The Recall Desk

Hazard

Endotoxin recalls

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

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.

26–50 of 130

  • HighFDA (Devices)·Z-2034-2026·2026-05-06

    Medline medical procedure kits with neuro sponges recalled for endotoxin

    Medline Industries is recalling medical procedure kits containing neuro sponges after internal review identified higher-than-expected endotoxin levels. In-market product may be out-of-specification for endotoxin.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. SPINE PROCEDURES PACK-LF, Medline Kit Number/SKU DYNJ0751220P; 2. ENSEMBLE RACHIS-LF, Medline Kit Number/SKU DYNJ47568B; 3. UROLOGY ROBOTIC, Medline Kit Number/SKU DYNJ55555B; 4. UROLOG
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2035-2026·2026-05-06

    Medline robotic hysterectomy procedure kits recalled for elevated endotoxin

    Medline Industries is recalling robotic hysterectomy procedure kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels that may indicate out-of-specification product in distribution worldwide.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269B; 2. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269C; 3. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269D.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2008-2026·2026-05-06

    Medline Neuro Sponges recalled for out-of-specification endotoxin levels

    Medline Industries is recalling Medline Neuro Sponges in multiple sizes worldwide after internal review found higher-than-expected endotoxin levels in representative product samples.

    Product
    Medline Neuro Sponges, various dimensions, labeled as: 1. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.25" X 0.25", XR, 10/PK, Medline SKU NEUROSPNG02; 2. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.5" X 0.5", XR, 10/PK, Medline SKU NEUROSPNG05; 3. Neu
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2037-2026·2026-05-06

    Medline medical procedure kits recalled for endotoxin contamination

    Medline is recalling medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels. The affected in-market product may be out-of-specification for endotoxin.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. CATARACT PACK, Medline Kit Number/SKU DYNJ48725A; 2. OCULAR PACK, Medline Kit Number/SKU DYNJ64138B; 3. OCULOPLASTY PACK, Medline Kit Number/SKU DYNJ64572A; 4. OCULOPLASTY PACK, Medli
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2029-2026·2026-05-06

    Medline Neuro Sponges Cervical Pack Kits Recalled for Endotoxin

    Medline Industries is recalling medical procedure kits containing Medline Neuro Sponges (Cervical Pack) due to higher-than-expected endotoxin levels that may be out-of-specification.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: CERVICAL PACK, Medline Kit Number/SKU DYNJ37902F
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2014-2026·2026-05-06

    Medline Neuro Sponges in Medical Procedure Kits Recalled for Endotoxin

    Medline Industries is recalling medical procedure kits containing Medline Neuro Sponges (ANGIO PACK-LF) due to higher-than-expected endotoxin levels that may exceed specifications.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: ANGIO PACK-LF, Medline Kit Number/SKU DYNJ0774765U
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1816-2026·2026-04-22

    Cytal Wound Matrix 5x5 cm recalled over out-of-specification endotoxin results

    Cytal Wound Matrix 2-Layer 5x5 cm dressings are being recalled because of an increased rate of out-of-specification endotoxin results. 148 units are affected.

    Product
    Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1819-2026·2026-04-22

    Cytal Burn Matrix recalled over out-of-specification endotoxin test results

    Cytal Burn Matrix 7x10 cm wound dressings are being recalled because of an increased rate of out-of-specification endotoxin results. Seven units are affected.

    Product
    Cytal Burn Matrix 7x10 cm. Product ID: BMM0710.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1818-2026·2026-04-22

    Cytal Wound Matrix 10x15 cm recalled over out-of-specification endotoxin results

    Cytal Wound Matrix 2-Layer 10x15 cm dressings are being recalled because of an increased rate of out-of-specification endotoxin results. 452 units are affected.

    Product
    Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1817-2026·2026-04-22

    Cytal Wound Matrix recalled over out-of-specification endotoxin test results

    Cytal Wound Matrix 2-Layer 7x10 cm dressings are being recalled because of an increased rate of out-of-specification endotoxin results. 46 units are affected.

    Product
    Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0094-2026·2025-10-15

    NAD+ injection recalled after elevated endotoxin levels found in one lot

    GenoGenix is recalling NAD+ for Injection at 100 mg/mL and 200 mg/mL from one lot for microbial contamination of sterile products, with elevated endotoxin levels.

    Product
    NAD+ (Nicotinamide adenine dinucleotide) for Injection, a) 100 mg/mL b) 200 mg/mL, 10 mL multi-dose amber vials, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1959-2025·2025-07-02

    Extended Tip Applicator 15 CM recalled for endotoxin and sterility issues

    Integra LifeSciences is recalling Extended Tip Applicators (15 CM, Box of 5) because they may contain out-of-specification levels of endotoxins and lack sterility assurance.

