BD Luer-Lok, BD Glaspak 405671Recalls & reported problems
Becton, Dickinson And Company · TRAY SPN WHIT25G3.5 L/B-D/E PLAST DRAPE · Class 2
All models of BD Luer-Lok, BD Glaspak (16)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This BD Luer-Lok Glaspak tray is a single-use anesthesia kit for nerve blocks and C-sections. Most of its 69 reports describe the bupivacaine in the tray not working well enough to numb the patient, so surgery had to be converted to general anesthesia, along with reports of ascending numbness and slow breathing. There were 24 injuries and no deaths. One open recall, started in April 2026, covers a quality issue with the bupivacaine itself.
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
- 68
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 50382904056716), received between Nov 27, 2017 and Aug 11, 2026 — classified as 23 injuries, 45 malfunctions.
The most frequently reported specific device problem is “Lack of Effect” (29 reports).
1 FDA recall record name this device's 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, 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 18, 2026.
Reports received per month
Recalls naming this device
- Apr 27, 2026Class IOpen, Classified
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
Z-2256-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Lack of Effect29
- Patient-Device Incompatibility21
- Adverse Event Without Identified Device or Use Problem3
- Device Contamination with Chemical or Other Material3
- Device Markings/Labelling Problem3
- Break2
- Leak/Splash2
- Packaging Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions42
- Insufficient Information8
- No Known Impact Or Consequence To Patient7
- No Consequences Or Impact To Patient5
- Awareness During Anesthesia2
- Numbness2
- Pain2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 68 reports, in the reporter's own words as published by the FDA.
InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Numbness; Respiratory Insufficiency
MAUDE report 50208690 ↗InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
EVENT DESCRIPTION: DATE OF EVENT: 8/28/2025. TRAY DID NOT WORK - MEDICATION FAILURE. HB. PATIENT OR END-USER INJURED: N. WHEN WAS INCIDENT NOTICED: AFTER USE. WAS INCIDENT DISCOVERED DURING DIRECT PATIENT CARE: Y. WAS ANY MEDICAL TREATMENT REQUIRED: N. PER CUSTOMER RESPONSE ON (B)(6) 2025: THEY HAD TO CONVERT TO GENERAL ANESTHESIA.
Patient problems: Awareness During Anesthesia
MAUDE report 23087453 ↗InjuryMay 21, 2025Lack of Effect; Lack of Effect
MATERIAL 405671, BATCH 0001608768. IT WAS REPORTED BY CUSTOMER THAT THE MEDICATION IN THE TRAY WAS NOT EFFECTIVE ON SEVERAL CSECTION PATIENTS. THE PATIENT ON MAY 5 WAS NOT CLINICALLY STABLE TO REPEAT NEURAXIAL AND THUS CONVERTED TO GENERAL. VERBATIM: MEDICATION IN THE TRAY WAS NOT EFFECTIVE ON SEVERAL CSECTION PATIENTS. CUSTOMER RESPONSE: CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT? 412, 417, 430, 55. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL IF YES, PLEASE PROVIDE THE DETAILS. NO INJURY, HOWEVER NECESSITATED ADDITIONAL PROCEDURES 1 ADDITIONAL CSE, 1 ADDITIONAL SPINAL, 1 GENERAL ANESTHETIC. COULD YOU PLEASE CONFIRM HOW MANY PATIENTS WERE AFFECTED. 4 PATIENTS. CUSTOMER RESPONSE: THE PATIENT ON MAY 5 WAS NOT CLINICALLY STABLE TO REPEAT NEURAXIAL AND THUS CONVERTED TO GENERAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22064885 ↗InjuryDec 12, 2024Lack of Effect; Lack of Effect
