Candid Aligner FA-0001Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00850004223567), received between Nov 10, 2021 and Aug 4, 2026 — classified as 54 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (53 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2026Patient Device Interaction Problem

  The provider/patient reported the following: "The provider's assistant mentioned that the patient has an allergic reaction and asked for the aligner materials. It was mentioned that the aligners are made of Zendura FLX, which has thermoplastic urethane and copolyester. She mentioned that the patient has a history of allergy to polyester".

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 50131224 ↗
• InjuryJun 25, 2026Patient Device Interaction Problem

  THE PROVIDER/PATIENT REPORTED THE FOLLOWING: THE PATIENT REPORTED WATERY EYES. EXCESSIVE SALIVA AND SWALLOWING. MUCUS. IRRITATED THROAT. REDNESS AROUND MOUTH. IMMEDIATE HEADACHE LAST NIGHT WHEN I REMOVED ALIGNERS TO EAT. HEART PALPITATIONS AND SKIPPING BEATS. BURNING AND IRRITATION IN CHEST.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 25630807 ↗
• InjuryJun 23, 2026Patient Device Interaction Problem

  PATIENT/PROVIDER REPORTED THE FOLLOWING : MY PATIENT CAME TO THE OFFICE ON MAY, 25 SAYING THAT SHE STRONGLY BELIEVES SHE HAS AN ALLERGY REACTION TO THE ALIGNERS. SHE SAID SHE HAD BRONCHITIS AND THE DOCTOR DID NOT FIND THE CAUSE AND RECENTLY SHE HAD MOUTH AND FOOT DISEASE ( OR SIMILAR TO THAT) AND HERSELF AND HER DOCTOR COULD NOT FIND THE CAUSE. ACCORDING TO THE PATIENT, THE DOCTOR RECOMMENDED SHE STOP USING THE TRAY. PATIENT WORE 10 STAGES, STATED TO HAVE HAD RESPIRATORY ISSUES AND ILLNESSES THE ENTIRE TIME; THEY STOPPED WHEN SHE DISCONTINUED WEAR.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 25598008 ↗
• InjuryMay 5, 2026Patient Device Interaction Problem

  THE PROVIDER/PATIENT REPORTED THE FOLLOWING: THE PATIENT IS EXPERIENCING A BURNING SENSATION ON HIS LIPS, AND HIS LIPS ARE ITCHING.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 25088645 ↗
• InjuryApr 17, 2026Patient Device Interaction Problem

  THE PROVIDER/PATIENT REPORTED THE FOLLOWING: THE CASE WE HAD FOR PATIENT (B)(6), WELL SHE WAS JUST IN AND I THINK THE FIRST ALIGNERS THAT WERE SUPER TIGHT WITH MINIMAL BLOCKOUT. AGGRAVATED #13 PRETTY BADLY. THE TOOTH LOOSENED UP AND WE NEEDED TO PULL IT TODAY. SHE KNOWS THAT IT ALREADY HAD SEVERE BONE LOSS AND WAS MOBILE BUT IT SCARED HER SO MUCH SHE DOES NOT WANT TO CONTINUE TREATMENT WITH ALIGNERS. I TRIED EXPLAINING THAT WITHOUT THE TOOTH THEY SHOULD FEEL MORE COMFORTABLE. I ALSO EXPLAINED THAT THE NEW ONES SHOULDN'T HURT AS BADLY BECAUSE THEY HAVE BEEN MODIFIED. SHE IS PRETTY ADAMANT ABOUT NOT WANTING TO LOSE ANY MORE TEETH AND DOES NOT WANT TO CONTINUE.

