Richard-Allan® Needle 1/2 Circle Taper 216705Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840113217564), received between Aug 15, 2025 and Dec 10, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 10, 2025Break; Break
COMPLAINANT ALLEGES "EYE OF NEEDLE BROKE OFF DURING USE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23771733 ↗MalfunctionAug 15, 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 AND SENT FOR MDIP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22819975 ↗
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 216735Aspen Surgical Products, Inc. · NEEDLE, SUTURING, DISPOSABLE4 reports
- Richard-Allan® Needle 1/2 Circle Taper 216701Aspen 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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