Kangaroo 8884721088ERecalls & reported problems
Cardinal Health, Inc. · Feeding Tube · Class 2
Quick summary
This Kangaroo feeding tube from Cardinal Health is a tube placed in the stomach through the nose for feeding. Many of the 82 reports describe guide wires that cannot be removed, tubes tearing or detaching, and fluid leaking. The reports include 19 injuries and 1 death, and reports fell from 10 in the previous 12 months to 4 in the last 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 82
- Deaths reported
- 1
- Injuries reported
- 19
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 10884521582996), received between Dec 14, 2018 and Apr 7, 2026 — classified as 1 death, 19 injuries, 62 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (27 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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component27
- Fluid/Blood Leak15
- Difficult to Remove14
- Adverse Event Without Identified Device or Use Problem11
- Break8
- Material Separation8
- Obstruction of Flow4
- Disconnection2
Patient problems
- No Clinical Signs, Symptoms or Conditions38
- Foreign Body In Patient13
- No Consequences Or Impact To Patient12
- No Known Impact Or Consequence To Patient6
- Pneumothorax6
- Internal Organ Perforation5
- Vomiting2
- Aspiration/Inhalation1
Recent adverse event reports
The 25 most recent of 82 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 7, 2026Difficult to Remove
THE CUSTOMER REPORTED THE PATIENT HAD AN NG TUBE INSERTED AND AFTER THE X-RAY, ONE OF NURSES TRYING TO TAKE THE WIRE OUT NOTED IT WAS A FAULTY NG TUBE. THE PATIENT HAD THE NG TUBE INSERTED BY A SENIOR RN COLLEAGUE FROM ANOTHER AREA WITH EXPERIENCE OF NGT INSERTION IN PATIENTS WITH EATING DISORDERS. X-RAY ATTENDED AND WAS DEEMED PLACED SUITABLY FOR USE. AFTER THE X-RAY, THE PATIENT AND MUM REQUESTED TO REMOVE THE WIRE. A FEW RNS TRIED TO TAKE THE WIRE OUT BUT IT WAS NOT SUCCESSFUL. NGT WAS EVENTUALLY REMOVED FOLLOWING A CODE BLACK ON PATIENT AND HER MOTHER. A SENIOR NURSE FROM MET TEAM WENT TO HELP AND HE FOUND THE NG TUBE WAS FAULTY SO HE TOOK OUT WHOLE TUBE. THE TREATING TEAM WAS INFORMED. A NEW NGT WAS INSERTED OVERNIGHT AS PATIENT IS ON AN ED3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24801108 ↗MalfunctionMar 30, 2026Difficult to Remove
THE CUSTOMER REPORTED THEY WERE UNABLE TO REMOVE THE GUIDEWIRES (STYLETS). THE NGTS WERE SOURCED FROM ICU. PER ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2026, THE TUBES WERE INJECTED WITH 10ML H2O. THE TUBES WERE NOT USED WITH A PATIENT, THE ISSUE OCCURRED WHEN THE TUBES WERE TESTED BEFORE INSERTION. THE ISSUE WAS RESOLVED BY USING AN NG TUBE FROM ANOTHER MANUFACTURER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24709385 ↗MalfunctionMar 30, 2026Difficult to Remove
