Richard-Allan® Needle 1/2 Circle Taper 216735Recalls & reported problems
Aspen Surgical Products, Inc. · Intent to be used with suture material for tissue closure · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00840113217601), received between Dec 30, 2024 and Nov 24, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (4 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
- Break4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 24, 2025Break; Break
COMPLAINANT ALLEGES "THE RESIDENT WAS SUTURING USING THE NEEDLE (NEEDLE STYLE MAYO 1/2 TAPER) WHEN HE NOTICED THAT IT WAS ACCIDENTALLY BROKEN. THERE WAS A PART OF NEEDLE THAT WAS MISSING IN IT. THE SURGEON WAS CALLED AND NOTIFIED. THE XRAY WAS CALLED AND WAS PERFORMED. FLAT PLATE WAS ALSO PERFORMED AFTER THE PROCEDURE WAS DONE FOR FINAL IMAGING."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23638426 ↗MalfunctionOct 27, 2025Break
THE RESIDENT WAS SUTURING USING THE NEEDLE (NEEDLE STYLE MAYO 1/2 TAPER) WHEN HE NOTICED THAT IT WAS ACCIDENTALLY BROKEN. THERE WAS A PART OF NEEDLE THAT WAS MISSING IN IT. THE SURGEON WAS CALLED AND NOTIFIED. THE XRAY WAS CALLED AND WAS PERFORMED. FLAT PLATE WAS ALSO PERFORMED AFTER THE PROCEDURE WAS DONE FOR FINAL IMAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23390345 ↗MalfunctionJul 8, 2025Break; Break
COMPLAINANT ALLEGES "MAYO NEEDLE IS USED TO HELP PASS THE SUTURE THROUGH THE TISSUE, BUT DURING SURGERY THE SURGERY WAS TRYING TO PASS THE NEEDLE THROUGH THE PATIENT'S FOREARM AREA. UNFORTUNATELY, THE NEEDLE WAS BROKEN. THE SURGEON REMOVED THE BROKEN PART OF THE NEEDLE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22440956 ↗MalfunctionDec 30, 2024Break; Break
COMPLAINANT ALLEGES "THE NEEDLE ACTUALLY SNAPPED OFF INTO PIECES INSIDE A PATIENT. THANKFULLY ALL THE PIECES WERE RETRIEVED." PATIENT WAS HAVING A QUADRICEPS LIGAMENT REPAIR. ALL FRAGMENTS AND PIECES WERE REMOVED FROM THE PATIENT. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21036824 ↗
Other NEEDLE, SUTURING, DISPOSABLE devices
- Quattro® Suture Passer Needle CM-9011Cayenne Medical, Inc. · Needle, Suturing, Disposable28 reports
- Injector CAT01857Stryker Corporation · NEEDLE, SUTURING, DISPOSABLE8 reports
- Richard-Allan® Needle 1/2 Circle Taper 216706Aspen Surgical Products, Inc. · NEEDLE, SUTURING, DISPOSABLE4 reports
- Richard-Allan® Needle 1/2 Circle Taper 216704Aspen Surgical Products, Inc. · NEEDLE, SUTURING, DISPOSABLE4 reports
- Richard-Allan® Needle 1/2 Circle Taper 216701Aspen Surgical Products, Inc. · NEEDLE, SUTURING, DISPOSABLE2 reports
- Richard-Allan® Needle 1/2 Circle Taper 216705Aspen Surgical Products, Inc. · NEEDLE, SUTURING, DISPOSABLE2 reports
- Versipass Suture Passer Needle 4727Lincotek Medical LLC · Needle, Suturing, Disposable2 reports
- NA 223173Medos International Sàrl · NEEDLE, SUTURING, DISPOSABLE1 report
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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