BiPAP System One 60 SeriesRecalls & reported problems across all models

Respironics, Inc. · 40 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 4,599
Deaths reported: 82
Injuries reported: 1,020
Recalls: 0

We found 40 models of BiPAP System One 60 Series by Respironics, Inc. in the FDA's device registry (GUDID). Together they are named in 4,599 adverse event reports in the FDA's MAUDE database, received between Jul 19, 2018 and Sep 30, 2026 — classified as 82 deaths, 1,020 injuries, 3,497 malfunctions.

The most frequently reported specific device problem is “Degraded” (4,553 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. 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

Last 36 months. The most recent month may be incomplete.

Most reported BiPAP System One 60 Series problems

Device problems

Degraded4,553
Contamination386
Overheating of Device114
Adverse Event Without Identified Device or Use Problem28
Material Integrity Problem9
Contamination /Decontamination Problem5
Device Emits Odor5
Device Contamination with Chemical or Other Material4

Patient problems

No Clinical Signs, Symptoms or Conditions2,994
Unspecified Respiratory Problem650
Headache454
Cancer393
Dizziness386
Asthma292
Unspecified Kidney or Urinary Problem269
Eye Irritation205

BiPAP System One 60 Series models

40 models, most reported first. Each model has its own page with its reports, recalls and device details.

BiPAP System One 60 Series BiPAP Auto BiFlex, w/Humid System One 60 Series,US
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
23 deaths1,494 reports
BiPAP System One 60 Series BiPAP Pro BiFlex, w/Humid System One 60 Series, US
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
17 deaths862 reports
BiPAP System One 60 Series BiPAP Auto BiFlex System One 60 Series,US
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
13 deaths610 reports
BiPAP System One 60 Series BiPAP Auto BiFlex, w/HT Humid System One 60 Series, US
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
6 deaths548 reports
BiPAP System One 60 Series BiPAP Pro BiFlex System One 60 Series US
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
4 deaths302 reports
BiPAP System One 60 Series BiPAP Auto, US
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
6 deaths137 reports
BiPAP System One 60 Series BiPAP Pro BiFlex, w/HT Humid System One 60 Series, US
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
3 deaths123 reports
BiPAP System One 60 Series BiPAP Auto, INTL
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
97 reports
BiPAP System One 60 Series BiPAP Pro, US
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
6 deaths95 reports
BiPAP System One 60 Series BiPAP Pro, INTL
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
54 reports
BiPAP System One 60 Series BiPAP Auto BiFlex w/Humidifier, System One 60 Series, AHP
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1 death47 reports
BiPAP System One 60 Series BiPAP Auto Bi-Flex w/HT Humid, BTOOTH Sys One 60 Srs, US
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1 death33 reports
BiPAP System One 60 Series BiPAP Auto BiFlex System One 60 Series INT
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
23 reports
BiPAP System One 60 Series BiPAP Auto BiFlex, System One 60 Series, DE
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
23 reports
BiPAP System One 60 Series BiPAP Auto BiFlex w/H Tube Humid, 60 Series, CA
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1 death22 reports
BiPAP System One 60 Series BiPAP Pro BiFlex with Humidifier, System One 60 Srs, AHP
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
16 reports
BiPAP System One 60 Series BiPAP Pro BiFlex System One 60 Series INT
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
16 reports
BiPAP System One 60 Series BiPAP Auto BiFlex, w/Humid System One 60 Series LA
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
12 reports
BiPAP System One 60 Series BiPAP Auto BiFlex w/Humid, BTooth, SystemOne 60Srs, AHP
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
10 reports
BiPAP System One 60 Series BiPAP Auto BiFlex w/H Tube Humid, St Tube, 60 Srs, CA
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
10 reports
BiPAP System One 60 Series BiPAP Auto, CN
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1 death10 reports
BiPAP System One 60 Series BiPAP Auto BiFlex with Humidifier 60 Series, CA
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
7 reports
BiPAP System One 60 Series BiPAP Auto BiFlex, System One 60 Series, FR
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
7 reports
BiPAP System One 60 Series BiPAP Auto Bi-Flex w/ Humid, BTOOTH Sys One 60 Srs, US
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
6 reports
BiPAP System One 60 Series BiPAP Auto, BR
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
6 reports
BiPAP System One 60 Series BiPAP Pro Bi-Flex w/ Humid, BTOOTH Sys One 60 Srs, US
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
5 reports
BiPAP System One 60 Series BiPAP Pro BiFlex, w/Humid System One 60 Series INT
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
4 reports
BiPAP System One 60 Series BiPAP Auto BiFlex, w/HTD Humid, System One 60 Srs, AHP
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
3 reports
BiPAP System One 60 Series BiPAP Auto BiFlex, System One 60 Series, GB
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
3 reports
BiPAP System One 60 Series BiPAP Auto BiFlex System One 60 Series, AHP
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
2 reports
BiPAP System One 60 Series BiPAP Pro C-Flex+ HTHum,BT,SystemOne, 60Series, US
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
2 reports
BiPAP System One 60 Series BiPAP Pro BiFlex, w/H Tube Humid, 60 Series, CA
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
2 reports
BiPAP System One 60 Series BiPAP Auto BiFlex, System One 60 Series, AU
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1 report
BiPAP System One 60 Series BiPAP Pro BiFlex, System One 60 Series, AHP
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1 report
BiPAP System One 60 Series BiPAP Auto BlueTooth, US
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1 report
BiPAP System One 60 Series BiPAP Auto Bi-Flex, BTOOTH System One 60 Series, US
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1 report
BiPAP System One 60 Series BiPAP Auto BiFlex, 60 Series, CA
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1 report
BiPAP System One 60 Series BiPAP Auto, DE
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1 report
BiPAP System One 60 Series BiPAP Auto, JP
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1 report
BiPAP System One 60 Series BiPAP Pro, BR
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
1 report

