Kiwi OmniCupRecalls & reported problems across all models
Clinical Innovations, LLC · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Kiwi OmniCup model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 51
- Deaths reported
- 2
- Injuries reported
- 32
- Recalls
- 2
We found 4 models of Kiwi OmniCup by Clinical Innovations, LLC in the FDA's device registry (GUDID). Together they are named in 51 adverse event reports in the FDA's MAUDE database, received between Sep 18, 2017 and Sep 28, 2026 — classified as 2 deaths, 32 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (23 reports).
2 FDA recall records name at least one of these models by its device identifier, 1 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
Reports received per month, all models
Kiwi OmniCup 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.
- Mar 9, 2026Open, Classified
Due to complaints of device breakage at the traction force gauge to handle joint.
Z-1945-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Aug 6, 2019Terminated
There is a potential for loss of vacuum or failure to generate vacuum when using the firm's fetal vacuum delivery system.
Z-2072-2020 · Root cause: Process control · Recall details · FDA record ↗
Most reported Kiwi OmniCup problems
Device problems
- Insufficient Device Problem Information23
- Material Separation9
- Use of Device Problem8
- Adverse Event Without Identified Device or Use Problem4
- Appropriate Device Problem Term/Code Not Available3
- Device Dislodged or Dislocated2
- Pressure Problem2
- Suction Failure2
Patient problems
- Insufficient Information10
- Fetal Distress6
- Hematoma6
- Pain6
- Distress5
- Laceration(s)5
- Cephalohematoma4
- Anxiety3
Kiwi OmniCup models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Kiwi® OmniCup® VAC-6000MTEExtractor, Vacuum, Fetal1 recall1 death20 reports
- Kiwi® OmniCup® VAC-6000MTExtractor, Vacuum, Fetal1 recall1 death7 reports
- Kiwi® OmniCup® VAC-6000MExtractor, Vacuum, Fetal14 reports
- Kiwi® OmniCup® VAC-6000MEExtractor, Vacuum, Fetal10 reports
Recent Kiwi OmniCup adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Insufficient Device Problem Information
Patient problems: Skin Tears
MAUDE report 50923231 ↗MalfunctionApr 22, 2026Material Separation; Insufficient Device Problem Information
