HUDSON RCI IPN049847Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 14026704640352), received between Aug 6, 2021 and Jun 4, 2025 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2025Detachment of Device or Device Component; Patient Device Interaction Problem; Detachment of Device or Device Component; Patient Device Interaction Problem

  IT WAS REPORTED THAT: "BITE BLOCK BROKE WHILE INSIDE THE PATIENTS MOUTH. THE TIP OF THE BITE BLOCK DETACHED FROM THE BITE BLOCK ITSELF- WHITE HANDLE AND GREEN BLOCK. THE PATIENT WAS INTUBATED WITH A PROTECTED AIRWAY. THERE WAS NO HARM OR CONSEQUENCE AND THE PATIENT WAS REPORTED AS FINE." CONFIRMED TO HAPPEN ON TWO SEPARATE DEVICES FROM THE SAME LOT: ASSOCIATED COMPLAINTS 3004365956-2025-00027.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22141632 ↗
• MalfunctionJun 4, 2025Detachment of Device or Device Component; Patient Device Interaction Problem; Detachment of Device or Device Component; Patient Device Interaction Problem

  IT WAS REPORTED THAT: "BITE BLOCK BROKE WHILE INSIDE THE PATIENTS MOUTH. THE TIP OF THE BITE BLOCK DETACHED FROM THE BITE BLOCK ITSELF- WHITE HANDLE AND GREEN BLOCK. THE PATIENT WAS INTUBATED WITH A PROTECTED AIRWAY. THERE WAS NO HARM OR CONSEQUENCE AND THE PATIENT WAS REPORTED AS FINE." CONFIRMED TO HAPPEN ON TWO SEPARATE DEVICES FROM THE SAME LOT: ASSOCIATED COMPLAINTS 3004365956-2025-0002.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22141417 ↗
• InjuryJan 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE GREEN PART OF THE BITE-GARD BLOCK SNAPPED OFF IN THE PATIENT'S MOUTH WHEN TRYING TO REMOVE IT FOR PAC. THE WHITE PART ALSO SEPARATED, AND THE GREEN PORTION BECAME STUCK IN THE PATIENT'S MOUTH. SEDATION AND THE USE OF INOTROPES WAS REQUIRED TO REMOVE THE BLOCK WITH FORCEPS. ADDITIONAL INFORMATION INDICATED THAT THE BITE BLOCK WAS IN PLACE AS THE PATIENT WAS BITING DOWN, SO SEDATION WAS NECESSARY TO RELAX THE PATIENT'S MOUTH AND RETRIEVE THE BLOCK. A PROPOFOL BOLUS WAS ADMINISTERED FOR SEDATION, AND NORADRENALINE WAS STARTED TO OFFSET THE HYPOTENSIVE EFFECTS OF PROPOFOL, WHICH WAS DISCONTINUED ONCE THE EFFECTS WORE OFF. THERE WAS NO INJURY TO THE PATIENT, AND THE PATIENT'S OUTCOME WAS UNAFFECTED BY THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21196539 ↗
• MalfunctionFeb 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: "AFTER EXTUBATION THE BEDSIDE NURSE FOUND THE GREEN PART OF THE DEVICE IN THE PATIENT'S MOUTH AND THE WHITE PART IN THE BED." THERE WAS NO PATIENT INJURY AND NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18765788 ↗
• MalfunctionJan 17, 2024Separation Failure; Separation Failure

  IT WAS REPORTED THAT: ANESTHESIOLOGIST USED AN ORAL BITE GUARD FOR PATIENT TO PROTECT AIRWAY. AFTER THE PROCEDURE WAS COMPLETE AND THE PATIENT WAS WAKING UP THE PATIENT BIT DOWN ON THE MOUTH GUARD AND IT SNAPPED APART INTO TWO PIECES. THE DEVICE BROKE (HANDLE SEPARATED FROM THE BITE GUARD THAT WAS POSITIONED BETWEEN THE PTS MOLARS) PATIENT WAS PLACED AT RISK OF ASPIRATION AND/OR POSSIBILITY OF SWALLOWING THE PART THAT WAS STILL RETAINED IN THE MOUTH. DUE TO PATIENT STILL BEING SEDATED AND UNCOOPERATIVE IT TOOK 5 MINUTES TO RETRIEVE THE BROKEN PIECE FROM THE PATIENTS MOUTH. ADDITIONAL INFORMATION: THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. THEY WERE DISCHARGED AS PER CARE PLAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18524068 ↗
• MalfunctionJul 25, 2022Break; Break