  Patient problems: Tooth Loss

  MAUDE report 24915926 ↗
• InjuryMar 30, 2026Patient Device Interaction Problem

  THE PROVIDER/PATIENT REPORTED THE FOLLOWING:" WE PUT TOGETHER A CANDID TXP TOGETHER IN (B)(6) 2025. THROUGHOUT TREATMENT THE PATIENT HAS HAD CONCERNS ABOUT HER BITE NOT COMING TOGETHER AT ALL, AT ONE POINT IT STARTED CAUSING SOME SYMPTOMS OF TMD. I SAW HER ON (B)(6) 2025 AND NOTED SHE WAS HAVING PREMOLAR INTERFERENCES ON BOTH SIDES IN HER OCCLUSION THAT WAS PREVENTING ANY OTHER TEETH FROM OCCLUDING. AT THAT TIME I ENCOURAGED HER TO BE PATIENT THAT THESE INTERFERENCES WOULD MOVE OUT OF THE WAY AND HER BITE WOULD COME TOGETHER. SHE IS NOW ON ALIGNER 21 OF 25 AND STILL REPORTS SHE CANNOT CLOSE DOWN/CAN'T BITE. THE PATIENT IS COMING ON NEXT WEEK MONDAY FOR ME TO TAKE A LOOK. I WAS JUST REVIEWING HER TREATMENT PLAN AT STAGE ZERO AND COMPARING IT TO OUR PHOTOS AND AM STARTING TO GET CONCERNED THAT THE BITE WAS OFF IN THE DIGITAL CANDID TREATMENT PLAN STARTING POINT. IF YOU LOOK AT THE CANDID PLAN AND COMPARE IT TO THE PHOTOS IT APPEARS THE DIGITAL SETUP AT STAGE ZERO HAS A LOT MORE OVERJET ON TEETH #12 AND 13 (WHERE HER OCCLUSAL INTERFERENCE IS) WHEN COMPARED TO THE PHOTOS I SUBMITTED. HOPEFULLY I'M WRONG ABOUT THIS BUT WANTED YOU TO REVIEW AND HEAR YOUR THOUGHTS. SHOULD WE CONSIDER STOP

  Patient problems: Joint locking

  MAUDE report 24716237 ↗
• InjuryMar 13, 2026Patient Device Interaction Problem

  THE PROVIDER/PATIENT REPORTED THE FOLLOWING: PT COMPLAINS OF TMJ PAIN ON RIGHT SIDE AFTER PUTTING IN ALIGNER #9.

  Patient problems: Joint locking

  MAUDE report 24598909 ↗
• InjuryMar 13, 2026Patient Device Interaction Problem

  THE PROVIDER/PATIENT REPORTED THE FOLLOWING: THE PATIENT (B)(6). (B)(6), (B)(6) EMAILED US BECAUSE SHE STARTED HER ALIGNER NUMBER 4 ON SATURDAY, AND SHE'S EXPERIENCING NERVE PAIN WHEN SHE CHEWS SOFT OR SEMI-HARD FOOD ON THE RIGHT SIDE. IT RADIATES FROM THE JAW TO THE BOTTOM OF THE RIGHT EAR.

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

  MAUDE report 24595415 ↗
• InjuryMar 13, 2026Patient Device Interaction Problem

  THE PROVIDER/PATIENT REPORTED THE FOLLOWING: PATIENT REPORTED: "I HAVE HAD COLD SORES THE ENTIRE TIME I HAVE BEEN WEARING THESE ALOGHNERS. I ALSO HAVE A PERPETUAL SORE THROAT, RUNNY NOSE AND RINGING IN EARS. I HAVE ALSO HAD SMALL BLISTERS ON MY NECK SO I AM DISCONTINUING USE OF THE ALIGNERS. I HAVE LEFT A MESSAGE FOR MY DENTIST BUT HE IS OUT OF TOWN UNTIL NEXT WEEK. I CANNOT KEEP WEARING THESE AND BLISTERING AMONG OTHER SYMPTOMS. ALSO, ALREADY WITHOUT THE LINERS (ABOUT 15 HOURS) I AM FEELING THE SYMPTOMS SIBSIDE."