COMPLAINT DESCRIPTION FROM USER IS AS FOLLOWS: "13 APR 2026: UPDATED INFORMATION: "ONE OF THESE BATCHES": 251652, 250956, 251597. "OUTSIDE PAPERWORK WAS DISCARDED AND NOT ABLE TO BE RETRIEVED." INCIDENT DESCRIPTION: BABY WAS DELIVERED AT 41+3 WEEKS FOLLOWING AN UNCOMPLICATED ANTENATAL COURSE. THE BABY WAS BORN IN POOR CONDITION AFTER FETAL BRADYCARDIA AND A PROLONGED INSTRUMENTAL DELIVERY DUE TO A SNAPPED KIWI, MEETING CRITERIA A AND B FOR THERAPEUTIC HYPOTHERMIA. SHE WAS INTUBATED AND VENTILATED SHORTLY AFTER BIRTH, TRANSFERRED TO HEARTLANDS HOSPITAL, BIRMINGHAM FOR COOLING ON DAY OF BIRTH, AND REPATRIATED TO KMH ON (B)(6) 2026. THERAPEUTIC HYPOTHERMIA WAS COMPLETED, AND SHE WAS REWARMED ON 20/03. SHE REQUIRED MECHANICAL VENTILATION UNTIL 20/03, WHEN SHE WAS SUCCESSFULLY EXTUBATED. SINCE THEN, SHE HAS BEEN SELF-VENTILATING IN AIR. SHE WAS INITIALLY SCREENED FOR SEPSIS; INFECTION MARKERS WERE NORMAL AND BLOOD CULTURES WERE STERILE, SO ANTIBIOTICS WERE DISCONTINUED. SHE HAS REMAINED CLINICALLY STABLE WITH NORMAL NEUROLOGICAL EXAMINATIONS. MRI PERFORMED SHOWED RESTRICTED DIFFUSION OF THE INTERNAL CAPSULE CONSISTENT WITH MODERATE TO SEVERE HIE. IT IS LIKELY THAT SHE MAY DEVELOP CEREBR
Patient problems: Distress; Fetal Distress
MAUDE report 24954557 ↗MalfunctionMar 12, 2026Material Separation
TRANSLATED FROM FRENCH USING GOOGLE TRANSLATE: "THIS IS A FOLLOW-UP TO OUR TELEPHONE CONVERSATION YESTERDAY WITH (B)(6) REGARDING A MEDICAL DEVICE VIGILANCE REPORT CONCERNING KIWI OMNICUP TRACTION FORCE DEVICES AT THE (B)(6) HOSPITAL. THE DEVICE IN QUESTION IS THE KIWI OMNICUP TRACTION FORCE VAC-6000MTE, BATCH NUMBER 251652. WE HAVE OBSERVED THAT THE TRACTION INDICATOR CARTRIDGE DETACHES FROM THE VACUUM EXTRACTOR HANDLE DURING USE, BOTH DURING VAGINAL DELIVERIES AND CESAREAN SECTIONS. THIS MALFUNCTION HAS RESULTED IN INJURIES TO NEWBORNS, DOCUMENTED IN AT LEAST FOUR SEPARATE INCIDENTS, REPORTED BY AT LEAST TWO OBSTETRICIANS AT OUR FACILITY. TO DATE, A TOTAL OF 75 DEVICES FROM THIS BATCH HAVE BEEN IDENTIFIED AND IMMEDIATELY PLACED IN QUARANTINE. FURTHERMORE, OBSTETRICIANS ARE NOW REFUSING TO USE THIS DEVICE AND ARE TURNING TO ALTERNATIVE SOLUTIONS, SUCH AS SPATULAS OR FORCEPS, TO ENSURE PATIENT SAFETY. WE REQUEST THE IMMEDIATE RECALL OF THIS BATCH AND ITS REPLACEMENT WITH COMPLIANT DEVICES TO ENSURE CONTINUITY OF CARE UNDER OPTIMAL SAFETY CONDITIONS. THANK YOU IN ADVANCE FOR KEEPING US INFORMED OF ANY DEVELOPMENTS IN THIS MATTER. SINCE THE CHANGE IN MEDICAL DEVICES, THE INSERTION OF
Patient problems: Insufficient Information
MAUDE report 24586233 ↗MalfunctionMar 12, 2026Material Separation
TRANSLATED FROM FRENCH USING GOOGLE TRANSLATE: "THIS IS A FOLLOW-UP TO OUR TELEPHONE CONVERSATION YESTERDAY WITH (B)(6) REGARDING A MEDICAL DEVICE VIGILANCE REPORT CONCERNING KIWI OMNICUP TRACTION FORCE DEVICES AT THE (B)(6) HOSPITAL. THE DEVICE IN QUESTION IS THE KIWI OMNICUP TRACTION FORCE VAC-6000MTE, BATCH NUMBER 251652. WE HAVE OBSERVED THAT THE TRACTION INDICATOR CARTRIDGE DETACHES FROM THE VACUUM EXTRACTOR HANDLE DURING USE, BOTH DURING VAGINAL DELIVERIES AND CESAREAN SECTIONS. THIS