Recall archive
111 recalls · page 1 of 5
In the agency's Nov 11, 2026 enforcement report
Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cardinal Health 200, LLC
Matched: Brand · Product · Product details — Kits contain infusion sets which were recalled for performance issues.
6 more products in this recall
FDA (weekly enforcement report)
Reported Oct 14, 2026Updated Oct 20, 2026
Presource Packs containing Medtronic Microstream Components: Intubation Kit Catalog Numbers AN23366084 AN23366085…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand — Kits contain Microstream components. Medtronic issued an update to the Instructions for Use of these components due reports of difficulty in…
FDA (openFDA device enforcement)
Reported Oct 14, 2026Updated Oct 20, 2026
Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.K.C. Pharmaceuticals, Inc.
Matched: Product details — Lack of Assurance of Sterility
6 more products in this recall
FDA (openFDA drug enforcement)
Reported Oct 7, 2026Updated Oct 13, 2026
McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001; Alere hCG Cassette (20 mIU/mL) in Urine, Model/ Part:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alere San Diego, Inc.
Matched: Product details — hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 7, 2026Updated Oct 13, 2026
Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAP CHOLE , Catalog Number: PGCGLCBAC; 2)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand — The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 30, 2026Updated Oct 6, 2026
Presource Convenience Kits: 1) KIT, PRE OP , Catalog Number: AMN548616A; 2) KIT, NICU ADMIT NEW HAN , Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand — The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 9, 2026Updated Sep 14, 2026
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GYN ROBOTIC GSAM ,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand — The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing…
11 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 19, 2026Updated Aug 25, 2026
Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD , Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand · Product · Product details — Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
7 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 8, 2026
A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit
High riskUsing this product could cause serious injury, illness or death — stop using it now.Windstone Medical Packaging, Inc.
Matched: Reason for recall — Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis)…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 8, 2026
Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand · Product · Product details — The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the…
FDA (openFDA device enforcement)
Reported Mar 25, 2026
Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply, 200 count boxes, Cardinal Health 200 LLC 3651 Birchwood Drive,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cardinal Health 200, LLC
Matched: Brand · Product · Product details — Non-Sterility: microbial contamination identified as Paenibacillus phoenicis
FDA (openFDA drug enforcement)
DrugsReported Mar 20, 2026Updated Sep 18, 2026
Cardinal Health recalls Webcol Large Alcohol Prep Pads (70% isopropyl alcohol) due to Microbial Contamination
Risk not classifiedThe agency has not ranked the risk yet — treat the notice as a caution.Cardinal Health
Matched: Brand · Product — Microbial Contamination
FDA (recalls & safety alerts)
Reported Mar 18, 2026
Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Number: DYNJ902487A; 2)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medline Industries, LP
Matched: Product · Product details · Reason for recall — The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 4, 2026
Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand · Product · Product details — The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years…
FDA (openFDA device enforcement)
Reported Dec 17, 2025
ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand — Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the…
FDA (openFDA device enforcement)
Reported Oct 29, 2025
Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 8888264929E ENFit"…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand — Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 3, 2025
Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled syringes further packaged in bags of 5…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health Inc.
Matched: Brand — Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
FDA (openFDA drug enforcement)
Reported Aug 13, 2025
Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health Inc.
Matched: Brand — CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Jun 18, 2025
SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand — Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 4, 2025
Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand — Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
5 more products in this recall
FDA (openFDA device enforcement)
Reported May 7, 2025
Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health Inc.
Matched: Brand · Reason for recall — Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error…
FDA (openFDA drug enforcement)
Reported Feb 19, 2025
Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog Number:PB23DFCM3; 2) KIT,DIEP FLAP , Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand · Product · Product details — Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
11 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2025
Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951; 2) KIT,ORP PLASTIC FLAP,Catalog Number…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand · Product · Product details — Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
9 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 18, 2024
Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand — Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI…
1 more product in this recall
FDA (openFDA device enforcement)
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