FDA Device Recalls

Recalls / Firms / Cardinal Health

Cardinal Health

168 FDA device recalls on record.

DateClassProductReason
2022-11-01—Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 100
2022-11-01—Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter Product Code: 2480 In
2022-11-01—Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 14 Fr/Ch (4.7 mm) Product Code
2022-11-01—Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 100
2022-11-01—Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended for urinary drainage fro
2022-11-01—Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch (5.3 mm) Product Code:
2021-11-02—Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010
2021-11-02—SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011
2021-11-02—SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041EL
2021-11-02—Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040
2021-11-02—RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548
2021-11-02—RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578
2021-11-02—Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070
2021-11-02—SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474
2021-11-02—RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998
2021-11-02—RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518
2021-11-02—SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041
2021-08-04—Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8881570121 The prop
2021-08-04—Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code 8881570123 The propo
2021-08-04—Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125 The propos
2021-06-16—Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for u
2021-06-09—Infant Heel Warmer without Attachment Tab, Nonsterile, Active Product SKU MH00002N The infant heel
2021-06-09—Infant Heel Warmer with Attachment Tab, Nonsterile, Active Product SKU MH00002T The infant heel wa
2021-02-09—Magellan 3 mL Syringe with Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single lumen
2021-02-09—McKesson PREVENT M NEEDLE (Magellan Technology) 25G X 5/8". A single lumen needle intended to inje
2021-02-09—Magellan Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single lumen needle intended t
2020-09-25—Covidien MONOJECT Standard Hypodermic Needle, Polypropylene Hub 22 G x 3/4". Intended use to facilit
2020-09-22—Kangaroo Connect 1000ml Bag Set, Non-Sterile, Product Code 77100FD - Product Usage: single-use tubin
2020-09-22—Kangaroo Connect 500ml Bag Set, Non-Sterile, Product Code 77500FD - Product Usage: single-use tubing
2020-01-15—Monoject Hypodermic Safety Needle 25G x 5/8" Item Code 1182558 - Product Usage: used for general pu
2020-01-15—Monoject Bluntfill with Filter, 18G x 1-1/2" Item Code 11811022F. Used for drawing fluid from a via
2020-01-15—Monoject Hypodermic Safety Needle 30G X 1/2" Item Code 1183005 - Product Usage: used for general pur
2020-01-15—Monoject 3mL Syringe with Hypodermic Safety Needle, 22G x 1-1/2 . Item Code 11832215 - Product Usage
2020-01-11—AAMI 3 NONREINF SURGICAL GOWN 4XL, Item Code 9599
2020-01-11—AAMI 3 NON-REINF SURG GOWN 2XL BNS, Item Code 9575NB
2020-01-11—AAMI 3 FABREINF SURG GOWN L NS, Item Code 9511NB
2020-01-11—AAMI 3 NON-RNF SURG GOWN 3XL LONG, Item Code 95995N
2020-01-11—ROYALSILK 2XLARGE, Gown. Item Code 9578
2020-01-11—AAMI 3 NON-REINF SURGICAL GOWN XXL, Item Code 9575
2020-01-11—AAMI 3 ROYALSILK SCRBNURGOWN BNS L, Gown. Item Code 90280NC
2020-01-11—AAMI 3 NON-REINF SURG GWN 3XL XLONG, Gown. Item Code 95995
2020-01-11—ROYALSILK LARGE, Gown. Item Code 9518
2020-01-11—AAMI 3 FABREINF SURG GOWN LARGE, Item Code 9511
