Alexis O Wound Protector-Retractor C8404Recalls & reported problems
Applied Medical Resources Corporation · Wound Retractor and Protector · Class 2
All models of Alexis O Wound Protector-Retractor (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00607915117283), received between May 7, 2022 and Sep 9, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (3 reports).
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
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NAME OF PROCEDURE BEING PERFORMED: NA (BEFORE USE) DETAILED DESCRIPTION OF EVENT: THIS IS A COMPLAINT FROM THE HOSPITAL; THE HAIR WAS FOUND AT THE SEALED PART OF STERILIZED POUCH. NO PATIENT INJURY OR ILLNESS ASSOCIATED WITH THIS EVENT. REPLACED TO A NEW HOSPITAL INVENTORY C8404 AND PROCEDURE WAS COMPLETED. THIS EVENT UNIT WILL BE RETURNED. TYPE OF INTERVENTION: REPLACED TO A HOSPITAL INVENTORY AND THE PROCEDURE WAS COMPLETED. PATIENT STATUS: NA (BEFORE USE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23012103 ↗MalfunctionNov 17, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NAME OF PROCEDURE BEING PERFORMED: NA (INCOMING INSPECTION). DETAILED DESCRIPTION OF EVENT: [FACILITY] INCOMING INSPECTION PO#(B)(6). WE WOULD LIKE TO INFORM YOU THAT SOME OF THE PRODUCTS DIDN'T PASS OUR RECEIVING INSPECTION. PLEASE FIND ATTACHED SPREADSHEET. C8404 LOT #1453797 (1 EA.) - PARTICULATE: HAIR. PRODUCTS AVAILABLE FOR RETURN. PATIENT STATUS: NA (NO PATIENT INVOLVEMENT). TYPE OF INTERVENTION: NA (INCOMING INSPECTION).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15821099 ↗MalfunctionMay 7, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NAME OF PROCEDURE BEING PERFORMED: NA (INCOMING INSPECTION). DETAILED DESCRIPTION OF EVENT [FACILITY] INSPECTION (B)(4). WE WOULD LIKE TO INFORM YOU THAT SOME OF THE PRODUCTS DIDN'T PASS OUR RECEIVING INSPECTION. THERE ARE ITEMS REQUIRE CER IN THIS REPORT. C8404 LOT #1433010 - PARTICULATE: HAIR(1 EA.) PATIENT STATUS: NA (NO PATIENT INVOLVEMENT). TYPE OF INTERVENTION: NA (INCOMING INSPECTION).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14322941 ↗
Other Ring (Wound Protector), Drape Retention, Internal devices
- Alexis Laparoscopic System C8501Applied Medical Resources Corporation · Ring (Wound Protector), Drape Retention, Internal18 reports
- Alexis Wound Protector-Retractor C8301Applied Medical Resources Corporation · Ring (Wound Protector), Drape Retention, Internal14 reports
- Alexis ® Orthopaedic Protector HR004Applied Medical Resources Corporation · Ring (Wound Protector), Drape Retention, Internal14 reports
- Alexis O Wound Protector-Retractor C8401Applied Medical Resources Corporation · Ring (Wound Protector), Drape Retention, Internal10 reports
- Alexis Laparoscopic System C8502Applied Medical Resources Corporation · Ring (Wound Protector), Drape Retention, Internal9 reports
- Alexis Wound Protector-Retractor C8312Applied Medical Resources Corporation · Ring (Wound Protector), Drape Retention, Internal7 reports
- Alexis O Wound Protector-Retractor C8402Applied Medical Resources Corporation · Ring (Wound Protector), Drape Retention, Internal7 reports
- Alexis Wound Protector-Retractor C8323Applied Medical Resources Corporation · Ring (Wound Protector), Drape Retention, Internal6 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
- 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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