OneTouch Ultra BlueRecalls & reported problems across all models
LifeScan U.S. LLC · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one OneTouch Ultra Blue model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls
- 2
We found 3 models of OneTouch Ultra Blue by LifeScan U.S. LLC in the FDA's device registry (GUDID). Together they are named in 11 adverse event reports in the FDA's MAUDE database, received between Jan 7, 2017 and Aug 11, 2022 — classified as 9 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (4 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
OneTouch Ultra Blue 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 16, 2021Open, Classified
Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Z-1938-2021 · Root cause: Environmental control · Recall details · FDA record ↗
- Mar 16, 2021Open, Classified
Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Z-1936-2021 · Root cause: Environmental control · Recall details · FDA record ↗
Most reported OneTouch Ultra Blue problems
Device problems
- Peeled/Delaminated4
- Appropriate Device Problem Term/Code Not Available3
- Bent2
- Defective Component1
- Physical Resistance/Sticking1
Patient problems
- Fatigue4
- Headache3
- Shaking/Tremors3
- Hyperglycemia2
- Nausea2
- No Consequences Or Impact To Patient2
- Sweating2
- Anxiety1
OneTouch Ultra Blue models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- OneTouch Ultra Blue 022-895GLUCOSE OXIDASE, GLUCOSE1 recall7 reports
- OneTouch Ultra Blue 020-994GLUCOSE OXIDASE, GLUCOSE1 recall2 reports
- OneTouch Ultra Blue 022-896GLUCOSE OXIDASE, GLUCOSE2 reports
Recent OneTouch Ultra Blue adverse event reports
The 11 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 11, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ON (B)(6) 2022, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONE TOUCH ULTRA TEST TRIPS WERE ¿MESSED UP¿ AND ¿DIDN T REGISTER¿. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION AND ON ADDITIONAL INFORMATION OBTAINED DURING A FOLLOW-UP CALL WITH THE PATIENT. THE PATIENT DID NOT REPORT WHEN THE ALLEGED STRIP ISSUE STARTED. DURING THE FOLLOW-UP CALL THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH AN INSULIN PUMP AND PILLS (TYPE AND DOSE UNSPECIFIED) AND INDICATED THAT SHE DID NOT MADE ANY CHANGES TO HER DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT INFORMED THE AGENT THAT DUE TO THE ALLEGED STRIP ISSUE HER BLOOD SUGAR LEVELS WENT UP TO 500 MG/DL FOR THREE DAYS. DURING THE FOLLOW-UP CALL THE PATIENT CONFIRMED THAT SHE WAS ABLE TO RECEIVE THESE READINGS WITH THE SUBJECT TEST STRIPS. THE PATIENT DID NOT REPORT ANY SYMPTOMS AND DENIED RECEIVING ANY MEDICAL TREATMENT DUE TO THE ALLEGED ISSUE. THE CCA WAS NOT ABLE TO TROUBLESHOOT THE PROBLEM DURING THE INITIAL CALL AND THE PATIENT WAS UNABLE TO READ THE LOT NUMBER. REPLACEMENT TEST STRIPS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECA
Patient problems: Hyperglycemia
MAUDE report 15214728 ↗InjuryAug 11, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ON (B)(6) 2022, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONETOUCH ULTRA TEST TRIPS WERE ¿MESSED UP¿ AND ¿DIDN¿T REGISTER¿. