Alexis Wound Protector-Retractor C8303Recalls & reported problems
Applied Medical Resources Corporation · Wound Retractor and Protector · Class 2
All models of Alexis Wound Protector-Retractor (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00607915117221), received between Nov 23, 2021 and Nov 23, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).
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 16, 2026.
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping1
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.
MalfunctionNov 23, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NAME OF PROCEDURE BEING PERFORMED. NA (INCOMING INSPECTION). DETAILED DESCRIPTION OF EVENT: [NAME] INCOMING INSPECTION (B)(4). WE WOULD LIKE TO INFORM YOU THAT SOME OF THE PRODUCTS DIDN'T PASS OUR RECEIVING INSPECTION. PLEASE FIND ATTACHED SPREADSHEET. THERE IS A ITEM REQUIRE CER IN THIS REPORT. PARTICULATE: HAIR, BUG - C8303 LOT# 1424309 (1 EA). ADDITIONAL INFORMATION RECEIVED VIA EMAIL 01NOV2021 FROM [NAME] REGULATORY AFFAIRS AND QUALITY ASSURANCE: IT WAS REPORTED THAT THERE WAS ONLY ONE BUG FOUND. NO REPORT OF HAIR IN PACKAGING. PATIENT STATUS: NA (NO PATIENT INVOLVEMENT). TYPE OF INTERVENTION: NA (INCOMING INSPECTION).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12865965 ↗
Other Ring (Wound Protector), Drape Retention, Internal devices
- Alexis Laparoscopic System C8501Applied Medical Resources Corporation · Ring (Wound Protector), Drape Retention, Internal18 reports
- Alexis ® Orthopaedic Protector HR004Applied Medical Resources Corporation · Ring (Wound Protector), Drape Retention, Internal14 reports
- Alexis Wound Protector-Retractor C8301Applied 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 O Wound Protector-Retractor C8402Applied Medical Resources Corporation · Ring (Wound Protector), Drape Retention, Internal7 reports
- Alexis Wound Protector-Retractor C8312Applied 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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