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Cardinal Health

112 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter Product Code recall (Z-0356-2023)Cardinal Health2022-12-02
Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch (5.3 mm) Prod recall (Z-0357-2023)Cardinal Health2022-12-02
Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 14 Fr/Ch (4.7 mm) Prod recall (Z-0358-2023)Cardinal Health2022-12-02
Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended for urinary dra recall (Z-0359-2023)Cardinal Health2022-12-02
Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connec recall (Z-0360-2023)Cardinal Health2022-12-02
Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connec recall (Z-0361-2023)Cardinal Health2022-12-02
AAMI 3 FABRIC REINFORCEDGown 2XL NS, Item Code 9571NA recall (Z-1002-2020)Cardinal Health2020-01-24
AAMI 3 NON-REINF SURG GOWN 2XL BNS, Item Code 9575NB recall (Z-1003-2020)Cardinal Health2020-01-24
AAMI 3 FABREINF SURG GOWN L NS, Item Code 9511NB recall (Z-1004-2020)Cardinal Health2020-01-24
AAMI 3 FABREINF SCRUB SURG GWN L NS, Gown. Item Code 90970NA recall (Z-1005-2020)Cardinal Health2020-01-24
AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB recall (Z-1006-2020)Cardinal Health2020-01-24
AAMI 3 NONREIN SCRBNURGOWN BNS XL, Gown. Item Code 90370NB recall (Z-1007-2020)Cardinal Health2020-01-24
AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB recall (Z-1008-2020)Cardinal Health2020-01-24
AAMI 3 ROYALSILK SCRBNURGOWN BNS L, Gown. Item Code 90280NC recall (Z-1009-2020)Cardinal Health2020-01-24
AAMI 3 ROYALSILK SCRBNURGOWN BNS XL, Gown. Item Code 90380NC recall (Z-1010-2020)Cardinal Health2020-01-24
AAMI 3 ROYALSILK SURGGOWN BNS L, Gown. Item Code 9518NC recall (Z-1011-2020)Cardinal Health2020-01-24
AAMI 3 ROYALSILK SURGGOWN BNS XL, Item Code 9548NC recall (Z-1012-2020)Cardinal Health2020-01-24
AAMI 3 ROYALSILK SURGGOWN BNS 2XL, Item Code 9578NB recall (Z-1013-2020)Cardinal Health2020-01-24
ROYALSILK 3XLARGE/XLONG NS, Gown Item Code 95998N recall (Z-1014-2020)Cardinal Health2020-01-24
AAMI 3 NON-RNF SURG GOWN 3XL LONG, Item Code 95995N recall (Z-1015-2020)Cardinal Health2020-01-24
AAMI 3 NONREIN SCRBNURGOWN BNS L, Item Code 90270NB recall (Z-1016-2020)Cardinal Health2020-01-24
AAMI 3 FABRIC REINF SURG GOWN XL NS, Item Code 9541NA recall (Z-1017-2020)Cardinal Health2020-01-24
AAMI 3 NONREIN SURG GOWN L BNS, Item Code 9515NB recall (Z-1018-2020)Cardinal Health2020-01-24
AAMI 3 NONREIN SURGGOWN BNS XL, Item Code 9545NC recall (Z-1019-2020)Cardinal Health2020-01-24
AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA recall (Z-1020-2020)Cardinal Health2020-01-24
AAMI 3 NONREINF SURG GOWN 3XL BNS, Item Code 9585N recall (Z-1021-2020)Cardinal Health2020-01-24
ROYALSILK LARGE, Gown. Item Code 9518 recall (Z-1022-2020)Cardinal Health2020-01-24
ROYALSILK 2XLARGE, Gown. Item Code 9578 recall (Z-1023-2020)Cardinal Health2020-01-24
ROYALSILK 3XLARGE/XLONG, Gown. Item Code 95998 recall (Z-1024-2020)Cardinal Health2020-01-24
AAMI 3 FABRIC REINF SURG GOWN XL, Item Code 9541 recall (Z-1025-2020)Cardinal Health2020-01-24
AAMI 3 FABRIC REINF SURG GOWN 2XL, Item Code 9571 recall (Z-1026-2020)Cardinal Health2020-01-24
ROYALSILK XLARGE, Gown. Item Code 9548 recall (Z-1027-2020)Cardinal Health2020-01-24
AAMI 3 NON-REINF SURGICAL GOWN XXL, Item Code 9575 recall (Z-1028-2020)Cardinal Health2020-01-24
AAMI 3 NONREINF SURG GOWN 2XL XLONG, Item Code 9575EL recall (Z-1029-2020)Cardinal Health2020-01-24
AAMI 3 NONREINF SURGICAL GOWN 4XL, Item Code 9599 recall (Z-1030-2020)Cardinal Health2020-01-24
AAMI 3 NON-REINF SURG GWN 3XL XLONG, Gown. Item Code 95995 recall (Z-1031-2020)Cardinal Health2020-01-24
GOWN SURG LG W/TOWEL ST BACK, Item Code 9515 recall (Z-1032-2020)Cardinal Health2020-01-24
