The Recall Desk

Manufacturer

CAREFUSION

25 recalls in our database name CAREFUSION as the manufacturing or recalling firm.

What the numbers show

Total
25
Critical
0
Severe
0
Most recent
2022-09-28

Of the 25 recalls from CAREFUSION we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 25

  • HighFDA (Devices)·Z-1752-2022·2022-09-28

    BD MaxGuard Extension Set labeled with incorrect expiration year 2027

    46,900 BD MaxGuard Extension Sets are labeled with expiration year 2027 but should expire in 2025. Using expired product may compromise integrity and cause leaks, risking infection.

    Product
    BD MaxGuard Extension Set with 4-way stopcock, REF: M4058
    Category
    Medical Device
    Distribution
    39 states
  • HighFDA (Devices)·Z-1756-2022·2022-09-28

    BD MaxGuard Administration Set Recalled for Incorrect Expiration Date Labels

    BD MaxGuard Drop Administration set labels incorrectly list expiration year 2027 instead of 2025. Use of expired product risks compromised integrity, potential leaks, and patient or worker infection.

    Product
    BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port Manifold and removable 4-way stopcock, REF: MX4436
    Category
    Medical Device
    Distribution
    39 states
  • HighFDA (Devices)·Z-1760-2022·2022-09-28

    BD MaxGuard Administration Set Recalled for Incorrect Expiration Labeling

    CAREFUSION is recalling BD MaxGuard 15 Drop Administration Sets with incorrect expiration year labels (showing 2027 instead of 2025). Use of expired product may compromise integrity and risk infection.

    Product
    BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites, REF: MX9433
    Category
    Medical Device
    Distribution
    39 states
  • HighFDA (Devices)·Z-1759-2022·2022-09-28

    BD MaxGuard Extension Set Recalled for Incorrect Expiration Year

    CAREFUSION's BD MaxGuard Extension Set is being recalled because product labels incorrectly list expiration year 2027 instead of 2025. Using expired product may compromise integrity, potentially causing leaks and infection risk.

    Product
    BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: MX9171
    Category
    Medical Device
    Distribution
    39 states
  • HighFDA (Devices)·Z-1755-2022·2022-09-28

    BD MaxGuard Flow Controller Extension Set recalled for mislabeled expiration dates

    CAREFUSION is recalling BD MaxGuard Flow Controller Extension Sets because product labels show expiration year 2027 instead of 2025. Using expired sets risks product integrity failure and potential patient infection.

    Product
    BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS141
    Category
    Medical Device
    Distribution
    39 states
  • HighFDA (Devices)·Z-1754-2022·2022-09-28

    BD MaxGuard Extension Set Mislabeled with Wrong Expiration Year

    BD MaxGuard Flow Controller Extension Set labels incorrectly list 2027 expiration instead of 2025. Use of expired product could compromise device integrity and create infection risk.

    Product
    BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS106
    Category
    Medical Device
    Distribution
    39 states
  • HighFDA (Devices)·Z-1758-2022·2022-09-28

    BD MaxGuard Extension Set Wrong Expiration Label Poses Infection Risk

    CAREFUSION is recalling 600 BD MaxGuard Extension Sets because labels list expiration year 2027 instead of 2025. Using expired products may cause leaks and infection risk.

    Product
    BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site, REF: MX9166
    Category
    Medical Device
    Distribution
    39 states
  • HighFDA (Devices)·Z-1753-2022·2022-09-28

    BD MaxGuard Extension Set Mislabeled With Wrong Expiration Date

    BD MaxGuard Extension Set units have labels listing 2027 as the expiration year instead of 2025. Using expired medical devices may compromise product integrity and increase the risk of leaks and infection.

    Product
    BD MaxGuard Extension Set, REF: ME1069
    Category
    Medical Device
    Distribution
    39 states
  • HighFDA (Devices)·Z-1757-2022·2022-09-28

    BD MaxGuard Extension Sets Recalled for Mislabeled Expiration Dates

    CAREFUSION is recalling 17,250 BD MaxGuard Extension Set units with labels listing incorrect expiration year 2027 instead of 2025. Using expired products could compromise device integrity and create infection risk to patients and healthcare workers.

