Recall archive
59 recalls · page 2 of 3
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)
Reported Jun 14, 2023
Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand — Inadvertently released for distibution without sterility assurance.
FDA (openFDA device enforcement)
Reported Mar 1, 2023
Cardinal Health Presource Packs IV START KIT- Intended for IV access device CATALOG #: 01-5798B
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand · Product · Product details — Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 25, 2023
Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2186
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 — Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains…
27 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 16, 2022
Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand · Product · Product details — 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…
7 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 20, 2022
Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand · Product · Product details — Product was distributed without being sterilized.
FDA (openFDA device enforcement)
Reported Aug 25, 2021
Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to insert an…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cardinal Health 200, LLC
Matched: Brand — The current Argyle UVC Insertion Tray does not include a specific IFU to operate the Safety Scalpel N11. The Safety Scalpel N11 features a permanent…
FDA (openFDA device enforcement)
Reported Jul 28, 2021
Infant Heel Warmer with Attachment Tab, Nonsterile, Active Product SKU MH00002T The infant heel warmer is activated at…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand — A caution statement is being added to remind the user to activate away from face and infant as reports of pack rupture or leaking during activation…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 14, 2021
Sterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525 - Product Usage: intended to be used as…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand — The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the…
7 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 14, 2021
Enteral Infusion Pump
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand — The potential for air appearing in the enteral feed pumping set tubing during set-up.
FDA (openFDA device enforcement)
Reported Mar 31, 2021
In-View Clear Leggings Sterile
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 determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 24, 2021
Magellan Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single lumen needle intended to inject fluids…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand — Safety shield not locking into the cannula. If the safety shield activation fails to lock a contaminated needle, a needlestick may occur and there is…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 17, 2021
Covidien ChemoPlus Chemo Spill Kit, Nonsterile, SKU DP5108K
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand — Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.
18 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 25, 2020
Kangaroo Connect 500ml Bag Set, Non-Sterile, Product Code 77500FD - Product Usage: single-use tubing sets used with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand — The feeding spike sets may leak at the interface of the tube and spike connector.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 11, 2020
Covidien MONOJECT Standard Hypodermic Needle, Polypropylene Hub 22 G x 3/4". Intended use to facilitate activities such…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand — Potential for the needle to detach from the cartridge after the bottom of the cartridge is twisted and removed. If the needle is not securely seated,…
FDA (openFDA device enforcement)
Reported Oct 7, 2020
KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S. aureus.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand — Only providing one nasal swab in our pre-operative kit instead of the 4 required for proper treatment.
FDA (openFDA device enforcement)
Reported Sep 9, 2020
PROTEXIS Latex Micro Surgical Gloves Size 5.5 - Product Usage: This surgeon s glove is a disposable device made of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand — A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.
7 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 15, 2020
Cardinal Health NPWT Canister with Gel 300cc, Prescription Only - Product Usage: The systems are intended for use on…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Brand · Product · Product details — Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device.
1 more product in this recall
FDA (openFDA device enforcement)
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 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 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)
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