{"url_path":"/fda/device/recalls/Z-2008-2026","section_key":"summary","section_title":"DEVICE Recall: Medline Industries, LP — 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. Neuro Sponges,  Eponges neuro,  Neuroesponjas,  size 0.5\" X 1\", XR, LF, 10/PK, Med…","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-03-19","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2008-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Medline Industries, LP"},"word_count":273,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2008-2026\n\n**Recalling firm:** Medline Industries, LP\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-03-19\n**Report date:** 2026-05-06\n\n## Product\nMedline 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. Neuro Sponges,  Eponges neuro,  Neuroesponjas,  size 0.5\" X 1\", XR, LF, 10/PK, Medline SKU NEUROSPNG06;   4. Neuro Sponges,  Eponges neuro,  Neuroesponjas,  size 0.5\" X 1.5\", XR, LF, 10/PK, Medline SKU NEUROSPNG07;   5. Neuro Sponges,  Eponges neuro,  Neuroesponjas,  size 0.5\" X 3\", XR, LF, 10/PK, Medline SKU NEUROSPNG09;   6. Neuro Sponges,  Eponges neuro,  Neuroesponjas,  size .75\" X .75\", XR, LF, 10/PK, Medline SKU NEUROSPNG11;   7. Neuro Sponges,  Eponges neuro,  Neuroesponjas,  size 1\" X 1\", XR, LF, 10/PK, Medline SKU NEUROSPNG13;   8. Neuro Sponges,  Eponges neuro,  Neuroesponjas,  size 1\" X 3\", XR, LF, 10/PK, Medline SKU NEUROSPNG14.\n\n## Reason\nDuring 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.\n\n## Affected lots\n1. NEUROSPNG02:  UDI/DI each 10197344111572, UDI/DI case 20197344111579, ALL LOTS;  2. NEUROSPNG05:  UDI/DI each 20080196286659, UDI/DI case 30080196286656, ALL LOTS;  3. NEUROSPNG06:  UDI/DI each 20080196286505, UDI/DI case 30080196286502, ALL LOTS;  4. NEUROSPNG07:  UDI/DI each 10080196286485, UDI/DI case 40080196286486, ALL LOTS;  5. NEUROSPNG09:  UDI/DI each 20080196286536, UDI/DI case 30080196286533, ALL LOTS;  6. NEUROSPNG11:  UDI/DI each 20080196286550, UDI/DI case 30080196286557, ALL LOTS;  7. NEUROSPNG13:  UDI/DI each 10080196286577, UDI/DI case 40080196286578, ALL LOTS;  8. NEUROSPNG14:  UDI/DI each 10080196286584, UDI/DI case 40080196286585, ALL LOTS.\n\n## Distribution\nWorldwide distribution."}