MALFUNCTION HAS RESULTED IN INJURIES TO NEWBORNS, DOCUMENTED IN AT LEAST FOUR SEPARATE INCIDENTS, REPORTED BY AT LEAST TWO OBSTETRICIANS AT OUR FACILITY. TO DATE, A TOTAL OF 75 DEVICES FROM THIS BATCH HAVE BEEN IDENTIFIED AND IMMEDIATELY PLACED IN QUARANTINE. FURTHERMORE, OBSTETRICIANS ARE NOW REFUSING TO USE THIS DEVICE AND ARE TURNING TO ALTERNATIVE SOLUTIONS, SUCH AS SPATULAS OR FORCEPS, TO ENSURE PATIENT SAFETY. WE REQUEST THE IMMEDIATE RECALL OF THIS BATCH AND ITS REPLACEMENT WITH COMPLIANT DEVICES TO ENSURE CONTINUITY OF CARE UNDER OPTIMAL SAFETY CONDITIONS. THANK YOU IN ADVANCE FOR KEEPING US INFORMED OF ANY DEVELOPMENTS IN THIS MATTER. SINCE THE CHANGE IN MEDICAL DEVICES, THE INSERTION OF
Patient problems: Insufficient Information
MAUDE report 24580751 ↗MalfunctionMar 12, 2026Material Separation
TRANSLATED FROM FRENCH USING GOOGLE TRANSLATE: "DESCRIPTION OF THE INCIDENT: OCCURRENCE OF THE INCIDENT; DURING AN INSTRUMENTAL DELIVERY USING A KIWI VACUUM EXTRACTOR DUE TO FAILURE TO PROGRESS AND FETAL HEART RATE ABNORMALITIES, THE DEVICE BROKE. THE INCIDENT OCCURRED 3 TIMES WITH 3 NEW DEVICES, LEADING TO THE MEDICAL DECISION TO USE SUZOR FORCEPS. IMMEDIATE ACTION: REPLACEMENT OF 3 VACUUM EXTRACTORS WITH NEW DEVICES. REPLACEMENT OF THE DEVICE WITH SUZOR FORCEPS. IMMEDIATE APPARENT CONSEQUENCES: FOR PATIENTS: FOR THE MOTHER; PROLONGED DELIVERY WITH INCREASED PAIN, STRESS WITH POST-TRAUMATIC ANXIETY, AND OTHER POTENTIAL RISKS. FOR THE BABY: FETAL DISTRESS IN A NEWBORN ALREADY EXPERIENCING AN ABNORMAL HEART RHYTHM, PROLONGED DELIVERY TIME, WITH POTENTIAL INCREASED PAIN, PROBABLE POST-TRAUMATIC STRESS. FOR HEALTHCARE PROFESSIONALS: INSECURITY, EVENT MANAGEMENT, STRESS, WORKLOAD OVERLOAD. FOR THE FACILITY: ECONOMIC COST DUE TO THE NEED FOR ADDITIONAL EQUIPMENT AND OTHER POTENTIAL CONSEQUENCES ON PATIENT CARE. WE WOULD APPRECIATE IT IF YOU COULD INFORM US WHETHER THIS TYPE OF INCIDENT IS RECURRING OR ISOLATED. ASSURED THAT WE SHARE THIS SAME COMMITMENT TO IMPROVING THE QUALITY AND SAFE
Patient problems: Anxiety; Distress; Fetal Distress; Pain
MAUDE report 24580749 ↗MalfunctionMar 12, 2026Material Separation
TRANSLATED FROM FRENCH USING GOOGLE TRANSLATE: "DESCRIPTION OF THE INCIDENT OCCURRENCE OF THE INCIDENT: DURING AN INSTRUMENTAL DELIVERY USING A KIWI VACUUM EXTRACTOR DUE TO FAILURE TO PROGRESS AND FETAL HEART RATE ABNORMALITIES, THE DEVICE BROKE. THE INCIDENT OCCURRED 3 TIMES WITH 3 NEW DEVICES, LEADING TO THE MEDICAL DECISION TO USE SUZOR FORCEPS. IMMEDIATE ACTION: REPLACEMENT OF 3 VACUUM EXTRACTORS WITH NEW DEVICES. REPLACEMENT OF THE DEVICE WITH SUZOR FORCEPS. IMMEDIATE APPARENT CONSEQUENCES: FOR PATIENTS: FOR THE MOTHER: PROLONGED DELIVERY WITH INCREASED