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.

451–475 of 493

  • HighFDA (Devices)·Z-1259-2015·2015-03-18

    Arrow Intra-Aortic Balloon Catheter Kit Recalled for Potential Helium Leak

    Arrow International Inc is recalling 166 units of Intra-Aortic Balloon Catheter Kits due to a potential leak that allows helium to escape.

    Product
    Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0301-2015·2014-12-24

    Baxter Recalls Clinimix E IV Bags Due to Sterility Concerns

    Baxter Healthcare is recalling 7,220 bags of Clinimix E IV solution because leaks were observed, raising concerns about sterility.

    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-0278-2015·2014-12-03

    Hospira Recalls Potassium Chloride IV Bags Due to Sterility Concerns

    Hospira is recalling 836,460 bags of Potassium Chloride IV solution due to potential punctures that may compromise sterility and cause leaks.

    Product
    Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7902-09.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0287-2015·2014-12-03

    Hospira Recalls Sterile Water for Injection Due to Sterility Concerns

    Hospira is recalling 153,504 bags of Sterile Water for Injection due to potential punctures that may compromise sterility and cause leaks.

    Product
    Sterile Water for Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7990-09.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0277-2015·2014-12-03

    Hospira Recalls Normosol-R IV Bags Due to Sterility Concerns

    Hospira is recalling 152,172 bags of Normosol-R IV solution due to potential punctures that may compromise sterility and cause leaks.

    Product
    Normosol-R pH 7.4 Multiple Electrolytes Injection Type 1, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7670-09.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0285-2015·2014-12-03

    Hospira Recalls 0.9% Sodium Chloride Injection Bags Due to Sterility Concerns

    Hospira is recalling 16.5 million bags of 0.9% Sodium Chloride Injection due to potential punctures that may compromise sterility and cause leaks.

    Product
    0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2028-2014·2014-07-23

    Terumo Sarns Centrifugal Pump Recalled for Pumphead Leaks

    Terumo is recalling Sarns Disposable Centrifugal Pumps because leaks were detected on the pumphead during set-up and priming.

    Product
    Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2029-2014·2014-07-23

    Terumo Sarns Centrifugal Pump Recalled for Pumphead Leaks

    Terumo is recalling specific lots of Sarns Disposable Centrifugal Pumps because leaks were detected on the pumphead during set-up and priming.

    Product
    Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2030-2014·2014-07-23

    Terumo Cardiovascular Procedure Kit Recall for Pumphead Leaks

    Terumo is recalling 256 Cardiovascular Procedure Kits because leaks were detected on the centrifugal pumphead during set-up and priming of the bypass circuit.

    Product
    Cardiovascular Procedure Kit containing Disposable Centrifugal Pumphead with or without X-Coating, sterile single use. Catalog numbers 73431, 73813-03, 74277, 72481-01, 72427, 70947-03, 74570-01, 74031-01, 73312-01, 74362, 74928, 74928-01, 72997-03, 74277, 70334-03, 73230,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1621-2014·2014-05-21

    InterValve V8 Balloon Aortic Valvuloplasty Catheter Recalled for Leak Issues

    InterValve Inc is recalling specific V8 Balloon Aortic Valvuloplasty Catheters due to leak issues discovered during accelerated age testing.

    Product
    InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedures for Balloon Aortic Valvuloplasty.
    Category
    Medical Device
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-1276-2014·2014-05-07

    Baxter Recalls Dianeal Peritoneal Dialysis Solution Due to Mold Contamination

    Baxter Healthcare is recalling 27,169 containers of Dianeal Low Calcium with Dextrose peritoneal dialysis solution due to reported leaks and mold contamination.

    Product
    DIANEAL LOW CALCIUM WITH DEXTROSE — DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1443-2014·2014-04-16

    Smiths Medical HOTLINE Fluid Warming Set Recall for Injection Port Leaks

    Smiths Medical is recalling HOTLINE Fluid Warming Sets because the injection port septum may leak or become dislodged, potentially causing blood or IV fluid leaks.

    Product
    Smiths Medical HOTLINE¿ Fluid Warming Set L-70. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1105-2014·2014-03-05

    Fresenius Recalls Optiflux B200 Flux Dialyzers Due to Port Leak Risk

    Fresenius Medical Care is recalling 100,008 Optiflux B200 Flux Dialyzers because the dialysate port may leak during priming.

