Richard-Allan® Needle 1/2 Circle Taper 216701Recalls & 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 00840113217663), received between Feb 20, 2025 and May 21, 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
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2025Break; Break
COMPLAINANT ALLEGES "END OF THE LOOP OF THE NEEDLE BROKE OFF IN PATIENT WHILE BEING USED. SURGEON WAS UNABLE TO RETRIEVE BROKEN PIECE. A SUBSTITUTE NEEDLE WAS USED TO FINISH THE CASE. THE NEEDLE PIECE WAS LEFT INSIDE PATIENT. PATIENT DID NOT REQUIRE ADDITIONAL TREATMENT."
Patient problems: Foreign Body In Patient
MAUDE report 22062702 ↗MalfunctionFeb 20, 2025Break; Break
COMPLAINANT ALLEGES "WE USED THE FOLLOWING NEEDLE ON THE (B)(6) 2025, A FRAGMENT OF THE NEEDLE BROKE OFF DURING SURGERY. THE CONSULTANT SURGEON OPERATING MADE THE CLINICAL DECISION TO LEAVE THE FRAGMENT IN THE PATIENT AS THE RISKS TO REMOVE IT WERE HIGH."
Patient problems: Foreign Body In Patient
MAUDE report 21421827 ↗
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 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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