THE CUSTOMER REPORTED THEY WERE UNABLE TO REMOVE THE GUIDEWIRES (STYLETS). STERILE WATER WAS FLUSHED INTO THE TUBES BUT THEY WERE STILL UNABLE TO REMOVE THE GUIDEWIRES (STYLETS). THE NGTS WERE SOURCED FROM ICU. PER ADDITIONAL INFORMATION PROVIDED ON 26MAR2026, THE TUBES WERE INJECTED WITH 10ML H2O. THE TUBES WERE NOT USED WITH A PATIENT, THE ISSUE OCCURRED WHEN THE TUBES WERE TESTED BEFORE INSERTION. THE ISSUE WAS RESOLVED BY USING AN NG TUBE FROM ANOTHER MANUFACTURER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24709364 ↗MalfunctionJan 22, 2026Difficult to Remove
THE CUSTOMER REPORTED A NORMAL INSERTION BUT THE WIRE WAS UNABLE TO BE REMOVED AFTER THE TUBE WAS INSERTED INTO THE PATIENT. THE PROCEDURE WAS ABANDONED AND THE TUBE WAS REMOVED. THERE WAS NO PATIENT HARM. PER ADDITIONAL INFORMATION PROVIDED ON JANUARY 29, 2026 BY THE STORES AND EQUIPMENT NURSE WHO RAISED THE ISSUE, THEY DID NOT HAVE ACCESS TO THE IFU (INSTRUCTIONS FOR USE) AT THE POINT OF CARE AS WHEN THEY RECEIVE A DELIVERY OF EQUIPMENT THEY DO NOT RECEIVE IT IN A BOX BUT INDIVIDUALLY AND THERE IS NO IFU IN THE PRODUCT PACK WHICH MADE THEM UNAWARE OF CHANGES TO INSERTION INSTRUCTIONS. THEY WERE MADE AWARE BY ANOTHER STAFF MEMBER THE FOLLOWING SHIFT. INSERTING NGTS IS NOT SOMETHING THAT HAPPENS OFTEN ON THEIR WARD AND THEY CANNOT REMEMBER THE LAST TIME THAT AN NGT WAS INSERTED ON THE WARD. THEY KNEW ABOUT USING WATER TO ACTIVATE THE OUTER COATING OF THE TUBE, BUT NOTHING ELSE. THE STAFF HAVE NOW BEEN MADE AWARE OF THE REQUIREMENT TO ACTIVATE THE HYDROMER PRIOR TO AND AFTER PLACEMENT. PER THE INITIAL REPORTER, THE LACK OF IFUS & EASY ACCESS TO THESE IS AN ONGOING CHALLENGE IN HEALTH CARE. THIS MATTER IS NOT LIMITED TO CARDINAL HEALTH. THE TOPIC IS A MATTER OF ONGOING DISCUSSION WIT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24150321 ↗MalfunctionOct 23, 2025Difficult to Remove; Difficult to Remove
THE CUSTOMER REPORTED THE CU [CARDIAC CARE UNIT] PROVIDER INSERTED A DOBHOFF INTO THE LEFT NARE OF THE PATIENT AND WAS UNABLE TO REMOVE THE GUIDE WIRE. SEVERAL ATTEMPTS WERE MADE TO REMOVE THE GUIDE WIRE WITHOUT SUCCESS. X-RAY HAD VERIFIED PLACEMENT PRIOR TO ATTEMPTING TO REMOVE THE GUIDE WIRE. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS TO PULL THE GUIDE WIRE, THE CCU PROVIDER MADE THE DECISION TO PULL THE DOBHOFF. UPON INSPECTION THE WEIGHTED TIP OF THE GUIDE WIRE WAS GETTING HUNG UP ON THE JUNCTION BETWEEN THE CLEAR FENESTRATED TIP AND THE YELLOW OPAQUE TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23372216 ↗MalfunctionAug 26, 2025Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE FEEDING TUBE APPEARS TO HAVE BURST AND THE WEIGHTED END REMAINS IN PATIENT ABDOMEN, PROXIMAL END FELL OUT WHEN PATIENT MOVED FOR PT. ADDITIONAL INFORMATION RECEIVED ON 08SEP2025 STATED THAT THEY TRIED TO HAVE THE PATIENT PASS THE TIP BUT WERE UNSUCCESSFUL AND THE WEIGHTED TIP WAS REMOVED BY ENDOSCOPY.
Patient problems: Foreign Body In Patient
MAUDE report 22893669 ↗MalfunctionAug 7, 2025Material Separation; Material Separation
THE CUSTOMER REPORTED THAT UPON DISCONTINUING THE TUBE OVER THE WEEKEND, IT WAS FOUND THAT THE DEVICE WAS TORN IN HALF. THE PATIENT NOW HAS TO HAVE AN EGD IN ORDER TO REMOVE THE OTHER HALF.