    Product
    Optiflux B200 Flux Dialyzers; Product Number: 0500325E. Single Use acute or chronic hemanalysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1102-2014·2014-03-05

    Fresenius Optiflux F200NRe Dialyzers Recalled for Dialysate Port Leak

    Fresenius Medical Care is recalling Optiflux F200NRe dialyzers because the dialysate port may leak during priming, posing a risk to patients.

    Product
    Optiflux F200NRe High Flux Dialyzers; Product Number: 0500320E. Single Use acute or chronic hemanalysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1098-2014·2014-03-05

    Fresenius Optiflux Dialyzers Recalled for Dialysate Port Leak During Priming

    Fresenius Medical Care is recalling Optiflux F160NRe dialyzers because the dialysate port may leak during priming. The recall covers 3.4 million units distributed in the US and Mexico.

    Product
    Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E. Single Use acute or chronic hemanalysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1104-2014·2014-03-05

    Fresenius Optiflux F200A Dialyzers Recalled for Dialysate Port Leak

    Fresenius Medical Care is recalling 5,244 Optiflux F200A dialyzers due to a dialysate port leak during priming.

    Product
    Optiflux F200A High Flux Dialyzers; Product Number: 0500320A. Single Use acute or chronic hemanalysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1100-2014·2014-03-05

    Fresenius Optiflux F180NRe Dialyzers Recalled for Port Leak During Priming

    Fresenius Medical Care is recalling Optiflux F180NRe dialyzers because the dialysate port may leak during priming, potentially compromising treatment.

    Product
    Optiflux F180NRe High Flux Dialyzers; Product Number: 0500318E. Single Use acute or chronic hemanalysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1099-2014·2014-03-05

    Fresenius Optiflux F160NR Dialyzers Recalled for Dialysate Port Leak

    Fresenius Medical Care is recalling Optiflux F160NR dialyzers because the dialysate port may leak during priming. The recall covers 6,720 units distributed in the US and Mexico.

    Product
    Optiflux F160NR High Flux Dialyzers; Product Number: 0500316N. Single Use acute or chronic hemanalysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1101-2014·2014-03-05

    Fresenius Optiflux F180NR Dialyzers Recalled for Dialysate Port Leak

    Fresenius Medical Care is recalling Optiflux F180NR dialyzers due to a dialysate port leak during priming. The recall covers 52,752 units distributed in the US and Mexico.

    Product
    Optiflux F180NR High Flux Dialyzers; Product Number: 0500318N. Single Use acute or chronic hemanalysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1103-2014·2014-03-05

    Fresenius Optiflux F200NR Dialyzers Recalled for Dialysate Port Leak

    Fresenius Medical Care is recalling 19,596 Optiflux F200NR dialyzers due to a dialysate port leak during priming. The units were distributed in the US and Mexico.

    Product
    Optiflux F200NR High Flux Dialyzers; Product Number: 0500320N. Single Use acute or chronic hemanalysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0827-2014·2014-02-19

    Tandem T:slim Insulin Pump Cartridges Recalled for Leak Risk

    Tandem Diabetes Care is recalling specific lots of T:slim insulin cartridges due to a risk of leaking, which could cause incorrect insulin delivery.

    Product
    T:slim Insulin Delivery System Insulin Infusion Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0743-2014·2014-01-22

    Atrium Medical Recalls Chest Drain Tubing Due to Leak or Disconnect Risk

    Atrium Medical Corporation is recalling 1,944 units of Express Dry Seal ATS Chest Drains because the tubing may leak or disconnect.

    Product
    Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with Prefilled Air Leak Monitor; Product Code: 4050-100P. To evacuate air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0735-2014·2014-01-22

    Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System Recall

    Atrium Medical Corporation is recalling Ocean Water Seal Chest Drain ATS Blood Recovery Systems because the tubing may leak or disconnect.

    Product
    Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock and in-line connectors; Product Code: 2050-000. To evacuate air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0739-2014·2014-01-22

    Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System Recall

    Atrium Medical Corporation is recalling 1,002 units of Ocean Water Seal Chest Drain ATS Blood Recovery Systems due to potential tubing leaks or disconnections.

    Product
    Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock; .Product Code: 2052-300. To evacuate air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0742-2014·2014-01-22

    Atrium Express Dry Seal ATS Chest Drain Recalled for Leak or Disconnect Risk

    Atrium Medical Corporation is recalling 7,274 units of the Express Dry Seal ATS Chest Drain because the tubing may leak or disconnect.

    Product
    Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain; Product Code: 4050-100N. To evacuate air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    Distributed nationwide