PAIN, STRESS WITH POST-TRAUMATIC ANXIETY, AND OTHER POTENTIAL RISKS. FOR THE BABY: FETAL DISTRESS IN A NEWBORN ALREADY EXPERIENCING AN ABNORMAL HEART RHYTHM, PROLONGED DELIVERY TIME, WITH POTENTIAL INCREASED PAIN, PROBABLE POST-TRAUMATIC STRESS. FOR HEALTHCARE PROFESSIONALS: INSECURITY, EVENT MANAGEMENT, STRESS, WORKLOAD OVERLOAD. FOR THE FACILITY: ECONOMIC COST DUE TO THE NEED FOR ADDITIONAL EQUIPMENT AND OTHER POTENTIAL CONSEQUENCES ON PATIENT CARE. WE WOULD APPRECIATE IT IF YOU COULD INFORM US WHETHER THIS TYPE OF INCIDENT IS RECURRING OR ISOLATED. ASSURED THAT WE SHARE THIS SAME COMMITMENT TO IMPROVING THE QUALITY AND SAFET
Patient problems: Anxiety; Distress; Fetal Distress; Pain
MAUDE report 24579451 ↗MalfunctionMar 12, 2026Material Separation
TRANSLATED FROM FRENCH USING GOOGLE TRANSLATE: "DESCRIPTION OF THE INCIDENT/ OCCURRENCE OF THE INCIDENT: DURING AN INSTRUMENTAL DELIVERY USING A KIWI VACUUM EXTRACTOR DUE TO FAILURE TO PROGRESS AND FETAL HEART RATE ABNORMALITIES, THE DEVICE BROKE. THE INCIDENT OCCURRED 3 TIMES WITH 3 NEW DEVICES, LEADING TO THE MEDICAL DECISION TO USE SUZOR FORCEPS. IMMEDIATE ACTION: REPLACEMENT OF 3 VACUUM EXTRACTORS WITH NEW DEVICES. REPLACEMENT OF THE DEVICE WITH SUZOR FORCEPS. IMMEDIATE APPARENT CONSEQUENCES: FOR PATIENTS: FOR THE MOTHER: PROLONGED DELIVERY WITH INCREASED PAIN, STRESS WITH POST-TRAUMATIC ANXIETY, AND OTHER POTENTIAL RISKS. FOR THE BABY: FETAL DISTRESS IN A NEWBORN ALREADY EXPERIENCING AN ABNORMAL HEART RHYTHM, PROLONGED DELIVERY TIME, WITH POTENTIAL INCREASED PAIN, PROBABLE POST-TRAUMATIC STRESS. FOR HEALTHCARE PROFESSIONALS: INSECURITY, EVENT MANAGEMENT, STRESS, WORKLOAD OVERLOAD. FOR THE FACILITY: ECONOMIC COST DUE TO THE NEED FOR ADDITIONAL EQUIPMENT AND OTHER POTENTIAL CONSEQUENCES ON PATIENT CARE. WE WOULD APPRECIATE IT IF YOU COULD INFORM US WHETHER THIS TYPE OF INCIDENT IS RECURRING OR ISOLATED. ASSURED THAT WE SHARE THIS SAME COMMITMENT TO IMPROVING THE QUALITY AND SAFE
Patient problems: Anxiety; Distress; Fetal Distress; Pain
MAUDE report 24579026 ↗MalfunctionMar 12, 2026Material Separation
TRANSLATED FROM FRENCH USING GOOGLE TRANSLATE: "THIS IS A FOLLOW-UP TO OUR TELEPHONE CONVERSATION YESTERDAY WITH (B)(6) REGARDING A MEDICAL DEVICE VIGILANCE REPORT CONCERNING KIWI OMNICUP TRACTION FORCE DEVICES AT THE (B)(6) HOSPITAL. THE DEVICE IN QUESTION IS THE KIWI OMNICUP TRACTION FORCE VAC-6000MTE, BATCH NUMBER 251652. WE HAVE OBSERVED THAT THE TRACTION INDICATOR CARTRIDGE DETACHES FROM THE VACUUM EXTRACTOR HANDLE DURING USE, BOTH DURING VAGINAL DELIVERIES AND CESAREAN SECTIONS. THIS MALFUNCTION HAS RESULTED IN INJURIES TO NEWBORNS, DOCUMENTED IN AT LEAST FOUR SEPARATE INCIDENTS, REPORTED BY AT LEAST TWO OBSTETRICIANS