Endoscopic Injection Needle, Gastroenterology-Urology
FDA adverse event reports and recall history for endoscopic injection needle, gastroenterology-urology (product code FBK), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 563
- Deaths
- 0
- Injuries
- 62
- Malfunctions
- 493
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2024-11-15Open, ClassifiedProcess change control
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4720
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
- 2024-11-15Open, ClassifiedProcess change control
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4702
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
- 2024-11-15Open, ClassifiedProcess change control
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4706
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
- 2024-11-15Open, ClassifiedProcess change control
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4716
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
- 2024-11-15Open, ClassifiedProcess change control
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4721
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
- 2024-11-15Open, ClassifiedProcess change control
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4704
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
- 2024-11-15Open, ClassifiedProcess change control
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4718
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
- 2024-11-15Open, ClassifiedProcess change control
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4722
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
- 2024-11-15Open, ClassifiedProcess change control
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4723
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
- 2023-12-18Open, ClassifiedDevice Design
Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A
The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.
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