Cardinal Health Inc.: 27 FDA recall reports
Every medical device recall the FDA has published for Cardinal Health Inc.. The fault, and how the agency graded it.
27Reports
0Class I
23Ongoing
2021-06-30Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326
Z-1941-2021 · Class II · reported 2021-06-30 · Ongoing
- Why it was recalled
- Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
- Product
- OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326
- Where it went
- US Nationwide distribution in the states of FL, GA, SC.
- How much
- 375 units
ACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862
Z-1942-2021 · Class II · reported 2021-06-30 · Ongoing
- Why it was recalled
- Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
- Product
- ACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862
- Where it went
- US Nationwide distribution in the states of FL, GA, SC.
- How much
- 537 boxes of 100 strips
FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877
Z-1931-2021 · Class II · reported 2021-06-30 · Ongoing
- Why it was recalled
- Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
- Product
- FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877
- Where it went
- US Nationwide distribution in the states of FL, GA, SC.
- How much
- 2,115 kits
FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084
Z-1930-2021 · Class II · reported 2021-06-30 · Ongoing
- Why it was recalled
- Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
- Product
- FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084
- Where it went
- US Nationwide distribution in the states of FL, GA, SC.
- How much
- 8,959 kits
DEXCOM G6 SENSOR 3 PACK Item Number: 5447552
Z-1934-2021 · Class II · reported 2021-06-30 · Ongoing
- Why it was recalled
- Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
- Product
- DEXCOM G6 SENSOR 3 PACK Item Number: 5447552
- Where it went
- US Nationwide distribution in the states of FL, GA, SC.
- How much
- 2357 kits
ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174
Z-1936-2021 · Class II · reported 2021-06-30 · Ongoing
- Why it was recalled
- Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
- Product
- ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174
- Where it went
- US Nationwide distribution in the states of FL, GA, SC.
- How much
- 5,356 boxes of 100 strips
VAPORIZER VICKS 1.5GAL Item Number: 2354942
Z-1935-2021 · Class II · reported 2021-06-30 · Ongoing
- Why it was recalled
- Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
- Product
- VAPORIZER VICKS 1.5GAL Item Number: 2354942
- Where it went
- US Nationwide distribution in the states of FL, GA, SC.
- How much
- 1 unit
ONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610
Z-1939-2021 · Class II · reported 2021-06-30 · Ongoing
- Why it was recalled
- Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
- Product
- ONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610
- Where it went
- US Nationwide distribution in the states of FL, GA, SC.
- How much
- 2,315 boxes of 100 lancets
BD UF PEN 32GX4MM 100 NANO Item Number: 4292272
Z-1933-2021 · Class II · reported 2021-06-30 · Ongoing
- Why it was recalled
- Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
- Product
- BD UF PEN 32GX4MM 100 NANO Item Number: 4292272
- Where it went
- US Nationwide distribution in the states of FL, GA, SC.
- How much
- 1,599 boxes of 100 needles
ONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443
Z-1938-2021 · Class II · reported 2021-06-30 · Ongoing
- Why it was recalled
- Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
- Product
- ONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443
- Where it went
- US Nationwide distribution in the states of FL, GA, SC.
- How much
- 144 boxes of 25 strips
AEROCHAMBER PLS W/MASK LRG BLU Item Number: 1496033
Z-1932-2021 · Class II · reported 2021-06-30 · Ongoing
- Why it was recalled
- Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
- Product
- AEROCHAMBER PLS W/MASK LRG BLU Item Number: 1496033
- Where it went
- US Nationwide distribution in the states of FL, GA, SC.
- How much
- 100 units
FREESTYLE LANCETS 28G 100CT Item Number:2975670
Z-1929-2021 · Class II · reported 2021-06-30 · Ongoing
- Why it was recalled
- Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
- Product
- FREESTYLE LANCETS 28G 100CT Item Number:2975670
- Where it went
- US Nationwide distribution in the states of FL, GA, SC.
- How much
- 377 boxes of 100 lancets
ONETOUCH DELICA LANCETS 33G 100 COUNT Item Number: 5541628
Z-1940-2021 · Class II · reported 2021-06-30 · Ongoing
- Why it was recalled
- Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
- Product
- ONETOUCH DELICA LANCETS 33G 100 COUNT Item Number: 5541628
- Where it went
- US Nationwide distribution in the states of FL, GA, SC.
- How much
- 4,896 boxes of 100 lancets
ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788
Z-1937-2021 · Class II · reported 2021-06-30 · Ongoing
- Why it was recalled
- Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
- Product
- ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788
- Where it went
- US Nationwide distribution in the states of FL, GA, SC.
- How much
- 531 boxes of 100 lancets
Kangaroo Connect ENPlus Spike Set Anti-free Flow, Product Code 77000FD
Z-2102-2020 · Class II · reported 2020-06-03 · Ongoing
- Why it was recalled
- The feeding spike sets may leak at the interface of the tube and spike connector.
- Product
- Kangaroo Connect ENPlus Spike Set Anti-free Flow, Product Code 77000FD
- Where it went
- Worldwide distribution.