AT OUR FACILITY. TO DATE, A TOTAL OF (B)(4) DEVICES FROM THIS BATCH HAVE BEEN IDENTIFIED AND IMMEDIATELY PLACED IN QUARANTINE. FURTHERMORE, OBSTETRICIANS ARE NOW REFUSING TO USE THIS DEVICE AND ARE TURNING TO ALTERNATIVE SOLUTIONS, SUCH AS SPATULAS OR FORCEPS, TO ENSURE PATIENT SAFETY. WE REQUEST THE IMMEDIATE RECALL OF THIS BATCH AND ITS REPLACEMENT WITH COMPLIANT DEVICES TO ENSURE CONTINUITY OF CARE UNDER OPTIMAL SAFETY CONDITIONS. THANK YOU IN ADVANCE FOR KEEPING US INFORMED OF ANY DEVELOPMENTS IN THIS MATTER. SINCE THE CHANGE IN MEDICAL DEVICES, THE INSERTIO
Patient problems: Insufficient Information
MAUDE report 24578956 ↗MalfunctionMar 12, 2026Material Separation
TRANSLATED FROM FRENCH USING GOOGLE TRANSLATE: "THIS IS A FOLLOW-UP TO OUR TELEPHONE CONVERSATION YESTERDAY WITH (B)(6) REGARDING A MEDICAL DEVICE VIGILANCE REPORT CONCERNING KIWI OMNICUP TRACTION FORCE DEVICES AT THE (B)(6) HOSPITAL. THE DEVICE IN QUESTION IS THE KIWI OMNICUP TRACTION FORCE VAC-6000MTE, BATCH NUMBER 251652. WE HAVE OBSERVED THAT THE TRACTION INDICATOR CARTRIDGE DETACHES FROM THE VACUUM EXTRACTOR HANDLE DURING USE, BOTH DURING VAGINAL DELIVERIES AND CESAREAN SECTIONS. THIS MALFUNCTION HAS RESULTED IN INJURIES TO NEWBORNS, DOCUMENTED IN AT LEAST FOUR SEPARATE INCIDENTS, REPORTED BY AT LEAST TWO OBSTETRICIANS AT OUR FACILITY. TO DATE, A TOTAL OF (B)(4) DEVICES FROM THIS BATCH HAVE BEEN IDENTIFIED AND IMMEDIATELY PLACED IN QUARANTINE. FURTHERMORE, OBSTETRICIANS ARE NOW REFUSING TO USE THIS DEVICE AND ARE TURNING TO ALTERNATIVE SOLUTIONS, SUCH AS SPATULAS OR FORCEPS, TO ENSURE PATIENT SAFETY. WE REQUEST THE IMMEDIATE RECALL OF THIS BATCH AND ITS REPLACEMENT WITH COMPLIANT DEVICES TO ENSURE CONTINUITY OF CARE UNDER OPTIMAL SAFETY CONDITIONS. THANK YOU IN ADVANCE FOR KEEPING US INFORMED OF ANY DEVELOPMENTS IN THIS MATTER. SINCE THE CHANGE IN MEDICAL DEVICES, THE INSERTIO
Patient problems: Insufficient Information
MAUDE report 24578954 ↗MalfunctionNov 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
DESCRIPTION OF INCIDENT: MALFUNCTION DURING THE REMOVAL OF THE KIWI SUCTION CUP FROM THE NEWBORN'S OCCIPUT. THE REMOVAL BUTTON ON THE HANDLE WAS STUCK. IT WAS IMPOSSIBLE TO UNBLOCK IT AND CREATE THE NECESSARY SUCTION TO REMOVE THE CUP. IT WAS NECESSARY TO DISASSEMBLE IT, REMOVING THE SPRING FROM THE HANDLE. THIS CAUSED A DELAY IN REMOVAL, RESULTING IN A SIGNIFICANT CEPHALIC BUMP THAT COULD HAVE CAUSED A SUBCUTANEOUS HEMATOMA. THE BABY'S OCCIPUT WAS PURPLISH (SIGNIFICANT OCCIPITAL HUMP + SMALL HEMATOMA). CURRENT PATIENT CONDITION: SIGNIFICANT OCCIPITAL HUMP THAT MAY HAVE CAUSED A SUBCUTANEOUS HEMATOMA. THE BABY'S OCCIPUT WAS PURPLISH (SIGNIFICANT OCCIPITAL HUMP + SMALL HEMATOMA).