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION AND ON ADDITIONAL INFORMATION OBTAINED DURING A FOLLOW-UP CALL WITH THE PATIENT. THE PATIENT DID NOT REPORT WHEN THE ALLEGED STRIP ISSUE STARTED. DURING THE FOLLOW-UP CALL THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH AN INSULIN PUMP AND PILLS (TYPE AND DOSE UNSPECIFIED) AND INDICATED THAT SHE DID NOT MADE ANY CHANGES TO HER DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT INFORMED THE AGENT THAT DUE TO THE ALLEGED STRIP ISSUE HER BLOOD SUGAR LEVELS WENT UP TO 500 MG/DL FOR THREE DAYS. DURING THE FOLLOW-UP CALL THE PATIENT CONFIRMED THAT SHE WAS ABLE TO RECEIVE THESE READINGS WITH THE SUBJECT TEST STRIPS. THE PATIENT DID NOT REPORT ANY SYMPTOMS AND DENIED RECEIVING ANY MEDICAL TREATMENT DUE TO THE ALLEGED ISSUE. THE CCA WAS NOT ABLE TO TROUBLESHOOT THE PROBLEM DURING THE INITIAL CALL AND THE PATIENT WAS UNABLE TO READ THE LOT NUMBER. REPLACEMENT TEST STRIPS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAU
Patient problems: Hyperglycemia
MAUDE report 15214727 ↗MalfunctionAug 26, 2019Physical Resistance/Sticking; Physical Resistance/Sticking
THE LAY USER/PATIENTS TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS FAILED TESTING. THE TEST STRIPS APPEAR TO HAVE BEEN CONTAMINATED WITH EXCESS ADHESIVE. COMPLAINTS RELATING TO THE REPORTED PRODUCT(S) WERE EVALUATED. IT WAS CONCLUDED THAT THE NUMBER OF COMPLAINTS FOR THE PRODUCT(S) DID NOT BREACH THRESHOLDS INDICATIVE OF A SYSTEMIC ISSUE. ON (B)(6) 2018, THE LAY USER/PATIENT CONTACTED LIFESCAN USA, ALLEGING THAT THE SUBJECT OT ULTRA BLUE TEST STRIPS WERE STICKING TOGETHER. THIS COMPLAINT WAS INITIALLY RULED OUT BECAUSE DURING CUSTOMER SERVICES TROUBLESHOOTING, THERE WAS NO INDICATION TO REASONABLY SUGGEST THAT THE PRODUCT MALFUNCTIONED AND THERE WAS ALSO NO ALLEGATION OF AN ADVERSE EVENT AS A RESULT OF THE REPORTED ISSUE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8929425 ↗InjuryJul 15, 2019Peeled/Delaminated; Peeled/Delaminated
ON (B)(6) 2019, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HIS ONETOUCH ULTRA BLUE TEST STRIPS WERE PEELING AND STICKING TOGETHER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION OF THE CALL. THE PATIENT REPORTED THAT THE TEST STRIPS WERE PEELING AND STICKING TOGETHER AROUND 9-10 AM ON (B)(6) 2019. THE PATIENT MANAGES HIS DIABETES WITH HUMULIN INSULIN (NO ADJUSTMENTS). HE INDICATED THAT BECAUSE HE WAS UNABLE TO OBTAIN A READING, HE ATE SUGAR TO INCREASE HIS BLOOD GLUCOSE LEVEL ABOUT 30-45 MINUTES LATER. HE REPORTED THAT ABOUT AN HOUR LATER, HE FELT SYMPTOMS OF "NAUSEA, FATIGUE, SHAKING AND ANXIETY". HE DENIED RECEIVING ANY TREATMENT FOR HIS SYMPTOMS ABOVE OR BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT ALLEGED ISSUE OCCURRED BEFORE INSERTING THE STRIP INTO THE METER AND MORE THAN ONE TEST STRIP FROM THE VIAL WAS AFFECTED. THE ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT, AFTER THE ALLEGED ISSUE WITH PEELING
Patient problems: Anxiety; Fatigue; Nausea; Shaking/Tremors
MAUDE report 8789109 ↗InjuryJul 15, 2019Peeled/Delaminated; Peeled/Delaminated
ON (B)(6) 2019, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HIS ONETOUCH ULTRA BLUE TEST STRIPS WERE PEELING AND STICKING TOGETHER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION OF THE CALL. THE PATIENT REPORTED THAT THE TEST STRIPS WERE PEELING AND STICKING TOGETHER AROUND 9-10 AM ON (B)(6) 2019. THE PATIENT MANAGES HIS DIABETES WITH HUMULIN INSULIN (NO ADJUSTMENTS). HE INDICATED THAT BECAUSE HE WAS UNABLE TO OBTAIN A READING, HE ATE SUGAR TO INCREASE HIS BLOOD GLUCOSE LEVEL ABOUT 30-45 MINUTES LATER. HE REPORTED THAT ABOUT AN HOUR LATER, HE FELT SYMPTOMS OF ¿NAUSEA, FATIGUE, SHAKING AND ANXIETY¿. HE DENIED RECEIVING ANY TREATMENT FOR HIS SYMPTOMS ABOVE OR BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT ALLEGED ISSUE OCCURRED BEFORE INSERTING THE STRIP INTO THE METER AND MORE THAN ONE TEST STRIP FROM THE VIAL WAS AFFECTED. THE ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT, AFTER THE ALLEGED ISSUE WITH PEELING
