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Cardinal Health 200 Recalls
285 recalls on record · October 19, 2016 to August 19, 2026 · Drugs, Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
February 19, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC12; 2) CHI STD NEURO CRANI OPT 1, C
Hazard: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
February 19, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA; 2) KIT,ROBOTIC HYSTERECTOMY, Ca
Hazard: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
February 19, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG4; 2) KIT,NASAL SEPTOPLASTY,FA
Hazard: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
February 19, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET0979N;
Hazard: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
February 19, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF104; 2) KIT,MAXILLOFACIAL,PRES
Hazard: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
February 19, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110B; 2) KIT, CAROTID ENDARTERECTO
Hazard: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
February 19, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFA; 2) UROLOGY ROBOTIC PACK, Catalog N
Hazard: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
February 19, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMM14; 2) KIT,NEURO LAMI,MD ANDERSON
Hazard: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
February 19, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog Number:PB23DFCM3; 2) KIT,DIEP FLAP
Hazard: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
January 22, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) KIT, H N FREE FLAP, Catalog Number: PEHFHNAMHJ; 2) KIT,H N FREE FLAP , Catalog Num
Hazard: Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
January 22, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLY; 2) ORTHO PLASTIC MICROVAS
Hazard: Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
January 22, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) CRANIOTOMY PACK, Catalog Number: 2NE69CNK12; 2) CHI STD NEURO CRANI OPT 4, Catalog
Hazard: Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
January 22, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1 ) KIT, FETAL SURGERY, Catalog Number PB11FSC10 2 ) KIT, FETAL SURGERY , Catalog Numb
Hazard: Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
January 22, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 0 ) DESCRIPTION Catalog Number: CATALOG #; 1 ) KIT, NASAL , Catalog Number: PE23NSME
Hazard: Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
January 22, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH2 ; 2 ) LARYNGOSCOPY PACK, Catalog Num
Hazard: Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
January 22, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1 ) KIT, MAJOR ORAL SURGERY, Catalog Number: PGDHMOWOE; 2 ) ORP DENTAL PACK , Catalog
Hazard: Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
January 22, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM1; 2 ) ANEURYSM PACK , Catalog Number: SC
Hazard: Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
January 22, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHH1:; 2 ) TRIPLE ENDO PACK, Catalog Numbe
Hazard: Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
January 22, 2025Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951; 2) KIT,ORP PLASTIC FLAP,Catalog Number
Hazard: Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
December 18, 2024Medical DevicesFDA
Cardinal Health 200, LLC recalls Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back, Product Codes AT6588-2XL, AT6588-BD, AT658
Hazard: Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancement of Medical Instrumentation) Level 3 protection requirements.
December 18, 2024Medical DevicesFDA
Cardinal Health 200, LLC recalls Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL
Hazard: Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancement of Medical Instrumentation) Level 3 protection requirements.
November 20, 2024Medical DevicesFDA
Cardinal Health 200, LLC recalls Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777
Hazard: 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 with needleless Intravenous (IV) connectors. Cardinal Health recommends that they not be used for administration of IV push insulin via needleless connector.
October 2, 2024Medical DevicesFDA
Cardinal Health 200, LLC recalls (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model
Hazard: The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.
October 2, 2024Medical DevicesFDA
Cardinal Health 200, LLC recalls (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888264929, Sterile;
Hazard: The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.
July 17, 2024Medical DevicesFDA
Cardinal Health 200, LLC recalls Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number SAN29NICCA; 2) Neurological Tray, Catalog
Hazard: Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical¿ supplied finished kits. Merit Medical¿ supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical¿ kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk of patient harm such as inaccurate dosing and a leaking device.
July 17, 2024Medical DevicesFDA
Cardinal Health 200, LLC recalls Presource kits and trays, labeled as: 1) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC3; 2) Cardiovascular P
Hazard: Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical¿ supplied finished kits. Merit Medical¿ supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical¿ kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk of patient harm such as inaccurate dosing and a leaking device.
July 17, 2024Medical DevicesFDA
Cardinal Health 200, LLC recalls Presource kits and trays, labeled as: 1) Cardiac Catheterization Kit, Catalog Number SAN69CCKRB; 2) Cardiac Cathete
Hazard: Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical¿ supplied finished kits. Merit Medical¿ supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical¿ kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk of patient harm such as inaccurate dosing and a leaking device.
July 17, 2024Medical DevicesFDA
Cardinal Health 200, LLC recalls Presource kits and trays, labeled as: 1) ANGIOGRAPHY PACK, Catalog Number SAN13BS605; 2) ANGIOGRAPHY PACK, Catalog Nu
Hazard: Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical¿ supplied finished kits. Merit Medical¿ supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical¿ kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk of patient harm such as inaccurate dosing and a leaking device.
May 22, 2024Medical DevicesFDA
Cardinal Health 200, LLC recalls CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9.5 cm), Model 44102, Sterile, Hypoallergeni
Hazard: Potential contamination of the product with latex adhesive residual.
May 8, 2024Medical DevicesFDA
Cardinal Health 200, LLC recalls Jackson-Pratt 3-Spring Reservoir with Silicone Adapters, 400mL, REF SU130-475
Hazard: Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.