Cardinal Health recalls
41 official recalls and safety alerts involving Cardinal Health since 2021-12, from FDA · Device, FDA · Drug. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Cardinal Health or the relevant agency.
- 2026-10-14
USCardinal Health 200, LLC recalls Presource Packs containing Medtronic Microstream Components: Intubation Kit Catalog Numbers AN23366084 AN23366085 AN2336608H AN2336608J…
Kits contain Microstream components. Medtronic issued an update to the Instructions for Use of these components due reports of difficulty in disconnecting the adapter from the patient's endotracheal tube to perform a…
- 2026-10-07
- US
Cardinal Health 200, LLC recalls Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLAC; 2)…
The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user…
FDA · DeviceCardinal Health 200, LLCUS Nationwide distribution in the states of CA, IL, KY, MO, NC, NY, OH, TX.Official notice → - 2026-09-30
- US
Cardinal Health 200, LLC recalls Presource Convenience Kits: 1) KIT, PRE OP , Catalog Number: AMN548616A; 2) KIT, NICU ADMIT NEW HAN , Catalog Number: BA1DH0116B; 3)…
The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could result in no patient harm or may lead to localized skin or…
FDA · DeviceCardinal Health 200, LLCUS Nationwide distribution in the states of FL, KY, MO, NC, OH, TX.Official notice → - 2026-09-09
- US
Cardinal Health 200, LLC recalls Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) PBCGLVBLI, Catalog Number: KIT, BLO LAVH ; 2)…
The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin…
- 2026-08-19
- US
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog Number: PE13SPAJA; 3) KIT,SINUS , Catalog…
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
- 2026-04-08
- US
Cardinal Health 200, LLC recalls Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777
The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the syringes contained within the packages are U-100 Insulin syringes.
FDA · DeviceCardinal Health 200, LLCWorldwide distribution - US Nationwide and the country of Canada.Official notice → - 2026-03-25
- US
Cardinal Health 200, LLC recalls Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply, 200 count boxes, Cardinal Health 200 LLC 3651 Birchwood Drive, Waukegan, IL 60085.
Non-Sterility: microbial contamination identified as Paenibacillus phoenicis
FDA · DrugCardinal Health 200, LLCNationwide within the United States, Puerto Rico and Japan.Official notice → - 2026-02-04
- US
Cardinal Health 200, LLC recalls Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 8888571513 Cardinal…
The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate…
FDA · DeviceCardinal Health 200, LLCWorldwide distribution - US Nationwide and the countries of Brazil, Canada,…Official notice → - 2025-12-17
- US
Cardinal Health 200, LLC recalls ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-sterile; CT5502T…
Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years.
FDA · DeviceCardinal Health 200, LLCWorldwide distribution - US Nationwide and the country of Canada.Official notice → - 2025-10-29
- US
Cardinal Health 200, LLC recalls Salem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 10 Fr/Ch (3.3…
Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
FDA · DeviceCardinal Health 200, LLCWorldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice → - 2025-09-03
- US
Cardinal Health Inc. recalls Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled syringes further packaged in bags of 5 prefilled syringes, Rx…
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
- 2025-08-13
- US
Cardinal Health Inc. recalls RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
- 2025-06-18
- US
Cardinal Health 200, LLC recalls SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
FDA · DeviceCardinal Health 200, LLCDomestic US distribution to AK, CA, FL, MA, TX. International distribution to…Official notice → - 2025-06-04
- US
Cardinal Health 200, LLC recalls Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
FDA · DeviceCardinal Health 200, LLCWorldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice → - 2025-05-07
- US
Cardinal Health Inc. recalls Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx Only, Single-Dose…
Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically,…
- 2025-02-19
- US
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG4; 2) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog…
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
FDA · DeviceCardinal Health 200, LLCWorldwide distribution - US Nationwide and the countries of Canada, Saudi…Official notice → - 2025-01-22
- US
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM1; 2 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM3; 3 )…
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
FDA · DeviceCardinal Health 200, LLCWorldwide distribution - US Nationwide and the countries of Canada, Saudi…Official notice → - 2024-12-18
- US
Cardinal Health 200, LLC recalls Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back, Product Codes AT6588-2XL, AT6588-BD, AT6588-XL,…
Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancement of Medical Instrumentation) Level…
- 2024-11-20
- US
Cardinal Health 200, LLC recalls Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777
Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack have demonstrated incompatibility with needleless Intravenous (IV) connectors. Cardinal Health…
- 2024-10-02
- US
Cardinal Health 200, LLC recalls (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888266114,…
The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.