Patient problems: Foreign Body In Patient
MAUDE report 22744438 ↗MalfunctionMay 19, 2025Break; Break
THE CUSTOMER REPORTED THAT THE FEEDING TUBE HAD A TEAR IN IT, 15CM FROM THE DISTAL END (SO STILL IN THE STOMACH). THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22048265 ↗MalfunctionMay 7, 2025Break; Break
THE CUSTOMER REPORTED THEIR CUSTOMER REPORTED A DEFECTIVE PRODUCT. PER ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2025, THE DOBBHOFF DEVELOPED A HOLE IN IT JUST UNDER THE PATIENT'S NOSE, WHICH THEN REQUIRED REINSERTION OF ANOTHER TUBE. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21977123 ↗InjuryMar 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED ON (B)(6) 2025, THE PATIENT HAD AN NG TUBE WITH ENTERAL FEEDS INFUSING AND REQUIRED IMAGING RELATED TO EMESIS AND LOOSE STOOLS. HOWEVER, ON REVIEW OF IMAGING, IT WAS NOTED THAT THE TIP OF THE NG TUBE HAD BROKEN OFF. THE TIP OF THE TUBE WAS NOTED IN THE ABDOMEN. FEEDS WERE STOPPED AND THE NG TUBE WAS REMOVED, REQUIRING NEW NG INSERTION. SERIAL X-RAYS COMPLETED, MINIMAL MOVEMENT OF TUBE FRAGMENT. NOW NOTED PATIENT HAS BEEN DIAGNOSED WITH ASPIRATION PNEUMONIA AND GI BLEED.
Patient problems: Aspiration/Inhalation; Diarrhea; Foreign Body In Patient; Pneumonia; Vomiting
MAUDE report 21526545 ↗MalfunctionFeb 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THE NGT (NASOGASTRIC TUBE) WAS PLACED ON (B)(6) 2025 AT 1500HRS AND PULLED ON (B)(6) 2025 FOR PLANNED EXTUBATION. WHEN REMOVED, THE WEIGHTED TIP WAS MISSING. X-RAY WAS COMPLETED AND CONFIRMED THE WEIGHTED TIP WAS IN THE STOMACH. GI WAS CONSULTED AND THERE WAS NO URGENCY TO REMOVE IT, FOLLOW STOOL OUTPUT. PER ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER ON 11FEB2025, THE PATIENT PASSED THE FOREIGN BODY SPONTANEOUSLY IN HIS STOOL, NO PROCEDURE WAS NEEDED TO REMOVE IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21326930 ↗MalfunctionNov 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED ON INSERTION OF THE NASOGASTRIC TUBE, THE WEIGHTED TIP SEPARATED FROM THE POLYURETHANE TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20730213 ↗MalfunctionNov 19, 2024Material Separation; Material Separation
THE CUSTOMER REPORTED ON REMOVAL OF THE NASOGASTRIC TUBE, 30CM OF TUBING WAS MISSING. DISSECTION/SEPARATION OF THE TUBE WITHIN THE POLYURETHANE TUBING SECTION. THE FINE BORE NASOGASTRIC TUBE SEPARATED/BROKE IN HALF. THE CONNECTION END WAS REMOVED, HOWEVER THE REMAINDER OF THE DISTAL END OF THE TUBE WAS NOT RETRIEVED FROM THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 20729491 ↗MalfunctionNov 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED WHEN FLUSHING THE NGT PRE-INSERTION, AT THE JUNCTION OF THE SILVER TIP AND JOINING OF THE TUBE, HERNIATION OF THE TUBE OCCURRED AROUND THE JOIN OF THE PU (POLYURETHANE) AND METAL TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20663621 ↗InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED A PNEUMOTHORAX RESULTING FROM THE CARDINAL KANGAROO DOBHOFF TUBE. THE CLINICIAN STATED THAT THE TIP OF THE STYLET IS VERY STIFF.
Patient problems: Pneumothorax
MAUDE report 20078488 ↗InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED A PNEUMOTHORAX RESULTING FROM THE CARDINAL KANGAROO DOBHOFF TUBE. THE CLINICIAN STATED THAT THE TIP OF THE STYLET IS VERY STIFF.
