Alexis O Wound Protector-RetractorRecalls & reported problems across all models

We found 5 models of Alexis O Wound Protector-Retractor by Applied Medical Resources Corporation in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between Mar 4, 2017 and Feb 12, 2026 — classified as 1 injury, 26 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (14 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Alexis O Wound Protector-Retractor problems

Alexis O Wound Protector-Retractor models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Alexis O Wound Protector-Retractor C8401

  Ring (Wound Protector), Drape Retention, Internal
  10 reports
• Alexis O Wound Protector-Retractor C8402

  Ring (Wound Protector), Drape Retention, Internal
  7 reports
• Alexis O Wound Protector-Retractor C8405

  Ring (Wound Protector), Drape Retention, Internal
  4 reports
• Alexis O Wound Protector-Retractor C8403

  Ring (Wound Protector), Drape Retention, Internal
  3 reports
• Alexis O Wound Protector-Retractor C8404

  Ring (Wound Protector), Drape Retention, Internal
  3 reports

Recent Alexis O Wound Protector-Retractor adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026Material Split, Cut or Torn

  PROCEDURE PERFORMED: NI EVENT DATE: UNKNOWN EVENT DESCRIPTION: I HAVE BEEN ALERTED BY MY CLINICAL COLLEAGUE (NAME REDACTED) THAT WHILST IN THE OPERATING THEATRE 2 OF YOUR PRODUCT C8401 HAVE BROKEN WHILST IN USE. (NAME REDACTED) WILL BE ABLE TO HAVE THE APPROPRIATE TEAM MEMBER EXPLAIN THE BEHAVIOR OF THIS ITEM PRIOR TO USE AND WHILST IN USE IN A HOPE YOUR TEAM CAN WORK OR THE CAUSATION OF THIS OCCURRENCE. THE LOT NUMBERS OF BOTH USED ALEXIS RING (SMALL) IS AS FOLLOWS (1550713). ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON (B)(6) 2026: IMAGES IN THE ATTACHMENTS. I HAVE REQUESTED THE BELOW INFORMATION FROM THE CUSTOMER AND HAVE ATTACHED 2 PICTURES THEY SENT TO ME. AS SOON AS I CAN OBTAIN ANY ADDITIONAL INFORMATION I WILL INFORM YOU. INTERVENTION: NI PATIENT STATUS: NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24328322 ↗
• MalfunctionFeb 12, 2026Material Split, Cut or Torn