- How much
- 114,731, 290 total units
Kangaroo 924 Safety Screw Spike Set, Product Code 775759
Z-2105-2020 · Class II · reported 2020-06-03 · Ongoing
- Why it was recalled
- The feeding spike sets may leak at the interface of the tube and spike connector.
- Product
- Kangaroo 924 Safety Screw Spike Set, Product Code 775759
- Where it went
- Worldwide distribution.
- How much
- 114,731, 290 total units
Kangaroo Epump Safety Screw Spike with Flush Bag, Anti-free Flow, 1000 mL, Product Code 775100
Z-2103-2020 · Class II · reported 2020-06-03 · Ongoing
- Why it was recalled
- The feeding spike sets may leak at the interface of the tube and spike connector.
- Product
- Kangaroo Epump Safety Screw Spike with Flush Bag, Anti-free Flow, 1000 mL, Product Code 775100
- Where it went
- Worldwide distribution.
- How much
- 114,731, 290 total units
Kangaroo Joey Safety Screw Spike with Flush Bag, Anti-free Flow,1000 mL, Product Code 765100
Z-2100-2020 · Class II · reported 2020-06-03 · Ongoing
- Why it was recalled
- The feeding spike sets may leak at the interface of the tube and spike connector.
- Product
- Kangaroo Joey Safety Screw Spike with Flush Bag, Anti-free Flow,1000 mL, Product Code 765100
- Where it went
- Worldwide distribution.
- How much
- 114,731, 290 total units
Kangaroo Joey Safety Screw Spike Set, Anti-free Flow, Product Code 765559
Z-2101-2020 · Class II · reported 2020-06-03 · Ongoing
- Why it was recalled
- The feeding spike sets may leak at the interface of the tube and spike connector.
- Product
- Kangaroo Joey Safety Screw Spike Set, Anti-free Flow, Product Code 765559
- Where it went
- Worldwide distribution.
- How much
- 114,731, 290 total units
Kangaroo Epump Safety Screw Spike Set, Anti-free Flow, Product Code 775659
Z-2104-2020 · Class II · reported 2020-06-03 · Ongoing
- Why it was recalled
- The feeding spike sets may leak at the interface of the tube and spike connector.
- Product
- Kangaroo Epump Safety Screw Spike Set, Anti-free Flow, Product Code 775659
- Where it went
- Worldwide distribution.
- How much
- 114,731, 290 total units
Professional Urine Drug Control, Item code 88010 - Product Usage: The Alere Professional Cup Urine Drug Contro
Z-2050-2020 · Class II · reported 2020-05-27 · Terminated
- Why it was recalled
- Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature abused products may result in misdiagnosis of the patient.
- Product
- Professional Urine Drug Control, Item code 88010 - Product Usage: The Alere Professional Cup Urine Drug Controls are compatible with all quantitative and qualitative drug detection procedures which are sufficiently sensitive to detect the control constituents.
- Where it went
- US Nationwide distribution NC, KS, and AL.
- How much
- N/A
B-Hydroxybutyrate LiquiColor, Item code CH2440058 - Product Usage: Product is used for the quantitative determ
Z-2049-2020 · Class II · reported 2020-05-27 · Terminated
- Why it was recalled
- Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature abused products may result in misdiagnosis of the patient.
- Product
- B-Hydroxybutyrate LiquiColor, Item code CH2440058 - Product Usage: Product is used for the quantitative determination of B-Hydroxybutyrate in human serum or plasma.
- Where it went
- US Nationwide distribution NC, KS, and AL.
- How much
- N/A
Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage: Intended to detect Group B
Z-2051-2020 · Class II · reported 2020-05-27 · Terminated
- Why it was recalled
- Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature abused products may result in misdiagnosis of the patient.
- Product
- Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage: Intended to detect Group B Streptococcus (GBS) from anovaginal specimen collected from pregnant women. If pregnant woman is positive for GBS colonization, this will indicate a need for treatment prior to vaginal delivery in order to prevent infection of the neonate.
- Where it went
- US Nationwide distribution NC, KS, and AL.
- How much
- N/A
Cordis Precise Nitinol Stent System. The Cordis PRECISE Nitinol Stent System devices are designed to deliv
Z-0729-2020 · Class II · reported 2020-01-01 · Ongoing
- Why it was recalled
- Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information on the IFU. The correct classification is "MRI Conditional" not "MRI Safe".
- Product
- Cordis Precise Nitinol Stent System. The Cordis PRECISE Nitinol Stent System devices are designed to deliver a flexible, self-expanding endoluminal stent to the carotid vasculature via over-the-wire (OTW) 5.5F or 6F sheathed delivery systems. The stent is cut from a solid nitinol tube into a fine mesh ( Z configuration) design. The delivery systems consist mainly of an inner shaft and an outer sheath with radiopaque markers, and a Tuohy Borst valve. The inner shaft terminates distally in a catheter tip and originates proximally in a luer hub designed to accept a 0.018 guidewire. The delivery systems have a nominal working length of 135 cm. The self-expanding PRECISE stent is constrained within the space between the inner shaft and the outer sheath, located between distal and proximal stent makers on the inner shaft. The stent expands to its unconstrained diameter when released from the deployment catheter into the carotid artery. Upon deployment the stent forms an open lattice and pushes outward on the luminal surface, helping to maintain the patency of the artery. Due to the self-expanding behavior of nitinol, the stents are indicated for placement into vessels...
