BD Luer-Lok, BD GlaspakRecalls & reported problems across all models
Becton, Dickinson And Company · 16 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
8 open recalls name at least one BD Luer-Lok, BD Glaspak model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 141
- Deaths reported
- 0
- Injuries reported
- 52
- Recalls
- 8
We found 16 models of BD Luer-Lok, BD Glaspak by Becton, Dickinson And Company in the FDA's device registry (GUDID). Together they are named in 141 adverse event reports in the FDA's MAUDE database, received between Nov 27, 2017 and Sep 15, 2026 — classified as 52 injuries, 89 malfunctions.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (52 reports).
8 FDA recall records name at least one of these models by its device identifier, 8 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
BD Luer-Lok, BD Glaspak 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.
- Apr 27, 2026Open, 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-2257-2026 · Root cause: Nonconforming Material/Component · names 2 of these models · Recall details · FDA record ↗
- Apr 27, 2026Open, 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 ↗
- Apr 27, 2026Open, 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-2255-2026 · Root cause: Nonconforming Material/Component · names 4 of these models · Recall details · FDA record ↗
- Apr 27, 2026Open, 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-2253-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Apr 27, 2026Open, 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-2252-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Apr 27, 2026Open, 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-2251-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Apr 27, 2026Open, 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-2249-2026 · Root cause: Nonconforming Material/Component · names 2 of these models · Recall details · FDA record ↗
- Apr 27, 2026Open, 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-2248-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported BD Luer-Lok, BD Glaspak problems
Device problems
- Patient-Device Incompatibility52
- Lack of Effect36
- Break7
- Adverse Event Without Identified Device or Use Problem6
- Device Markings/Labelling Problem6
- Device Contamination with Chemical or Other Material5
- Leak/Splash5
- Therapeutic or Diagnostic Output Failure4
Patient problems
- No Clinical Signs, Symptoms or Conditions60
- No Known Impact Or Consequence To Patient29
- Awareness During Anesthesia12
- Insufficient Information10
- No Consequences Or Impact To Patient7
- Inadequate Pain Relief5
- Pain4
- Foreign Body In Patient3
BD Luer-Lok, BD Glaspak models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BD Luer-Lok, BD Glaspak 405671Anesthesia conduction kit1 recall68 reports
- BD Luer-Lok, BD Glaspak 405672Anesthesia conduction kit1 recall27 reports
- BD Luer-Lok, BD Glaspak 405673Anesthesia conduction kit1 recall10 reports
- BD Luer-Lok, BD Glaspak 405637Anesthesia conduction kit1 recall7 reports
- BD Luer-Lok, BD Glaspak 405707Anesthesia conduction kit1 recall4 reports
- BD Luer-Lok, BD Glaspak 405609Anesthesia conduction kit1 recall3 reports
- BD Luer-Lok, BD Glaspak 405735Anesthesia conduction kit1 recall3 reports
- BD Luer-Lok, BD Glaspak 405621Anesthesia conduction kit1 recall1 report
- BD Luer-Lok, BD Glaspak 405741Anesthesia conduction kit1 recall1 report
- BD Luer-Lok, BD Glaspak 405645Anesthesia conduction kit1 recall0 reports
- BD Luer-Lok, BD Glaspak 405652Anesthesia conduction kit1 recall0 reports
- BD Luer-Lok, BD Glaspak 405674Anesthesia conduction kit1 recall0 reports
- BD Luer-Lok, BD Glaspak 405709Anesthesia conduction kit1 recall0 reports
- BD Luer-Lok, BD Glaspak 405699Anesthesia conduction kit14 reports
- BD Luer-Lok, BD Glaspak 405651Anesthesia conduction kit2 reports
- BD Luer-Lok, BD Glaspak 405733Anesthesia conduction kit1 report
Recent BD Luer-Lok, BD Glaspak adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Lack of Effect
Patient problems: Awareness During Anesthesia
MAUDE report 50779016 ↗InjurySep 15, 2026Lack of Effect
It was reported, Spinal tray, failed spinal, reverted to general anesthesia. Patient 2 of 3.The following was provided by the initial reporter: I am reaching out as our OR team advised yesterday that they reported 4 failed spinals in the past couple days due to the marcaine in these 405672 trays not working. Trays were ordered under purchase order (b)(4) and LOT of the trays was reported to be B01W139D with the LOT of the faulty marcaine ((b)(6)) in those trays being LP8046. I did try to file a case on the Customer Care portal however that kept giving me an error when trying to submit without telling me what the error was. Please let us know if there is any other information needed in order to investigate this.Additional information:Can you please confirm an exact date of event in format dd-mmm-yyyy? 19-Aug-2026 and 18-Aug-2026.Can you please provide the Lot number associated with reported issue? Item 405672 has a LOT B01W139D, marcaine contained in the kit (Hospira (b)(6)) that was reported to have failed has a LOT LP8046.Any sample or photo available for investigation: No.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event: 4
