The Recall Desk

Hazard

Leak recalls

493 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
493
Critical
3
Severe
28
Most recent
2026-08-26

Of the 493 leak recalls we have scored against our rubric, 3 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 28 (6%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all leak recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

126–150 of 493

  • HighFDA (Devices)·Z-2101-2020·2020-06-03

    Cardinal Health Recalls Kangaroo Joey Safety Screw Spike Sets

    Cardinal Health is recalling Kangaroo Joey Safety Screw Spike Sets because they may leak at the tube and spike connector interface.

    Product
    Kangaroo Joey Safety Screw Spike Set, Anti-free Flow, Product Code 765559
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1967-2020·2020-05-20

    BD Alaris PCEA Administration Set Recalled for Potential Leaking

    BD is recalling 110,350 Alaris PCEA Administration Sets because they may leak at the luer connection, potentially causing inadequate pain control.

    Product
    BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-07 - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Use Aseptic Technique Set cannot be used for gravity infusion. 1. Connect PCA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1968-2020·2020-05-20

    BD Alaris PCEA Administration Set Recalled for Potential Leakage

    BD Switzerland is recalling 110,350 units of Alaris PCEA Administration Sets due to a potential leak at the luer connection that may cause inadequate pain control.

    Product
    BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 10800177 - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Use Aseptic Technique Set cannot be used for gravity infusion. 1. Connect PCA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1969-2020·2020-05-20

    BD Alaris PCEA Administration Set Recalled for Potential Leaking

    BD is recalling Alaris PCEA Administration Sets because they may leak at the luer connection, potentially causing inadequate pain control.

    Product
    BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-04 (OUS Only) - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Use Aseptic Technique Set cannot be used for gravity infusion. 1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1754-2020·2020-04-29

    KT Health Recalls Ice/Heat Massage Balls Due to Leak Risk

    KT Health, LLC is recalling 94,554 KT RECOVERY+ Ice/Heat Massage Balls because overheating may cause leaks, potentially exposing users to hot fluid.

    Product
    KT RECOVERY+ ICE/HEAT MASSAGE BALL Rolling ball with hot and cold packs that can be interchanged depending on the therapy type desired
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1431-2020·2020-03-11

    Bard Biopsy EnCor Probe Recall for Sterility and Function Defects

    Bard Peripheral Vascular Inc is recalling specific lots of Bard Biopsy EnCor Probes due to leaks, suction issues, and failure to obtain samples.

    Product
    Bard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G, REF number ECP017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-1432-2020·2020-03-11

    Bard Biopsy EnCor Probe Recall for Performance Failures

    Bard Peripheral Vascular Inc is recalling specific lots of Bard Biopsy EnCor Probes due to performance failures including leaks and suction issues.

    Product
    Bard Biopsy EnCor Probe, MRI, 7G Trocar Tip, REF number ECPMR017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-1434-2020·2020-03-11

    Bard Biopsy EnCor Probe Recall for Performance Failures

    Bard Peripheral Vascular Inc is recalling specific lots of Bard Biopsy EnCor Probes due to leaks, suction issues, and failure to obtain samples.

    Product
    Bard Biopsy EnCor Probe, MRI, 10G Blunt Tip, REF number ECPMR0110GBT, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-1433-2020·2020-03-11

    Bard Biopsy EnCor Probe Recall for Performance Failures

    Bard Peripheral Vascular Inc is recalling specific Bard Biopsy EnCor Probes due to leaks, suction issues, and failure to obtain samples.

    Product
    Bard Biopsy EnCor Probe, MRI, 10G Trocar Tip, REF number ECPMR0110G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-1219-2020·2020-02-19

    Bard Intra-abdominal Pressure Monitoring Device Recalled for Potential Leaks

    C.R. Bard Inc. is recalling 1,300 units of the Bard Intra-abdominal Pressure Monitoring Device due to leaks or disconnects that may cause inaccurate readings.

    Product
    The Bard Intra-abdominal Pressure Monitoring Device is composed of a tubing set used for infusing fluid into the urinary bladder through the Foley catheter sampling port. It utilizes a clamping device to occlude the urinary drainage tubing to form a fluid column through which pre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0887-2020·2020-02-05

    Haemonetics Recalls Cell Saver Bowl Sets Due to Leak Risk

    Haemonetics is recalling Cell Saver 5/5+ and Elite bowl sets because they may leak, trapping fluid and causing incomplete washing.

    Product
    High Speed Cell Saver¿5/5+ Bowl Set Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0903-2020·2020-02-05

    Haemonetics Recalls Cell Saver Elite Sets Due to Potential Bowl Leaks

    Haemonetics is recalling Cell Saver Elite sets because potential leaks in the bowl core may cause fluid trapping and incomplete washing.

