BD Allergy SyringeRecalls & reported problems across all models
Becton, Dickinson And Company · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 99
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 6 models of BD Allergy Syringe by Becton, Dickinson And Company in the FDA's device registry (GUDID). Together they are named in 99 adverse event reports in the FDA's MAUDE database, received between Oct 17, 2017 and Feb 27, 2026 — classified as 1 injury, 98 malfunctions.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (11 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
Most reported BD Allergy Syringe problems
Device problems
- Device Markings/Labelling Problem11
- Leak/Splash11
- Break10
- Delivered as Unsterile Product10
- Device Contamination with Chemical or Other Material10
- Material Protrusion/Extrusion7
- Defective Component6
- Physical Resistance/Sticking5
Patient problems
- No Clinical Signs, Symptoms or Conditions32
- No Known Impact Or Consequence To Patient32
- Needle Stick/Puncture14
- Pain9
- No Patient Involvement6
- No Consequences Or Impact To Patient3
- Insufficient Information2
- No Information1
BD Allergy Syringe models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BD Allergy Syringe 305540Syringe, piston47 reports
- BD Allergy Syringe 305500Syringe, piston19 reports
- BD Allergy Syringe 305541Syringe, piston14 reports
- BD™ Allergy Syringe 305536Syringe, piston12 reports
- BD™ Allergy Syringe 305539Syringe, piston4 reports
- BD Allergy Syringe 305537Syringe, piston3 reports
Recent BD Allergy Syringe adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2026Break
IT WAS REPORTED THAT BD SYRINGE ALLERGY 1ML W/NDL 27X1/2 RB NEEDLE PULLED OUT OF HUB. RCC RECEIVED A COMPLAINT VIA EMAIL. OUR CUSTOMER REPORTED AN ISSUE WITH ITEM 305540. PLEASE SEE BELOW IN RED AND ADVISE NEXT STEP. I WERE PREPPING INJECTIONS, ONE OF THE NEEDLES STAYED IN THE VIAL WHEN WITHDRAWING THE SYRINGE. PRODUCT ALLERGY SYRINGE TRAY 1ML 27GX1/2IN (305540). LOT: 5129219. EXP: 2030-05-31. IT WAS THE LAST IN THIS TRAY, WE DID NOT HAVE THIS ISSUE WITH ANY OF THE OTHERS. WE DO HAVE TRAYS WITH THE SAME LOT NUMBER. MCKESSON PO#: (B)(4). 1/30/2026: 1 SYRINGE FROM 1 UNIT UNNECESSARY TO SHIP BACK AT THIS TIME. IT WAS THE LAST OUT OF THE BOX AND THE REST OF THE PRODUCT WORKED CORRECTLY NO PATIENT HARM, COMPLICATIONS OR NEGATIVE OUTCOMES OCCURRED. THE NEEDLE DID PULL COMPLETELY OUT OF THE HUB. THERE WAS NO SPINNING AND THE CONNECTION DID NOT SEEM LOOSE WHEN FIRST INSERTED INTO THE VIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24474256 ↗MalfunctionJan 6, 2026Physical Resistance/Sticking
MalfunctionSep 10, 2025Material Perforation; Material Perforation
MalfunctionSep 10, 2025Material Perforation; Material Perforation
