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.

Which agencies issued them

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.

426–450 of 493

  • HighFDA (Devices)·Z-2815-2016·2016-09-21

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 10 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    Monitoring Kit with 30mL Flush Device, Item No. 46076-15 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2805-2016·2016-09-21

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 420 Transpac IV Monitoring Kits with SafeSet Reservoirs due to a potential leak. The affected units were distributed nationwide in the US.

    Product
    Transpac IV Monitoring Kit with SafeSet 84inch Arterial Pressure Tubing, Reservoir, Squeeze Flush and 2 Needleless Valves, Item No. 011-42646-66 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces betwee
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2816-2016·2016-09-21

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 150 units of SafeSet Reservoir kits with Transpac IV transducers due to a potential for leak.

    Product
    Triple Line SafeSet Kit with 03mL Flush Device, Item No. 46076-27 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure int
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2810-2016·2016-09-21

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 1,420 Transpac IV Monitoring Kits because of a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac IV Monitoring Kit with 2 SafeSet 84" Arterial Pressure Tubing, Reservoir, 03 mL Squeeze Flush and 2 Needleless Valves, Item No. 42646-66 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces betwe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2049-2016·2016-07-06

    Baxter Recalls PrismaSate Dialysis Solution Bags Due to Leaks

    Baxter Healthcare is recalling 10,054 units of PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy because of leaks near the top of the bags.

    Product
    PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-1579-2016·2016-05-04

    Hologic Recalls CF InPlex ASR Cards Due to False Positive Results

    Hologic is recalling CF InPlex ASR Cards because they may produce false positive results or leak, potentially leading to unnecessary invasive testing during pregnancy.

    Product
    CF InPlex ASR Card; Catalog Number: 95-0501.
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-1324-2016·2016-04-13

    Fresenius Hemoflow F3 Dialyzer Recalled for Potential Header Leak

    Fresenius Medical Care is recalling 1,650 Hemoflow F3 Dialyzers due to a potential header leak caused by improper torque.

    Product
    Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1254-2016·2016-04-06

    ICU Medical Recalls IV Administration Sets with ChemoLock Port Leak Risk

    ICU Medical is recalling specific IV administration sets because a connection may develop a leak. The sets are distributed in the US and several international locations.

    Product
    74" (188cm) approximately 9.0ml, 20 Drop Admin Set w/ Integrated ChemoLock Port sterile IV Administration sets are intended for the infusion and withdrawal of fluids. Drip Chamber, Rotating Luer, Bag Hanger, Item No. 011-CL3341.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1255-2016·2016-04-06

    ICU Medical Recalls I.V. Infusion Sets with Potential Leak

    ICU Medical is recalling 215 I.V. infusion administration sets because a connection may develop a leak.

    Product
    30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, ChemoLock, Bag Hanger, Item No. 011-CL3511 sterile devices intended for the infusion and withdrawal of fluids.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1258-2016·2016-04-06

    ICU Medical Recalls ChemLock I.V. Infusion Administration Sets

    ICU Medical is recalling specific I.V. infusion administration sets because a connection may develop a leak.

    Product
    30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Integrated ChemoLock Drip Chamber, Spiros, Hanger, Drop-In Red Cap, Item No. CL 3011 Clerestories devices intended for the infusion and withdrawal of fluids.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1259-2016·2016-04-06

    ICU Medical Recalls ChemoLock IV Administration Sets Due to Leak Risk

    ICU Medical is recalling specific IV infusion administration sets with ChemoLock ports because the connection may develop a leak.

    Product
    30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, ChemoLock, Hanger, Item No. CL3511 sterile devices intended for the infusion and withdrawal of fluids.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1261-2016·2016-04-06

    ICU Medical Recalls I.V. Infusion Sets with Potential Leak

    ICU Medical is recalling 400 units of I.V. infusion administration sets because the connection between the drip chamber and ChemoLock port may develop a leak.

