F01 S8F01-MFRecalls & reported problems
Burlington Medical, LLC · S8F01-MF, FEMALE (Custom F01: Frontal Apron with Back Strap and Tie Closure .35MM XENOLITE 800, MF) · Class 1
Data updated Oct 13, 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
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
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. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Feb 11, 2026Open, Classified
Potential for attenuation degradation over time, decreasing the lifespan.
Z-1756-2026 · Root cause: Process change control · FDA record ↗
Other Apron, Protective devices
- 601 S8601-LFBurlington Medical, LLC · Apron, Protective1 recall0 reports
- A10 R8A10-XSFBurlington Medical, LLC · Apron, Protective1 recall0 reports
- A10 R8A10-XSMBurlington Medical, LLC · Apron, Protective1 recall0 reports
- A10 U8A10-MFBurlington Medical, LLC · Apron, Protective1 recall0 reports
- EURO R8EURO-LMBurlington Medical, LLC · Apron, Protective1 recall0 reports
- EURO S8EURO-XLFBurlington Medical, LLC · Apron, Protective1 recall0 reports
- F17 S8F17-MFBurlington Medical, LLC · Apron, Protective1 recall0 reports
- K303 R8K303-MMBurlington Medical, LLC · Apron, Protective1 recall0 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 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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