Recall archive
55 recalls · page 1 of 3
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 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)
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 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 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)
Reported Nov 20, 2024
Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cardinal Health 200, LLC
Matched: Brand · Reason for recall — 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…
FDA (openFDA device enforcement)
Reported Oct 2, 2024
(a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888264929, Sterile;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand · Product · Product details — The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 17, 2024
Presource kits and trays, labeled as: 1) ANGIOGRAPHY PACK, Catalog Number SAN13BS605; 2) ANGIOGRAPHY PACK, Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand · Product details · Reason for recall — Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli)…
3 more products in this recall
FDA (openFDA device enforcement)
Reported May 22, 2024
CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9.5 cm), Model 44102, Sterile,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand · Product · Product details — Potential contamination of the product with latex adhesive residual.
FDA (openFDA device enforcement)
Reported May 8, 2024
Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr., REF SU130-401D
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand · Reason for recall — Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 28, 2024
Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline 18 Fr/Ch (6.0mm); Argyle" Suction Catheter Tray with…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cardinal Health 200, LLC
Matched: Brand — Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
9 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 14, 2024
Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cardinal Health 200, LLC
Matched: Brand · Product · Product details · Reason for recall — The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain…
12 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 24, 2024
CardinalHealth Suction Canister Liner, MEDI-VAC CRD, REF 65651-510
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand · Product · Product details · Reason for recall — 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…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 1, 2023
Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cardinal Health 200, LLC
Matched: Brand — Demonstrated recognition and compatibility issues with syringe infusion pumps.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 25, 2023
Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand — Syringe contains conical tip that is not compatible with certain needleless IV connector(s).
FDA (openFDA device enforcement)
Reported Oct 18, 2023
Procedure packs: (1) Presource Pain Tray, Catalog SBAHFPTAS2, Advanced Surgery Center SAR, Sterile. (2) Presource Block…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand — Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
9 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 26, 2023
NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand · Reason for recall — Cardinal Health has received an increase in burst/leaking complaints from mid-April to May regarding the above listed lot of the Novalplus Infant…
FDA (openFDA device enforcement)
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