The Recall Desk

Hazard

Bacterial Endotoxin recalls

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

What the numbers show

Total
72
Critical
2
Severe
25
Most recent
2026-08-19

Of the 72 bacterial endotoxin recalls we have scored against our rubric, 2 (3%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 25 (35%) 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 bacterial endotoxin 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.

51–72 of 72

  • SevereFDA (Devices)·Z-2196-2018·2018-06-20

    Angiodynamics Recalls Bio-Stable Kits Due to Bacterial Endotoxin Risk

    Angiodynamics Inc. is recalling 298 boxes of Bio-Stable 5F kits because a component may contain unsafe levels of bacterial endotoxins.

    Product
    Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved with Nitinol Guidewire PG, Catalog Number 45-895
    Category
    Medical Device
    Distribution
    34 states
  • SevereFDA (Devices)·Z-2188-2018·2018-06-20

    Angiodynamics Recalls XCELA PASV Nitinol Wire Kits Due to Endotoxin Risk

    Angiodynamics Inc. is recalling 7 boxes of XCELA PASV 5F SL 55CM IR-145 Nitinol Wire Kits because a component may contain unsafe levels of bacterial endotoxins.

    Product
    XCELA PASV 5F SL 55CM IR-145 Nitinol Wire KIT PG, Catalog Number 25-124
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2190-2018·2018-06-20

    Angiodynamics Recalls Bio-Stable Kits Due to Bacterial Endotoxin Risk

    Angiodynamics Inc. is recalling Bio-Stable 5F kits because a component may contain unsafe levels of bacterial endotoxins.

    Product
    Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, Catalog Number 45-871
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2200-2018·2018-06-20

    Angiodynamics Recalls RS TANDEM 5F DL XPP Kits Due to Endotoxins

    Angiodynamics Inc. is recalling 7 units of RS TANDEM 5F DL XPP kits because components may contain unsafe levels of bacterial endotoxins.

    Product
    RS TANDEM 5F DL XPP, Catalog Number 60M019881
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2224-2018·2018-06-20

    Angiodynamics Recalls BioFlo PICC Kits Due to Bacterial Endotoxins

    Angiodynamics Inc. is recalling BioFlo PICC nursing kits because a component may contain unsafe levels of bacterial endotoxins.

    Product
    BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG, Catalog Number 75-038
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2199-2018·2018-06-20

    Angiodynamics Recalls BioFlo Midline Kits Due to Bacterial Endotoxins

    Angiodynamics Inc. is recalling 23 boxes of BioFlo Midline kits because a component may contain unsafe levels of bacterial endotoxins.

    Product
    BioFlo Midline 5F DL-20cm MST-45 Kit w/ Two Nitinol Guidewires PG, Catalog Number 46-810
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2194-2018·2018-06-20

    Angiodynamics Recalls Bio-Stable Kits Due to Bacterial Endotoxin Risk

    Angiodynamics Inc. is recalling Bio-Stable 5F kits because components may contain unsafe levels of bacterial endotoxins.

    Product
    Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-887
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2191-2018·2018-06-20

    Angiodynamics Recalls Bio-Stable Kits Due to Bacterial Endotoxin Risk

    Angiodynamics Inc. is recalling 20 boxes of Bio-Stable 5F kits because a component may contain unsafe levels of bacterial endotoxins.

    Product
    Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved PG, Catalog Number 45-872
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2206-2018·2018-06-20

    Angiodynamics Recalls TANDEM 5F DL BIOFLO PASV Kits Due to Endotoxins

    Angiodynamics Inc. is recalling TANDEM 5F DL BIOFLO PASV kits because a component may contain unsafe levels of bacterial endotoxins.

    Product
    TANDEM 5F DL BIOFLO PASV, Catalog Number 60M140567
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2204-2018·2018-06-20

    Angiodynamics Recalls RS Tandem 5F DL Bioflo Pasv Catheters

    Angiodynamics Inc. is recalling RS Tandem 5F DL Bioflo Pasv catheters because components may contain unsafe levels of bacterial endotoxins.

    Product
    RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M120196
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-1803-2018·2018-05-23

    Bard Peripheral Vascular Seeker Crossing Support Catheter Recalled for Endotoxin Risk

    Bard Peripheral Vascular Inc is recalling 130 units of Seeker Crossing Support Catheters due to potential bacterial endotoxin on packaging hoops, posing a cross-contamination risk.

    Product
    BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.014", 150 cm, REF SK15014. Intended to support a guidewire during access into the vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1802-2018·2018-05-23

    Bard Peripheral Vascular Seeker Crossing Support Catheter Recalled for Endotoxin Risk

    Bard Peripheral Vascular Inc is recalling 140 units of the Seeker Crossing Support Catheter due to potential bacterial endotoxin on packaging hoops.

