Richard-Allan® Needle 1/2 Circle Taper 216703Recalls & 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
- 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 00840113217625), received between Mar 27, 2025 and Mar 27, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
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.
MalfunctionMar 27, 2025Break; Break
COMPLAINANT ALLEGES "THE TIP OF THE NEEDLE BROKE OFF WHILE THE MD WAS SUTURING. NO HARM TO PATIENT." THIS WAS RECEIVED VIA MEDWATCH, REPORT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21710170 ↗
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
- 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
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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