MATERIAL#: 405671, BATCH#: 0001558421 AWARE DATE: 22NOV2024. UPON FOLLOW UP FROM EXISTING COMPLAINT IT WAS REPORTED: ONE ANESTHESIA PHYSICIAN SAID THAT HER PATIENT COULD STILL MOVE HIS LEGS AND WAS SENSITIVE TO TEMPERATURE. A SECOND ANESTHESIOLOGIST SAID THAT HE HAD 3 CASES AND TWO OF THE PATIENTS COULD MOVE THEIR LEGS AND STILL HAD SENSORY FUNCTIONS WHILE THE THIRD PATIENT OF HIS HAD A MINIMAL REDUCTION OF SENSORY FUNCTION. REVERTED TO GENERAL ANESTHESIA. THIS RECORD CAPTURES THE THREE ADDITIONAL PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20913802 ↗InjuryDec 12, 2024Lack of Effect; Lack of Effect
MATERIAL# 405671 BATCH# 0001558421 AWARE DATE: 22NOV2024. UPON FOLLOW UP FROM EXISTING COMPLAINT IT WAS REPORTED: ONE ANESTHESIA PHYSICIAN SAID THAT HER PATIENT COULD STILL MOVE HIS LEGS AND WAS SENSITIVE TO TEMPERATURE. A SECOND ANESTHESIOLOGIST SAID THAT HE HAD 3 CASES AND TWO OF THE PATIENTS COULD MOVE THEIR LEGS AND STILL HAD SENSORY FUNCTIONS WHILE THE THIRD PATIENT OF HIS HAD A MINIMAL REDUCTION OF SENSORY FUNCTION. REVERTED TO GENERAL ANESTHESIA THIS RECORD CAPTURES THE THREE ADDITIONAL PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20913358 ↗InjuryDec 12, 2024Lack of Effect; Lack of Effect
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20913337 ↗InjuryDec 11, 2024Lack of Effect; Lack of Effect
MATERIAL #:405671. BATCH#: 0001562074. VERBATIM: DID NOT PERFORM AS EXPECTED. BUPIVACAINE DID NOT WORK TO NUMB AS IT IS SUPPOSED TO.
Patient problems: Insufficient Information
MAUDE report 20907286 ↗InjuryNov 26, 2024Lack of Effect; Lack of Effect
MATERIAL# 405671 BATCH# 0001558421 IT WAS REPORTED BY CUSTOMER THAT WE HAVE BEEN INFORMED BY OUR ANESTHESIOLOGISTS THAT THE TRAY COMPONENT (MARCAINE AMPULE) IN TRAY LOT# 0001558421 IS NOT PRODUCING THE DESIRED RESULTS. THERE HAVE BEEN 4 INSTANCES OF THIS SAME COMPLAINT, WITH THE FINAL COMPLAINT BEING THIS MORNING. ALL HAVE BEEN FROM THE SAME LOT NUMBER AND WE HAVE 6 MORE TRAYS IN INVENTORY VERBATIM: WE HAVE BEEN INFORMED BY OUR ANESTHESIOLOGISTS THAT THE TRAY COMPONENT (MARCAINE AMPULE) IN TRAY LOT# 0001558421 IS NOT PRODUCING THE DESIRED RESULTS. THERE HAVE BEEN 4 INSTANCES OF THIS SAME COMPLAINT, WITH THE FINAL COMPLAINT BEING THIS MORNING. ALL HAVE BEEN FROM THE SAME LOT NUMBER AND WE HAVE 6 MORE TRAYS IN INVENTORY
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20787547 ↗MalfunctionOct 21, 2024Lack of Effect; Lack of Effect
MATERIAL #: 405671 ; BATCH#: 0001558421. IT WAS REPORTED BY CUSTOMER THAT LOCAL ANESTHETIC POTENCY, DURING ADMINISTRATION THE PRODUCT WAS NOT WORKING ALL THE PRODUCT WAS ADMINISTERED FROM THE VIAL. NONE LEFT. PT HARM: NO. ADDITIONAL INFORMATION: PLEASE SEE BELOW. THIS IS THE EMAIL FROM THE PHYSICIAN. THIS IS ALL THE INFORMATION I HAVE. I'M ONE OF THE ANESTHESIOLOGISTS WORKING IN OB TODAY (B)(6) 2024. WE DID SPINAL FOR C-SECTION TODAY USING BUPIVACAINE FROM THE LOT NUMBER 0001558421. THE SPINAL WAS DONE BY A SRNA STUDENT UNDER MY SUPERVISION. THE SPINAL WAS UNEVENTFUL AND SUCCESSFULLY PLACED. SPINAL FLUID WAS VISUALIZED PRIOR TO DOSING AND AT THE END OF DOSING. HOWEVER, THE PATIENT DID NOT GET A GOOD SPINAL BLOCKADE, AND WE HAD TO REPEAT THE PROCEDURE WITH BUPIVACAINE FROM A DIFFERENT SPINAL KIT FROM A DIFFERENT LOT. THE SECOND SPINAL WAS SUCCESSFUL AND WE WERE ABLE TO DO THE PROCEDURE UNDER SPINAL ANESTHESIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20492921 ↗MalfunctionSep 4, 2024Lack of Effect; Lack of Effect
ADDITIONAL INFORMATION: 09SEP2024, CUSTOMER RESPONDED THERE WAS NO INJURY TO PATIENT OR HEALTHCARE PROVIDER.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20134383 ↗InjuryJul 18, 2024Lack of Effect; Lack of Effect
InjuryJul 18, 2024Lack of Effect; Lack of Effect
MATERIAL # 405671, BATCH # 0001558620, 0001540339. IT WAS REPORTED BY CUSTOMER THAT THEY HAD 2 MORE TRAYS FAIL ON MONDAY 15TH. ONE WAS A TOTAL HIP AND ONE WAS A TOTAL KNEE. THEY BOTH WERE CONVERTED TO A GENERAL.