2020-01-11—ROYALSILK 3XLARGE/XLONG, Gown. Item Code 95998
2020-01-11—AAMI 3 NONREIN SCRBNURGOWN BNS L, Item Code 90270NB
2020-01-11—AAMI 3 NONREIN SCRBNURGOWN BNS XL, Gown. Item Code 90370NB
2020-01-11—AAMI 3 FABRIC REINF SURG GOWN XL NS, Item Code 9541NA
2020-01-11—AAMI 3 NONREIN SURG GOWN L BNS, Item Code 9515NB
2020-01-11—AAMI 3 ROYALSILK SURGGOWN BNS 2XL, Item Code 9578NB
2020-01-11—AAMI 3 ROYALSILK SURGGOWN BNS XL, Item Code 9548NC
2020-01-11—AAMI 3 NONREINF SURG GOWN 3XL BNS, Item Code 9585N
2020-01-11—GOWN SURG LG W/TOWEL ST BACK, Item Code 9515
2020-01-11—AAMI 3 NON-REINF SURG GOWN LG 2 TWL, Item Code ASG9515
2020-01-11—AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB
2020-01-11—AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA
2020-01-11—AAMI 3 ROYALSILK SCRBNURGOWN BNS XL, Gown. Item Code 90380NC
2020-01-11—AAMI 3 FABREINF SCRUB SURG GWN L NS, Gown. Item Code 90970NA
2020-01-11—AAMI 3 NON-REINF SURG GWN XL 2 TWL, Gown Item Code ASG9545
2020-01-11—AAMI 3 FABRIC REINF SURG GOWN XL, Item Code 9541
2020-01-11—AAMI 3 NON-REINF SURGICAL GOWN XL, Item Code 9545
2020-01-11—AAMI 3 NONREINF SURGICAL GOWN 3XL, Item Code 9585
2020-01-11—ROYALSILK 3XLARGE/XLONG NS, Gown Item Code 95998N
2020-01-11—AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB
2020-01-11—AAMI 3 FABRNF SURG GWN XL 2 TOWELS, Gown. Item Code ASG9541
2020-01-11—AAMI 3 FABRIC REINF SURG GOWN 2XL, Item Code 9571
2020-01-11—AAMI 3 FABRNF SURGGWN XL LONG 2 TWL, Gown. Item Code ASG9541EL
2020-01-11—AAMI 3 FABRIC REINFORCEDGown 2XL NS, Item Code 9571NA
2020-01-11—AAMI 3 FABRNF SURG GOWN L 2 TOWELS, Item Code ASG9511
2020-01-11—AAMI 3 NONREINF SURG GOWN 2XL XLONG, Item Code 9575EL
2020-01-11—AAMI 3 NONREIN SURGGOWN BNS XL, Item Code 9545NC
2020-01-11—ROYALSILK XLARGE, Gown. Item Code 9548
2020-01-11—AAMI 3 ROYALSILK SURGGOWN BNS L, Gown. Item Code 9518NC
2019-10-28—Genius 2 Tympanic Thermometer Private Label Item Code: 3069
2019-10-28—Genius 2 Tympanic Thermometer (discontinued) Item Code: 303000
2019-10-28—Genius 3 Tympanic Thermometer- electric thermometer Item Code: 303013
2019-10-28—Genius 2 Tympanic Thermometer OEM Tympanic Item Code:303062
2019-10-28—Genius 2 Tympanic Thermometer OEM Tympanic Item Code: 303063
2019-04-30—Monoject Standard Hypodermic Needle, 14 G x 1-1/2" Item code: 8881200011
2019-04-30—Monoject" 201 Vet Pak Hypodermic Needle, 16 ga x 1-1/2 Item code: 8881201654
2019-04-30—Monoject Standard Hypodermic Needle, 18 G x 1-1/2" Item code: 8881200078
2019-04-30—Monoject Blunt Cannula, 19 G x 1-1/2" (1.067 mm x 3.8 cm) Item code: 8881202355
2019-04-30—Monoject Standard Hypodermic Needle Item code: 8881200029
2019-04-30—Monoject 201 Vet Pak Hypodermic Needle, 18 ga x 1-1/2 Item code: 8881201548
2019-04-30—Monoject 201 Vet Pak Hypodermic Needle, 22 ga x 1-1/2" Item code: 8881201456
2019-04-30—Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code: 8881200037
2019-04-30—Monoject Blunt Cannula, 22 G x 1-1/2" (0.711 mm x 3.8 cm) Item code: 8881202389
2019-04-30—Monoject Blunt Cannula, 16 G x 1-1/2" (1.651 mm x 3.8 cm) Item code: 8881202322
2019-04-30—Monoject Standard Hypodermic Needle, 20 G x 1-1/2" bulk Item code: 8881200664
2019-04-30—Monoject 201 Vet Pak Hypodermic Needle, 20 ga x 1-1/2" Item code: 8881201498
2019-04-30—Monoject Blunt Cannula, 20 G x 1-1/2" (0.902 mm x 3.8 cm) Item code: 8881202363
2019-04-30—Monoject Standard Hypodermic Needle, 27 G x 1-1/4" Item code: 8881200508
2019-04-30—Monoject Blunt Cannula, 15 G x 1-1/2" (1.829 mm x 3.8 cm) Item code: 8881202314
2019-04-30—Monoject 201 Vet Pak Hypodermic Needle, 19 ga x 1-1/2 Item code: 8881201522
2019-04-30—Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code:8881200045