Patient problems: Hematoma
MAUDE report 23511045 ↗MalfunctionNov 4, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
DESCRIPTION OF THE INCIDENT: DURING AN INSTRUMENTAL DELIVERY FOR BRADYCARDIA IN THE BABY, DESPITE EASY PLACEMENT OF THE DEVICE AND ADHESION OF THE SUCTION CUP TO THE BABY'S HEAD, DURING THE MANEUVER PERFORMED BY THE OBSTETRICIAN, THE HANDLE OF THE DEVICE BECAME COMPLETELY DETACHED FROM THE REST OF THE DEVICE, WITH THE SPRINGS EXTERIORIZING AND ONE SUCTION CUP STILL IN PLACE. CURRENT STATE OF THE PATIENT: FOR THE MOTHER: PROLONGATION OF THE EXTRACTION DURATION WITH INCREASED PAIN, STRESS WITH POST-TRAUMATIC ANXIETY, AND OTHER POTENTIAL RISKS. FOR THE BABY: FETAL DISTRESS IN A NEWBORN ALREADY EXPERIENCING BRADYCARDIA DUE TO THE PROLONGED EXTRACTION TIME, INCREASED PAIN DUE TO MULTIPLE VACUUM REPOSITIONINGS REQUIRING UNUSUAL MEDICAL INTERVENTION, PROBABLE POST-TRAUMATIC STRESS. FOR THE OBSTETRIC SURGEON: RISK OF FALLING DURING THE DELIVERY PROCEDURE WITH A RISK OF THE NEWBORN FALLING.
Patient problems: Distress; Fetal Distress; Pain
MAUDE report 23465508 ↗MalfunctionOct 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
INCIDENT DESCRIPTION: OCCURRENCE OF THE INCIDENT: THE VACUUM CUP USED DID NOT FUNCTION PROPERLY: "THE CABLE STRETCHED ABNORMALLY WITHOUT BREAKING, INSTEAD OF PROVIDING THE RESISTANCE TO ALLOW TRACTION." IMMEDIATE ACTION: - REPLACEMENT OF THE DEVICE WITH A NEW ONE: "ATTEMPTED VACUUM CUP PLACEMENT DUE TO FETAL BRADYCARDIA, PREVENTING THE FETAL MOBILE FROM PROGRESSING." CODE RED CAESAREAN SECTION FOR BRADYCARDIA AND INSTRUMENT FAILURE. IMMEDIATE APPARENT CONSEQUENCES: FOR PATIENTS: FOR THE MOTHER, PROLONGED DELIVERY TIME WITH SIGNIFICANT PAIN AND A CODE RED CAESAREAN SECTION. FOR THE BABY: BRADYCARDIA AND POTENTIAL RISK OF FETAL DISTRESS. FOR PROFESSIONALS: EVENT MANAGEMENT - STRESS - WORK OVERLOAD.
Patient problems: Discomfort; Pain
MAUDE report 23370346 ↗MalfunctionNov 22, 2024
WHEN APPLYING THE VACUUM, AND SUCTION WAS ATTEMPTED, THE DEVICE "FELL APART".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20757030 ↗InjuryNov 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
PROLONGED 2ND STAGE. 2 PULLS GIVEN. KIWI CAME OFF BEGINNING OF 2ND PULL. SUBGALEAL HEMATOMA.
Patient problems: Hematoma
MAUDE report 20612399 ↗InjuryNov 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ABRASIONS WERE MADE ON THE ADSORPTION AREA (HEAD) OF THE CHILD.
Patient problems: Abrasion
MAUDE report 20612225 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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