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: I HAVE BEEN ALERTED BY MY CLINICAL COLLEAGUE (NAME REDACTED) THAT WHILST IN THE OPERATING THEATRE 2 OF YOUR PRODUCT C8401 HAVE BROKEN WHILST IN USE. (NAME REDACTED) WILL BE ABLE TO HAVE THE APPROPRIATE TEAM MEMBER EXPLAIN THE BEHAVIOR OF THIS ITEM PRIOR TO USE AND WHILST IN USE IN A HOPE YOUR TEAM CAN WORK OR THE CAUSATION OF THIS OCCURRENCE. THE LOT NUMBERS OF BOTH USED ALEXIS RING (SMALL) IS AS FOLLOWS (B)(6). ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 27JAN2026: IMAGES IN THE ATTACHMENTS. I HAVE REQUESTED THE BELOW INFORMATION FROM THE CUSTOMER AND HAVE ATTACHED 2 PICTURES THEY SENT TO ME. AS SOON AS I CAN OBTAIN ANY ADDITIONAL INFORMATION I WILL INFORM YOU. INTERVENTION: NI. PATIENT STATUS: NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24328310 ↗
• 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 ↗
• MalfunctionSep 5, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: ALEXIS RETRACTOR TORE IN USE. CLEAR FILM DETACHED FROM GREEN RING. REMOVED FROM ABDOMEN. RETAINED FOR INSPECTION. INTERVENTION: REMOVED FROM ABDOMEN. PATIENT STATUS: NO PATIENT INJURY INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22986530 ↗
• MalfunctionJul 31, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: OPEN MYOMECTOMY. EVENT DESCRIPTION: THE SHEATH BROKE OFF OF THE RING. ADDITIONAL INFORMATION PROVIDED BY ACCOUNT MANAGER VIA EMAIL ON (B)(6) 2025: FROM PCF: ALEXIS BEING USED DURING/FOR OPEN MYOMECTOMY. ALEXIS RING DISCONNECTED FROM SHEATH INTERVENTION: USED NEW ALEXISE. PATIENT STATUS: NO INJURY DUE TO COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22682672 ↗
• MalfunctionApr 2, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: ROBOTIC ILEOSTOMY CLOSURE EVENT DESCRIPTION: DURING OPERATION AND REMOVAL, BOTH THE ALEXIS AND [COMPETITOR] BAGS ([COMPETITOR] IS AN [COMPETITOR] PRODUCT) BROKE APART IN THE PATIENT AND ALL PIECES WERE REMOVED FROM THE PATIENT SUCCESSFULLY AND SAVED FOR RETURN. ADDITIONAL INFORMATION PROVIDED BY ACCOUNT MGR ON 04MAR2025 VIA EMAIL: I CAN CONFIRM THAT IT WAS A [COMPETITOR] BAG THAT ALSO BROKE. INTERVENTION: PIECES WERE SUCCESSFULLY REMOVED FORM PATIENT. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21758855 ↗
• MalfunctionSep 19, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: VATS DESCRIPTION OF EVENT: COMPLAINT 1 OF 2: (B)(4) MODEL C8401 LOT 1506767 1EA. COMPLAINT 2 OF 2: (B)(4) MODEL C8401 LOT 1506767 1EA. TWO DEVICE MALFUNCTIONS OCCURRED DURING THE SAME PROCEDURE. [HOSPITAL] I¿M HERE AT THE [FACILITY] IN ANOTHER VATS CASE. 2 MORE ALEXIS TORE AT THE RING. SAME LOT NUMBER AS THE PREVIOUS ONE: LOT # 1506767. ADDITIONAL INFORMATION RECEIVED FROM ACCOUNT MANAGER VIA EMAIL ON 28AUG2024: THEY ARE GOING TO SAVE THE 2 FROM TODAY TO SEND BACK TO CORPORATE THE PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED FROM ACCOUNT MANAGER VIA EMAIL ON 29AUG2024: NO PATIENT INJURY OCCURRED. THE SURGEON OPENED A NEW ALEXIS TO COMPLETE THE PROCEDURE. THE FIRST ALEXIS SHEATH TORE MID-PROCEDURE. THE SECOND ALEXIS TORE MID-PROCEDURE. SUCTION, BOVIE, AND STAPLER WERE USED WITHIN THE ALEXIS. THE SHEATH DID NOT PARTICULATE. ADDITIONAL INFORMATION RECEIVED FROM ACCOUNT MANAGER VIA EMAIL ON 29AUG2024: THEY WILL RETURN THE 2 ALEXIS THAT WERE USED IN THE CASE YESTERDAY. INTERVENTION: THE SURGEON OPENED A NEW ALEXIS TO COMPLETE THE PROCEDURE. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20263016 ↗
• MalfunctionSep 19, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: VATS DESCRIPTION OF EVENT: COMPLAINT 1 OF 2: (B)(4) MODEL C8401 LOT 1506767 1EA - MFR# 2027111-2024-00833. COMPLAINT 2 OF 2: (B)(4) MODEL C8401 LOT 1506767 1EA - MFR# 2027111-2024-00834. TWO DEVICE MALFUNCTIONS OCCURRED DURING THE SAME PROCEDURE. [HOSPITAL]: I¿M HERE AT THE [FACILITY] IN ANOTHER VATS CASE. 2 MORE ALEXIS TORE AT THE RING. SAME LOT NUMBER AS THE PREVIOUS ONE: LOT # 1506767. ADDITIONAL INFORMATION RECEIVED FROM ACCOUNT MANAGER VIA EMAIL ON 28AUG2024: THEY ARE GOING TO SAVE THE 2 FROM TODAY TO SEND BACK TO CORPORATE THE PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED FROM ACCOUNT MANAGER VIA EMAIL ON 29AUG2024: NO PATIENT INJURY OCCURRED. THE SURGEON OPENED A NEW ALEXIS TO COMPLETE THE PROCEDURE. THE FIRST ALEXIS SHEATH TORE MID-PROCEDURE. THE SECOND ALEXIS TORE MID-PROCEDURE. SUCTION, BOVIE, AND STAPLER WERE USED WITHIN THE ALEXIS. THE SHEATH DID NOT PARTICULATE. ADDITIONAL INFORMATION RECEIVED FROM ACCOUNT MANAGER VIA EMAIL ON 29AUG2024: THEY WILL RETURN THE 2 ALEXIS THAT WERE USED IN THE CASE YESTERDAY. INTERVENTION: THE SURGEON OPENED A NEW ALEXIS TO COMPLETE THE PROCEDURE. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20262804 ↗
• MalfunctionAug 27, 2024Break; Break

