BD Allergy Syringe 305500Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00382903055005), received between Oct 17, 2017 and Aug 11, 2025 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (4 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionJan 6, 2023Contamination; Contamination

  IT WAS REPORTED WHILE USING BD ALLERGY SYRINGE WITH PERMANENTLY ATTACHED NEEDLE FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN I REMOVED THE COVER FROM THE NEEDLE THERE WERE 2 OR 3 WHITE FLAKES OF SOMETHING ON THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16117200 ↗
• MalfunctionOct 6, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED WHILE USING BD ALLERGY SYRINGE WITH PERMANENTLY ATTACHED NEEDLE THE PLUNGER MOVEMENT WAS DIFFICULT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED PLUNGER WOULD NOT MOVE WHEN TRYING TO TAKE HER INJECTION DATE OF EVENT: (B)(6) 2022 SAMPLES: YES CL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15557177 ↗
• MalfunctionOct 6, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED WHILE USING BD ALLERGY SYRINGE WITH PERMANENTLY ATTACHED NEEDLE THE PLUNGER MOVEMENT WAS DIFFICULT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED PLUNGER WOULD NOT MOVE WHEN TRYING TO TAKE HER INJECTION. DATE OF EVENT: (B)(6). SAMPLES: YES CL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15556967 ↗
• MalfunctionOct 6, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED WHILE USING BD ALLERGY SYRINGE WITH PERMANENTLY ATTACHED NEEDLE THE PLUNGER MOVEMENT WAS DIFFICULT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED PLUNGER WOULD NOT MOVE WHEN TRYING TO TAKE HER INJECTION. DATE OF EVENT: (B)(6)2022. SAMPLES: YES CL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15556798 ↗
• MalfunctionMar 9, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED WHILE USING BD ALLERGY SYRINGE WITH PERMANENTLY ATTACHED NEEDLE THE STERILITY WAS COMPROMISED BEFORE USE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATED THAT THERE WAS A SINGLE SYRINGE IN HIS PACK OF 10 THAT DID NOT HAVE A CAP ON IT.

  Patient problems: Needle Stick/Puncture

  MAUDE report 13709998 ↗
• MalfunctionFeb 4, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT BD PRECISIONGLIDE¿ ALLERGY SYRINGE HAD THE NEEDLE POINT PENETRATE THE SAFETY SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " CONSUMER REPORTED NEEDLE THROUGH SHIELD. "

  Patient problems: Needle Stick/Puncture

  MAUDE report 13459245 ↗
• MalfunctionNov 16, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ ALLERGY SYRINGE HAD A NEEDLE THAT HAD PENETRATED THE SHIELD. STAFF MEMBER OBTAINED CLEAN NEEDLE STICK INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT IT WAS REPORTED THAT "THE NEEDLE WAS STICKING THROUGH THE CAP AND STUCK A STAFF MEMBER."

  Patient problems: Needle Stick/Puncture

  MAUDE report 12823487 ↗
• MalfunctionSep 23, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED SYRINGE ALLERGY 1ML W/NDL 28X1/2 RB HAD A NEEDLE SEPARATION ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BD ALLERGY SYRINGES... NEEDLE SEPARATED FROM THE SYRINGE, CAUSING HIM TO LOSE THE MEDICATION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12523088 ↗
• MalfunctionNov 12, 2020Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT 5 SYRINGE ALLERGY 1ML W/NDL 28X1/2 RB EXPERIENCED DEVICE DAMAGE/DEFORMATION WHILE STILL CONSIDERED OEPRABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305500, BATCH NO: UNKNOWN. I NEED TO REPORT A DAMAGED & REFUSED RECEIPT. BD ALLERGY SYRINGE 28G 1/2" 100 305500 UPC: 38290550003. ORDERED 15, RECEIVED 15, DAMAGED & REFUSED 5.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10832474 ↗
• MalfunctionJun 29, 2020Leak/Splash; Failure to Deliver; Leak/Splash; Failure to Deliver

  IT WAS REPORTED THAT SYRINGE ALLERGY 1ML W/NDL 28X1/2 RB PLUNGER WOULD NOT MOVE WHILE DRAWING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305500, BATCH NO: 730251. IT WAS REPORTED THAT PLUNGERS WOULD NOT MOVE WHILE DRAWING AND OTHERS HAVE BLUNT NEEDLES.