Patient problems: Pneumothorax
MAUDE report 20078090 ↗MalfunctionJul 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THE NG TUBE WAS FOUND TO BE BROKEN ABOVE THE METAL WEIGHTS. ALL OF THE METAL PIECES APPEAR TO REMAIN INTACT AND CONTAINED WITHIN THE TUBING, BUT THE TUBING REMAINED CONNECTED BY ONLY APPROXIMATELY 4MM. THE TUBING BECAME COMPLETELY SEPARATED AFTER BEING PLACED INTO PLASTIC BAG FOR ASSESSMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19805156 ↗MalfunctionJun 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THE TUBE BROKE DURING PATIENT CARE IN THE ICU.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19527665 ↗MalfunctionJun 7, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
CUSTOMER REPORTS: THE NURSE MET RESISTANCE RIGHT AFTER THE NASAL PASSAGE, AND PULLED THE TUBE BACK OUT AND THEN REALIZED THE WEIGHTS WERE NO LONGER THERE. THE PATIENT WAS NOT INJURED. A KIDNEY, URETER AND BLADDER (KUB) XRAY WAS ORDERED AND OBTAINED AFTER ESCALATING TO THE PHYSICIAN. THE KUB INDICATED THE WEIGHTS WERE IN THE SMALL INTESTINE. THE PHYSICIAN ORDERED ANOTHER KUB FOR THE MORNING AND THERE WAS NO CHANGE IN THE LOCATION OF THE WEIGHTS. THE PATIENT IS CURRENTLY BEING MONITORED CLOSELY WITHOUT ANY SURGICAL INTERVENTION. PER ADDITIONAL INFORMATION RECEIVED ON 06/06/24, THE TUBE WAS REPLACED AND REMOVED AS SOON AS THE NURSE REALIZED THE WEIGHTS WERE MISSING OFF THE END. THERE WERE NO ADDITIONAL INTERVENTIONS REQUIRED. THE PATIENT IS STABLE AND DOING WELL. HE HAS BEEN DOWNGRADED TO INTERMEDIATE CARE. IT IS UNKNOWN IF THE PATIENT HAS PASSED THE WEIGHTS IN THEIR STOOL AT THIS TIME.
Patient problems: Foreign Body In Patient
MAUDE report 19490857 ↗MalfunctionMay 7, 2024Material Separation; Material Separation
THE CUSTOMER REPORTED THAT THE TUBE WAS INSERTED ON APRIL 14TH AND WAS CLOGGED AND NURSE HEARD TUBE BURST WHEN ATTEMPTING TO UNCLOG. THE TUBE WAS BROKEN IN TWO SPOTS. THE SPLIT OCCURRED IN THE MIDDLE OF THE TUBE NOT AT THE WEIGHT OR Y-PORT AND THE WEIGHTED TIP WAS ATTACHED TO THE PIECE. THE TUBE WAS REMOVED IN ONE PIECE, NO ENDOSCOPY WAS REQUIRED. PER CUSTOMER, THE STAFF HAVE STATED THAT THEY THINK THE TUBES THAT ARE BREAKING ARE MORE PLIABLE THAN NORMAL AND SEEM TO BE SOFTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19262188 ↗InjuryMay 7, 2024Material Separation; Material Separation
THE CUSTOMER REPORTED THAT THE PATIENT NG TUBE BROKE INTO TWO PIECES AND PIECE NEEDED TO BE REMOVED FROM INSIDE THE PATIENT SURGICALLY. THE TUBE WAS NOT CLOGGED, THE NURSE HEARD A GURGLING SOUND WHEN DELIVERING MEDS TO PATIENT. THIS IS THE SECOND TIME THIS HAS OCCURRED WITH THIS PATIENT. THIS TUBE WAS INSERTED ON (B)(6) FOLLOWING FIRST INCIDENT AND BROKE AGAIN ON (B)(6). THE STAFF FURTHER STATED THAT THEY THINK THE TUBES THAT ARE BREAKING ARE MORE PLIABLE THAN NORMAL AND SEEM TO BE SOFTER. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE NURSE HEARD A POP AND GURGLING WHEN PUSHING MEDS, FEEDS WERE DISCONTINUED, AND PATIENT EXPIRED SHORTLY AFTER. PER CUSTOMER, CAUSE OF DEATH WAS DUE TO PATIENT'S UNDERLYING CONDITION AND NOT RELATED TO THE NASOGASTRIC TUBE (NGT).