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 24592571 ↗
• InjuryFeb 27, 2026Patient Device Interaction Problem

  THE PROVIDER/PATIENT REPORTED THE FOLLOWING: THE NEW OFFICE MANAGER FOR THE PRACTICE REACHED OUT ABOUT THIS PATIENT'S CASE AND INFORMED US THAT THE PATIENT HAD AN ALLERGIC REACTION TO THEIR ALIGNER. AS FAR AS REACTIONS I'M HAVING: A MAINLY ON MY LIP. A WHEN I PUT IN THE NEW SET (#1), MY LIP SWELLED A BIT, AND I DEVELOPED A LITTLE SORE, BUT IT EVENTUALLY WENT AWAY. A I GET A DRY MOUTH AND A SLIGHT SORE THROAT, BUT NOT TOO BAD. WHEN I PUT IN THE SECOND ALIGNERS, THE SAME THING HAPPENED BUT WENT AWAY A LITTLE BIT QUICKER. WHEN I TRIED THE THIRD SET, THE TOP ONES DON'T FIT ONCE AGAIN. SO ATTACHED ARE PICTURES OF SOME OF THE RASHES, MY LIP, AND THE POOR ALIGNMENT OF MY TOP 3RD TRAY. A BOTTOM ONE FIT, BUT THERE'S NO WAY THE TOP ONE LINES UP.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 24471760 ↗
• InjuryFeb 26, 2026Patient Device Interaction Problem

  THE PROVIDER/PATIENT REPORTED THE FOLLOWING: PATIENT STARTED FEELING JAW PAIN AND NECK PAIN AROUND THE SECOND DAY OF WEARING THE SECOND ALIGNERS. IT STARTED PROGRESSING INTO SEVERE NECK, SHOULDER AND JAW PAIN THAT STARTED CAUSING MIGRAINE LIKE HEADACHES. IT STARTED WHEN SHE SLOWLY HAD MORE PRESSURE ON #22. BUT STARTED FEELING ALL THE NECK AND JAW PAIN ON THE RIGHT SIDE AND THEN THE LEFT. ONCE TOOK OFF THE ALIGNERS FOR AN EVENING, ALL SYMPTOMS WENT AWAY.

  Patient problems: Joint locking

  MAUDE report 24464706 ↗
• InjuryFeb 26, 2026Patient Device Interaction Problem

  THE PROVIDER/PATIENT REPORTED THE FOLLOWING: PROVIDER REPORTING POSSIBLE CHIPPING ON THE INCISAL EDGE OF THE ANTERIORS THAT WAS NOT THERE FROM THE BEGINNING OF TREATMENT.

  Patient problems: Tooth Fracture

  MAUDE report 24464548 ↗
• InjuryFeb 26, 2026Patient Device Interaction Problem

  THE PROVIDER/PATIENT REPORTED THE FOLLOWING: DOCTOR IS NOTICING A "CHIPPING" ALONG THE INCISAL EDGE THAT WAS NOT PRESENT BEFORE BEGINNING TREATMENT AND WANTS TO KNOW IF IT IS ALIGNER RELATED.

  Patient problems: Tooth Fracture

  MAUDE report 24464408 ↗
• InjuryJan 13, 2026Patient Device Interaction Problem

  THE PROVIDER/PATIENT REPORTED THE FOLLOWING: THE PATIENT STATES THAT SHE IS HAVING JAW LOCKING OCCASIONALLY AND POPPING ON BOTH SIDES.

  Patient problems: Joint locking

  MAUDE report 24062871 ↗
• InjuryJan 6, 2026Patient Device Interaction Problem

  THE PROVIDER/PATIENT REPORTED THE FOLLOWING: "I JUST WANTED TO MAKE SURE AND LET YOU KNOW THAT MY LEFT JAW WAS POPPING WHEN I WAS DOING THE SCAN THIS MORNING THAT REQUIRED ME TO BITE DOWN ON MY BACK TEETH. I'M NOT SURE IF THAT IS IMPORTANT FOR YOU ALL TO KNOW AT THIS JUNCTURE, BUT I WANTED TO LET YOU KNOW BECAUSE I WAS HAVING SOME PROBLEMS WITH THAT AND THAT IS ONE OF THE REASONS WHY I WANTED TO GET THE ALIGNERS. I HAVE NOT HAD THAT ISSUE WITH ANY OF THE OTHER SCANS".