Patient problems: Fatigue; Nausea; Shaking/Tremors
MAUDE report 8788399 ↗MalfunctionJun 17, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
DEVICE EVALUATION: THE LAY USER/PATIENTS TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS FAILED TESTING; THE REPORTED ISSUE WAS CONFIRMED. THE TEST STRIPS WERE FOUND TO HAVE SCRAP TOP TAPE OVER THE ELECTRODES. ON (B)(6) 2019, THE REPORTER CONTACTED LIFESCAN USA ALLEGING THAT ¿SOME¿ OF THE PATIENT¿S ONETOUCH ULTRA TEST STRIPS DIDN'T ¿HAVE BLACK AND WHITE STRIPS ON THE STRIP, ONLY BLUE LABEL¿. THIS COMPLAINT WAS INITIALLY RULED OUR BECAUSE INFORMATION OBTAINED DURING THE INITIAL CALL DID NOT REASONABLY SUGGEST A MALFUNCTION HAD OCCURRED. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT AS A RESULT OF THE REPORTED ISSUE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8702771 ↗InjuryJan 26, 2018Defective Component; Defective Component
ON (B)(6) 2018, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING AN ISSUE WITH HER ONETOUCH ULTRA TEST STRIP VIAL. THE PATIENT CLAIMED THAT THE VIAL INSIDE A SEALED CONTAINER WAS OPEN. THE COMPLAINT WAS CLASSIFIED BASED ON FURTHER INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST AFTER REVIEWING THE CALL RECORDING SINCE THE PATIENT WAS UNABLE TO BE CONTACTED BY PHONE FOR ADDITIONAL INFORMATION. THE PATIENT REPORTED THAT SHE BECAME AWARE OF THE ALLEGED OPEN VIAL ON (B)(6) 2018 AT 8:00 AM. THE PATIENT INFORMED THE CSR THAT SHE MANAGES HER DIABETES WITH A COMBINATION OF ORAL MEDICATION (METFORMIN) AND INSULIN (HUMULIN). THE PATIENT DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN WHEN SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE ALLEGED ISSUE. DURING THE CALL, THE PATIENT REPORTED DEVELOPING ¿LOW BLOOD SUGAR¿ AS A RESULT OF THE ALLEGED ISSUE. THE PATIENT CLAIMED SHE PROCEEDED TO THE URGENT CARE CLINIC ON (B)(6) 2018 AT 10:00 AM WHERE HER BLOOD GLUCOSE WAS MEASURED AT ¿48 MG/DL¿ ON THE CLINIC DEVICE. DURING THE CALL, THE PATIENT CLAIMED SHE RECEIVED UNSPECIFIED TREATMENT AND WAS REPORTEDLY ADVISED TO INCREASE HER DAILY DOSE OF METFORMIN MED
Patient problems: Hypoglycemia
MAUDE report 7220952 ↗InjuryNov 3, 2017Bent; Bent
ON (B)(6) 2017 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING AN ISSUE WITH HER ONETOUCH ULTRA BLUE TEST STRIPS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION AND ADDITIONAL INFORMATION OBTAINED WHEN THE MEDICAL SURVEILLANCE SPECIALIST LISTENED AGAIN TO THE CALL RECORDING. THE PATIENT STATED THAT THE ALLEGED ISSUE BEGAN AROUND 1 MONTH AGO, HOWEVER COULD NOT REMEMBER THE SPECIFIC DATE OR TIME WHEN SHE NOTED THAT APPROXIMATELY HALF OF THE TEST STRIPS WERE BENT IN THE VIAL SHE RECEIVED FROM THE PHARMACY. THE PATIENT MANAGES HER DIABETES USING LANTUS INSULIN (SELF-ADJUSTS) AND SHE REPORTEDLY DECREASED HER FOOD/DRINK CONSUMPTION AND TOOK INSULIN AT THE TIME THE PRODUCT ISSUE OCCURRED. THE PATIENT CLAIMED EXPERIENCING SYMPTOMS OF ¿SHAKING, DIZZY AND LIGHT-HEADED¿ AN UNSPECIFIED AMOUNT OF TIME AFTER THE ALLEGED ISSUE BEGAN, AND REPORTEDLY VISITED THE HOSPITAL WHERE SHE RECEIVED HCP TREATMENT OF ¿SWEET FOOD AND APPLE JUICE¿ IN RESPONSE TO THE REPORTED ISSUE. THE PATIENT CONFIRMED THAT HER BLOOD GLUCOSE WAS NOT MEASURED USING ANY OTHER DEVICE AT THE TIME. THE CSR WAS UNABLE TO RESOLVE THE ISSUE DURING TROUBLESHOOTING. REPLACEMENT PROD
Patient problems: Dizziness; Shaking/Tremors
MAUDE report 6998549 ↗InjurySep 27, 2017Peeled/Delaminated; Peeled/Delaminated
