The Recall Desk

Hazard

Pyrogen recalls

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

What the numbers show

Total
20
Critical
0
Severe
6
Most recent
2021-03-03

Of the 20 pyrogen recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 6 (30%) 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 pyrogen 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.

1–20 of 20

  • HighFDA (Devices)·Z-1143-2021·2021-03-03

    Natus EDS 3 CSF External Drainage System Recalled for Pyrogen Test Failure

    Natus Manufacturing Limited is recalling 7 units of the EDS 3 CSF External Drainage System because the device failed to meet pyrogen test requirements for endotoxins.

    Product
    Ref: NT821731C, Natus EDS 3 CSF External Drainage System - Product Usage: indicated for draining cerebrospinal fluid (CFS) from the cerebral ventricles or the lumbar subarachnoid space as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2558-2018·2018-08-08

    Galt Medical Recalls Sterile Hemostasis Valve Introducer Systems Due to Endotoxins

    Galt Medical Corporation is recalling specific sterile hemostasis valve introducer systems and kits because they may contain unsafe levels of bacterial endotoxins introduced during manufacturing.

    Product
    1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog #: a) BCL-100-04; b) BCL-100-05; c) BCL-100-06; d) BCL-500-36; 2) Elite HV Introducer Set, Sterile EO, Rx Only, Catalog #: a) CLI-105-14; 3) AngioGate HV Introducer Kit, Sterile EO, Catalog #: a
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2560-2018·2018-08-08

    Galt Medical Recalls Centesis Catheters Due to Bacterial Endotoxin Contamination

    Galt Medical Corporation is recalling specific lots of Drainer and Centeze Centesis Catheters because they may contain unsafe levels of bacterial endotoxins.

    Product
    1) Drainer Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-001-05, b) DRC-001-06, c) DRC-001-15, 2) Centeze Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-002-02, b) DRC-002-05, c) DRC-002-06, d) DRC-002-08,
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2217-2018·2018-06-20

    Angiodynamics Recalls PICC Nursing Trays Due to Bacterial Endotoxins

    Angiodynamics Inc. is recalling 2 boxes of CAN 5F DL BIOFLO PASV PICC Nursing Trays because a component may contain unsafe levels of bacterial endotoxins.

    Product
    CAN 5F DL BIOFLO PASV PICC NURSING TRAY, Catalog Number 60M700936
    Category
    Medical Device
    Distribution
    34 states
  • 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-2211-2018·2018-06-20

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

    Angiodynamics Inc. is recalling 11 boxes of RS 5F DL BIOFLO PASV kits because components may contain unsafe levels of bacterial endotoxins.

    Product
    RS 5F DL BIOFLO PASV, Catalog Number 60M181578
    Category
    Medical Device
    Distribution
    34 states
  • SevereFDA (Devices)·Z-2222-2018·2018-06-20

    BioFlo PICC Nursing Kit Recalled for Unsafe Bacterial Endotoxin Levels

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

    Product
    BioFlo PICC (NV) 5FSL-55cm Maximal Barrier Nursing Kit w/ 70cm Nitinol Wire PG, Catalog Number 75-032
    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-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-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-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-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-1298-2013·2013-05-22

    Integra Recalls OraMem Absorbable Collagen Membrane Due to Pyrogen Levels

    Integra LifeSciences is recalling 812 boxes of OraMem Absorbable Collagen Membrane because process deviations may have resulted in higher levels of pyrogens than permitted.

    Product
    OraMem Absorbable Collagen Membrane OraMem¿ Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1289-2013·2013-05-22

    Integra Recalls Helistat Absorbable Hemostatic Due to Pyrogen Levels

    Integra LifeSciences is recalling 24,342 boxes of Helistat Absorbable Hemostatic because process deviations may have resulted in higher levels of pyrogens than permitted.

    Product
    Helistat Absorbable Hemostatic,Collagen Based Helistat is indicated in surgical procedures (other than ophthalmological and urological surgery) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1302-2013·2013-05-22

    Integra Absorbable Collagen Sponge Recalled for Pyrogen Levels

    Integra LifeSciences is recalling absorbable collagen sponges due to a process deviation that may have resulted in higher pyrogen levels than permitted.

    Product
    Absorbable Collagen Sponge Provided As Intermediate to Another Company
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1294-2013·2013-05-22

    Integra HeliTape Collagen Wound Dressing Recalled for Pyrogen Levels

    Integra LifeSciences is recalling HeliTape Absorbable Collagen Wound Dressings for dental surgery due to potential pyrogen levels exceeding specifications.

    Product
    HeliTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1299-2013·2013-05-22

    Integra Recalls BioMend Extend Membranes Due to Pyrogen Levels

    Integra LifeSciences is recalling BioMend Extend Absorbable Collagen Membranes because process deviations may have resulted in higher levels of pyrogens than permitted.

    Product
    BioMend¿ Extend" Absorbable Collagen Membrane BioMend¿ Extend" Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1296-2013·2013-05-22

    Integra OraTape Collagen Wound Dressing Recalled for Pyrogen Levels

    Integra LifeSciences is recalling OraTape Absorbable Collagen Wound Dressings because process deviations may have resulted in higher levels of pyrogens than permitted.

    Product
    OraTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1290-2013·2013-05-22

    Integra Recalls Helitene Absorbable Collagen Hemostatic Sponge

    Integra LifeSciences is recalling Helitene Absorbable Collagen Hemostatic Sponge because process deviations may have resulted in higher levels of pyrogens than permitted.

    Product
    Helitene Absorbable Collagen Hemostatic Sponge Helitene is indicated in surgical procedures (other than ophthalmological and urological surgery) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1283-2013·2013-05-22

    Integra Recalls Suturable DuraGen Dural Matrix Due to Pyrogen Levels

    Integra LifeSciences is recalling Suturable DuraGen Dural Regenerative Matrix because process deviations may have resulted in higher pyrogen levels than permitted.

    Product
    Suturable DuraGen Dural Regenerative Matrix Suturable DuraGen Dural Regenerative Matrix is an absorbable implant for repair of dural defects. Suturable DuraGen is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix with a mechanically strengthened colla
    Category
    Medical Device
    Distribution
    Distributed nationwide