Patient problems: Foreign Body In Patient
MAUDE report 19262174 ↗InjuryMay 7, 2024Material Separation; Material Separation
PER CUSTOMER, THE GASTROINTESTINAL (GI) REPORTED THAT THE KF TUBE HAVE HAD REMOVED VIA SCOPE. THE TUBE WAS INSERTED ON APRIL 10TH. IT WAS IDENTIFIED AS A PROBLEM AND THE PROXIMAL PIECE REMOVED ON APRIL 19TH. THE DISTAL PIECE WAS REMOVED VIA SCOPE ON APRIL 20TH. IN ADDITION TO AN UNNECESSARY PROCEDURE, THE PATIENT ALSO WENT APPROXIMATELY 24 HOURS WITHOUT FEEDS AND MISSED MEDICATIONS. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE TUBE BURST INTO TWO PIECES. THE SPLIT OCCURRED IN THE MIDDLE OF THE TUBE NOT AT THE WEIGHT OR Y-PORT. THE WEIGHT WAS STILL ATTACHED. THE DISTAL PIECE REFERS TO THE PIECE OF THE TUBE THAT WAS REMAINING IN THE PATIENT AND THE WEIGHTED TIP WAS ATTACHED TO THIS PIECE. THE DISTAL PIECE WAS REMOVED VIA ENDOSCOPY PROCEDURE. THE STAFF FURTHER STATED THAT THEY THINK THE TUBES THAT ARE BREAKING ARE MORE PLIABLE THAN NORMAL AND SEEM TO BE SOFTER.
Patient problems: Foreign Body In Patient
MAUDE report 19261945 ↗MalfunctionFeb 22, 2024Break; Break
THE CUSTOMER REPORTED THAT THE FEEDING TUBE BURST. PER ADDITIONAL INFORMATION RECEIVED, THE TUBE SPLIT IN TO TWO PIECES. THEY REMOVED THE REMAINING PORTION AND A NEW TUBE WAS PLACED. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18757473 ↗InjuryDec 28, 2023Material Separation; Material Separation
THE CUSTOMER REPORTED THROUGH MEDWATCH THAT A RETAINED FOREIGN OBJECT WAS FOUND AND COLLECTED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD)/COLONOSCOPY PERFORMED TO RULE OUT A GASTROINTESTINAL BLEED. THE DISTAL 10CM OF A NASOENTERIC TUBE WAS FOUND IN THE GASTRIC FUNDUS. GIVEN NECESSITY FOR REMOVAL OF FOREIGN BODY, THE PATIENT WAS INTUBATED FOR AIRWAY PROTECTION. AFTER INTUBATION, AN ENDOSCOPE WAS REINTRODUCED AND USING A COLD SNARE, THE FEEDING TUBE FRAGMENT WAS SUCCESSFULLY RETRIEVED. ENDOSCOPE ONCE MORE REINSERTED AND NO EVIDENCE OF ANY MUCOSAL INJURY FROM RETRIEVAL WAS NOTED. THE EXAMINED DUODENUM WAS NORMAL. UNFORTUNATELY, THE TUBE WAS NOT SAVED¿IT WAS DISCARDED. ROOT CAUSE ANALYSIS OF EVENT: DURING THE HOSPITALIZATION OF THE PATIENT, THE NASOGASTRIC (NG) TUBE WAS PULLED OUT MULTIPLE TIMES AND REPLACED. PATIENT HAD PULLED ON THE NG AND THE NG HAD COME OUT A FEW INCHES. THE RN ATTEMPTED TO ADVANCE IT BACK IN WITHOUT COMPLETELY REMOVING THE NG. AFTER THE RN ADVANCED, SHE ORDERED AN X-RAY TO RECHECK PLACEMENT. THE RADIOLOGIST HAD DOCUMENTED FRAGMENT OF DISTAL PORTION OF THE FEEDING TUBE WAS PRESENT WITHIN THE STOMACH, BUT THIS INFORMATION APPARENTLY WAS NOT COMMUNICATED TO THE PATIEN
Patient problems: Foreign Body In Patient
MAUDE report 18408878 ↗InjuryDec 15, 2023Material Separation; Material Separation
THE CUSTOMER REPORTED THE PATIENT'S FEEDING TUBE WAS FOUND 10 CM OUT FROM THE PREVIOUSLY DOCUMENTED POSITION, SO THE TUBE WAS REINSERTED AND AN X-RAY WAS DONE TO CONFIRM THE POSITION. ON THE X-RAY IT WAS FOUND THAT THE FEEDING TUBE HAD FRACTURED IN THE MIDPORTION OF THE TUBE. THE TIP OF THE PROXIMAL TUBE WAS IN THE ESOPHAGUS, AND THE DISTAL HALF OF THE TUBE WAS IN THE STOMACH. THE DISTAL PORTION WAS RETRIEVED FROM THE PATIENT¿S STOMACH.
Patient problems: Foreign Body In Patient
MAUDE report 18333938 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.