    Product
    BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.035", 150 cm, REF SK15035M. Intended to support a guidewire during access into the vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0823-2018·2018-03-07

    LifeCell Revolve Advanced Adipose System Recalled for Bacterial Endotoxins

    LifeCell is recalling 25,798 units of the Revolve Advanced Adipose System due to bacterial endotoxin levels above acceptable limits.

    Product
    REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0562-2015·2014-12-17

    PFM Medical Recalls ASEPT Drainage Kits for Bacterial Endotoxin Concerns

    PFM Medical is recalling ASEPT 600 ml Drainage Kits because they may exceed USP limits for bacterial endotoxin. The recall affects 1,470 units distributed in the US and abroad.

    Product
    ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit is an accessory to be used to connect to the ASEPT Pleural or Peritoneal Drainage Catheter to drain fluid from the chest or abdomen.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0566-2015·2014-12-17

    PFM Medical Recalls Thoracentesis and Paracentesis Procedure Trays

    PFM Medical is recalling 75 units of Thoracentesis & Paracentesis Procedure Trays because they may exceed USP limits for bacterial endotoxin.

    Product
    Thoracentesis & Paracentesis Procedure Tray, Ref No. M7553, 850004 Product Usage: Short term percutaneous fluid drainage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0567-2015·2014-12-17

    PFM Medical Recalls Veta Peritoneal Catheter Kits for Bacterial Endotoxin

    PFM Medical is recalling Veta Peritoneal Catheter Kits because they may exceed USP limits for bacterial endotoxin.

    Product
    Veta Peritoneal Catheter Kit, Curled, Ref No. M7225 Product Usage: Veta Peritoneal Dialysis Catheters are intended for acute and chronic access to the peritoneal cavity.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0565-2015·2014-12-17

    Pfm Medical Recalls ASEPT Peritoneal Drainage Systems for Bacterial Endotoxin

    Pfm Medical is recalling 83 units of the ASEPT Peritoneal Drainage System because the devices may exceed USP limits for bacterial endotoxin.

    Product
    ASEPT Peritoneal Drainage System, Ref No. P09080002 Product Usage: The pfm medical ASEPT Peritoneal Drainage System is a tunneled, indwelling catheter used to drain accumulated fluid from the abdomen.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0563-2015·2014-12-17

    PFM Medical Recalls Micro Introducer Kits Due to Bacterial Endotoxin Limits

    PFM Medical is recalling 100 units of Micro Introducer Kits because they may exceed USP limits for bacterial endotoxin. The devices are used for introducing therapeutic devices like PICCs.

    Product
    Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: These introducers are used for the percutaneous introduction of therapeutic devices, such as PICCS. The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0564-2015·2014-12-17

    PFM Medical Recalls Dual Lumen CT PICC Catheters for Bacterial Endotoxin

    PFM Medical is recalling 90 units of 6F x 60 cm Dual Lumen CT PICC catheters because they may exceed USP limits for bacterial endotoxin.

    Product
    6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage:The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media. For blood sampling, infusions, or therapies
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0561-2015·2014-12-17

    Pfm Medical Recalls ASEPT Pleural Drainage Systems for Bacterial Endotoxin

    Pfm Medical is recalling ASEPT Pleural Drainage Systems because they may exceed USP limits for bacterial endotoxin. The recall affects 120 units distributed in the US and internationally.

    Product
    ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The pfm medical ASEPT Pleural Drainage System is a tunneled, long term catheter used to drain accumulated fluid from the pleural cavity in order to relieve symptoms associated
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0568-2015·2014-12-17

    PFM Medical Recalls ASEPT Drainage Bags Due to Bacterial Endotoxin Concerns

    PFM Medical is recalling ASEPT 2000 ml Drainage Bags because they may exceed USP limits for bacterial endotoxin. The recall affects 370 units distributed in the US and internationally.

    Product
    ASEPT 2000 ml Drainage Bag, Ref No. 622280 Product Usage: The ASEPT Drainage Bag is to be used for peritoneal drainage with the ASEPT Peritoneal Drainage Catheter only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0560-2015·2014-12-17

    Pfm Medical Recalls Rapid Centesis Catheters Due to Bacterial Endotoxin

    Pfm Medical Inc is recalling Rapid Centesis Catheters because they may exceed USP limits for bacterial endotoxin. The recall affects 480 units distributed in the US and abroad.

    Product
    Rapid Centesis Catheter, 5 Fr x 7 cm Catheter, Ref No. M7513 Product Usage: Short term percutaneous fluid drainage
    Category
    Medical Device
    Distribution
    Distributed nationwide