Patient problems: Insufficient Information
MAUDE report 19771651 ↗MalfunctionJul 17, 2024Lack of Effect; Lack of Effect
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19761912 ↗MalfunctionJul 17, 2024Lack of Effect; Lack of Effect
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19761909 ↗MalfunctionJul 17, 2024Lack of Effect; Lack of Effect
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19761904 ↗InjuryJul 15, 2024Lack of Effect; Lack of Effect
THERE WERE 3 REPORTED EVENTS WITH THE SAME PROVIDED LOT NUMBER OCCURRING. ONE EVENT USED ANOTHER VIAL OF MEDICATION, AND 2 WERE REVERTED TO GENERAL ANESTHESIA. EVENT 2 REQUIRED ANESTHESIA. MATERIAL#:405671. BATCH#: 0001544106. IT WAS REPORTED BY THE CUSTOMER THAT THE MEDICATION IN THE SPINAL TRAY WAS FAILING. CRNA BROUGHT US 3 TRAYS WITH THE SAME LOT NUMBERS THAT ANESTHESIA HAD NOTED TO HAVE FAILED DURING SEVERAL PREVIOUS CASES. VERBATIM: GOOD MORNING (B)(6) AND COMPLAINTS TEAM, PLEASE OPEN A QUALITY COMPLAINT FOR THIS BD PRODUCT AT COREWELL HEALTH. HERE ARE THE RELEVANT EVENT AND PRODUCT DETAILS: EVENT DATE: 6-26-2024. EVENT LOCATION: (B)(6) HOSPITAL, 1 N. ATKINSON. DR. (B)(6), MI 49431. EVENT DESCRIPTION: " IT WAS BROUGHT TO OUR ATTENTION THAT THE MEDICATION IN THE SPINAL TRAY WAS FAILING. CRNA BROUGHT US 3 TRAYS WITH THE SAME LOT NUMBERS THAT ANESTHESIA HAD NOTED TO HAVE FAILED DURING SEVERAL PREVIOUS CASES.¿ HARM TO TEAM MEMBER OR PATIENT? NO INJURY TO MY KNOWLEDGE. PRODUCT NAME: ITM-1138260 BD SPINAL ANESTHESIA TRAY. PRODUCT REF: (B)(4). LOT NUMBER: 0001544106. BD CUSTOMER ACCOUNT NUMBER: 1001031612. I HAVE SEVERAL UNUSED SPINAL TRAYS OF THE SAME PRODUCT CODE AND LOT NUMBER BE
Patient problems: Insufficient Information
MAUDE report 19744272 ↗MalfunctionJul 15, 2024Lack of Effect; Lack of Effect
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19744268 ↗InjuryJul 15, 2024Lack of Effect; Lack of Effect
THERE WERE 3 REPORTED EVENTS WITH THE SAME PROVIDED LOT NUMBER OCCURRING. ONE EVENT USED ANOTHER VIAL OF MEDICATION, AND 2 WERE REVERTED TO GENERAL ANESTHESIA. EVENT 3 REQUIRED ANESTHESIA. MATERIAL#:405671 BATCH#: 0001544106. IT WAS REPORTED BY THE CUSTOMER THAT THE MEDICATION IN THE SPINAL TRAY WAS FAILING. CRNA BROUGHT US 3 TRAYS WITH THE SAME LOT NUMBERS THAT ANESTHESIA HAD NOTED TO HAVE FAILED DURING SEVERAL PREVIOUS CASES. VERBATIM: GOOD MORNING