PENTAX of America Inc.

Country not established

Devices: 0
FDA recalls: 55 ongoing

No devices from this company are in the catalogue yet.

At a glance

Counted by deviCERTS from registry records

Market reach

United States: FDA recalls

Company details

DUNS number: 083211284

FDA recalls5

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

Recalls initiated per year

2017 0
2018 0
2019 0
2020 0
2021 0
2022 0
2023 0
2024 0
2025 0
2026 5

2026
- 9 Sep 2026 Z-0306-2027 Not yet classified Ongoing Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during the procedure. Distribution: Worldwide - US Nationwide and International distribution - Pending. Submission number: K200090
- 9 Sep 2026 Z-0307-2027 Not yet classified Ongoing Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during the procedure. Distribution: Worldwide - US Nationwide and International distribution - Pending. Submission number: K200090
- 9 Sep 2026 Z-0308-2027 Not yet classified Ongoing Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during the procedure. Distribution: Worldwide - US Nationwide and International distribution - Pending. Submission number: K182004
- 9 Sep 2026 Z-0309-2027 Not yet classified Ongoing Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during the procedure. Distribution: Worldwide - US Nationwide and International distribution - Pending. Submission number: K182004
- 9 Sep 2026 Z-0310-2027 Not yet classified Ongoing Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during the procedure. Distribution: Worldwide - US Nationwide and International distribution - Pending. Submission number: K191282