FDA · DeviceCardinal Health 200, LLCDistribution was nationwide, including Puerto Rico and Guam. There was also…Official notice → - 2024-07-17
- US
Cardinal Health 200, LLC recalls Presource kits and trays, labeled as: 1) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC3; 2) Cardiovascular Procedure Kit,…
Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical¿ supplied finished kits. Merit Medical¿…
- 2024-05-22
- US
Cardinal Health 200, LLC recalls CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9.5 cm), Model 44102, Sterile, Hypoallergenic.
Potential contamination of the product with latex adhesive residual.
- 2024-05-08
- US
Cardinal Health 200, LLC recalls Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr., REF SU130-401D
Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.
FDA · DeviceCardinal Health 200, LLCWorldwide distribution - US Nationwide and the countries of Panama, Guatemala,…Official notice → - 2024-02-28
- US
Cardinal Health 200, LLC recalls Dover" IRRIGATION 1200 CC TRAY, 60 CC PISTON SYRINGE, STERILE SALINE, TIP PROTECTOR, ALCOHOL, LIDDED
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
- 2024-02-14
- US
Cardinal Health 200, LLC recalls Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 401SE
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health…
FDA · DeviceCardinal Health 200, LLCDistribution US nationwide and Canada. Foreign distribution updated 9/6/2024…Official notice → - US
Cardinal Health 200, LLC recalls Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SE
The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends…
FDA · DeviceCardinal Health 200, LLCDistribution US nationwide and Canada. Foreign distribution updated 9/6/2024…Official notice → - 2024-01-24
- US
Cardinal Health 200, LLC recalls CardinalHealth Suction Canister Liner, MEDI-VAC CRD, REF 65651-510
The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard…
- 2023-11-29
- US
Cardinal Health Inc. recalls LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, 0.3%); 0.33 FL OZ (10 mL) dropper bottle, Sterile,…
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
- 2023-11-01
- US
Cardinal Health 200, LLC recalls Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack
Demonstrated recognition and compatibility issues with syringe infusion pumps.
FDA · DeviceCardinal Health 200, LLCUS Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID,…Official notice → - 2023-10-25
- US
Cardinal Health 200, LLC recalls Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777
Syringe contains conical tip that is not compatible with certain needleless IV connector(s).
FDA · DeviceCardinal Health 200, LLCNationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL,…Official notice → - 2023-10-18
- US
Cardinal Health 200, LLC recalls Procedure packs: (1) Presource PBDS Cat. PN33BPCR2, Kit, Back, Sterile; (2) Presource PBDS Cat. POCGANA11, Kit, ARN Anterior Hip,…
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FDA · DeviceCardinal Health 200, LLCWorldwide distribution - US Nationwide distribution in the states of AZ, CA,…Official notice → - US
Cardinal Health 200, LLC recalls Procedure pack: Presource PBDS Cat. PLMHCSBHF, Hermann Hospital MHHS, Kit, C Section B MHHS, Sterile.
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
FDA · DeviceCardinal Health 200, LLCWorldwide distribution - US Nationwide distribution in the states of AZ, CA,…Official notice → - 2023-07-26
- US
Cardinal Health 200, LLC recalls NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010
Cardinal Health has received an increase in burst/leaking complaints from mid-April to May regarding the above listed lot of the Novalplus Infant Heel Warmer with tape.
- 2023-06-14
- US
Cardinal Health 200, LLC recalls Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery
Inadvertently released for distibution without sterility assurance.
- 2023-03-01
- US
Cardinal Health 200, LLC recalls Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device CATALOG #: 01-5799A
Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which may lead to fluid leaks and loss of fluid path integrity
FDA · DeviceCardinal Health 200, LLCUS Nationwide distribution in the states of GA, PA.Official notice → - 2023-01-25
- US
Cardinal Health 200, LLC recalls Cardinal Health Jackson-Pratt Channel Drain, 32 Fr, REF JP-2292
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product…
FDA · DeviceCardinal Health 200, LLCWorldwide distribution - US Nationwide and the countries of Canada, Saudi…Official notice → - 2022-12-14
- US
Cardinal Health recalls Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter Product Code: 2480 Intended for urinary drainage from the…
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…
- 2022-11-16
- US
Cardinal Health 200, LLC recalls Cardinal Health GEL PACK REUSABLE, SMALL, Cat. 70204
Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates .
- 2022-05-25
- US
Cardinal Health Inc. recalls Trulicity (dulaglutide) injection, 0.75 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, Indianapolis, IN 46285,…
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions
- 2022-04-20
- US
Cardinal Health 200, LLC recalls Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves
Product was distributed without being sterilized.
FDA · DeviceCardinal Health 200, LLCProduct distributed throughout United States and GuamOfficial notice → - 2021-12-22
- US
Cardinal Health recalls RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548
Potential for open packaging seals compromising the sterility of the surgical gowns
FDA · DeviceCardinal HealthWorldwide distribution - US Nationwide and the countries of Chile, Thailand,…Official notice →