XXXXXXX AND COMPLAINTS TEAM, PLEASE OPEN A QUALITY COMPLAINT FOR THIS BD PRODUCT AT COREWELL HEALTH. HERE ARE THE RELEVANT EVENT AND PRODUCT DETAILS: EVENT DATE: 6-26-2024 EVENT LOCATION: COREWELL HEALTH LUDINGTON HOSPITAL, 1 N. ATKINSON DR., LUDINGTON, MI 49431 EVENT DESCRIPTION: " IT WAS BROUGHT TO OUR ATTENTION THAT THE MEDICATION IN THE SPINAL TRAY WAS FAILING. CRNA BROUGHT US 3 TRAYS WITH THE SAME LOT NUMBERS THAT ANESTHESIA HAD NOTED TO HAVE FAILED DURING SEVERAL PREVIOUS CASES.¿ HARM TO TEAM MEMBER OR PATIENT? NO INJURY TO MY KNOWLEDGE. PRODUCT NAME: ITM-1138260 BD SPINAL ANESTHESIA TRAY. PRODUCT REF: 405671. LOT NUMBER: 0001544106. BD CUSTOMER ACCOUNT NUMBER: 1001031612. I HAVE SEVERAL UNUSED SPINAL TRAYS OF THE SAME PRODUCT CO
Patient problems: Insufficient Information
MAUDE report 19744243 ↗InjuryJul 15, 2024Lack of Effect; Lack of Effect
MATERIAL #: 405671 BATCH#: 0001536091 IT WAS REPORTED BY CUSTOMER THAT THE MEDICATION IN THE TRAY WAS NOT EFFECTIVE ¿ FORCED TO REVERT TO GENERAL ANESTHESIA FOR THE CASE. COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. PLEASE OPEN A QUALITY COMPLAINT FOR THIS BD PRODUCT AT COREWELL HEALTH. HERE ARE THE RELEVANT EVENT AND PRODUCT DETAILS: EVENT DATE: 7-8-2024 EVENT LOCATION: (B)(6) HOSPITAL, (B)(6), EVENT DESCRIPTION: ¿THE MEDICATION IN THE TRAY WAS NOT EFFECTIVE ¿ FORCED TO REVERT TO GENERAL ANESTHESIA FOR THE CASE¿. HARM TO TEAM MEMBER OR PATIENT? NO INJURY TO MY KNOWLEDGE. PRODUCT NAME: ITM-1138260 BD SPINAL ANESTHESIA TRAY PRODUCT REF: 405671. LOT NUMBER: 0001536091. BD CUSTOMER ACCOUNT NUMBER: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19740489 ↗InjuryJul 8, 2024Lack of Effect; Lack of Effect
MATERIAL: 405671. BATCH#: UNKNOWN. IT WAS REPORTED BY THE CUSTOMER THAT WHILE SURGEON WAS MAKING INCISION PATIENT WAS MOVING HER LEG. SURGEON STOPPED AND (B)(6) CONVERTED TO GENERAL. SPINAL KIT WAS A BD LOT NUMBER WAS MORE THAN LIKELY 405671, BUT NOT POSITIVE. MEDICATION IN QUESTION IS BUPIVACAINE 0.75%. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CRNA (CERTIFIED REGISTERED NURSE ANESTHETIST) COMPLETED SPINAL WITHOUT DIFFICULTY. WHILE SURGEON WAS MAKING INCISION PATIENT WAS MOVING HER LEG. SURGEON STOPPED AND (B)(6)CONVERTED TO GENERAL. SPINAL KIT WAS A BD LOT NUMBER WAS MORE THAN LIKELY 405671, BUT NOT POSITIVE. MEDICATION IN QUESTION IS BUPIVACAINE 0.75%..
