Recall archive
105 recalls · page 4 of 5
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)
Reported Nov 2, 2016
The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringes. It is designed…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.AccessClosure, Inc., A Cardinal Health Company
Matched: Brand — AccessClosure, Inc. (ACI) is voluntarily recalling the PAXWIRE Occlusion Balloon System device because it was made aware from customers that the…
FDA (openFDA device enforcement)
Reported Oct 19, 2016
V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand — Potential risk associated with corrosion demonstrated on the distraction screw surface.
FDA (openFDA device enforcement)
Reported Oct 12, 2016
BLUE IMPERVIOUS GOWN WITH THUMBHOOKS, X-LARGE. Non-Sterile, Single Use Only, Plastic Non-Surgical Isolation Gown…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health
Matched: Brand — Blue Impervious Gown with thumbhooks, X-large. All lots do not meet design specifications, specifically 16 CFR 1611 - Standard for the Flammability…
FDA (openFDA device enforcement)
Reported Sep 7, 2016
The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas, Electrolyte and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health
Matched: Brand — Arterial Blood Gas (ABG) Kit- Missing Safety Component. The ABG Kit(s) have been identified as missing the locking clasp component. CareFusion/BD has…
FDA (openFDA device enforcement)
Reported Aug 10, 2016
6F/7F MynxGrip Vascular Closure Device; Product Model MX6721, Product Usage: The 6F/7F MynxGrip Vascular Closure Device…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.AccessClosure, Inc., A Cardinal Health Company
Matched: Brand — A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/packaging configurations.
FDA (openFDA device enforcement)
Reported Apr 13, 2016
Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during circumcision of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health
Matched: Brand — Two lots of Gomco Style Circumcision Clamp Trays, SSI-0034 and 10-1100 contained a 1.3cm circumcision clamp. They both were labelled as containing a…
FDA (openFDA device enforcement)
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