2019-03-22—ChemoPlus Chemo Spill Kit Product Code:DP5016K Product Usage: ChemoPlus chemotherapy spill kits ar
2019-03-22—ChemoPlus Chemo Spill Kit, Home Health Kit Product Code:DP5108K Product Usage: ChemoPlus chemother
2019-03-22—ChemoPlus Chemo Spill Kit Product Code:CT4004 Product Usage: ChemoPlus chemotherapy spill kits are
2019-03-22—ChemoPlus Protective Wrap-around Goggles Product Code:DP5030G Product Usage: ChemoPlus chemotherap
2018-12-27—Curity All Purpose Sponges, Non-woven, 4 Ply, 4" x 4" (10.2 cm x 10.2 cm) Product Code: 8044 - Produ
2016-07-20—BLUE IMPERVIOUS GOWN WITH THUMBHOOKS, X-LARGE. Non-Sterile, Single Use Only, Plastic Non-Surgical Is
2016-06-27—The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas
2016-02-29—Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis dur
2015-08-25—Ambitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal use. Intended to be w
2014-12-23—Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube to facilitate intubation
2012-12-18—Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block;
2012-12-18—Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam Stri
2012-12-18—Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam Strip
2012-12-18—Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/80 Capacity; Sterile; Double Removable Numbered Foam
2012-12-18—Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable
2012-12-18—Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block;
2012-12-18—Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Removable N
2012-12-18—Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable N
2012-12-18—Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 60 Count/100 Capacity; Sterile; Removable
2012-01-27—Presource Custom Sterile Surgical and Procedure Kits containing Ethicon Ethilon Black Nylon Nonabsor
2011-12-23—Presource Custom Sterile Surgical and Procedure Kits; surgical trays; Cardinal Health, McGaw Park, I
2011-12-23—Presource Custom Sterile Surgical and Procedure Kits; general surgery trays; Cardinal Health, McGaw
2011-12-12—Presource Custom Sterile Surgical and Procedure Kits; general surgery trays; Cardinal Health, McGaw
2011-12-12—Presource Custom Sterile Surgical and Procedure Kits; surgical trays; Cardinal Health, McGaw Park, I
2011-09-30—Presource Custom Sterile Surgical and Procedure Kits; general surgery trays; Cardinal Health, McGaw
2011-09-30—Presource Custom Sterile Surgical and Procedure Kits; surgical trays; Cardinal Health, McGaw Park, I
2011-09-03—Presource Custom Sterile Surgical and Procedure Kits; surgical trays; Cardinal Health, McGaw Park, I
2011-09-03—Presource Custom Sterile Surgical and Procedure Kits; general surgery trays; Cardinal Health, McGaw
2011-02-28—Lube Jelly, 1 oz. water-base sterile lubricating jelly, a component of various Presource Custom Ster
2011-01-28—Innovate Esmark Bandages, a component of various Presource Custom Sterile Packs/Presource PBDS Modul
2010-08-16—Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 5 mm (3/16"), Length
2010-08-16—Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 6 mm (1/4"), Length:
2010-08-16—Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 7 mm (9/32"), Length
2010-08-16—Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 5 mm (3/16"), Length
2010-08-16—Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 7 mm (9/32"), Length
2010-08-16—Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 5 mm (3/16"), Length
2010-08-16—Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 7 mm (9/32"), Length
2010-08-16—All Presource Kits that contain Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors; Ster