IT WAS REPORTED THAT THE BD SYRINGE ALLERGY 1ML W/NDL 27X1/2 RB NEEDLE WENT THROUGH THE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 305540 , BATCH # 5097095. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. I WASN'T SURE IF I LET YOU KNOW OR IF YOU KNOW WHO I REACHED OUT TO BUT I HAD AN INCIDENT IN THE PAST THAT HAS NOW HAPPENED AGAIN. IT MIGHT BE A DEFECT IN THE ORDER BUT I WANTED TO BRING IT TO SOMEONE ATTENTION SINCE IT'S THE SECOND TIME. ONE OF OUR NEEDLES WAS STICKING OUT OF THE TOP, I HAVE ATTACHED PICTURES FOR REFERENCE. I¿M NOT SURE IF THIS IS A BUSINESS UNIT THAT YOU CAN HELP WITH BUT I NEED SOMEONE TO GET IN TOUCH WITH REGARDING ISSUES MY CUSTOMER IS HAVING. THIS ISN¿T THE FIRST INCIDENT THEY¿VE EXPERIENCED WITH BROKEN NEEDLES FROM THE BD ALLERGY TRAYS. I¿VE INCLUDED THE PHOTOS THEY SENT ME. IF YOU¿RE ABLE TO HELP ME GET THEM WORKING PRODUCT THAT WOULD BE GREAT, OR GET ME IN CONTACT WITH WHO CAN HELP! THE CUSTOMER EXPERIENCED WITH BROKEN NEEDLES FROM THE BD ALLERGY TRAYS. ITEM# 305540. LOT# 5097095.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23020343 ↗MalfunctionAug 11, 2025Material Perforation; Material Perforation
IT WAS REPORTED THAT THE BD SYRINGE ALLERGY 1ML W/NDL 28X1/2 RB NEEDLE WENT THROUGH THE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 305500 BATCH # 0069100. IT WAS REPORTED BY THE CUSTOMER THAT PATIENT WAS STUCK BY THE NEEDLE WHILE PULLING IT OUT OF THE PACKAGE. THE NEEDLE WAS STICKING OUT OF THE GRAY COVER THAT'S SUPPOSED TO COVER THE NEEDLE. RCC RECEIVED A COMPLAINT VIA EMAIL. ITEM(S): 305500, LOT(S): 0069100D, DATE INCIDENT OCCURRED: (B)(6) 2025. WAS THE PATIENT IMPACTED? IF YES, DESCRIBE: YES, PATIENT WAS STUCK BY THE NEEDLE WHILE PULLING IT OUT OF THE PACKAGE. THE NEEDLE WAS STICKING OUT OF THE GRAY COVER THAT'S SUPPOSE TO COVER THE NEEDLE. IS A SAMPLE AVAILABLE? YES CUSTOMER REQUEST? CUSTOMER WOULD LIKE REPLACEMENT NEEDLE.
Patient problems: Needle Stick/Puncture
MAUDE report 22779052 ↗MalfunctionNov 24, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20767537 ↗MalfunctionNov 24, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
MalfunctionNov 19, 2024Packaging Problem; Packaging Problem
MalfunctionNov 5, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
MalfunctionOct 15, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING A CATHETER INTEGRITY CHECK, A DROP OF BLOOD AND DRUG SOLUTION MIXED TOGETHER WAS OBSERVED. THERE SEEMED TO BE A CRACK THROUGH WHICH A DRIP IS DETECTED: THE DRUG SOLUTION PASSES INTO THIS CRACK AND NOT INTO THE PATIENT¿S VEIN. THERE WAS PATIENT INVOLVEMENT, AND NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20453692 ↗MalfunctionJun 25, 2024Packaging Problem; Packaging Problem
MATERIAL# 305540 , BATCH# 2304613. IT WAS REPORTED THAT THE BD SYRINGE ALLERGY 1ML W/NDL 27X1/2 RB PACKAGING WAS DAMAGED/DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. WE RECEIVED A CUSTOMER COMPLAINT ON 23MAY24 FOR 46 TRAYS OF 1CC, 27G X ½, SYRINGES (ITEM# BD5540, LOT# 2304613), STATING ¿SYRINGES ARE MELTED TO PACKAGING¿. THE CUSTOMER RETURNED THE PRODUCT ON (B)(6) 2024. ONE BOX WITH 5 UNOPENED TRAYS AND ONE OPEN TRAY AND ONE CASE CONTAINING 40 UNOPENED TRAYS WERE RETURNED. PLEASE PROVIDE A PREPAID RETURN LABEL TO FORWARD THE REPORTED PRODUCT TO YOU. CAN YOU PLEASE INITIATE AN INVESTIGATION AND FORWARD YOUR FINDINGS TO ME. WE HAVE ASSIGNED COMPLAINT NUMBER (B)(4) TO THIS COMPLAINT. PLEASE REFERENCE THIS COMPLAINT NUMBER IN ALL FUTURE CORRESPONDENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19606041 ↗MalfunctionJul 24, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THE UNSPECIFIED ABOUT OF BD ALLERGY SYRINGE EXPERIENCED SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AS PER ACCOUNT, UNFORTUNATELY THERE IS AN ISSUE WITH THE SYRINGES. I HAVE FOUND MULTIPLE SYRINGES THAT DO NOT HAVE THE 1 MLS LINE (ONLY GOES UP TO 9 MLS). WE REQUIRE THIS 1 MLS LINE FOR OUR ALLERGY SHOTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17384420 ↗MalfunctionJul 13, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT 12 OF THE BD ALLERGY SYRINGES HAVE INCORRECT GRADUATION MARKS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: CALLER STATES THAT BEGINNING ON (B)(6) 2023, EVERY BOX OF SYRINGES THEY HAVE OPENED HAS CONTAINED 7-12 SYRINGES THAT BEAR INCORRECT GRADUATION. NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17322246 ↗MalfunctionJul 13, 2023Break; Break
IT WAS REPORTED WHILE USING BD® ALLERGY SYRINGE WITH PERMANENTLY ATTACHED NEEDLE THE PLUNGER ROD WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ARE YOU ABLE TO PROVIDE THE DATE OF EVENT IN FORMAT DD-MMM-YYYY? (B)(6) 2023. HOW MANY OCCURRENCES OF SYRINGE(S) AFFECTED? AT LEAST 3. WAS ISSUE BEING DESCRIBED NOTED BEFORE, OR DURING USED? DURING. ANY ADVERSE EVENTS OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? NO - ONLY WASTED EXTRACT. WAS THERE ANY PATIENT INVOLVEMENT? YES. WHAT WAS THE PATIENT OUTCOME? MEDICATION COULD NOT BE ADMINISTERED, NEEDED A SECOND INJECTION. WAS THERE ANY DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THIS EVENT? TEMPORARY DELAY. WHAT PROCEDURE WAS BEING PERFORMED? SUBCUTANEOUS ALLERGY INJECTION. WHAT MEDICATION WAS USED IN THE PROCEDURE? ALLERGY SERUM. IS SAMPLE AVAILABLE FOR RETURN TO BD FOR INVESTIGATION? NO. IF SAMPLE IS AVAILABLE TO BE RETURNED, DOES THE SAMPLE CONTAMINATED WITH BLOOD/BODY FLUID/HIV OR CHEMO? YES- BLOOD. WAS THERE ANY MEDICAL INTERVENTION DUE TO THIS EVENT? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17321719 ↗MalfunctionJun 28, 2023Break; Break
IT WAS REPORTED THAT 1 OF THE BD® ALLERGY SYRINGE WITH PERMANENTLY ATTACHED NEEDLE BASE WAS BROKEN. REPORT 2 OF 3. THE FOLLOWING WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: 1 WITH MALFORMED PLUNGER BASE ARE YOU ABLE TO IDENTIFY THE PROBLEM REGARDING TO THE ¿MALFORMED PLUNGER BASE¿? WAS IT STOPPER DEFECTIVE? THE STOPPER WAS FINE- IT WAS THE BASE OF THE ACTUAL SYRINGE THAT WAS BROKEN WAS THERE ANY PATIENT INVOLVEMENT? YES WHAT WAS THE PATIENT OUTCOME? NO REMARKABLE OUTCOME WAS THERE ANY DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THIS EVENT? NO WAS THERE ANY LEAKAGE FOR THE BREAKAGE ISSUE? NO ARE YOU ABLE TO PROVIDE THE INCIDENT DATE FOR ¿MALFORMED PLUNGER BASE¿ AND¿ BREAK WHILE ASPIRATING¿? THE BASE NO, I REMEMBER INJECTING A PATIENT AND IT CAUGHT ME OFF GUARD ONCE I HAD THE PROPER GRIP. THE BREAK WHILE ASPIRATING HAPPENED ON (B)(6) 2023.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17221853 ↗
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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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