Patient problems: Awareness During Anesthesia
MAUDE report 50779014 ↗InjurySep 15, 2026Lack of Effect
Patient problems: Awareness During Anesthesia
MAUDE report 50779009 ↗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 ↗InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DESCRIPTION: INEFFECTIVE ANESTHESIA, EPIDURAL PLACED. EVENT DETAILS: WE EXPERIENCED A TOTAL OF 5 FAILED SPINALS (4 WITHIN THE PAST WEEK, THE OTHER 1 EARLIER IN THE MONTH) AND ARE QUESTIONING THE EFFICACY OF THE INCLUDED MEDICATIONS AS THAT IS THE PRIMARY CONSISTENT FACTOR DURING THESE EVENTS THAT OCCURRED. WE ARE STILL CONFIRMING THE NUMBER OF REPORTS AND VERIFYING NONE OF THESE HAVE BEEN DUPLICATED, BUT THIS IS THE DETAIL WE HAVE RECEIVED SO FAR. NO SPECIFIC PATIENT HARM WAS REPORTED, ALTHOUGH CONVERSION TO GENERAL ANESTHESIA WAS REQUIRED SO THE ASSOCIATED ADDITIONAL RISKS THAT GO ALONG WITH ADDED PROCEDURE TIME, EXTENDED RECOVERY, ETC. ADDITIONAL INFORMATION: WE DO NOT KNOW WHICH TRAY WAS USED FOR WHICH CASE. WE KNOW OF 4 CASES IN TOTAL (B)(6) 2025. ONE OF THE CASES, THE MEDICATION DID NOT WORK AT ALL; THE OTHER 3, IT WORE OFF RAPIDLY. TWO CASES WERE ANECDOTALLY REPORTED AS ABOUT 20 MINUTES; THE OTHER CASE WAS NOT REPORTED (THE DURATION). TWO MOVED TO GENERAL ANESTHESIA, ONE TO AN EPIDURAL AND ONE WAS ABLE TO BE MANAGED WITH ADDITIONAL MEDICATION. AT THIS POINT, A 5TH CASE HAS NOT BEEN CONFIRMED. WE HAVE ONLY THE THREE TRAYS WE HAD PREVIOUSLY REPORTED. (B)(6) 2025 - RESOLVED WITH
Patient problems: Awareness During Anesthesia
MAUDE report 22555641 ↗InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DESCRIPTION: INEFFECTIVE ANESTHESIA, RESOLVED WITH ADDITIONAL MEDICATION. EVENT DETAILS: WE EXPERIENCED A TOTAL OF 5 FAILED SPINALS (4 WITHIN THE PAST WEEK, THE OTHER 1 EARLIER IN THE MONTH) AND ARE QUESTIONING THE EFFICACY OF THE INCLUDED MEDICATIONS AS THAT IS THE PRIMARY CONSISTENT FACTOR DURING THESE EVENTS THAT OCCURRED. WE ARE STILL CONFIRMING THE NUMBER OF REPORTS AND VERIFYING NONE OF THESE HAVE BEEN DUPLICATED, BUT THIS IS THE DETAIL WE HAVE RECEIVED SO FAR. NO SPECIFIC PATIENT HARM WAS REPORTED, ALTHOUGH CONVERSION TO GENERAL ANESTHESIA WAS REQUIRED SO THE ASSOCIATED ADDITIONAL RISKS THAT GO ALONG WITH ADDED PROCEDURE TIME, EXTENDED RECOVERY, ETC. ADDITIONAL INFORMATION: WE DO NOT KNOW WHICH TRAY WAS USED FOR WHICH CASE. WE KNOW OF 4 CASES IN TOTAL ON (B)(6) 2025. ONE OF THE CASES THE MEDICATION DID NOT WORK AT ALL THE OTHER 3 IT WORE OFF RAPIDLY. TWO CASES WERE ANECDOTALLY REPORTED AS ABOUT 20 MINUTES; THE OTHER CASE WAS NOT REPORTED THE DURATION. TWO MOVED TO GENERAL ANESTHESIA, ONE TO AN EPIDURAL AND ONE WAS ABLE TO BE MANAGED WITH ADDITIONAL MEDICATION. AT THIS POINT A 5TH CASE HAS NOT BEEN CONFIRMED. WE HAVE ONLY THE THREE TRAYS WE HAD PREVIOUSLY REPORTED. ON (B)(6)
Patient problems: Awareness During Anesthesia
MAUDE report 22555628 ↗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 ↗MalfunctionApr 2, 2025Break; Break
MalfunctionJan 1, 2025Lack of Effect; Lack of Effect
MATERIAL# 405735, BATCH# 0001547937. VERBATIM: PT WAS AN UNSCHEDULED CESAREAN SECTION FOR HELLP AT 25.2 WEEKS GESTATION. SPINAL WAS PLACED BY DR; PATIENT DID NOT GET NUMB. DR. STATED IT IS THE MEDICATION IN THE SPINAL TRAYS AND TO FIND ANOTHER LOT NUMBER. ANOTHER TRAY BY A DIFFERENT MANUFACTURER WAS FOUND AND THE SPINAL WAS EFFECTIVE. THE PATIENT HAD TO BE POKED TWICE DUE TO THE DEFECTIVE SPINAL TRAY. A GENERAL ON A 25.2 WEEK FETUS WOULD HAVE FURTHER COMPROMISED THE FETUS. THIS ALSO CAUSED A DELAY OF CARE AS THE PATIENT HAD A SECOND SPINAL PLACED AND HAD TO BE PREPPED AGAIN. ALSO NOTE THAT THE NICU TEAM HAD TO BE OFF THEIR UNIT FOR LONGER THAN EXPECTED DUE TO THE DELAY OF CARE. THE DEFECTIVE SPINAL TRAYS LOT # IS 0001547937. EVENT DATE: 12/23/2024 DESCRIPTION: TRAY SPINAL ANESTH 25G 3.5IN QNKE L/E/P SAMPLE AVAILABLE: YES (IF SAMPLE IS AVAILABLE AND WOULD LIKE IT SENT FOR YOUR EVALUATION, PLEASE REPLY ALL, AND ATTACH A RETURN SHIPPING LABEL VIA EMAIL) LOT #: 0001547937. WAS THERE INJURY? CAUSED THE PATIENT TO HAVE MULTIPLE STICKS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21052138 ↗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 ↗
Other Becton, Dickinson And Company products
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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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