Richard-Allan® Needle 1/2 Circle Taper 216704Recalls & 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 00840113217588), received between Mar 24, 2023 and Dec 29, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Foreign Body In Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 29, 2025Break; Break
COMPLAINANT ALLEGES "THE ISSUE IS THEY ARE BENDING AND BREAKING THE TIPS OFF WHEN PASSING THROUGH BONE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23916996 ↗MalfunctionMar 27, 2025Break; Break
COMPLAINANT ALLEGES: "WE HAVE HAD 2 ISSUES WITH ITEM NUMBER 216704 (LOT # 324834) A NEEDLE STYLE MAYO ½ TAPER WHERE THE EYELET WILL BREAK WITH THE SUTURE. IT HAPPENED IN 2 CASES TODAY 3/11. NO INJURY TO PATIENTS." NOTE THAT THIS REPORT IS FOR THE SECOND INSTANCE OF THIS MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21712985 ↗MalfunctionMar 27, 2025Break; Break
COMPLAINANT ALLEGES: "WE HAVE HAD 2 ISSUES WITH ITEM NUMBER 216704 (LOT # 324834) A NEEDLE STYLE MAYO ½ TAPER WHERE THE EYELET WILL BREAK WITH THE SUTURE. IT HAPPENED IN 2 CASES TODAY (B)(6). NO INJURY TO PATIENTS." NOTE THAT THIS REPORT IS FOR THE FIRST INSTANCE OF THIS MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21712793 ↗MalfunctionMar 24, 2023Detachment of Device or Device Component
PATIENT UNDERWENT SUBACROMIAL DECOMPRESSION REPAIR OF RIGHT ROTATOR CUFF. AT CLOSING COUNT SCRUB TECH IDENTIFIED THAT ONE OF THE FREE NEEDLES HAD LOST ITS TIP. A RIGHT SHOULDER X-RAY WAS PERFORMED AND IT WAS IDENTIFIED THAT A SMALL LINEAR METALLIC FOREIGN BODY WAS IN THE REGION OF THE ARTICULA CAPSULE OF THE RIGHT SHOULDER.
Patient problems: Foreign Body In Patient
MAUDE report 16618548 ↗
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 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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