BD Allergy Syringe 305540Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00382903055401), received between May 1, 2018 and Feb 27, 2026 — classified as 47 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (7 reports).

10 other recalls cover devices cleared under the same FDA submission (K110771); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 47 reports, 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

  SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23978417 ↗
• MalfunctionSep 10, 2025Material Perforation; Material Perforation

  PHOTOS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23020350 ↗
• 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 ↗
• MalfunctionNov 24, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IMDRF CODES MUST BE UPDATED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 20767381 ↗
• MalfunctionNov 19, 2024Packaging Problem; Packaging Problem

  SAMPLE RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20717739 ↗
• 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 ↗
• MalfunctionJun 28, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT 5 THE BD® ALLERGY SYRINGE WITH PERMANENTLY ATTACHED NEEDLE HAD SCALE MARKING ISSUES, PRINT WAS LIGHT AND MISALIGNED. REPORT 1 OF 3. THE FOLLOWING WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: MISPRINT ON THE SYRINGE. WE'VE HAD AT LEAST 5 WITH PRINTING ERRORS. DO YOU MEAN BY SCALE MARKING ISSUE FOR THE ¿MISPRINT ON THE SYRINGE? YES- SOME HAVE EXTRA INK ON THE BASE, SOME ARE BLURRY, ONE WAS SKEWED. WAS ISSUE BEING DESCRIBED NOTED BEFORE, OR DURING USED? MISPRINT BEFORE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17221665 ↗
• MalfunctionJun 28, 2023Break; Break

  IT WAS REPORTED THAT 3 OF THE BD® ALLERGY SYRINGE WITH PERMANENTLY ATTACHED NEEDLE BROKE DURING USE. REPORT 3 OF 3 THE FOLLOWING WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: THE PLUNGER WAS FINE INITIALLY, BARREL FINE; THE PLUNGER DID NOT WITHSTAND THE ASPIRATION AND BROKE WHILE PULLING BACK HOW MANY OCCURRENCES OF SYRINGE(S) AFFECTED? 3 THAT BREAK WHILE ASPIRATING WAS ISSUE BEING DESCRIBED NOTED BEFORE, OR DURING USED? BREAKS DURING USE WAS THERE ANY PATIENT INVOLVEMENT? YES WHAT WAS THE PATIENT OUTCOME? NO REMARKABLE OUTCOME 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 17221663 ↗
• MalfunctionJun 27, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED WHILE USING BD ALLERGY SYRINGE TRAY WITH BD PRECISIONGLIDE¿ PERMANENTLY ATTACHED NEEDLE THERE WERE SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM THE LAST BATCH OF ALLERGY SYRINGES WE PURCHASED SEEM TO HAVE SOME ISSUES. THERE ARE RANDOMLY SYRINGES THAT ARE MISSING NUMBERS. ANYWHERE FROM 0.4 AND UP COULD BE MISSING. SEE ONE PHOTO EXAMPLE BELOW. THIS IS BECOMING AN ISSUE AS WE CAN NOT TELL AHEAD OF TIME AS TO WHICH TRAYS CONTAIN ¿DEFECTIVE¿ SYRINGES AS THEY ARE SEALED WHEN WE SEND THEM HOME WITH CLIENTS. THESE ARE THE BD SYRINGES WE BUY BY THE CASE ( 40 TRAYS PER CASE WITH 25 SYRINGES PER TRAY ) THIS BATCH IS LOT # 2283768 WITH AN EXPIRATION OF 10/31/2027 I WOULD THINK BD WOULD WANT TO KNOW ABOUT THIS, AND I¿M HOPING THEY WOULD OFFER SOME SORT OF REPLACEMENT. WE ARE HAPPY TO RETURN THE REMAINING IN STOCK SYRINGES SO THEY CAN CHECK THEM. WE HAVE NO WAY OF KNOWING HOW MANY OF THE REMAINING TRAYS HAVE SYRINGE ISSUES WITHOUT FIRST OPENING THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17213564 ↗
• MalfunctionJun 19, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED WHILE USING BD ALLERGY SYRINGE TRAY WITH BD PRECISIONGLIDE¿ PERMANENTLY ATTACHED NEEDLE THERE WERE SCALE MARKING ISSUES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED A QUALITY COMPLAINT ON PRODUCT SOLD TO OUR CUSTOMER. ITEM: 305540 QUANTITY AFFECTED: 2 CS SERIAL/LOT NUMBER: (B)(6) PO : 4516148201 REPORTED ISSUE: THESE ARE 1 ML SYRINGES. A LOT OF THE SYRINGES ONLY GO UP TO 0.9 VOLUME. THE LAST .10 OF VOLUME IS MISSING. I HAVE OPENED MULTIPLE PACKAGES, AND IN EACH BOX OF 25, AT LEAST 6-7 ARE NOT LABELED CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17159563 ↗
• MalfunctionMar 2, 2023Missing Information; Missing Information