Patient problems: Twitching
MAUDE report 19689465 ↗MalfunctionJun 7, 2024Lack of Effect; Lack of Effect
MATERIAL# 405671 BATCH# 0001528811 IT WAS REPORTED BY CUSTOMER THAT THEY HAD ISSUE REGARDING ON 405671 SPINAL ANESTHESIA KIT WHICH HAS HYPERBARIC BUPIVACAINE 0.75% PACKAGED WITHIN THE KIT. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CAN I PLEASE REQUEST A PHONE CALL TOMORROW ((B)(6)) FROM THE BD REP WHO COVERS BRIGHAM AND WOMEN¿S HOSPITAL IN BOSTON, AND SPECIFICALLY, THE L&D UNIT /OBSTETRIC ANESTHESIA? I HAVE A SOMEWHAT URGENT ISSUE REGARDING OUR 405671 SPINAL ANESTHESIA KIT WHICH HAS HYPERBARIC BUPIVACAINE 0.75% PACKAGED WITHIN THE KIT. MY CENTER HAS HAD APPROXIMATELY 10 CASES OF FAILED SPINALS IN THE PAST 2 MONTHS AND I¿D LIKE TO UNDERSTAND WHETHER THIS MAY BE ISOLATED TO THIS PARTICULAR LOT (PHOTO BELOW).
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19485168 ↗InjuryJun 7, 2024Lack of Effect; Lack of Effect
MATERIAL# 405671. BATCH# 0001528811. IT WAS REPORTED BY CUSTOMER THAT THEY HAD ISSUE REGARDING ON 405671 SPINAL ANESTHESIA KIT WHICH HAS HYPERBARIC BUPIVACAINE 0.75% PACKAGED WITHIN THE KIT. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CAN I PLEASE REQUEST A PHONE CALL TOMORROW (MONDAY (B)(6) FROM THE BD REP WHO COVERS (B)(6) HOSPITAL, AND SPECIFICALLY, THE L&D UNIT /OBSTETRIC ANESTHESIA? I HAVE A SOMEWHAT URGENT ISSUE REGARDING OUR 405671 SPINAL ANESTHESIA KIT WHICH HAS HYPERBARIC BUPIVACAINE 0.75% PACKAGED WITHIN THE KIT. MY CENTER HAS HAD APPROXIMATELY 10 CASES OF FAILED SPINALS IN THE PAST 2 MONTHS AND I¿D LIKE TO UNDERSTAND WHETHER THIS MAY BE ISOLATED TO THIS PARTICULAR LOT (PHOTO BELOW). ADDITIONAL INFORMATION: SOME MDS REPEATED A SPINAL, AND OTHERS PROVIDED GENERAL ANESTHESIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19482865 ↗MalfunctionApr 29, 2024Lack of Effect; Lack of Effect
MATERIAL # 405671, LOT # 0001523530. IT WAS REPORTED BY CUSTOMER THAT THEY HAVE EXPERIENCED 2 EPISODES WHERE THE ANESTHESIA WAS INEFFECTIVE. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. PRODUCTCOMPLAINT - CUSTOMER CALLED TO REPORT THAT THE DOCTOR ADVISED THEY HAVE EXPERIENCED 2 EPISODES WHERE THE ANESTHESIA WAS INEFFECTIVE. 405671 LOT 0001523530 NO HARM TO THE PT, HAD TO GIVE ADDITIONAL MEDICATION TO COMPLETE PROCEDURE. SAMPLES AVAILABLE - 2 UNUSED PRODUCTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19200967 ↗InjuryFeb 21, 2024Lack of Effect; Lack of Effect
MATERIAL#: 405671 LOT#: 0001536091, 0001537529 IT WAS REPORTED BY THE CUSTOMER REPORTED I AM WRITING REGARDING SPINAL TRAYS HAVING MEDICATION NOT WORKING DURING PROCEDURES. PATIENT IS FEELING PAIN. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. I AM WRITING REGARDING SPINAL TRAYS HAVING MEDICATION NOT WORKING DURING PROCEDURES. PATIENT IS FEELING PAIN. ITEM# 405671 ((B)(4)) LOT# 0001536091 LOT# 0001537529
Patient problems: Pain
MAUDE report 18751785 ↗InjuryFeb 21, 2024Lack of Effect; Lack of Effect
MATERIAL#: (B)(4) LOT#: 0001536091, 0001537529 IT WAS REPORTED BY THE CUSTOMER REPORTED I AM WRITING REGARDING SPINAL TRAYS HAVING MEDICATION NOT WORKING DURING PROCEDURES. PATIENT IS FEELING PAIN. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. I AM WRITING REGARDING SPINAL TRAYS HAVING MEDICATION NOT WORKING DURING PROCEDURES. PATIENT IS FEELING PAIN. ITEM# 405671 (BF405671) LOT# 0001536091 LOT# 0001537529.
Patient problems: Pain
MAUDE report 18751784 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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