ON (B)(6) 2017, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA TEST STRIPS WERE PEELING. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT SHE FIRST NOTICED THAT THE TEST STRIPS WERE PEELING AT 7:00PM ON (B)(6) 2017; THE ALLEGED ISSUE OCCURRED WHEN THE TEST STRIPS WAS INSERTED INTO THE TEST STRIP PORT OF THE METER. THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATION, DIET AND/OR EXERCISE. SHE DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED ISSUE. SHE REPORTED THAT ONE DAY AFTER THE ISSUE BEGAN, SHE DEVELOPED SYMPTOMS OF ¿HEADACHE, SWEATING AND TIRED¿. SHE DENIED RECEIVING ANY TREATMENT FOR HER SYMPTOMS ABOVE AND BEYOND HER USUAL DIABETES CARE AND MANAGEMENT ROUTINE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE PATIENT WAS USING THE CORRECT TESTING STEPS. THE ALLEGED ISSUE OCCURRED AFTER INSERTING THE STRIP INTO THE METER. THE CCA WALKED THE PATIENT THROUGH INSERTING A NEW TEST STRIP AND THE ISSUE WAS RESOLVED. REPLACEMENT TEST STRIPS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED
Patient problems: Fatigue; Headache; Sweating
MAUDE report 6896588 ↗InjurySep 19, 2017Peeled/Delaminated; Peeled/Delaminated
ON (B)(6) 2017, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA TEST STRIPS WERE PEELING. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT SHE FIRST NOTICED THAT THE TEST STRIPS WERE PEELING AT 7:00PM ON (B)(6) 2017; THE ALLEGED ISSUE OCCURRED WHEN THE TEST STRIPS WAS INSERTED INTO THE TEST STRIP PORT OF THE METER. THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATION, DIET AND/OR EXERCISE. SHE DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED ISSUE. SHE REPORTED THAT ONE DAY AFTER THE ISSUE BEGAN, SHE DEVELOPED SYMPTOMS OF ¿HEADACHE, SWEATING AND TIRED¿. SHE DENIED RECEIVING ANY TREATMENT FOR HER SYMPTOMS ABOVE AND BEYOND HER USUAL DIABETES CARE AND MANAGEMENT ROUTINE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE PATIENT WAS USING THE CORRECT TESTING STEPS. THE ALLEGED ISSUE OCCURRED AFTER INSERTING THE STRIP INTO THE METER. THE CCA WALKED THE PATIENT THROUGH INSERTING A NEW TEST STRIP AND THE ISSUE WAS RESOLVED. REPLACEMENT TEST STRIPS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED
Patient problems: Fatigue; Headache; Sweating
MAUDE report 6875034 ↗InjuryJan 7, 2017Bent; Bent
ON (B)(6) 2016, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) TO REPORT THAT HIS ONETOUCH ULTRA TEST STRIPS WERE BENT AND PEELING. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ISSUE OCCURRED ¿2 TO 3 WEEKS¿ PRIOR TO CONTACTING LFS. THE PATIENT MANAGES HIS DIABETES BY SELF-ADJUSTING HIS INSULIN DOSES AND INCREASED THE DOSE OF HIS HUMALOG INSULIN BY 1-2 UNITS DURING THE DAY AND HIS LANTUS INSULIN BY 2 UNITS AT NIGHT IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT REPORTED THAT ¿30 MINUTES¿ AFTER THE ALLEGED ISSUE OCCURRED HE DEVELOPED SYMPTOMS OF ¿HEADACHES, BLURRED VISION, BOTHER WITH HIS LEGS AND CHEST PAINS¿ AND STATED THAT ¿A COUPLE OF WEEKS¿ PRIOR TO CONTACTING LFS HE VISITED HIS DOCTOR, WHO ¿REFERRED HIM TO ANOTHER DOCTOR¿. DURING THE CALL THE CCA NOTED THAT MORE THAN ONE STRIP IN THE VIAL WAS AFFECTED AND THEY WERE BENT AND PEELING PRIOR TO INSERTING THE STRIP INTO THE METER. THE PRODUCT WAS REPLACED AND REQUESTED BACK FOR EVALUATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS AND/OR SYMPTOMS THAT MEET LFS¿ CRITERIA FOR A SERIOUS INJURY REPORTABLE ADVERSE EVENT AFTER THE ALLEGE
Patient problems: Blurred Vision; Chest Pain; Headache
MAUDE report 6231579 ↗
Other LifeScan U.S. LLC products
All LifeScan U.S. LLC devices →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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