  IT WAS REPORTED THAT 20 - 30 BD ALLERGY SYRINGE TRAYS WITH BD PRECISIONGLIDE¿ PERMANENTLY ATTACHED NEEDLE HAD NO EXPIRATION DATES ON THEIR LABELS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER CALLED AND STATED THAT THERE ARE NO EXPIRATION DATES ON ALLERGY SYRINGE TRAYS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16475896 ↗
• MalfunctionMar 1, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO USE WITH A BD¿ ALLERGY SYRINGE WITH PERMANENTLY ATTACHED NEEDLE 27 G X 1/2 IN., 1 ML, FOREIGN MATTER WAS FOUND ON THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS SOME LINT ON THE NEEDLES COMING OUT OF A FRESH NEW TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13636933 ↗
• MalfunctionJan 31, 2022Leak/Splash; Fitting Problem; Leak/Splash; Fitting Problem

  IT WAS REPORTED THAT THE BD ALLERGY SYRINGE TRAY WITH BD PRECISIONGLIDE¿ PERMANENTLY ATTACHED NEEDLE HAD A LOOSE PLUNGER THAT CAUSED MEDICATION TO LEAK OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED LOOSE PLUNGERS THAT DO NOT CREATE A SEAL AND ALLOW MEDICATION TO LEAK OUT OF SYRINGE BARREL. CONSUMER STATED SHE HAS BEEN USING THIS ITEM FOR OVER 10 YEARS AND NEVER HAD A PROBLEM PREVIOUSLY. CONSUMER STATED SHE USES SYRINGES TO INJECT VITAMIN B12. CONSUMER STATED SHE HAS 3 ALLERGY SYRINGE TRAYS ALL WITH THE SAME LOT # BUT HAS ONLY OPENED & EXPERIENCED PROBLEMS WITH ONE TRAY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13391849 ↗
• MalfunctionMay 5, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT SYRINGE ALLERGY 1ML W/NDL 27X1/2 RB NEEDLE WAS STICKING OUTSIDE THE PACKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305540 BATCH NO: 7116549, 7116548. IT WAS REPORTED THE NEEDLE WAS BENT OUTSIDE OF THE CAP / NEEDLE STICKING OUTSIDE THE PACKAGE. VERBATIM: PER UPDATE FROM THE CUSTOMER ON 04/09/2021. ON 3/31/21 OUR MEDICAL ASSISTANT SUSTAINED A CLEAN NEEDLE STICK INJURY WHILE TRYING TO REMOVE THE NEEDLE CAP, AFTER TAKING IT OUT OF THE PACKAGE TRAY. THE NEEDLE WAS BENT AT ~160 DEGREE ANGLE AND STICKING THROUGH THE CAP AND SHE DID NOT SEE THIS UNTIL THE NEEDLE PUNCTURED HER SKIN.

  Patient problems: Needle Stick/Puncture

  MAUDE report 11776754 ↗
• MalfunctionJan 14, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THERE WAS NO EXPIRATION DATE ON THE BD ALLERGY SYRINGE TRAY WITH BD PRECISIONGLIDE¿ PERMANENTLY ATTACHED NEEDLE PACKAGE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHARMACIST REPORTED ITEM # 305540 LOT # 6062968 NO EXPIRATION DATES ON PACKAGES".

  Patient problems: No Patient Involvement

  MAUDE report 11175111 ↗
• MalfunctionAug 24, 2020Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT SCALE MARKINGS WERE DISCOVERED TO BE MISSING PRIOR TO USE WITH A BD SYRINGE ALLERGY 1ML W/NDL 27X1/2 RB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE WAS ONE CASE OF SYRINGES THAT WERE LABELED INCORRECTLY. PICTURES RECEIVED SHOW THAT THE SCALE MARKINGS ARE MISSING.

  Patient problems: No Patient Involvement

  MAUDE report 10446153 ↗
• MalfunctionAug 20, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT SYRINGE ALLERGY 1ML W/NDL 27X1/2 RB CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE CUSTOMER FOUND 1 SYRINGE WITH A FOREIGN MATTER WRAPPED AROUND THE NEEDLE VERBATIM: CONSUMER REPORTED FOUND 1 SYRINGE WITH A FOREIGN MATTER WRAPPED AROUND THE NEEDLE LOT #: 9064872; CATALOG#: 305540; DATE OF EVENT: (B)(6) 2020. SAMPLES STATUS AWAITING SAMPLE. THIS CALLER CAME INTO BD COM TODAY (B)(6) 2020 VIA TRANSFER FROM BD PRODUCT COMPLAINTS. BD PRODUCT COMPLAINTS ALSO RECEIVED AN EMAIL WITH PHOTOS ON (B)(6) 2020. SENDING MAILING KIT TO CONSUMER AND REPLACEMENTS TO VET. I HAVE BEEN GIVING MY DOG ALLERGEN IMMUNOTHERAPY INJECTIONS FOR THE PAST SIX (6) YEARS. I¿VE ALWAYS USED BD ALLERGY SYRINGES WITH GREAT SATISFACTION. HOWEVER, THIS WEEK I REMOVED A NEW SYRINGE FROM THE TRAY, REMOVED THE CAP AND WAS ABOUT TO INSERT IT INTO THE ALLERGEN VIAL WHEN I NOTICED SOMETHING ON THE NEEDLE DID NOT LOOK RIGHT. UPON CLOSER EXAMINATION UNDER A MAGNIFYING GLASS IT WAS EVIDENT THERE WAS SOMETHING ON THE SHAFT OF THE NEEDLE. OF COURSE I WAS VERY UPSET, FOR IF THE SYRINGE WOULD HAVE BEEN ROTATED 180 DEGREES I WOULD HAVE NEVER SEE

