Recall archive
111 recalls · page 3 of 5
Reported May 25, 2022
Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Prefilled Pens per box, Marketed by Lilly…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cardinal Health Inc.
Matched: Brand — TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
2 more products in this recall
FDA (openFDA drug 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 Dec 22, 2021
SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health
Matched: Brand — Potential for open packaging seals compromising the sterility of the surgical gowns
10 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 10, 2021
Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned Medical…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Windstone Medical Packaging, Inc.
Matched: Reason for recall — Monoject 0.9% Sodium Chloride Flush Syringe Manufactured by Cardinal Health and placed into kits. Potential for the plunger to draw back after air…
FDA (openFDA device enforcement)
Reported Oct 27, 2021
Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole magnesium), 24 Hour, 14-count capsules…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dr. Reddy's Laboratories, Inc.
Matched: Product details — CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
FDA (openFDA drug enforcement)
Reported Sep 1, 2021
Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8881570121 The proposed device is…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cardinal Health
Matched: Brand — Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
2 more products in this recall
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 Jun 30, 2021
FREESTYLE LANCETS 28G 100CT Item Number:2975670
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health Inc.
Matched: Brand — Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which…
13 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 2, 2021
THERAPEUTIC M 130; NDC/UPC 740985223680; OTC; TABLETS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health Inc.
Matched: Brand — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
197 more products in this recall
FDA (openFDA drug 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 Apr 7, 2021
Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe per carton, Rx only, Manufactured by:…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Cardinal Health Inc.
Matched: Brand — Temperature Abuse
FDA (openFDA drug 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 21, 2020
Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alcon Research, LLC
Matched: Product · Product details — The third-party brand latex micro surgical gloves packaged within specific custom packs may have a degradation defect that could lead to holes and…
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 Jun 3, 2020
Kangaroo Joey Safety Screw Spike with Flush Bag, Anti-free Flow,1000 mL, Product Code 765100
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health Inc.
Matched: Brand — The feeding spike sets may leak at the interface of the tube and spike connector.
5 more products in this recall
FDA (openFDA device enforcement)
Reported May 27, 2020
B-Hydroxybutyrate LiquiColor, Item code CH2440058 - Product Usage: Product is used for the quantitative determination…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health Inc.
Matched: Brand — Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature…
2 more products in this recall
FDA (openFDA device enforcement)
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