  IT WAS REPORTED THAT: "WE HAVE RECENTLY HAD ISSUES WITH THE BITEGARD ORAL BITE BLOCKS BREAKING IN PATIENTS MOUTHS WHEN THEY ARE DIFFICULT TO REMOVE". PATIENT CONDITION REPORTED, AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15092872 ↗
• MalfunctionJul 25, 2022Break; Break

  IT WAS REPORTED THAT: "WE HAVE RECENTLY HAD ISSUES WITH THE BITEGARD ORAL BITE BLOCKS BREAKING IN PATIENTS MOUTHS WHEN THEY ARE DIFFICULT TO REMOVE". PATIENT CONDITION REPORTED, AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15092817 ↗
• MalfunctionJul 20, 2022Break; Break

  IT WAS REPORTED THAT: "WE HAVE RECENTLY HAD ISSUES WITH THE BITEGARD ORAL BITE BLOCKS BREAKING IN PATIENTS MOUTHS WHEN THEY ARE DIFFICULT TO REMOVE." THERE WAS NO REPORT OF PATIENT INJURY. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15068866 ↗
• MalfunctionJul 20, 2022Break; Break

  IT WAS REPORTED THAT: "WE HAVE RECENTLY HAD ISSUES WITH THE BITEGARD ORAL BITE BLOCKS BREAKING IN PATIENTS MOUTHS WHEN THEY ARE DIFFICULT TO REMOVE." THERE WAS NO REPORT OF PATIENT INJURY. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15068754 ↗
• MalfunctionDec 7, 2021Material Separation; Material Separation

  IT WAS REPORTED AN "INTUBATED PATIENT HAD BITE BLOCK IN HIS MOUTH. UPON DOING MOUTH CARE AT 6 PM, THE PCA HELPING ME NOTICED THAT THE GREEN PART THAT GOES BETWEEN PATIENT'S TEETH WAS IN HIS MOUTH AND WAS NO LONGER ATTACHED TO THE LONG WHITE PART THAT COMES OUT OF THE MOUTH. THE WHITE PART WAS FOUND IN THE BED BY PATIENT'S NECK". NO PATIENT INJURY OR HARM REPORTED. NO MEDICAL INTERVENTION REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12951906 ↗
• InjuryAug 6, 2021Material Separation; Material Separation

  IT WAS REPORTED "PATIENT HAS A BRAIN INJURY AND BITES LIPS & MOUTH. FACILITY PLACED THE BITE GUARD-I CONFIRMED THAT IT WAS NOT SECURED AND WAS IN PLACE CONTINUOUSLY. UPON PERFORMING ROUTINE ORAL CARE, THE CN FOUND THE "BITE BLOCK WAS IN THE MIDDLE OF HIS MOUTH NOT ALIGNED WITH HIS TEETH. WHEN SHE MOVED THE BITE BLOCK, SHE SAW THAT THE GREEN BITE BLOCK PIECE WAS GONE, NO LONGER CONNECTED TO THE HANDLE. THE SUPERVISOR CAME IN TO ASSIST ALONG WITH RT. THEY GOT A LATERAL XR OF THE NECK AND COULD SEE IT AT THE BACK OF THE THROAT. AS THEY OPENED THE PATIENT'S MOUTH THE GREEN PIECE WAS VISUALIZED, AND THEY SAID THAT IT WAS MOVING UP AND DOWN WITH EACH BREATH. WHEN THEY COULD VISUALIZE IT, THEY WERE ABLE TO REMOVE THE FOREIGN OBJECT WITH FORCEPS. PATIENT HAS HAD SOME BLEEDING IN THE MOUTH. THE PATIENT WAS SENT TO ER FOR EVALUATION OF ANY TRAUMA AFTER THE FOREIGN BODY WAS REMOVED. BRONCHOSCOPE WAS UTILIZED TO VISUALIZE THE POSTERIOR OROPHARYNX. THE PATIENT HAD A SMALL AREA OF ERYTHEMA".

  Patient problems: Laceration(s)

  MAUDE report 12287575 ↗