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Recall archive

95,413 stored notices, from Jun 20, 2012 to Nov 11, 2026.

111 recalls · page 2 of 5

Medical devices

Reported Nov 20, 2024

Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Cardinal Health 200, LLC

Matched: Brand · Reason for recall — Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack have demonstrated incompatibility…

FDA (openFDA device enforcement)

Medical devices

Reported Oct 16, 2024

Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Windstone Medical Packaging, Inc.

Matched: Product · Product details — Due to convenience kits containing a kit component that is under a recall action for improper use.

4 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Oct 2, 2024

(a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888264929, Sterile;…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Cardinal Health 200, LLC

Matched: Brand · Product · Product details — The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Jul 31, 2024

Brand Name: Perfusor Space Product Name: Perfusor Space Infusion Pump System Model/Catalog Number: 8713030U Product…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

B Braun Medical Inc.

Matched: Reason for recall — Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to…

4 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Jul 17, 2024

Presource kits and trays, labeled as: 1) ANGIOGRAPHY PACK, Catalog Number SAN13BS605; 2) ANGIOGRAPHY PACK, Catalog…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Cardinal Health 200, LLC

Matched: Brand · Product details · Reason for recall — Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli)…

3 more products in this recall

FDA (openFDA device enforcement)

Medical devices

Reported May 22, 2024

CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9.5 cm), Model 44102, Sterile,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Cardinal Health 200, LLC

Matched: Brand · Product · Product details — Potential contamination of the product with latex adhesive residual.

FDA (openFDA device enforcement)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Drugs

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)

Medical devices

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)

Drugs

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Drugs

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

Medical devices

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)

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