  PROCEDURE PERFORMED: COLECTOMY. DESCRIPTION OF EVENT: [HOSPITAL] PRODUCT: C8401. DURING THE CASE, THE DOCTOR TRIED ROLLING THE ALEXIS ONLY ONCE ROLLING THEN THE RETRACTION RING(WHITE) WAS BROKEN. NO PRODUCT RETURNING. INTERVENTION: NI. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20080817 ↗
• MalfunctionJul 3, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: THP/ ANTERIOR APPROACH. DESCRIPTION OF EVENT: (NAME REDACTED) STARTED HIS PROCEDURES WITH THE ALEXIS O RIDGID. HE NOTICED THE SHEET TEARED. THEN HE STARTED TO USE THE ALEXIS ORTHO. IN 90% OF CASES, HE USES THE ANTERIOR APPOACH AND ALEXIS ORTHO. HE'S USING A RELATIVELY LARGE INCISION. PLACEMENT OF THE SHEET AFTER THE FEMURHEAD IS REMOVED. HE TRIED TO PLACE IT BEFORE BUT HE STATES THAT HE HAS LESS SPACE AND MOVED AWAY FROM THAT. FOR THE OTHER CASES (REVISIONS AND DISPLASIA) HE USES THE LATERAL APPROACH AND NO ALEXIS ORTHO. HE USES A RALATIVELY LARGE INCISION (NO BIKINY INCISION DUE TO MORE WOUND COMPLICATIONS IN RELATION TO STRAIGHT INCISIONS. MORE GRANULATION TUSSUE IN THE GROIN IS SEEN IF BIKINY INCISIONS ARE USED.) ADDITIONAL INFORMATION RECEIVED BY COMPANY REP. VIA E-MAIL ON 28JUN24: 1.IT WAS IN THE MIDDLE OF THE PLASTIC SHEET WERE THE BROACH SOMETIMES CATCHES UP ON THE SHEET (ALEXIS O RIDGID AND ALEXIS ORTHOPEDIC). 2.MALFUNCTION OCCURRED WHEN USING THE BROACH INTO THE FEMUR. 3. DUE TO THE ANGLE OF THE OPERATIONS THE SURFACE OF THE BROACH COMES INTO CONTACT WITH THE SHEET EASILY. ADDITIONAL INFORMATION RECEIVED BY COMPANY REP. VIA E-MAIL ON 02JULY24: THE PROD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19669290 ↗
• MalfunctionApr 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC ILEOCECECTOMY. EVENT DESCRIPTION: COMPLAINT CREATED BASED ON MEDWATCH RECEIVED VIA EMAIL. REPORT NUMBER (B)(4). "DURING THE PROCEDURE AN ALEXIS WOUND RETRACTOR WAS OPENED TO BE USED, UPON THE SURGEON UNRAVELING THE ALEXIS WOUND RETRACTOR A SMALL PIECE OF PLASTIC LIKE MATERIAL FELL OUT. THE FOREIGN MATERIAL WAS THEN PLACED IN A SPECIMEN CUP AND REMOVED OFF THE FIELD. MANAGEMENT WAS NOTIFIED AND THE OBJECT WAS HANDED OFF TO THEM." ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 24MAR2023 FROM [NAME], QUALITY COORDINATOR, [NAME] HOSPITAL . WHEN ASKED IF ANY PATIENT INJURY OCCURRED THE CONTACT RESPONDED "NOT THAT I AM AWARE OF." PATIENT STATUS IS "UNKNOWN". NO INSTRUMENTS WERE USED "AT THE TIME THAT THIS OCCURRED. IT WAS OPENED TO USE AND THE PIECE FELL INTO THE PATIENT." ALL PIECES WERE RETRIEVED FROM THE PATIENT. WHEN ASKED HOW THE CASE WAS COMPLETED THE RESPONSE WAS "YES". WHEN ASKED IF THE PIECE THAT FELL INTO THE PATIENT WAS THIN AND CLEAR LIKE THE SHEATH OR IF IT WAS GREEN OR WHITE LIKE PART OF THE RINGS THE RESPONSE WAS "IT WAS MADE OUT OF THE MATERIAL OF THE ITEM". "WE TYPICALLY DO NOT RETURN DEVICES. WE KEPT PACKAGE AND THE PIECE THAT FELL OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16745275 ↗
• MalfunctionDec 16, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NAME OF PROCEDURE BEING PERFORMED: NA (INCOMING INSPECTION). DETAILED DESCRIPTION OF EVENT: [DISTRIBUTOR] INCOMING INSPECTION PO#(B)(4). WE WOULD LIKE TO INFORM YOU THAT SOME OF THE PRODUCTS DIDN'T PASS OUR RECEIVING INSPECTION. PLEASE FIND ATTACHED SPREADSHEET. THERE ARE ITEMS REQUIRE CER IN THIS REPORT. C8403 LOT #1462152 - PARTICULATE: HAIR (1 EA.) PRODUCTS ARE AVAILABLE FOR RETURN. TYPE OF INTERVENTION: NA (INCOMING INSPECTION). PATIENT STATUS: NA (NO PATIENT INVOLVEMENT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15999956 ↗
• 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 ↗
• MalfunctionOct 3, 2022Material Fragmentation; Material Split, Cut or Torn; Material Fragmentation; Material Split, Cut or Torn

