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PENTAX OF AMERICA, INC. · Model 67077 · UDI-DI 04961333240791
OCX
Prescription
1
510(k) clearances
277
Adverse events
18
Recalls
97
Facilities
Description
DISPOSABLE 1500CC LINER WITH SOLIDIFIER
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-31 | Erbe Medical, LLC | Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water fl |
| 2026-03-31 | Erbe Medical, LLC | Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water fl |
| 2022-07-29 | Hobbs Medical, Inc. | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration |
| 2022-07-29 | Hobbs Medical, Inc. | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration |
| 2020-11-03 | GA HEALTH COMPANY LIMITED | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure |
| 2020-11-03 | GA HEALTH COMPANY LIMITED | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure |
| 2020-11-03 | GA HEALTH COMPANY LIMITED | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure |
| 2020-11-03 | GA HEALTH COMPANY LIMITED | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure |
| 2020-11-03 | GA HEALTH COMPANY LIMITED | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure |
| 2020-11-03 | GA HEALTH COMPANY LIMITED | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.