The Recall Desk

FDA (Devices) recall action 98664

Medline Industries, LP recalled 31 products on 2026-05-06

The FDA (Devices) publishes a recall like this one as 31 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 31 pages.

Products
31
Announced
2026-05-06
Critical
1
Units
7,169,771

Why these products were recalled

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

26–31 of 31

  • ModerateFDA (Devices)··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
    Distribution
    0 states
  • SevereFDA (Devices)··2026-05-06

    Medline and Centurion Medical Procedure Kits Recalled for High Endotoxin Levels

    Medline Industries is recalling Medline and Centurion medical procedure kits containing neuro sponges due to higher-than-expected endotoxin levels that may cause the products to be out-of-specification.

    Product
    Medline and Centurion medical procedure kits, containing Medline Neuro Sponges (1229 in total), HEAD & NECK TRAY, SINUS, SMR, etc.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··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
    Distribution
    0 states
  • HighFDA (Devices)··2026-05-06

    Medline Medical Procedure Kits With Neuro Sponges Recalled

    Medline Industries is recalling medical procedure kits containing Medline Neuro Sponges 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: 1. ZALE STEREOTACTIC CDS, Medline Kit Number/SKU CDS983173G; 2. EPISTAXIS TRAY, Medline Kit Number/SKU DYNDA3240; 3. RHINO PACK, Medline Kit Number/SKU DYNJ46504B; 4. MSC SEPTO RHINO PA
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2026-05-06

    Medline medical procedure kits recalled for elevated endotoxin levels

    Medline Industries is recalling 208 medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels that may exceed product specifications.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OSC COLEMAN FAT HARVEST KIT, Medline Kit Number/SKU DYNJ32854B; 2. RR-DR. CHHETRI MDL PACK, Medline Kit Number/SKU DYNJ62635B.
    Category
    Distribution
    0 states
  • CriticalFDA (Devices)··2026-05-06

    Insulin Pump Batteries Recalled After Sudden-Shutdown Reports

    OmniDose is recalling 23,000 lithium battery packs used in its X4 insulin pumps after reports of unexpected shutdown.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: GENERAL KIT, Medline Kit Number/SKU DYNJ905664I
    Category
    Distribution
    0 states