  Patient problems: Joint locking

  MAUDE report 23985728 ↗
• InjuryDec 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PROVIDER/PATIENT REPORTED THE FOLLOWING: THE PROVIDER PATIENT IS COMPLAINING OF LOCK JAW WHEN WEARING HER ALIGNERS.

  Patient problems: Joint locking

  MAUDE report 23785477 ↗
• InjuryDec 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PROVIDER/PATIENT REPORTED THE FOLLOWING: THE DOCTOR HAS ADVISED A BREAK FROM HER ALIGNERS BECAUSE HER JAW IS INFLAMED. THE PATIENT IS A CLENCHER AND IS HAVING THE JAW PAIN FROM IT/THE ALIGNERS.

  Patient problems: Joint locking

  MAUDE report 23761426 ↗
• InjuryDec 5, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PROVIDER/PATIENT REPORTED THE FOLLOWING: THE PATIENT, (B)(6), (B)(6), REACHED OUT TO ADVISE THAT SHE HAD STOPPED WEARING HER ALIGNERS BECAUSE SHE WAS EXPERIENCING JAW SPASMS AND EAR SPLUTTERING. WHEN SHE GOT TO THE 11TH SET, SHE WORE IT FOR ONE NIGHT, AND WHEN SHE WOKE UP, HER LEFT EAR WAS SPLUTTERING, SO SHE WENT TO SET 10 AND THE FLUTTERING CONTINUED FOR LIKE A MONTH, SHE WENT BACK TO NINE WHILE THE EMT CHECKED ON HER, WENT BACK TO THE DENTIST TO CHECK HER JAW BECAUSE IT WAS BOTHERING HER EARS. THE JAW SPASMS STARTED WHEN WEARING NUMBER 9. THE TEETH WERE BACK TO THE WAY THEY WERE, AND SHE'S TRYING TO GET A REFUND BECAUSE OF THE TERRIBLE EXPERIENCE.

  Patient problems: Joint locking

  MAUDE report 23733490 ↗
• InjuryDec 5, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  PROVIDER/PATIENT REPORTED "THE" FOLLOWING: PATIENT HAD ALLERGIC REACTION TO ALIGNER MATERIAL. HAPPENED IMMEDIATELY.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 23732781 ↗
• InjuryNov 26, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PROVIDER/PATIENT REPORTED THE FOLLOWING: THE ALIGNERS ARE SHIFTING MY TEETH IN THE WRONG DIRECTION, CAUSING ME TO HAVE MAJOR BONE LOSS. I'M IN JEOPARDY OF LOSING TWO UP TO POSSIBLY FIVE TEETH. NOW THEY ARE NOT SHIFTING MY TEETH IN THE DIRECTION THAT I WANTED IN ORDER FOR ME TO BE ABLE TO EVENTUALLY GET A PARTIAL. I AM VERY CONCERNED. HAD TO GO FOR A WEEK AND A HALF WITHOUT AN ALIGNER IN DUE TO THE SEVERE PAIN, SHIFTING BONE LOSS AND INFECTION THAT HAS SET UP MY X-RAYS FROM SIX MONTHS AGO LOOKED COMPLETELY DIFFERENT FROM WHAT THEY DID THIS WEEK DUE TO THE AMOUNT OF BONE LOSS AND PAIN I HAVE BEEN EXPERIENCING BECAUSE OF THE ALIGNERS.

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

  MAUDE report 23662766 ↗
• InjuryNov 26, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PROVIDER/PATIENT REPORTED THE FOLLOWING: PATIENT REPORTED "TMD PROBLEMS/JAW CLICKING AND POPPING" SINCE WEARING THEIR ALIGNERS AND IS NOW BLAMING THE ALIGNERS FOR CAUSING THESE PROBLEMS. THE PROVIDER MENTIONED THEY SPOKE WITH A TMD SPECIALIST, AND THEY EVALUATED THEIR PREVIOUS X-RAYS AND COULD SEE WHY THE PT WOULD POTENTIALLY GET TMD SYMPTOMS, BUT THE PROVIDER DID NOT HAVE ANY FURTHER DETAILS RETARDING THAT CONVERSATION WITH THE SPECIALIST.