    Product
    BD MaxGuard Extension Set with 2 Needleless Y-Site, REF: MX9059
    Category
    Medical Device
    Distribution
    39 states
  • HighFDA (Devices)·Z-2456-2021·2021-09-22

    FDA recalls BD burette sets for connector valve occlusion and flow defects

    BD Gravity Burette Sets and Add-On Burette Sets are being recalled due to needle-free connector valve defects that may cause flushing difficulties, flow problems, or complete occlusions, potentially delaying therapy. The recall affects approximately 77,802 units distributed worldwide.

    Product
    BD Gravity Burette Set 60 DROP 1.2 MF 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV, REF: 10037031; BD Gravity Burette Set 20 DROP 1.2 Micron Filter 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV , REF: 10037032; BD GRAVITY BURETTE SET 60 DROP 2 Smartsite VALVES BALL DRIP CHAM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2463-2021·2021-09-22

    BD Gravity IV needle-free connector valve occlusion risk

    BD Gravity IV needle-free connector valves may develop flow issues and partial or total occlusions that could delay therapy. The recall affects 24,360 units distributed worldwide.

    Product
    BD Gravity IV Set 3-port Closed Manifold Back Check Valve 3 Needle-Free Y-sites, REF: CM42500E-07; BD Gravity IV Set 3-port Closed Stopock Manifold Back Check Valve 2 Needle-Free Y-sites, REF: CS42522E-07; BD GRAVITY 10 DP V/NV CHECK VALVE 3-WAY STOPCOCK 4 Smartsite VALVES & Smar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2465-2021·2021-09-22

    BD SE Burette Set needle-free connectors recalled for flow obstruction risk

    CareFusion is recalling BD SE Burette Sets with needle-free connector valves that may fail to flush or develop flow obstructions, risking therapy delays. Approximately 56,680 units were distributed worldwide.

    Product
    BD SE Burette Set 20 Drops 2 Injection Ports Vented/NonVented, REF: 72103E-0006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2457-2021·2021-09-22

    BD Syringe Set Needle-Free Connector Valves May Cause Therapy Delay

    BD Syringe Set needle-free connector valves may experience difficulty flushing, flow issues, or occlusions that could delay patient therapy. About 16,700 units have been distributed worldwide.

    Product
    BD Syringe Set 20 DP MIC TBG 0.2MF CKV Anti-Siphon SmartSite VLV Sensing Disc, REF: 10798696; BD Syringe Set 20 DP MIC TBG CKV Anti-Siphon SmartSite VLV Sensing Disc, REF: 10798703;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2466-2021·2021-09-22

    BD Alaris Infusion Pump Buerette Set Connector Valve Occlusion Issues

    BD Alaris needle-free connector valves in Buerette Sets may develop occlusions, difficulty flushing, or flow issues that could delay patient therapy. The product was distributed worldwide across all US states and multiple countries.

    Product
    BD Alaris Pump Infusion Buerette Set Smallbore Tubing Smartsite Port (Burette) 3 SmartSite Y-Sites, REF: 2441-0006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2464-2021·2021-09-22

    Needle-Free Burette Set Valves Recalled for Occlusion and Flow Issues

    BD ADD-ON Burette Set V/NV Needle-Free Valves may experience occlusions or flow issues that could delay therapy. CAREFUSION recalled 44,120 units with this defect.

    Product
    BD ADD-ON Burette Set V/NV Needle-Free Valve, REF: 82113E-0006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2459-2021·2021-09-22

    BD Alaris Infusion Pump Buerette Sets Needle-Free Connector Valve Issues

    BD Alaris Pump Infusion Buerette Sets with needle-free connector valves may experience flushing difficulties, flow issues, or occlusions that could delay therapy delivery. No illnesses or injuries have been reported.

    Product
    BD Alaris Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSite Port (Burette) SmartSite Y-Site, REF: 10015012; BD Alaris Pump Infusion Buerette Set Ball Valve Smallbore Tubing Smartsite Port (Burette) SmartSite Y-Site, REF: 10817920; BD Alaris Pump Infusion Bue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2467-2021·2021-09-22

    BD SmartSite Needle-Free Connector Valves Recalled for Flow and Occlusion Issues

    CAREFUSION is recalling BD SmartSite needle-free connector valves due to difficulty flushing, flow issues, and occlusions that could delay therapy. Approximately 23.8 million units were distributed worldwide.

