The Recall Desk

Hazard

Endotoxin recalls

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

What the numbers show

Total
179
Critical
2
Severe
16
Most recent
2026-09-30

Of the 179 endotoxin recalls we have scored against our rubric, 2 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 16 (9%) 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 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.

151–175 of 179

  • HighFDA (Devices)·Z-2156-2020·2020-06-03

    Biomet Recalls Custom Knee Prosthesis Due to Potential Endotoxin Levels

    Biomet, Inc. is recalling a specific custom-made knee prosthesis due to the potential presence of elevated endotoxin levels that exceed specification limits.

    Product
    Knee Products: TMJPM-1510 Microfixation Custom Made Device, Left PM-TMJ Model (01)00841036226534(17)220111(10)735550 Product Usage: Knee prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1842-2019·2019-06-26

    Ethicon Recalls Ethibond Excel Polyester Sutures Due to Endotoxin Risk

    Ethicon, Inc. is recalling specific lots of Ethibond Excel polyester sutures because raw materials used in manufacturing may contain high endotoxin levels.

    Product
    ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1027-2019·2019-03-27

    CP Medical Recalls Sterile Surgical Sutures Due to Potential Sterility Compromise

    CP Medical Inc is recalling Plain and Chromic Gut Absorbable Surgical Sutures because routine endotoxin testing showed an out-of-limit result, potentially compromising sterility.

    Product
    Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box. Product Usage: Plain Gut Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neural…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0090-2019·2018-10-17

    Sterilmed Recalls Reprocessed Agilis Steerable Introducers Due to Endotoxin Concerns

    Sterilmed, Inc. is recalling 218 reprocessed Agilis Steerable Introducers because they may not meet endotoxin requirements. The devices were distributed in California, Colorado, Minnesota, and Washington.

    Product
    Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart. (a) small curl (16.8mm curve type/71 cm length), Product Code STJ408309; (b) medium curl (22.4 mm curve type/71 cm length), Product Code STJ408310; (c)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2791-2018·2018-08-22

    Cook Inc. Recalls VentriClear Ventricular Drainage Catheter Sets Due to Endotoxin Failure

    Cook Inc. is recalling 250 units of the VentriClear Ventricular Drainage Catheter Set because the product failed endotoxin testing. The recall involves one distributor in Indiana, and the product was not distributed to end users.

    Product
    VentriClear Ventricular Drainage Catheter Set, Cat. No. N-VVDC-01-ABRM Product Usage: The VentriClear Ventricular Drainage Catheter Set has been designed for obtaining access to a ventricular cavity of the brain for short-term use to externally drain fluid for the purpose of…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2219-2018·2018-06-20

    Angiodynamics Recalls CAN 5F Dual Xcela PICC Kits for Endotoxin Risk

    Angiodynamics Inc. is recalling 27 boxes of CAN 5F Dual Xcela PICC kits because a component may contain unsafe levels of bacterial endotoxins.

    Product
    CAN 5F DUAL XCELA PICC, Catalog Number 60M701532
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-0811-2018·2018-03-07

    NxStage Dialysate Sacks Recalled for Exceeding Endotoxin Quality Standards

    NxStage Medical is recalling dialysate sacks because endotoxin levels may exceed the ANSI/AAMI quality standard of 0.5 EU/ml.

    Product
    NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M535SAK3020, 3) REF SAK-303 UDI-M535SAK3030, 4) REF SAK-304 UDI-M535SAK3040, 5) REF SAK-306 UDI-M535SAK3060, 6) REF SAK-307 UDI- M535SAK3070, 6) REF SAK-402 UDI-M535SAK4020, 7) REF SAK-405 UDI…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0424-2018·2018-02-21

    PharMEDium Recalls Phenylephrine Injection Due to Sterility Assurance Failure

    PharMEDium Services, LLC is recalling 500 syringes of Phenylephrine HCl Injection due to a lack of assurance of sterility and potential endotoxin issues.

    Product
    100 mcg / mL Phenylephrine HCl (Preservative Free) Injection, 10 mL syringe, Rx only, PharMEDium Serivces, LLC
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0422-2018·2018-02-21

    PharMEDium Recalls Oxytocin Injection Bags Due to Sterility Concerns

    PharMEDium Services, LLC is recalling 24 bags of Oxytocin Injection due to a lack of assurance of sterility and potential endotoxin issues.

    Product
    15 units Oxytocin added to 0.9% Sodium Chloride Injection, 250 mL Viaflex Bag, Rx only, PharMEDium Serivces, LLC
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0423-2018·2018-02-21

    PharMEDium Recalls Ropivacaine Cassettes Due to Sterility Assurance Failure

    PharMEDium Services, LLC is recalling 21 cassettes of 0.2% Ropivacaine HCI due to a failure to follow proper testing procedures, raising concerns about sterility and endotoxin levels.

    Product
    0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 250 mL Yellow Cassette, Rx only, PharMEDium Serivces, LLC
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0948-2017·2017-01-11

    Tepha GalaSHAPE 3D Medical Device Recalled for Endotoxin Specification Exceedance

    Tepha Incorporated is recalling 29 units of GalaSHAPE 3D medical devices because endotoxin levels slightly exceeded specifications.

