Ongoing
21 Dec 2023	CardinalHealth Suction Canister Liner, MEDI-VAC CRD, REF 65651-510	Device	Class II	3	Ongoing
4 Dec 2023	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 Catheter Tray with Chimney Valve Sterile…	Device	Class I	10	Ongoing
20 Sep 2023	Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack	Device	Class I	6	Ongoing
13 Sep 2023	Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777	Device	Class II	1	Ongoing
16 Aug 2023	Procedure packs: (1) Presource Pain Tray, Catalog SBAHFPTAS2, Advanced Surgery Center SAR, Sterile. (2) Presource Block Tray, Catalog SNE37ANMOF, Medical Center Odessa.	Device	Class II	10	Ongoing
16 Jun 2023	NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010	Device	Class II	1	Ongoing
6 Apr 2023	Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery	Device	Class II	1	Ongoing
14 Dec 2022	Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2186	Device	Class II	28	Ongoing
18 Nov 2022	Cardinal Health Presource Packs IV START KIT- Intended for IV access device CATALOG #: 01-5798B	Device	Class II	3	Ongoing
28 Sep 2022	Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115	Device	Class II	8	Ongoing
15 Mar 2022	Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves	Device	Class II	1	Completed
16 Jun 2021	Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to insert an Umbilical Venous Catheter (UVC) into the umbilical artery or vein of neonate. Product Code: 43201	Device	Class I	1	Terminated
9 Jun 2021	Infant Heel Warmer with Attachment Tab, Nonsterile, Active Product SKU MH00002T The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the pouch causing an exothermic chemical reaction, warming the pouch, which is then applied to the heel of an infant to aid…	Device	Class II	2	Terminated
21 May 2021	Sterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525 - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.	Device	Class II	8	Terminated
25 Feb 2021	In-View Clear Leggings Sterile	Device	Class II	5	Terminated
11 Feb 2021	JUDKINS PACK	Device	Class II	1	Terminated
9 Feb 2021	Magellan Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. Product Code: 8881850558	Device	Class II	3	Terminated
19 Jan 2021	Enteral Infusion Pump	Device	Class II	1	Completed
7 Jan 2021	Covidien ChemoPlus Chemo Spill Kit, Nonsterile, SKU DP5108K	Device	Class II	6	Terminated
7 Jan 2021	Gown Isolation W/Ties Univ Ylw, SKU 1100PG, V1100PG, 2100PG, V2100PG, 2150PG, V2100PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and…	Device	Class II	13	Ongoing
25 Sep 2020	Covidien MONOJECT Standard Hypodermic Needle, Polypropylene Hub 22 G x 3/4". Intended use to facilitate activities such as: withdrawal of medication from a container, aspiration of fluid from a patient, injection of medication into a patient, and transfer fluids Item Code: 8881250248	Device	Class II	1	Terminated
22 Sep 2020	Kangaroo Connect 500ml Bag Set, Non-Sterile, Product Code 77500FD - Product Usage: single-use tubing sets used with pumps in the delivery of nutritional feeding product.	Device	Class II	2	Ongoing
30 Jul 2020	KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S. aureus.	Device	Class II	1	Terminated
29 Jul 2020	PROTEXIS Latex Micro Surgical Gloves Size 5.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.	Device	Class II	8	Completed
4 Jun 2020	Cardinal Health NPWT Canister with Gel 300cc, Prescription Only - Product Usage: The systems are intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The Cardinal Health NPWT PRO family of systems…	Device	Class II	2	Terminated
31 Jan 2020	Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.	Device	Class II	1	Terminated
31 Jan 2020	Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020	Device	Class II	1	Terminated
15 Jan 2020	Monoject 3mL Syringe with Hypodermic Safety Needle, 22G x 1-1/2 . Item Code 11832215 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin.	Device	Class II	4	Terminated
28 Oct 2019	Genius 2 Tympanic Thermometer (discontinued) Item Code: 303000	Device	Class II	5	Terminated
30 Apr 2019	Monoject Standard Hypodermic Needle, 14 G x 1-1/2" Item code: 8881200011	Device	Class II	17	Completed
22 Mar 2019	ChemoPlus Chemo Spill Kit Product Code:CT4004 Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills	Device	Class II	4	Terminated
27 Dec 2018	Curity All Purpose Sponges, Non-woven, 4 Ply, 4" x 4" (10.2 cm x 10.2 cm) Product Code: 8044 - Product Usage: Ideal for applying ointments, prepping, wiping needles, cleaning slides and more Rayon/polyester blend construction Highly absorbent.	Device	Class II	1	Terminated
31 Oct 2018	Protexis Neoprene Surgical Glove, Size 5.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.	Device	Class II	8	Terminated
11 Jun 2018	Hydroline Trumpet Valve with Pulse Wave Cassette, Cassette Trumpet Valve with Bariatric Probe, Double Spike, Ref ABP1201, packaged 1/box, 12 boxes/case, single use, RX, Sterile.	Device	Class II	11	Terminated
28 Mar 2018	Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: a) REF 6561-910C b) REF 6561-916K c) REF 6561-920C To remove blood and/or body fluids. These fluids may be suctioned during surgical procedures or other applications requiring the removal of built up fluids. The suction canisters are used in…	Device	Class II	1	Terminated
20 Feb 2018	Presource PBDS, Kit, Common Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as part of the Enhanced Recovery After Surgery…	Device	Class II	4	Terminated
1 Aug 2017	Presource(R) Kits (custom surgical/procedural kits): The standard and custom kits are packed with all of the specific disposable class I, II, and II implantable, life-supporting, or life-sustaining devices required by customers for common surgical and other medical procedures	Device	Class II	1	Terminated
28 Jul 2017	Convertors Robotic Drape with Attached Leggings; Product is packaged as Single Sterile Drape/8 per Case	Device	Class II	1	Terminated
27 Jun 2017	Converters(R) Under Buttocks Drape with Fluid Control Pouch II, REF 8482, STERILE R, Qty. 1, Cardinal Health, Waukegan, IL A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from…	Device	Class II	2	Terminated
21 Apr 2017	Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drain,19FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which…	Device	Class II	20	Terminated
23 Sep 2016	V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.	Device	Class II	1	Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

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Type and class

Cardinal Health 200, LLC: events for each product type
Type		Events
Device		58
Drug		1

Cardinal Health 200, LLC: events in each class
Class		Events
Class II		53
Class I		6

Share of the events of the firm in Class I: 10%
Share of all events on the register in Class I: 18%
Events with the status Ongoing: 29

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Cardinal Health 200, LLC, by the year that the recall started. The largest year is 2021, with 9 events.

Official channels

FDA enforcement reportsThe FDA search of the weekly enforcement reports.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA: report a problemThe FDA page that shows where a report about a product goes.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Cite this page

Recall Register. Cardinal Health 200, LLC: FDA recalls. https://recallregister.com/firm/cardinal-health-200-llc/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
State of the firm address: IL, MA

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Cardinal Health 200, LLC have?: Class II: 53 events. Class I: 6 events. The class is for the product of a recall. It is not a class of the firm.
Which product types do the FDA recalls of Cardinal Health 200, LLC have?: Device: 58 events. Drug: 1 event.
What is the newest FDA recall of Cardinal Health 200, LLC?: FDA event 99553, which the firm started on 29 Jul 2026. The first product in the record is: Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,GYN LAPAROSCOPY DH , Catalog Number: PBOCGLN17
How many FDA recalls of Cardinal Health 200, LLC have the status Ongoing?: 29 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.