    Product
    Extended Tip Applicator, 15 CM, Box of 5.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1958-2025·2025-07-02

    Extended Tip Applicator 8CM distributed by Integra LifeSciences recalled nationwide

    Integra LifeSciences is recalling Extended Tip Applicator 8CM devices due to potentially out-of-specification endotoxin levels and lack of sterility assurance. The recall affects 6,216 units distributed across the US and internationally.

    Product
    Extended Tip Applicator, 8CM, Box of 5.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1960-2025·2025-07-02

    Extended Tip Applicator 8CM medical devices recalled due to sterility concerns

    Integra LifeSciences is recalling Extended Tip Applicator 8CM devices nationwide and internationally because they may contain potentially out-of-specification endotoxin levels and lack sterility assurance.

    Product
    Extended Tip Applicator 8CM, Box of 1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1134-2025·2025-02-19

    Cardinal Health Presource Surgical Kits Recalled for Potential Endotoxin Contamination

    Cardinal Health Presource surgical kits containing non-sterile strips and patties may be contaminated with endotoxins, posing potential risk to patients during surgical procedures.

    Product
    Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC12; 2) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC13 3) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC14 4) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC15 5) CHI STD NEURO CRANI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1128-2025·2025-02-19

    Cardinal Health Urology Robotic Packs recalled for potential endotoxin contamination

    Cardinal Health Presource Kits for robotic urology surgery are being recalled due to potential endotoxin contamination in surgical strips and patties. No adverse events have been reported.

    Product
    Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFA; 2) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFB; 3) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1137-2025·2025-02-19

    Cardinal Health Presource Kits recalled for endotoxin contamination risk

    Cardinal Health is recalling certain Presource ACDF Kits due to potential endotoxin contamination in non-sterile surgical strips and patties used in spinal fusion procedures.

    Product
    Cardinal Health Presource Kits: 1) ACDF PACK, Catalog Number: SNEHBACSCA; 2) ACDF PACK, Catalog Number: SNEHBACSCB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1126-2025·2025-02-19

    Cardinal Health Surgical Kits Recalled for Potential Endotoxin Contamination

    Cardinal Health is recalling Presource surgical kits due to potential endotoxin contamination in non-sterile surgical strips and patties. Approximately 973,785 units were distributed to the US, Canada, and Saudi Arabia.

    Product
    Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog Number:PB23DFCM3; 2) KIT,DIEP FLAP , Catalog Number:PB23DFCM4; 3) KIT,DIEP FLAP , Catalog Number:PB23DFCM5; 4) KIT,DIEP FLAP , Catalog Number:PB23DFCM6; 5)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1130-2025·2025-02-19

    Cardinal Health Maxillofacial Surgical Kits Recalled for Potential Endotoxin Contamination

    Cardinal Health Presource maxillofacial surgical kits containing non-sterile strips and patties may have endotoxin contamination. 973,785 units distributed in the US, Canada, and Saudi Arabia are affected; users should stop using and contact the manufacturer.

    Product
    Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF104; 2) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF105 3) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF106 4) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF107 5)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1132-2025·2025-02-19

    Cardinal Health Presource Surgical Kits Recalled for Potential Endotoxin Contamination

    Cardinal Health is recalling approximately 973,785 Presource Kits due to potential endotoxin contamination in non-sterile surgical strips and patties. The kits were distributed to healthcare facilities worldwide.

    Product
    Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG4; 2) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG5 3) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG6 4) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG7 5) KIT,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1127-2025·2025-02-19

    Cardinal Health Presource Kits recalled for endotoxin contamination risk

    Cardinal Health is recalling Presource Kits containing surgical strips and patties due to potential endotoxin contamination. Approximately 973,785 units were distributed in the US, Canada, and Saudi Arabia.

    Product
    Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMM14; 2) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMD9; 3) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMDX;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1135-2025·2025-02-19

    Cardinal Health Presource surgical kits recalled for endotoxin contamination risk

    Cardinal Health is recalling Presource Kits for potential endotoxin contamination in non-sterile surgical strips and patties. These surgical components could pose infection risks if used in procedures.

    Product
    Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP12 3) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP13 4) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP1E 5) CHI STD SPINE OPTION 2, Catalog
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1136-2025·2025-02-19

    Cardinal Health Presource Surgical Kits Recalled for Potential Endotoxin Contamination

    Cardinal Health is recalling Presource Kits (surgical strips and patties used in ophthalmic procedures) due to potential endotoxin contamination in non-sterile components.

    Product
    Cardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVA; 2) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVB 3) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVC 4) OCULAR PLASTIC PACK, Catalog Number:SEY35OP961 5) OCULAR
    Category
    Medical Device
    Distribution
    Distributed nationwide