    Product
    31" (79 cm) Appx. 3.4 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, Spiros, Bag Hanger, Item No. SL3011 sterile devices intended for the infusion and withdrawal of fluids.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1257-2016·2016-04-06

    ICU Medical Recalls I.V. Infusion Sets with Potential Leak

    ICU Medical is recalling specific I.V. infusion administration sets because a connection may develop a leak. The recall affects 350 units distributed in the US and internationally.

    Product
    110" (279 cm) Appx 13.8 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, Clave, Rotating Luer, Bag Hanger, Item No. AHCL3300 sterile devices intended for the infusion and withdrawal of fluids.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1256-2016·2016-04-06

    ICU Medical Recalls IV Infusion Sets with Potential ChemoLock Port Leak

    ICU Medical is recalling specific IV infusion administration sets because the connection between the drip chamber or bag spike and the ChemoLock port may develop a leak.

    Product
    30" (76 cm) Appx 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, 0.2 Micron Filter, ChemoLock, Hanger, Item No. 011-CL3528 sterile devices intended for the infusion and withdrawal of fluids.
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-0600-2016·2016-01-13

    KCI ActiV.A.C. Canisters Recalled for Potential Pinhole Leaks

    KCI USA is recalling ActiV.A.C. 300ml Canisters distributed in Japan and Australia due to potential pinhole leaks in the pouches.

    Product
    ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of V.A.C. Therapy in the acute extended and home care settings. The software-controlled therapy unit applies negative pressure wound therapy. The dressing, to which the therapy unit is connecte
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0552-2016·2015-12-30

    Airways Development Recalls WaterPAP Positive Airway Pressure Devices

    Airways Development LLC is recalling 1,464 WaterPAP Positive Airway Pressure Devices due to a reported canister leak.

    Product
    Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0132-2016·2015-10-28

    Baxter Recalls Microbore Catheter Extension Sets Due to Potential Leak

    Baxter Healthcare Corp is recalling 23,600 units of One-Link Microbore Catheter Extension Sets due to a potential leak at the tubing to luer bond.

    Product
    ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACEMENT
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2202-2015·2015-07-29

    Abbott ARCHITECT c8000 System Recalled for Tubing Leak Risk

    Abbott Laboratories is recalling five ARCHITECT c8000 systems because the tubing may not meet specifications and could leak.

    Product
    ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARCHITECT cSystem is intended for In Vitro diagnostic use only. It is designed to perform automated: chemistry tests, utilizing photometry and potentiometric technology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1716-2015·2015-06-17

    Fresenius CRIT-LINE Blood Chamber Recalled for Connection Leaks

    Fresenius Medical Care is recalling CRIT-LINE Blood Chambers because the connection may leak during use.

    Product
    CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model: CL10021021
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0490-2015·2015-04-29

    Hospira Recalls Sodium Chloride Injection Due to Sterility Concerns

    Hospira Inc. is recalling 128,050 units of 0.9% Sodium Chloride Injection due to a potential leak at the administrative port that compromises sterility.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0428-2015·2015-04-08

    Baxter Recalls Clinimix E Due to Sterility Assurance Concerns

    Baxter Healthcare is recalling 7,444 containers of Clinimix E 5/20 due to a lack of assurance of sterility and increased leak complaints.

    Product
    CLINIMIX E — CLINIMIX E (LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0417-2015·2015-03-25

    Hospira Recalls 5% Dextrose Injection Due to Sterility Concerns

    Hospira is recalling 94,440 bags of 5% Dextrose Injection due to a potential leak at the administrative port that compromises sterility.

    Product
    DEXTROSE — DEXTROSE (DEXTROSE MONOHYDRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1286-2015·2015-03-25

    Smiths Medical Recalls CADD Medication Cassette Reservoirs Due to Leak Risk

    Smiths Medical is recalling specific lots of 50mL CADD Medication Cassette Reservoirs because they may leak at the sealing area. No serious injuries or deaths have been reported.

    Product
    CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx only.
    Category
    Medical Device
    Distribution
    Distributed nationwide