Richard-Allan® Needle 1/2 Circle Taper 216706Recalls & 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 00840113217540), received between Aug 14, 2025 and May 6, 2026 — 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.
MalfunctionMay 6, 2026Break
COMPLAINANT ALLEGES "NEEDLE TIP BROKE IN THE FIELD. SCRUB NURSE INFORMED CIRCULATOR. TWO PIECES (1 NEEDLE) RECOVERED AND ACCOUNTED FOR. REMOVED FROM FIELD."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25093578 ↗MalfunctionDec 11, 2025Break; Break
COMPLAINANT ALLEGES "DURING SURGERY A PACK OF 1/2 TAPER NEEDLES WERE OPENED TO USE IN A ROTATOR CUFF REPAIR. THE EYE BROKE OFF BOTH OF THE NEEDLES FROM THIS PACKAGE, ONE WAS RETRIEVED. THE SECOND FELL INTO THE FLUID/SUCTION BAG. SINCE WE WERE UNABLE TO RETRIEVE IT, AN X-RAY WAS PERFORMED PER POLICY. X-RAY READ AS NEGATIVE. DOCUMENTED IN MEDICAL RECORD. NEEDLE, ONE SMALL PIECE AND PACKAGE SECURED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23782698 ↗MalfunctionOct 22, 2025Break; Break
COMPLAINANT ALLEGES "NEEDLE BROKE WHILE IN USE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23359047 ↗MalfunctionAug 14, 2025Break; Break
COMPLAINANT ALLEGES "USING THE EYED NEEDLES TO SUTURE THE CAPIO SUTURES-- EYED NEEDLE END BROKE OFF INSIDE PATIENT SECOND EYED NEEDLE PACKAGE OPENED-- TIP AND END BROKE OFF INSIDE PATIENT A DIFFERENT LARGER SIZE OF EYED NEEDLE (AND TROCAR TIP) OPENED AND SUCCESSFULLY USED ALL PIECES OF THE EYED NEEDLES WERE FOUND AND ACCOUNTED FOR-- ISOLATED OFF THE SURGICAL FIELD."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22808714 ↗
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 216704Aspen Surgical Products, Inc. · NEEDLE, SUTURING, DISPOSABLE4 reports
- Richard-Allan® Needle 1/2 Circle Taper 216735Aspen 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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