Recent BiPAP System One 60 Series adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

MalfunctionSep 30, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954744 ↗
MalfunctionSep 30, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954670 ↗
MalfunctionAug 27, 2026Thermal Decomposition of Device
A BiPAP Auto Bi-Flex device was returned in reference to the voluntary Field Safety Notice / recall notification related to the sound abatement foam in certain CPAP, BiPAP, and mechanical ventilator devices. During the evaluation of the device, the service technician a burnt J9. Additionally, the evaluation of the device data identified unrelated error codes. These error codes are consistent with normal device operation and expected use conditions and are not considered. reportable under medical device reporting requirements. No evidence was identified to suggest that these error codes contributed to or caused the reported event. The device was scrapped by the service center after the evaluation was completed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50476859 ↗
MalfunctionJul 27, 2026Thermal Decomposition of Device; Degraded
A BiPAP Auto BiFlex device was returned in reference to the voluntary Field Safety Notice / recall notification related to the sound abatement foam in certain CPAP, BiPAP, and mechanical ventilator devices. There was no report of serious patient harm or injury. There was no report of medical intervention. During the evaluation of the device at the third-party service center, the device was visually inspected and found a burned connector. The device was forwarded to the PIL for further investigation. During the evaluation, PIL observed black substance, consistent with sound abatement foam degradation observed on the outside bottom of the blower box and was stuck to it, tiny black pieces of a black substance, consistent with sound abatement foam degradation, were found on the bottom of the enclosure and PIL was able to confirm the presence of degraded sound abatement foam. Dust-like contamination was observed at the air inlet, on the PCA, in the blower box and throughout the inside enclosure. Also, J9 thermal event was observed at humidifier connector.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50003779 ↗
MalfunctionJul 17, 2026Thermal Decomposition of Device
A BIPAP AUTO BIFLEX DEVICE WAS RETURNED TO A SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. DURING THE EVALUATION OF THE DEVICE AT THE SERVICE CENTER, THE UNIT WAS VISUALLY INSPECTED, AND A BURNT CONNECTOR WAS IDENTIFIED. BASED ON THE EVALUATION FINDINGS, THE DEVICE WAS FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25861006 ↗
MalfunctionJul 17, 2026Thermal Decomposition of Device
A BIPAP PRO BIFLEX AUTO DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. DURING THE EVALUATION OF THE THIRD-PARTY SERVICE CENTER NOTED AND OBSERVED A "BURNT CONNECTOR" WAS FOUND. DEVICE CAME IN WITH EVIDENCE OF THERMAL EVENT. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25860988 ↗
MalfunctionJun 30, 2026Degraded
THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP/ BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING BLACK PARTICLES BLOWING OUT OF THE DEVICE AND ALLEGED COUGH. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE DEVICE WAS RETURNED TO THIRD PARTY SERVICE CENTER AND EVALUATED. EVALUATION RESULT STATED THAT FOAM PARTICLES WERE NOT OBSERVED. THE DEVICE HAS BEEN SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25670759 ↗
MalfunctionJun 30, 2026Degraded
A BIPAP PRO BI-FLEX WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE AS PART OF THE SOUND ABATEMENT FOAM RECALL PROCESS. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM PARTICLES. ADDITIONALLY, UNRELATED TO THE REPORTABLE MALFUNCTION, THE TECHNICIAN OBSERVED CORROSION, WATER RESIDUE, MISSING KNOB AND THE EVALUATION OF THE DEVICE DATA IDENTIFIED UNRELATED ERROR CODES. THESE ERROR CODES ARE CONSISTENT WITH NORMAL DEVICE OPERATION AND EXPECTED USE CONDITIONS AND ARE NOT CONSIDERED REPORTABLE UNDER MEDICAL DEVICE REPORTING REQUIREMENTS. NO EVIDENCE WAS IDENTIFIED TO SUGGEST THAT THESE ERROR CODES CONTRIBUTED TO OR CAUSED THE REPORTED EVENT. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25668233 ↗
