Recall archive
105 recalls · page 2 of 5
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 Feb 5, 2024
Cardinal Health recalls Covidien and Cardinal Health Expanded list of Urology and OR room specific kits and trays due to Potential lack of sterility assurance…
Risk not classifiedThe agency has not ranked the risk yet — treat the notice as a caution.Cardinal Health
Matched: Brand · Product · Product details — Potential lack of sterility assurance which could result in non-sterile product
FDA (recalls & safety alerts)
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 Jan 3, 2024
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution (0.5 mg/3 mg per 3 mL), 60 x 3 mL Sterile Unit-Dose Vials…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Healthcare
Matched: Brand — CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
41 more products in this recall
FDA (openFDA drug enforcement)
Reported Dec 7, 2023
Cardinal Health recalls Covidien and Cardinal Health Urology and OR room specific kits and trays due to Potential lack of sterility assurance which could…
Risk not classifiedThe agency has not ranked the risk yet — treat the notice as a caution.Cardinal Health
Matched: Brand · Product · Product details — Potential lack of sterility assurance which could result in non-sterile product
FDA (recalls & safety alerts)
Reported Nov 29, 2023
LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), 0.5…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Cardinal Health Inc.
Matched: Brand · Product details — Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
5 more products in this recall
FDA (openFDA drug 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)
Reported Jul 19, 2023
Original Eye Drops; Redness Reliever; (Tetrahydrozoline HCl), 0.05%, 0.5 FL OZ (15mL); distributed by a) Original…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.K.C. Pharmaceuticals, Inc.
Matched: Product details — CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
1 more product in this recall
FDA (openFDA drug 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 Dec 14, 2022
Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter Product Code: 2480 Intended for urinary…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health
Matched: Brand — Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not…
5 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 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)
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