MEDLINE NEUROSPNG09Recalls & reported problems
Medline Industries, Inc. · SPONGE,NEURO,0.5"X3",XR,STRL,LF,10/PK · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20080196286536), received between Jul 9, 2024 and Jul 9, 2024 — classified as 1 injury.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Mar 19, 2026Class IIOpen, Classified
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.
Z-2008-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE CUSTOMER ON 06/10/2024, "DURING MMA (MAXILLOMANDIBULAR ADVANCEMENT) PROCEDURE, 1/2" BY 3" PATTY STRING RIPPED OUT OF PATTY AND PIECE OF PATTY BROKE OFF WITH IT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19700716 ↗
Other Neurosurgical paddie devices
- CODMAN® 801400Integra Lifesciences Production Corporation · Neurosurgical paddie2 recalls9 reports
- CODMAN® 801407Integra Lifesciences Production Corporation · Neurosurgical paddie1 recall6 reports
- CODMAN® 801451Integra Lifesciences Production Corporation · Neurosurgical paddie1 recall5 reports
- MEDLINE NEUROSPNG05Medline Industries, Inc. · Neurosurgical paddie1 recall5 reports
- CODMAN® 801404Integra Lifesciences Production Corporation · Neurosurgical paddie1 recall4 reports
- CODMAN® 801408Integra Lifesciences Production Corporation · Neurosurgical paddie1 recall2 reports
- CODMAN® 801406Integra Lifesciences Production Corporation · Neurosurgical paddie1 recall2 reports
- CODMAN® 801403Integra Lifesciences Production Corporation · Neurosurgical paddie1 recall2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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