  Patient problems: No Patient Involvement

  MAUDE report 10209600 ↗
• MalfunctionMay 8, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT MANY SYRINGE ALLERGY 1ML W/NDL 28X1/2 RB BOXES WERE MISSING AN EXPIRATION DATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHARMACIST REPORTED MANY ITEM #S AND LOT #S. THE BOXES ARE MISSING EXP DATES. CATALOG # 305500 ONE BOX WITH LOT # 7037942."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10040332 ↗
• MalfunctionMar 2, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE 1.0CC S/C 28G X 1/2" B-D ALLERGY SYRINGE EXPERIENCED A BREACH IN STERILITY, (PRODUCT NOT STERILE). THE PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305500 BATCH NO: 8099970. VERBATIM: ISSUE(S): FOUND 1 SYRINGE NEEDLE POKED THRU SHIELD - NO INJURY TO THIS CONSUMER/USER LOT #: 8099970 CATALOG#: 305500 DATE OF EVENT: UNKNOWN SAMPLES AVAILABLE NO DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9775398 ↗
• MalfunctionFeb 17, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE ALLERGY SYRINGE WITH BD PRECISIONGLIDE¿ PERMANENTLY ATTACHED NEEDLE WAS FOUND UNSHEATHED IN THE SEALED PACKAGING BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHARMACIST REPORTED THAT THE NEEDLE OF ONE SYRINGE WAS UNSHIELDED INSIDE OF THE SEALED BAG. THE NEEDLE CAME THROUGH THE BAG AND STUCK THE TECH ON THE FINGER WHILE HANDLING THE BAG. THE TECH WAS PREPARING TO SELL THE SYRINGES TO A CONSUMER. NO MEDICAL ATTENTION NEEDED, NO INJURY."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9718047 ↗
• MalfunctionMay 31, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT BD PRECISIONGLIDE¿ SYRINGE ALLERGY 1 ML W/ NEEDLE 28X1/2 RB PENETRATED THROUGH SHIELD AND CAUSED A NEEDLE STICK INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305500. BATCH NO: UNKNOWN. IT WAS REPORTED THAT THE SYRINGE NEEDLE STUCK HER FINGER AS SHE WAS PREPARING FOR HER INJECTION SHE IS CONCERNED THAT THE NEEDLE MAY CAUSE AN INFECTION. VERBATIM: CONSUMER REPORTED THAT THE SYRINGE NEEDLE STUCK HER FINGER AS SHE WAS PREPARING FOR HER INJECTION. SHE STATED THAT SHE TOOK THE SYRINGE OUT OF THE BAG AND PUT IT ON THE COUNTER AND WHEN SHE PICKED IT UP SHE WAS STUCK WITH THE NEEDLE THAT WAS BENT THROUGH THE SHIELD. CONSUMER DID NOT SEEK MEDICAL ATTENTION BUT SHE IS CONCERNED THAT THE NEEDLE MAY CAUSE AN INFECTION. SHE WILL CONTACT US WITH ANY UPDATES IF SHE GOES TO THE DOCTOR. PROBLEM OCCURRED ON (B)(6) 2019, LOT # IS UNAVAILABLE, PRODUCT # 305500, NO EXP DATE. CONSUMER WILL SEND SAMPLE AND POLY BAG.

  Patient problems: Needle Stick/Puncture

  MAUDE report 8660565 ↗
• MalfunctionFeb 25, 2019Problem with Sterilization

  IT WAS REPORTED THAT THE SYRINGE ALLERGY 1ML W/NDL 28X1/2 RB EXPERIENCED A STERILITY BREACH WHEN THE SHIELD WAS MISSING AND STUCK AN EMPLOYEE WHEN HANDLING THE SEALED BAG CONTAINING THE DEVICE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 8368207 ↗
• MalfunctionAug 7, 2018Material Separation; Material Twisted/Bent

  IT WAS REPORTED THAT ALLERGY SYRINGE WITH BD PRECISIONGLIDE NEEDLE HAD A BURR, SEPARATED FROM THE SYRINGE, AND WAS BENT. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7757543 ↗
• MalfunctionMar 9, 2018Loose or Intermittent Connection

  IT WAS REPORTED BEFORE USE OF THE ALLERGY SYRINGE WITH BD PRECISIONGLIDE¿ THE PHARMACIST REPORTED SYRINGE NEEDLE STUCK HER FINGER WHEN SHE GRABBED THE BAG TO GIVE TO A PATIENT. STATED THAT THE SYRINGE IS UNCAPPED AND SHIELD IS LOOSE INSIDE OF THE BOX.¿ THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: Needle Stick/Puncture

  MAUDE report 7329328 ↗
• MalfunctionOct 17, 2017Break

  IT WAS REPORTED THAT A 1 ML ALLERGY SYRINGE WITH 28 G X 1/2 IN. BD PRECISIONGLIDE¿ PERMANENTLY ATTACHED NEEDLE BROKE OFF IN THE VIAL WHILE DRAWING THE MEDICATION. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6956153 ↗

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-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-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-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-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