    Product
    GalaSHAPE 3D; product code SH3D03, a medium size oval GalaSHAPE" 3D is indicated for use as a bioresorbable scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1702-2016·2016-06-01

    AngioVac Circuit Packs Recalled for Excessive Endotoxin Levels

    AngioDynamics is recalling AngioVac Circuit Packs because they may contain RotaFlow Centrifugal Pumps with endotoxin levels exceeding regulatory limits.

    Product
    AngioVac Circuit Pack (Tandem Packs), REF/Catalog No. 25-187, UPN H965251870, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are designed to be used with the AngioVac Cannula.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1701-2016·2016-06-01

    AngioVac Circuit Recall Due to Potential Endotoxin Levels

    Angiodynamics is recalling Vortex MEDICAL AngioVac Circuits because they may contain endotoxin levels exceeding regulatory limits.

    Product
    Vortex MEDICAL AngioVac Circuit, REF/UPN VTX3100, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are designed to be used with the AngioVac Cannula.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1373-2016·2016-04-20

    Maquet Rotaflow Centrifugal Pump Tubing Recalled for Endotoxin Risk

    Maquet Cardiovascular is voluntarily recalling Rotaflow Centrifugal Pump custom tubing packs due to a potential risk of endotoxin exposure.

    Product
    Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2382-2015·2015-08-19

    B. Braun Recalls Celsite Implantable Access Port Systems Due to Endotoxin

    B. Braun Interventional Systems is recalling 11 Celsite Implantable Access Port Systems because endotoxin test results were out of specification.

    Product
    Celsite Implantable Access Port System, model ST301. The Celsite Implantable Access Port Systems (Celsite port systems) are implantable port and catheter systems that allow safe, repeated access to the patient's bloodstream. The port chamber and catheter design can be used for…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1723-2014·2014-06-11

    Medtronic Ascenda Intrathecal Catheter Recalled for Endotoxin Contamination

    Medtronic is recalling Model 8780 Ascenda Intrathecal Catheters because they may contain endotoxin levels exceeding USP limits.

    Product
    Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtronic Model 8780 Ascenda Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0974-2014·2014-02-19

    Custom Medical Specialties Recalls Ultrasound Probe Covers for Missing Endotoxin Testing

    Custom Medical Specialties is recalling 2,610 sterile ultrasound probe covers because they were not tested for endotoxins to the required level.

    Product
    5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, Inc., Pine Level, NC, Federal (USA) law restricts this device to the sale by or on the order of a physician. Probe cover
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0948-2014·2014-02-19

    Ecolab Recalls Vital Care Ultrasound Probe Covers Due to Testing Deficiencies

    Ecolab Inc is recalling specific lots of Vital Care ultrasound probe covers because they did not undergo endotoxin testing to the proper levels.

    Product
    Vital CARE(TM) REPS INC. ULTRASOUND PROBE COVER, BUR HOLE COVER, 5 x 96, REF VPC0699, STERILE EO, QTY 20, Manufactured for Vital Care Reps, Inc., Tinley Park, Illinois
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0946-2014·2014-02-19

    Ecolab Recalls Microtek Medical Bur Hole Latex Probe Covers

    Ecolab Inc is recalling specific lots of Microtek Medical Bur Hole Latex Probe Covers because they did not undergo endotoxin testing to the proper levels.

    Product
    MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL, featuring IsoSilk(R), 5" x 98", (13cm x 249 cm), REF 3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0945-2014·2014-02-19

    Ecolab Recalls Microtek Medical Bur Hole Probe Covers for Endotoxin Testing

    Ecolab Inc is recalling specific lots of Microtek Medical Bur Hole Probe Covers because they did not undergo proper endotoxin testing.

    Product
    MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER W/ GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688EU, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0944-2014·2014-02-19

    Ecolab Recalls Microtek Medical Bur Hole Probe Covers for Testing Defects

    Ecolab Inc is recalling specific lots of Microtek Medical Bur Hole Probe Covers because they did not undergo proper endotoxin testing.

    Product
    MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-928-2013·2013-09-11

    Teva Recalls CARBOplatin Injection Due to Sterility Assurance Failure

    Teva Pharmaceuticals is recalling CARBOplatin Injection because the required reduction of endotoxin was not met during annual revalidation of the vial washer.

    Product
    CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC 0703-3249-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1595-2013·2013-07-03

    Medtronic Recalls INFUSE Bone Graft Kits Due to Endotoxin Levels

    Medtronic is recalling INFUSE Bone Graft kits because they contain a collagen sponge with possible elevated endotoxin levels.

    Product
    INFUSE(R) Bone Graft, LARGE II KIT, REF 7510800AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1592-2013·2013-07-03

    Medtronic Recalls INFUSE Bone Graft Kits Due to Endotoxin Levels

    Medtronic is recalling INFUSE Bone Graft kits because they contain a collagen sponge with possible elevated endotoxin levels.

    Product
    INFUSE(R) Bone Graft,LARGE II KIT, REF 7510800, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1591-2013·2013-07-03

    Medtronic Recalls INFUSE Bone Graft Kits Due to Endotoxin Concerns

    Medtronic is recalling INFUSE Bone Graft kits because they contain a collagen sponge with possible elevated endotoxin levels.

    Product
    INFUSE(R) Bone Graft, LARGE KIT, REF 7510600, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
    Category
    Medical Device
    Distribution
    Distributed nationwide