  Patient problems: No Patient Involvement

  MAUDE report 10429398 ↗
• MalfunctionJul 23, 2020Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT SYRINGE ALLERGY 1ML W/NDL 27X1/2 RB WAS MISSING SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT SOME GRADUATION MARKINGS WERE MISSING FROM THE SYRINGE. EVENT DESCRIPTION: ITEM: 305540 QUANTITY AFFECTED: 1 CASE SERIAL/LOT NUMBER: NA ARE ANY SAMPLES AVAILABLE FOR RETURN? NO REPORTED ISSUE: SYRINGES DID NOT HAVE ALL THE GRADUATED MARKS"

  Patient problems: No Patient Involvement

  MAUDE report 10312194 ↗
• MalfunctionMay 15, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT 7 SYRINGES ALLERGY 1ML W/NDL 27X1/2 RB EXPERIENCED NEEDLE PENETRATION THROUGH THE SHIELD PRIOR TO USE. THE PRODUCT DEFECT RESULTED IN 7 DIFFERENT CLEAN NEEDLESTICK INJURIES TO NURSES, BUT NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A USER FACILITY RECEIVED A COMPLAINT FOR SEVEN BD SYRINGES, 1CC 27 X ½ (ITEM# BD5540 LOT# 7226827). CUSTOMER STATES THE NEEDLES ARE MESSED UP ON THESE SYRINGES. THE CUSTOMER IS NOT RETURNING THE PRODUCT HOWEVER THEY DID PROVIDE FOUR PHOTOS. NEEDLE STICK INJURIES DID OCCUR. IN FACT, THAT IS THE WAY WE STARTED REALIZING THAT THE NEEDLES WERE BENT AND STICKING OUT OF THE SYRINGES AT AN AWKWARD ANGLE. SINCE WE WERE NOT AWARE OF THIS IN THE BEGINNING, AS WE PUT OUR HANDS INTO THE BOXES TO TAKE OUT NEW SYRINGES, THE NURSES WOULD GET PRICKED BY THE NEEDLE. THIS IS BEFORE WE HAVE EVEN TAKEN THE CAPS OFF, IT IS VERY OBVIOUS THAT THE CAPS CANNOT EVEN BE TAKEN OFF DUE TO THE ANGLE OF THE BENT NEEDLE. NO PATIENTS HAVE HAD ANY NEEDLE STICK INJURIES. THREE NURSES RECEIVED MULTIPLE NEEDLE STICK INJURIES BEFORE WE REALIZED THIS WAS HAPPENING. WE ARE NOW HAVING TO OPEN EACH CONTAIN

  Patient problems: Needle Stick/Puncture

  MAUDE report 10063681 ↗
• MalfunctionFeb 25, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO USE THE NEEDLES WERE DISCOVERED TO HAVE FOREIGN MATTER ON TIP WITH A BD SYRINGE ALLERGY 1ML W/NDL 27X1/2 RB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT NUMEROUS NEEDLES WERE FOUND TO HAVE A PLASTIC PIECE ON THE END OF THE NEEDLES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9751123 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110771. One submission often covers many models, so check the product and lot details in each record.

• Z-2614-2026 · Apr 28, 2026 · Open, Classified
  SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston
• Z-2751-2017 · Sep 16, 2016 · Terminated
  BD 3ml Syringe Luer-Lok" Tip Catalog 309657 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
• Z-2750-2017 · Sep 16, 2016 · Terminated
  BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #309580 The BD Single Use, Hypodermic Syringe is intended for use by health care prof
• Z-2749-2017 · Sep 16, 2016 · Terminated
  BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 23G x 1 (0.6mm x 25mm) Catalog #309571 The BD Single Use, Hypodermic Syringe is intended for use by health care professi
• Z-2753-2017 · Sep 16, 2016 · Terminated
  BD 3ml Syringer Luer-Lok Tip Catalog #309604 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
• Z-2747-2017 · Sep 16, 2016 · Terminated
  BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #305062
• Z-2752-2017 · Sep 16, 2016 · Terminated
  BD 10mL Syringe Luer-Lok Tip Catalog number 301997 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injec
• Z-1936-2016 · Mar 25, 2016 · Terminated
  Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection
• Z-1937-2016 · Mar 25, 2016 · Terminated
  Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection
• Z-1055-2015 · Dec 19, 2014 · Terminated
  BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection ; Catalog #303348, BD 10 mL Syringe Luer-Lok Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 4