Recall archive
111 recalls · page 4 of 5
Reported Mar 18, 2020
Monoject 3mL Syringe with Hypodermic Safety Needle, 22G x 1-1/2 . Item Code 11832215 - Product Usage: used for general…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand — Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 11, 2020
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Outpatient Major 89-3865.12;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Deroyal Industries, Inc. Lafollette
Matched: Product · Product details · Reason for recall — Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
9 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 26, 2020
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand — The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 19, 2020
Leader Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer,100-count bottles,Distributed by…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Contract Pharmacal Corporation
Matched: Product details — Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength…
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Feb 12, 2020
Genius 2 Tympanic Thermometer (discontinued) Item Code: 303000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand — The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 12, 2020
AAMI 3 FABRIC REINFORCEDGown 2XL NS, Item Code 9571NA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health
Matched: Brand — The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
38 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 1, 2020
S.M.A.R.T. Nitinol Stent System and the S.M.A.R.T. Control Nitinol Stent System. The SMART stent system includes a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health Inc.
Matched: Brand — 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…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 13, 2019
Cardinal Health Brand 120mL/53mm sterile specimen container with orange cap, 75 pieces/pack, 4 packs/case Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Thermo Fisher Scientific (Monterrey)
Matched: Product · Product details · Reason for recall — Cardinal Health branded specimen containers, may potentially contain plastic shavings on threaded surfaces between the closure and vial
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 2, 2019
Nucala (mepolizumab) Injection, 100 mg/mL Prefilled Syringe, Single-Dose, For subcutaneous use only, Rx Only,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health dba Specialty Pharmaceutical Services
Matched: Brand — Temperature Abuse; Product stored and shipped outside of labeled storage requirements.
FDA (openFDA drug enforcement)
Reported Aug 21, 2019
Cardinal Health Jackson-Pratt Channel Drain 15FR Cardinal PN:JP-2223 An introduction/drainage catheter is a device that…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Degania Silicone, Ltd.
Matched: Product · Product details — 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile…
7 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 31, 2019
Monoject Standard Hypodermic Needle, 14 G x 1-1/2" Item code: 8881200011
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand — Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
16 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 24, 2019
DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07 custom surgical pack
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DeRoyal Industries Inc.
Matched: Reason for recall — Custom surgical packs are being recalled because it contains Cardinal Health Blunt Cannulas which were recalled due to a manufacturing defect in the…
FDA (openFDA device enforcement)
Reported May 15, 2019
ChemoPlus Chemo Spill Kit Product Code:CT4004 Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand — Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap
3 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 6, 2019
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…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand — Curity All Purpose Sponges were not sterilized and distributed
FDA (openFDA device enforcement)
Reported Jan 16, 2019
Presource Kit Total Joint Pack containing a double-wrapped basin component. Product Usage: This kit is used on patients…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health Inc.
Matched: Brand — The double wrapping of this custom kit basin set is not supported by the current sterility assurance validation.
FDA (openFDA device enforcement)
Reported Dec 26, 2018
Protexis Neoprene Surgical Glove, Size 5.5 This powder-free sterile light brown colored surgeons gloves are a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand — Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary…
7 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 25, 2018
Presource PBDS, Kit, Common Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand — A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a limited portion of the kit.
14 more products in this recall
FDA (openFDA device enforcement)
Reported May 9, 2018
Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: a) REF 6561-910C b) REF 6561-916K c) REF…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand · Product details — products may be missing a one-way valve on the fluid patient port.
FDA (openFDA device enforcement)
Reported Oct 11, 2017
Magnesium Citrate Oral Solution Lemon Flavor, 1.745g per fl oz, packaged in 10 fl. oz. (296 mL) bottles, Labeled as a)…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Vi-Jon, Inc.
Matched: Product details — Failed Impurities/Degradation Specifications.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Sep 13, 2017
Presource(R) Kits (custom surgical/procedural kits): The standard and custom kits are packed with all of the specific…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand — The firm manufactured and distributed Presource(R) kits which contained BD SafetyGlide" 22GA 1¿ inch Needles. BD subsequently recalled these needles…
FDA (openFDA device enforcement)
Reported Aug 30, 2017
Convertors Robotic Drape with Attached Leggings; Product is packaged as Single Sterile Drape/8 per Case
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand — Product 29474 LAVH drape was packaged as 29574 Robotic Drape with Leggings.
FDA (openFDA device enforcement)
Reported Aug 2, 2017
Converters(R) Under Buttocks Drape with Fluid Control Pouch II, REF 8482, STERILE R, Qty. 1, Cardinal Health, Waukegan,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand · Product · Product details — Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot number 9414, Lot 16LUS317 do not match the drape…
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 31, 2017
Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drain,19FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand — Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an…
19 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 1, 2017
Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Sterile. Rx Distributed by Cardinal Health, USA…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Degania Silicone, Ltd.
Matched: Product · Product details — Product sterility compromised due to breach of sterile barrier
FDA (openFDA device enforcement)
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