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.

26–50 of 493

  • HighFDA (Devices)·Z-0363-2026·2025-11-05

    ChemosafeLock bag spikes recalled over port weld separation risk

    ICU Medical is recalling 134,700 ChemosafeLock Bag Spikes because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0345-2026·2025-11-05

    13mm vented vial spikes recalled over port weld separation risk

    ICU Medical is recalling 9,004 ChemoLock Vented Vial Spikes, 13mm, because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0351-2026·2025-11-05

    21 inch extension sets recalled over port weld separation risk

    ICU Medical is recalling 950 21-inch extension sets with ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0337-2026·2025-11-05

    Oncology transfer kits recalled over port weld separation risk

    ICU Medical is recalling 600 Oncology Transfer Kits with ChemoClave and ChemoLock ports because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0342-2026·2025-11-05

    Double port syringe transfer sets recalled over port weld separation risk

    ICU Medical is recalling 4,000 Double ChemoLock Port Syringe Transfer Sets because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0339-2026·2025-11-05

    Smallbore extension sets recalled because port weld may separate and leak

    ICU Medical is recalling 200 60-inch smallbore extension sets with a ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0355-2026·2025-11-05

    Mini bag spike connectors recalled over port weld separation risk

    ICU Medical is recalling 400 ChemoLock connectors with Mini Bag Spike because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock w/Mini Bag Spike ¿ REF: C-17
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0361-2026·2025-11-05

    Six inch extension sets recalled because port weld may separate and leak

    ICU Medical is recalling 1,600 6-inch extension sets with MicroClave Clear and ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0344-2026·2025-11-05

    20mm vented vial spikes recalled over port weld separation risk

    ICU Medical is recalling 11,200 ChemoLock Vented Vial Spikes, 20mm, because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0328-2026·2025-11-05

    Single unit bag spikes recalled over port weld separation risk

    ICU Medical is recalling 875 single-unit ChemoLock Bag Spikes because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ChemoLock Bag Spike, 01 units REF: CL-10-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0343-2026·2025-11-05

    Universal vented vial spikes recalled over port weld separation risk

    ICU Medical is recalling 16,850 ChemoLock Universal Vented Vial Spikes because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0346-2026·2025-11-05

    ChemoLock closed vial spikes recalled over port weld separation risk

    ICU Medical is recalling 6,150 ChemoLock Closed Vial Spikes because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock Closed Vial Spike REF: CL-80
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0330-2026·2025-11-05

    Non-sterile bulk ChemoLock ports recalled over port weld separation risk

    ICU Medical is recalling 2,000 bulk non-sterile ChemoLock Ports because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0348-2026·2025-11-05

    Closed vial spikes with skirt recalled over port weld separation risk

    ICU Medical is recalling 8,475 ChemoLock Closed Vial Spikes with Skirt because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0349-2026·2025-11-05

    13mm closed vial spikes recalled because port weld may separate and leak

    ICU Medical is recalling 3,350 ChemoLock 13mm Closed Vial Spikes because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0358-2026·2025-11-05

    Chemotherapy extension sets recalled because port weld may separate during use

    ICU Medical is recalling 2,450 8-inch extension sets with ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0335-2026·2025-11-05

    Bag spikes with Clave additive port recalled over port weld separation

    ICU Medical is recalling 3,000 ChemoLock Bag Spikes with Clave additive port because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateCPSC·26057·2025-10-30

    Glow stick bracelets recalled because green bracelet can leak and irritate

    About 6,600 Destination Holiday Glow Light Stick bracelet 12-packs are being recalled because the green bracelet can leak, posing a skin irritation hazard.

    Product
    Destination Holiday Glow Light Stick Bracelets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0200-2026·2025-10-22

    Filtered extension sets recalled across two lots because IV sets may leak

    Baxter is recalling 69,936 CLEARLINK System non-DEHP extension sets with a 1.2 micron filter across two lots because the IV sets may leak.

    Product
    CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard Bore, 1.2 Micron Filter, CLEARLINK Luer Activated Valve, 19-inch (47 centimeters), Product Code 2H8603
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0196-2026·2025-10-22

    Three valve filtered solution sets recalled because IV sets may leak

    Baxter is recalling 8,368 CLEARLINK System Continu-Flo solution sets with three luer activated valves and a 0.2 micron filter from one lot because the IV sets may leak.

    Product
    CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 102-inch (2.6 meters), Product Code 2C8593
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0189-2026·2025-10-22

    Stopcock extension solution sets recalled from two lots because sets may leak

    Baxter is recalling 49,200 Continu-Flo solution sets with a 4-way stopcock extension set because the IV sets may leak.

    Product
    CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extension Set with two CLEARLINK Luer Activated Valve, Pfoduct code 2C6255
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0191-2026·2025-10-22

    Non-vented IV solution sets recalled from one lot because sets may leak

    Baxter is recalling 1,440 CLEARLINK System non-vented solution sets from one lot because the IV sets may leak.

    Product
    CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Product Code 2C8425
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0197-2026·2025-10-22

    Forty four inch extension sets recalled because the IV sets may leak

    Baxter is recalling 15,552 CLEARLINK System 44-inch straight-type extension sets from one lot because the IV sets may leak.

    Product
    CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 44-inch (111 centimeters), Product code 2C8610
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0192-2026·2025-10-22

    Continu-Flo solution sets recalled across six lots because sets may leak

    Baxter is recalling 473,040 CLEARLINK System Continu-Flo solution sets across six lots because the IV sets may leak.

    Product
    CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 112-inch (2.8 meters), Product Code 2C8519
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0199-2026·2025-10-22

    Extension IV sets recalled from one lot because the sets may leak

    Baxter is recalling 16,416 CLEARLINK System straight-type extension sets from one lot because the IV sets may leak.

    Product
    CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 7.9-inch (20 centimeters), Product Code 2C8634
    Category
    Medical Device
    Distribution
    Distributed nationwide