- Where it went
- Worldwide distribution - US Nationwide including Puerto Rico and countries of Algeria, Argentina, Armenia, Australia, Austria, Azerbaiian, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Repulic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Guatemala, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Maldives, Malta, Martinique, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Qatar, Russian Federation, Saint-Barthelemy, Saudia Arabia, Sinapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela.
- How much
- 267,247 units total (262,641 OUS, 4,606 US)
S.M.A.R.T. Nitinol Stent System and the S.M.A.R.T. Control Nitinol Stent System. The SMART stent system in
Z-0728-2020 · Class II · reported 2020-01-01 · Ongoing
- Why it was recalled
- Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information on the IFU. The correct classification is "MRI Conditional" not "MRI Safe".
- Product
- S.M.A.R.T. Nitinol Stent System and the S.M.A.R.T. Control Nitinol Stent System. The SMART stent system includes a self-expanding stent made of Nitinol (nickel-titanium alloy) material and a 6 French (2.0 mm) or 7 French (2.3 mm) sheathed delivery system. The stent is laser cut from a solid nitinol tube into a fine mesh ( Z Configuration) design. The stent expands to its unconstrained diameter when released from the deployment catheter into the iliac artery. Upon deployment, the stent forms an open lattice and pushes outward on the luminal surface, helping to maintain the patency of the artery. Due to the self-expanding behavior of nitinol, the stents are indicated for placement into vessels that are 1-2 mm smaller in diameter than the unconstrained diameter of the stent. The SMART Control stent system includes a self-expanding stent made of Nitinol (nickel-titanium alloy) material and a 6 French (2.0 mm) sheathed delivery system. The stent is laser cut from a solid nitinol tube into a fine mesh ( Z Configuration) design. The stent expands to its unconstrained diameter when released from the deployment catheter into the iliac artery. Upon deployment, the stent forms...
- Where it went
- Worldwide distribution - US Nationwide including Puerto Rico and countries of Algeria, Argentina, Armenia, Australia, Austria, Azerbaiian, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Repulic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Guatemala, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Maldives, Malta, Martinique, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Qatar, Russian Federation, Saint-Barthelemy, Saudia Arabia, Sinapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela.
- How much
- 267,247 units total (262,641 OUS, 4,606 US)
Cordis S.M.A.R.T. CONTROL /S.M.A.R.T. Vascular Stent System. The S.M.A.R.T. CONTROL and S.M.A.R.T. Vascula
Z-0730-2020 · Class II · reported 2020-01-01 · Ongoing
- Why it was recalled
- Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information on the IFU. The correct classification is "MRI Conditional" not "MRI Safe".
- Product
- Cordis S.M.A.R.T. CONTROL /S.M.A.R.T. Vascular Stent System. The S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent Systems consist of a self-expanding stent made of Nitinol (nickel-titanium alloy) material that is pre-mounted on an over-the-wire delivery system. The stents contain tantalum markers at each end. The S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stents are designed to open to a preprogrammed diameter at body temperature. There are two delivery system configurations S.M.A.R.T. CONTROL and S.M.A.R.T. The stent is contained within the outer sheath of the delivery system. Once the distal end of the delivery system reaches the treatment site, the outer sheath of the delivery system is retracted to expose the stent and start its self-expansion. For the S.M.A.R.T. CONTROL Stent System, sheath retraction is achieved by grasping the handle in a fixed position with the tuning dial held between the thumb and index fingers, and rotating the tuning dial in a clockwise direction until the distal end of the stent is visibly apposed to the vessel wall. For the S.M.A.R.T. Stent System, sheath retraction is achieved by grasping the inner shaft in a fixed position and...
- Where it went
- Worldwide distribution - US Nationwide including Puerto Rico and countries of Algeria, Argentina, Armenia, Australia, Austria, Azerbaiian, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Repulic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Guatemala, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Maldives, Malta, Martinique, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Qatar, Russian Federation, Saint-Barthelemy, Saudia Arabia, Sinapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela.
- How much
- 267,247 units total (262,641 OUS, 4,606 US)
Presource Kit Total Joint Pack containing a double-wrapped basin component. Product Usage: This kit is us
Z-0702-2019 · Class II · reported 2019-01-16 · Terminated
- Why it was recalled
- The double wrapping of this custom kit basin set is not supported by the current sterility assurance validation.
- Product
- Presource Kit Total Joint Pack containing a double-wrapped basin component. Product Usage: This kit is used on patients undergoing joint replacement knee or hip.
- Where it went
- US state of Florida
- How much
- 182 packs
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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