  Patient problems: Joint locking

  MAUDE report 23662708 ↗
• InjuryNov 17, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PROVIDER/PATIENT REPORTED THE FOLLOWING:: "I'VE BEEN HAVING BAD SINUS ISSUES, SORE THROAT. IT'S FROM THE ALIGNERS. I STARTED SET 2 TODAY BUT IT'S REALLY BEEN NEGATIVELY IMPACTING MY WORK, SLEEP, SINUSES, ETC." HERE IS ONE INTRA-ORAL PHOTO HE SENT OVER COMPLAINING OF HIS THROAT HURTING. AFTER TALKING WITH HIM AND EXPLAINING A FEW TIMES THAT IT'S NORMAL TO HAVE TENDERNESS AND SOMETIMES A LITTLE BIT OF PAIN WITH ALIGNERS, ESPECIALLY WHEN BEGINNING A NEW SET... HE STILL WANTS TO CALL IT QUITS. HERE'S WHAT HE'S LAST SAID TO ME "I'M UNFORTUNATELY UNABLE TO CONTINUE MY ALIGNERS. I HAVE BEEN TRYING UP THROUGH YESTERDAY BUT THEY JUST AREN'T WORKING FOR ME RIGHT NOW. THEY CAUSE HEADACHES, AND SINUS PRESSURE EVERY TIME I PUT THEM IN. IT'S STILL IMPACTING MY SLEEP AND WORK. WITH CURRENT LIFE SITUATION / WORK, I CAN'T DO IT."

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 23576031 ↗
• InjuryNov 3, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PROVIDER REPORTED THE FOLLOWING: THE OFFICE REPORTED THE PT IS EXPERIENCING AN ALLERGIC REACTION TO THE ALIGNERS. THEY GET A SORE THROAT, COLD SORES, BLEEDING GUMS, AND CRACKED/CHAPPED LIPS WHEN WEARING THE ALIGNERS. WHEN THEY STOP WEARING THE ALIGNERS, THESE SYMPTOMS TAPER DOWN.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 23459462 ↗
• InjuryAug 21, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PATIENT INITALLY REPORTED THE FOLLOWING: "THE PATIENT SAID SHE HAS NCH WHICH IS WHERE HER BODY REACTS TO CERTAIN THINGS. SHE SAID THE PROVIDER PUT ADHESIVE ON HER TEETH AND SHE WAS NEVER TOLD THAT, SHE SAID SHE REACTS TO ADHESIVE AND THE DAY THEY PUT THE BONDER IN IS WHEN SHE WENT TO THE ER DUE TO FEVER. ALSO MENTIONED SHE GOT CANKER SORES WHERE THEY BONDED. SHE WENT TO HER PROVIDER AFTER THE ER AND THEY SAID THE NEXT OPTION WOULD BE TO PULL THE TOOTH THAT WAS BONDED" . THE PATIENT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: "SIGNIFICANT ALLERGIC REACTION TO THE ALIGNERS WHICH TRIGGERED COMPLICATIONS WITH PATINNT'S UNDERLYING MEDICAL CONDITION, MCAS (MAST CELL ACTIVATION SYNDROME). ALSO EXPERIENCED PROLONGED SYMPTOMS, INCLUDING ORAL ITCHINESS AND SMALL CANKER SORES ON HER GUMS DIRECTLY ABOVE THE TREATED TEETH, WHICH TOOK OVER A MONTH TO FULLY RESOLVE."

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22866413 ↗
• InjuryJul 31, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PATIENT REPORTED THE FOLLOWING: THE PATIENT REPORTED VIA EMAIL THE FOLLOWING: "I HAVE BEEN USING THE GREEN CHEWIE REGULARLY, BUT STOPPED USING IT ON MY TWO FRONT TEETH BECAUSE I NOTICED A CHIP IN ONE OF THEM AND WAS WORRIED I CLAMPED TOO TIGHT. "

  Patient problems: Tooth Fracture

  MAUDE report 22682577 ↗