AAMI 3 NON-REINF SURGICAL GOWN XL, Item Code 9545 recall (Z-1033-2020)Cardinal Health2020-01-24
AAMI 3 FABRNF SURG GOWN L 2 TOWELS, Item Code ASG9511 recall (Z-1034-2020)Cardinal Health2020-01-24
AAMI 3 FABRNF SURG GWN XL 2 TOWELS, Gown. Item Code ASG9541 recall (Z-1035-2020)Cardinal Health2020-01-24
AAMI 3 FABRNF SURGGWN XL LONG 2 TWL, Gown. Item Code ASG9541EL recall (Z-1036-2020)Cardinal Health2020-01-24
AAMI 3 NON-REINF SURG GOWN LG 2 TWL, Item Code ASG9515 recall (Z-1037-2020)Cardinal Health2020-01-24
AAMI 3 NON-REINF SURG GWN XL 2 TWL, Gown Item Code ASG9545 recall (Z-1038-2020)Cardinal Health2020-01-24
AAMI 3 NONREINF SURGICAL GOWN 3XL, Item Code 9585 recall (Z-1039-2020)Cardinal Health2020-01-24
AAMI 3 FABREINF SURG GOWN LARGE, Item Code 9511 recall (Z-1040-2020)Cardinal Health2020-01-24
Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube to facilitate recall (Z-1054-2015)Cardinal Health2015-02-04
Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Fo recall (Z-0978-2013)Cardinal Health2013-03-28
Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; R recall (Z-0979-2013)Cardinal Health2013-03-28
Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; R recall (Z-0980-2013)Cardinal Health2013-03-28
Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; recall (Z-0981-2013)Cardinal Health2013-03-28
Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; recall (Z-0982-2013)Cardinal Health2013-03-28
Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered F recall (Z-0983-2013)Cardinal Health2013-03-28
Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/80 Capacity; Sterile; Double Removable Num recall (Z-0984-2013)Cardinal Health2013-03-28
Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; recall (Z-0985-2013)Cardinal Health2013-03-28
Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 60 Count/100 Capacity; Sterile; recall (Z-0986-2013)Cardinal Health2013-03-28
Presource Custom Sterile Surgical and Procedure Kits containing Ethicon Ethilon Black Nylo recall (Z-1104-2012)Cardinal Health2012-02-24
Presource Custom Sterile Surgical and Procedure Kits; general surgery trays; Cardinal Heal recall (Z-0925-2012)Cardinal Health2012-01-27
Presource Custom Sterile Surgical and Procedure Kits; surgical trays; Cardinal Health, McG recall (Z-0926-2012)Cardinal Health2012-01-27
Presource Custom Sterile Surgical and Procedure Kits; general surgery trays; Cardinal Heal recall (Z-0871-2012)Cardinal Health2012-01-26
Presource Custom Sterile Surgical and Procedure Kits; surgical trays; Cardinal Health, McG recall (Z-0872-2012)Cardinal Health2012-01-26
Presource Custom Sterile Surgical and Procedure Kits; general surgery trays; Cardinal Heal recall (Z-0169-2012)Cardinal Health2011-11-07
Presource Custom Sterile Surgical and Procedure Kits; surgical trays; Cardinal Health, McG recall (Z-0170-2012)Cardinal Health2011-11-07
Presource Custom Sterile Surgical and Procedure Kits; general surgery trays; Cardinal Heal recall (Z-0140-2012)Cardinal Health2011-10-31
Presource Custom Sterile Surgical and Procedure Kits; surgical trays; Cardinal Health, McG recall (Z-0141-2012)Cardinal Health2011-10-31
Lube Jelly, 1 oz. water-base sterile lubricating jelly, a component of various Presource C recall (Z-1968-2011)Cardinal Health2011-04-13
Innovate Esmark Bandages, a component of various Presource Custom Sterile Packs/Presource recall (Z-1667-2011)Cardinal Health2011-03-16
Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 5 mm (3/16 recall (Z-2450-2010)Cardinal Health2010-09-22
Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 5 mm (3/16 recall (Z-2451-2010)Cardinal Health2010-09-22
Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 5 mm (3/16 recall (Z-2452-2010)Cardinal Health2010-09-22
Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 6 mm (1/4" recall (Z-2453-2010)Cardinal Health2010-09-22
Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 6 mm (1/4" recall (Z-2454-2010)Cardinal Health2010-09-22
Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 6 mm (1/4" recall (Z-2455-2010)Cardinal Health2010-09-22
Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 7 mm (9/32 recall (Z-2456-2010)Cardinal Health2010-09-22
Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 7 mm (9/32 recall (Z-2457-2010)Cardinal Health2010-09-22
Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 7 mm (9/32 recall (Z-2458-2010)Cardinal Health2010-09-22
All Presource Kits that contain Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connec recall (Z-2459-2010)Cardinal Health2010-09-22
Disposable Skin Stapler - 35 Wide; Surgical Skin Stapler; Rx, sterile, single use skin sta recall (Z-1610-2010)Cardinal Health2010-05-19
Cardinal Health, Craig Calibrated Cannula, overall length 5-3/8" (13.7 cm), catalog #OS500 recall (Z-0141-2010)Cardinal Health2009-11-09
Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic pol recall (Z-1445-2009)Cardinal Health2009-06-18
Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic pol recall (Z-1446-2009)Cardinal Health2009-06-18
Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic pol recall (Z-1447-2009)Cardinal Health2009-06-18
Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic pol recall (Z-1448-2009)Cardinal Health2009-06-18
Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic pol recall (Z-1449-2009)Cardinal Health2009-06-18
Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic pol recall (Z-1450-2009)Cardinal Health2009-06-18
Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic pol recall (Z-1451-2009)Cardinal Health2009-06-18
Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic pol recall (Z-1452-2009)Cardinal Health2009-06-18
Esmark Elastic Bandage, 3" x 4 yards, sterile, for single use only, latex free. Distribute recall (Z-0615-2009)Cardinal Health2009-01-16
Esmark Elastic Bandage, 4" x 3 yards, sterile, for single use only, latex free. Distribute recall (Z-0616-2009)Cardinal Health2009-01-16
Corflo Anti-I.V. NG Tube for Pediatric and Neonatal Use; a sterile clear polyurethane with recall (Z-2306-2008)Cardinal Health2008-09-21
Presource Standard Sterile OR Scissors; straight scissors, S/B, 5.5", made in Pakistan; in recall (Z-1178-2008)Cardinal Health2008-06-11
AirLife Infant nCPAP System Driver (Catalog No: 006900;) a nasal continuous positive airwa recall (Z-0987-2008)Cardinal Health2008-05-14
AirLife nCPAP System Driver; a nasal continuous positive airway pressure device, which is recall (Z-1075-2007)Cardinal Health2007-07-12
Convertors Tiburon Cardiovascular Split Drape II, Sterile, for single use only; Cardinal H recall (Z-0058-2007)Cardinal Health2006-10-21
Convertors Cardiovascular Split Pack II, the pack contains 1 Tiburon Cardiovascular Split recall (Z-0059-2007)Cardinal Health2006-10-21
Presource Custom Sterile Packs containing the Cardiovascular Split Drape II; the custom st recall (Z-0060-2007)Cardinal Health2006-10-21
Cardiovascular Split Sheet II, Bulk Non-Sterile; 130 units per box; Cardinal Health, McGaw recall (Z-0061-2007)Cardinal Health2006-10-21
Cardinal Health Sterile Presource PBDS Modules, have Presource Custom Sterile Packs contai recall (Z-0062-2007)Cardinal Health2006-10-21
Cardinal Health Custom Sterile Latex Free Convenience Kits; sterile single use disposable recall (Z-0163-06)Cardinal Health2005-11-18
Cardinal Health Presource PBDS Latex Free Convenience Kits; sterile single use disposable recall (Z-0164-06)Cardinal Health2005-11-18
V. Mueller Pfister-Schwartz Stone Retriever 4-Wire Basket, Without Filiform Tip; a sterile recall (Z-0179-05)Cardinal Health2004-11-05
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Every clearance here is in the API, with alerts when new ones post.