SINGLE USE BIOPSY VALVERecalls & reported problems across all models

We found 3 models of SINGLE USE BIOPSY VALVE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 227 adverse event reports in the FDA's MAUDE database, received between Dec 7, 2018 and Sep 29, 2026 — classified as 110 injuries, 117 malfunctions.

The most frequently reported specific device problem is “Break” (127 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

SINGLE USE BIOPSY VALVE recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jan 29, 2026Open, Classified

   Potential for rubber fragment detachment during use.

   Z-1489-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Jan 29, 2026Open, Classified

   Potential for rubber fragment detachment during use.

   Z-1488-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported SINGLE USE BIOPSY VALVE problems

SINGLE USE BIOPSY VALVE models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SINGLE USE BIOPSY VALVE MAJ-210

  Nasopharyngoscope (Flexible Or Rigid)
  1 recall221 reports
• SINGLE USE BIOPSY VALVE MAJ-1218

  Nasopharyngoscope (Flexible Or Rigid)
  1 recall1 report
• SINGLE USE BIOPSY VALVE MAJ-1555

  Colonoscope And Accessories, Flexible/Rigid
  5 reports

Recent SINGLE USE BIOPSY VALVE adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Detachment of Device or Device Component

  The customer reported during a bronchoscopy, while applying anesthetic via a syringe, a fragment of the device was found to have detached. The fragment entered the syringe, so there was no drop inside the body. The procedure was completed after replacement with the similar product. There were no reports of health hazard due to this event and no delay in reporting.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927050 ↗
• InjurySep 28, 2026Fracture; Detachment of Device or Device Component

  The customer reported that during a diagnostic bronchoalveolar lavage and ultrasound examination, while the patient was under sedation, the rubber portion of the single use biopsy valve was chipped in a half-moon shape. The dropped-off portion was searched for, but its whereabouts are unknown. The customer also confirmed that an attempt was made to retrieve the broken portion, but no further details were provided. The procedure was completed with a similar device. There were no further reports of patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923202 ↗
• InjurySep 28, 2026Detachment of Device or Device Component

  The customer reported that a fragment of the Single-Use Biopsy Valve detached and fell into the bronchus during a diagnostic Endobronchial Ultrasound with a Guide Sheath (EBUS-GS) procedure for specimen collection. The event occurred while the patient was under sedation and the device was in use. The detached fragment was retrieved using biopsy forceps, and all components were reported to have been retrieved. The procedure was completed using an Olympus backup device. No serious injury or adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50919682 ↗
• InjurySep 22, 2026Detachment of Device or Device Component

  It was reported that during an unknown procedure, a piece of the biopsy valve rubber fell off into the patient¿s body but was retrieved immediately. It is unknown which part of the body the rubber piece fell into and what tool was used for retrieval. The procedure was completed after switching to another biopsy valve. There were no further reports of patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50856327 ↗
• InjurySep 16, 2026Break; Detachment of Device or Device Component

  It was reported that during a diagnostic bronchoscopy, after the biopsy forceps were inserted for the first time to remove a mucus plug, the single use biopsy valve broke and a fragment dropped into the bronchus. The fragment was grasped and retrieved with the forceps. There were no further reports of patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791333 ↗
• MalfunctionSep 15, 2026Residue After Decontamination; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779345 ↗
• MalfunctionSep 10, 2026Break

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50721702 ↗
• MalfunctionSep 9, 2026Break; Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50699106 ↗
• MalfunctionAug 28, 2026Break; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50506990 ↗
• MalfunctionAug 25, 2026Device Reprocessing Problem; Gas/Air Leak; Noise, Audible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50441694 ↗
• MalfunctionAug 21, 2026Gas/Air Leak; Noise, Audible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50376600 ↗
• MalfunctionAug 12, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50229589 ↗
• MalfunctionAug 12, 2026Gas/Air Leak; Suction Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50221417 ↗
• InjuryAug 4, 2026Break; Detachment of Device or Device Component

  It was reported during a diagnostic Endobronchial Ultrasound with Guide Sheath (EBUS-GS) procedure there was a black foreign material found inside the patient body. It was through to be a damaged part of the single use biopsy valve. It was suctioned and retrieved. The procedure was prolonged less than thirty minutes. There were no reports of patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50134036 ↗
• InjuryApr 30, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED DURING A DIAGNOSTIC ENDOBRONCHIAL BIOPSY PROCEDURE, A PART OF THE SINGLE USE BIOPSY VALVE WENT MISSING INSIDE THE PATIENT WHEN THE DEVICE WAS REMOVED FROM THE SCOPE. THE PART WAS RETRIEVED FROM PATIENT WITH NO REPORTS OF FURTHER PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25049233 ↗

Other Olympus Medical Systems Corp. products

• EVIS EXERA lll COLONOVIDEOSCOPE16 models · 15,013 reports · 7 recalls
• EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE7 models · 13,448 reports · 7 recalls
• EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE9 models · 8,317 reports · 2 recalls
• EVIS EXERA III BRONCHOVIDEOSCOPE11 models · 6,060 reports · 16 recalls
• EVIS EXERA III XENON LIGHT SOURCE2 models · 6,694 reports
• EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
• EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
• HD CAMERA HEAD2 models · 5,217 reports