  PROCEDURE PERFORMED: (B)(6). EVENT DESCRIPTION: BREAKAGE OF THE PLASTIC PART OF THE ALEXIS RETRACTOR, CLINICAL CONSEQUENCES OBSERVED: RISK OF RESIDUAL FRAGMENTS. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 6SEP22: SHEATH BREAKING. RISK OF SMALL PARTS (FRAGMENTS) OF THE SHEATH ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 9SEP22: THE INCIDENT TOOK PLACE AT THE EMERGENCIES OR. NO MORE DETAILS AT THE MOMENT. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 20SEP22: THE INCIDENT TOOK PLACE AT THE EMERGENCIES OR BY NIGHT AND I DID NOT FIND ANYBODY WHO COULD EXPLAIN TO ME WHAT OCCURRED. PATIENT STATUS: NO PATIENT INJURY HAS BEEN REPORTED. TYPE OF INTERVENTION: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15530178 ↗
• MalfunctionMay 9, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  NAME OF PROCEDURE PERFORMED: LAMINECTOMY. DESCRIPTION OF EVENT: [FACILITY] ENGLISH VERSION OF EVENT DESCRIPTION: WHEN THE ATTENDING PHYSICIAN REMOVED ALEXIS AT THE END OF SURGERY, HE CHECKED THE SURFACE OF ALEXIS AND CONFIRMED THAT THERE WERE HOLES. THE SHAPE OF THE HOLES APPEARS TO BE CRUSHED VISUALLY. AT THAT TIME, IT WAS CONFIRMED WHETHER OR NOT THE DEBRIS HAD FALLEN INTO THE BODY CAVITY, THE DEBRIS WAS FOUND, AND THE CONFIRMED DEBRIS WAS TAKEN OUT. THE DOCTOR ALSO MATCHED THE PERFORATED ALEXIS WITH THE DEBRIS, BUT THE DOCTOR WASN'T SURE IF ALL THE DEBRIS COULD BE REMOVED FROM THE BODY CAVITY. THE FACILITY ASKS THE MANUFACTURER FOR THEIR VIEWS ON THE RISKS OF RESIDUAL DEBRIS IN THE BODY CAVITY. THE FACILITY STATED THAT THE INSTRUMENTS USED VIOLENTLY INTERFERED WITH ALEXIS DURING A SERIES OF SURGICAL PROCEDURES, WHICH IS BELIEVED TO BE THE CAUSE OF THE DAMAGE. THE POSTOPERATIVE COURSE OF THE PATIENT IS SO FAR GOOD. THE USED INSTRUMENTS ARE REAMER, DRILL, HAMMER, BONE SAW, BONE HEAD REMOVER, RASP AND SO ON. TRANSLATED JAPANESE VERSION OF EVENT DESCRIPTION: USED IN SURGERY FOR SPINAL CANAL STENOSIS. I USED IT ACCORDING TO THE ATTACHED TEXT, BUT WHEN I REMOVED THE RETRACTOR AFTER TH

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 14338615 ↗

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