    Product
    JAPAN CELL SAVER ELITE SET - 125ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0896-2020·2020-02-05

    Haemonetics Recalls CS Elite Fastpack Autotransfusion Devices Due to Leak Risk

    Haemonetics is recalling CS Elite Fastpack autotransfusion devices because cracks in the bowl core may cause leaks and incomplete washing.

    Product
    CS Elite Fastpack, 125 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0905-2020·2020-02-05

    Haemonetics Recalls Cell Saver Bowl Sets Due to Leak Risk

    Haemonetics is recalling specific Cell Saver bowl sets because they may leak, potentially trapping fluid and causing incomplete washing.

    Product
    Japan DISP SET, 263J, 205J, 208 - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0898-2020·2020-02-05

    Haemonetics Recalls Cell Saver Bowl Sets Due to Leak Risk

    Haemonetics is recalling Cell Saver bowl sets because cracks in the inner core may cause leaks and incomplete blood washing.

    Product
    JAPAN BASIC HI SPEED CS5 SET,LN 263J - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. The recovered blood is processed by a centrifugation and was
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0900-2020·2020-02-05

    Haemonetics Recalls Cell Saver Bowl Sets Due to Leak Risk

    Haemonetics is recalling 739 Cell Saver bowl sets because cracks in the inner core can cause leaks and incomplete blood washing.

    Product
    JAPAN DISP SET, 261J, 205J, HAR - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. The recovered blood is processed by a centrifugation and washing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0906-2020·2020-02-05

    Haemonetics Recalls Japan DISP SETs Due to Potential Bowl Cracks

    Haemonetics is recalling 1,584 Japan DISP SETs because cracks in the bowl core may cause leaks and incomplete washing.

    Product
    Japan DISP SET, 263J, 205J, HAR - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0892-2020·2020-02-05

    Haemonetics Recalls CS Elite Processing Sets Due to Potential Bowl Cracks

    Haemonetics is recalling CS Elite Processing Sets because cracks in the bowl core may cause fluid trapping and incomplete washing.

    Product
    CS Elite Processing Set (225 ml) Autotransfusion Device - Product Usage:its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0894-2020·2020-02-05

    Haemonetics Recalls CS Elite Fastpack Autotransfusion Devices Due to Leak Risk

    Haemonetics is recalling CS Elite Fastpack autotransfusion devices because cracks in the bowl core may cause leaks and incomplete blood washing.

    Product
    CS Elite Fastpack, 225 mL, 20¿ Res Autotransfusion Device - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0895-2020·2020-02-05

    Haemonetics Recalls CS Elite Fastpack Autotransfusion Devices Due to Leak Risk

    Haemonetics is recalling CS Elite Fastpack autotransfusion devices because cracks in the bowl core may cause leaks and incomplete blood washing.

    Product
    CS Elite Fastpack, 225 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0901-2020·2020-02-05

    Haemonetics Recalls Cell Saver Bowl Sets Due to Potential Leaks

    Haemonetics is recalling Cell Saver bowl sets because cracks may cause leaks and incomplete blood washing.

    Product
    Japan CS Elite FASTPACK DISP. SET - 125ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0889-2020·2020-02-05

    Haemonetics Recalls Cell Saver 5/5+ Fastpacks Due to Potential Leaks

    Haemonetics is recalling 1,340 units of Cell Saver 5/5+ Fastpacks because potential leaks in the inner core may cause fluid trapping and incomplete washing.

    Product
    CS5/5+ Fastpacks, 125 mL, 20¿ Res Autotransfusion Device- Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0891-2020·2020-02-05

    Haemonetics Recalls Cell Saver 5/5+ Bowl Kits Due to Leak Risk

    Haemonetics is recalling Cell Saver 5/5+ Bowl Kits because they may leak, trapping fluid and causing incomplete washing.

    Product
    Cell Saver¿5/5+ Bowl Kit (225 ml) Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0899-2020·2020-02-05

    Haemonetics Recalls Japan Disp Sets Due to Potential Bowl Cracks

    Haemonetics is recalling specific Japan Disp Sets for Cell Saver systems due to potential bowl cracks that may cause leaks and incomplete blood washing.

    Product
    JAPAN DISP SET, 261J, 205J, 208 - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. The recovered blood is processed by a centrifugation and washing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0886-2020·2020-02-05

    Haemonetics Recalls CS5/5+ Bowl Kits Due to Potential Leaks

    Haemonetics is recalling CS5/5+ Bowl Kits because potential leaks may trap fluid, causing device errors and incomplete washing.

    Product
    CS5/5+ Bowl Kit-125 mL Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
    Category
    Medical Device
    Distribution
    Distributed nationwide