2010-08-16—Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 6 mm (1/4"), Length:
2010-08-16—Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 6 mm (1/4"), Length:
2010-04-01—Disposable Skin Stapler - 35 Wide; Surgical Skin Stapler; Rx, sterile, single use skin stapler, indi
2009-08-28—Cardinal Health, Craig Calibrated Cannula, overall length 5-3/8" (13.7 cm), catalog #OS5000-005, sol
2009-04-24—Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic polyisoprene
2009-04-24—Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic polyisoprene
2009-04-24—Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic polyisoprene
2009-04-24—Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic polyisoprene
2009-04-24—Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic polyisoprene
2009-04-24—Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic polyisoprene
2009-04-24—Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic polyisoprene
2009-04-24—Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic polyisoprene
2008-11-18—Esmark Elastic Bandage, 4" x 3 yards, sterile, for single use only, latex free. Distributed by Card
2008-11-18—Esmark Elastic Bandage, 3" x 4 yards, sterile, for single use only, latex free. Distributed by Card
2008-06-25—Corflo Anti-I.V. NG Tube for Pediatric and Neonatal Use; a sterile clear polyurethane with orange ra
2008-02-12—Presource Standard Sterile OR Scissors; straight scissors, S/B, 5.5", made in Pakistan; individually
2008-01-04—AirLife Infant nCPAP System Driver (Catalog No: 006900;) a nasal continuous positive airway pressure
2007-06-01—AirLife nCPAP System Driver; a nasal continuous positive airway pressure device, which is part of a
2006-09-27—Cardinal Health Sterile Presource PBDS Modules, have Presource Custom Sterile Packs containing the C
2006-09-27—Presource Custom Sterile Packs containing the Cardiovascular Split Drape II; the custom sterile pack
2006-09-27—Cardiovascular Split Sheet II, Bulk Non-Sterile; 130 units per box; Cardinal Health, McGaw Park, IL
2006-09-27—Convertors Tiburon Cardiovascular Split Drape II, Sterile, for single use only; Cardinal Health, McG
2006-09-27—Convertors Cardiovascular Split Pack II, the pack contains 1 Tiburon Cardiovascular Split Drape II a
2005-10-03—Cardinal Health Custom Sterile Latex Free Convenience Kits; sterile single use disposable devices pa
2005-10-03—Cardinal Health Presource PBDS Latex Free Convenience Kits; sterile single use disposable devices pa
2004-07-28—Jackson-Pratt Hemaduct, 15 Fr round, full duct silicone wound drain; a sterile, single use only, Rx
2004-07-28—Jackson-Pratt Reservoir, 400 mL suction reservoir; a sterile, single use only, Rx device used as a c
2003-12-11—Healon GV, 14 mg per mL, Sodium Hyaluronate, 0.55 ml each, supplied with sterile single-use cannula,
2003-11-15—Custom Sterile Cardiac Cath Pack, catalog SAN25CCEAQ, Cardinal Health, McGaw Park, IL 60085 USA
2003-11-03—Prolene Polyproplyene Mesh, 3'' x 6'', Nonabsorbable Synthetic Surgical Mesh; six packages per box;
2003-06-27—Catalog SBA35GSMOG, Sterile General Surgery Pack, Mfg date 5/21/03, order 101467;
2003-06-27—Catalog SBA61MJSFH, Sterile Laparotomy Pack, Mfg date 5/21/03, order 101438;
2003-06-27—Catalog SBA21MAHVJ, Sterile Major Abdominal Pack, Mfg date 5/22/03, Exp date 1/01/05, order 101491
2003-06-27—Catalog SBA11GLMMD, Sterile General Local Tray, Mfg date 5/20/03, exp date 1/01/05, order 101466;
2003-06-27—Custom Sterile Surgical Procedure Packs; Allegiance Healthcare Corporation, McGaw Park, IL 60085 USA
2003-06-02—Temno Chiba FIne Needle Aspiration, Soft Tissue Biopsy Needle, 18 GA x 15 cm., product CHI1815, Alle