MalfunctionJun 30, 2026Degraded
A BIPAP AUTO BIFLEX WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE AS PART OF THE SOUND ABATEMENT FOAM RECALL PROCESS. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM PARTICLES. ADDITIONALLY, UNRELATED TO THE REPORTABLE MALFUNCTION, THE TECHNICIAN OBSERVED CORROSION AND SD CARD SLOT IS UNRESPONSIVE. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25662328 ↗
MalfunctionJun 29, 2026Degraded
THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. A BIPAP AUTO DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER THE DEVICE WAS VISUALLY INSPECTED, AND EVIDENCE OF FOAM DEGRADATION WAS FOUND INSIDE THE BLOWER KIT. MOREOVER, THE DEVICE HAD UNIDENTIFIED ERROR CODES. IN ADDITION, THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25655358 ↗
MalfunctionJun 29, 2026Degraded
THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. A BIPAP PRO BIFLEX DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF VISIBLE FOAM PARTICLES. ADDITIONALLY, THE EVALUATION OF THE DEVICE DATA IDENTIFIED UNRELATED ERROR CODES. THESE ERROR CODES ARE CONSISTENT WITH NORMAL DEVICE OPERATION AND EXPECTED USE CONDITIONS AND ARE NOT CONSIDERED REPORTABLE UNDER MEDICAL DEVICE REPORTING REQUIREMENTS. NO EVIDENCE WAS IDENTIFIED TO SUGGEST THAT THESE ERROR CODES CONTRIBUTED TO OR CAUSED THE REPORTED EVENT. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25654316 ↗
MalfunctionJun 26, 2026Degraded
THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. A BIPAP AUTO BIFLEX DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF VISIBLE FOAM PARTICLES. ADDITIONALLY, THE EVALUATION OF THE DEVICE DATA IDENTIFIED UNRELATED ERROR CODES. THESE ERROR CODES ARE CONSISTENT WITH NORMAL DEVICE OPERATION AND EXPECTED USE CONDITIONS AND ARE NOT CONSIDERED REPORTABLE UNDER MEDICAL DEVICE REPORTING REQUIREMENTS. NO EVIDENCE WAS IDENTIFIED TO SUGGEST THAT THESE ERROR CODES CONTRIBUTED TO OR CAUSED THE REPORTED EVENT. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25642678 ↗
MalfunctionJun 26, 2026Degraded
THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. A BIPAP AUTO BIFLEX DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED, AND EVIDENCE OF FOAM PARTICLES WAS FOUND. ADDITIONALLY, THE EVALUATION OF THE DEVICE DATA IDENTIFIED UNRELATED ERROR CODES. THESE ERROR CODES ARE CONSISTENT WITH NORMAL DEVICE OPERATION AND EXPECTED USE CONDITIONS AND ARE NOT CONSIDERED REPORTABLE UNDER MEDICAL DEVICE REPORTING REQUIREMENTS. NO EVIDENCE WAS IDENTIFIED TO SUGGEST THAT THESE ERROR CODES CONTRIBUTED TO OR CAUSED THE REPORTED EVENT. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25641760 ↗
MalfunctionJun 26, 2026Degraded
A BIPAP AUTO BIFLEX DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE AS PART OF THE SOUND ABATEMENT FOAM RECALL PROCESS. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED, AND EVIDENCE OF FOAM DEGRADATION WAS FOUND. ADDITIONALLY, THE EVALUATION OF THE DEVICE DATA IDENTIFIED UNRELATED ERROR CODES. THESE ERROR CODES ARE CONSISTENT WITH NORMAL DEVICE OPERATION AND EXPECTED USE CONDITIONS AND ARE NOT CONSIDERED REPORTABLE UNDER MEDICAL DEVICE REPORTING REQUIREMENTS. NO EVIDENCE WAS IDENTIFIED TO SUGGEST THAT THESE ERROR CODES CONTRIBUTED TO OR CAUSED THE REPORTED EVENT. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25641054 ↗
MalfunctionJun 26, 2026Degraded
A BIPAP PRO DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY, AND NO MEDICAL INTERVENTION WAS REPORTED. DURING EVALUATION AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED, AND EVIDENCE OF FOAM DEGRADATION WAS IDENTIFIED. EVALUATION OF THE DEVICE DATA ALSO IDENTIFIED UNRELATED ERROR CODES. THESE ERROR CODES WERE CONSISTENT WITH NORMAL DEVICE OPERATION AND EXPECTED USE CONDITIONS AND WERE NOT CONSIDERED REPORTABLE UNDER MEDICAL DEVICE REPORTING REQUIREMENTS. NO EVIDENCE WAS IDENTIFIED TO SUGGEST THAT THE ERROR CODES CONTRIBUTED TO OR CAUSED THE REPORTED EVENT. FOLLOWING COMPLETION OF THE EVALUATION, THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25639745 ↗

Other Respironics, Inc. products

All Respironics, Inc. 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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