    Product
    BD SmartSite, REF: 2000E CHINA; BD SmartSite Connector, REF: 2000E-04; BD SmartSite J-LOOP Extension Set One Needle Free Valve, REF: 20021E7D; BD SmartSite Extension Set One Needle Free Valve Slip Luer, REF: 20037E7D; BD SmartSite Extension Set 3 Needle Free Valves, REF: 20038E7D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2454-2021·2021-09-22

    Extension Set SMALLBORE Tubing with SmartSite Valves Recalled for Flushing Issues

    BD Extension Set SMALLBORE Tubing with SmartSite Valves (REF: 20019E) is being recalled due to flushing difficulties, flow issues, and occlusions that could delay therapy. Over 1.4 million units distributed worldwide are affected.

    Product
    BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES, REF: 20019E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2461-2021·2021-09-22

    BD SmartSite Bag Access Device Recalled for Valve Occlusion Issues

    CAREFUSION is recalling BD SmartSite Bag Access Device needle-free connector valves due to potential occlusions and flow issues that could delay therapy delivery.

    Product
    BD SmartSite Bag Access Device, REF: 2300E-0500; BD BAG ACCESS DEVICE CHECK VALVE SmartSite VALVE, REF: 2309E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2458-2021·2021-09-22

    BD needle-free connector valves may occlude or restrict fluid flow

    BD Burette Gravity Set needle-free connector valves may fail to flush or develop blockages, potentially delaying patient therapy. Lot 21015553 consists of approximately 630 units distributed worldwide.

    Product
    BD BURETTE GRAVITY SET 60 DROP 2 Smartsite VALVES VENTED/NONVENTED, REF: 42163E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2462-2021·2021-09-22

    BD Gravity Burette Set Needle-Free Connector Valves Recalled for Flow Issues

    CAREFUSION is recalling BD Gravity Burette Sets with needle-free connector valves that may develop flow restrictions and blockages, potentially delaying medication delivery. Approximately 29,130 units were distributed.

    Product
    BD Gravity Burette Set 60 DP 3 SmartSite VALVES BALL VALVE DRIP CHAMBER, REF: 10012564
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2468-2021·2021-09-22

    BD Needle-Free Bag Access Valves Recalled for Flow Obstruction

    BD SmartSite needle-free valves may become obstructed, preventing proper fluid flow in medical infusions. The FDA recalls over 295,000 units due to risk of therapy delays.

    Product
    BD SmartSite Bag Access Device Needle-Free Valve, REF: 2300E; BD Bag access Device with 1 Check Valve And Needle Free Valve, REF: 2309E-0006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2460-2021·2021-09-22

    BD needle-free connector valves recalled for flow obstruction risk

    BD needle-free connector valves and extension sets may experience flow obstruction and flushing difficulties, potentially delaying medical therapy. No adverse events have been reported.

    Product
    BD Extension Set SMALLBORE Tubing SmartSite VALVE, REF: 10010511; BD SmartSite Extension Set Needle-Free Valve, REF: 10010912; BD EXTENSION SET SMALLBORE TUBING DETACHABLE SmartSite VALVE, REF: 10010983; BD Gravity Burette Set 60 DP 4 VersaSafe PORTS 3 SmartSite VALVES BALL VALV
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2455-2021·2021-09-22

    BD SmartSite Needle-Free Valve Extension Set Recalled for Potential Occlusion

    CareFusion recalls BD SmartSite needle-free valve extension sets due to potential occlusion, flow issues, and difficulty flushing that could delay medical therapy.

    Product
    BD SmartSite 'Y' Extension Set 2 Needle-Free Valves, REF: 20019E7D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1995-2021·2021-07-07

    Carefusion Recalls MaxPlus Bi Fuse Extension Sets for Leakage Defect

    Carefusion is recalling a batch of MaxPlus Bi Fuse extension sets due to leakage defects. The affected units failed validation testing for leakage and were inadvertently released to the Tennessee market.

    Product
    MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product Usage: The needleless connector can be used for direct injection, intermittent infusion, continuous infusion, or aspiration.
    Category
    Medical Device
    Distribution
    1 state

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

CareFusion

organization in San Diego, United States

Country
United States
Founded
2009

Official website

Source: Wikidata (Q5038833), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.